chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gigantic knot with bruising in a square around on the left arm; body was aching so bad; flu like symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN MASS (gigantic knot with bruising in a square around on the left arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (body was aching so bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B421A) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), HCTZ, AMLODIPINE, CLONAZEPAM (KLONOPIN), PRAVASTATIN, INSULIN DETEMIR (LEVEMIR) and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2010, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 22-Mar-2021, the patient experienced SKIN MASS (gigantic knot with bruising in a square around on the left arm) and MYALGIA (body was aching so bad). At the time of the report, SKIN MASS (gigantic knot with bruising in a square around on the left arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (body was aching so bad) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history reported.
25JUL94 rash; 20JUL94 from head to toe seen by ER MD 21JUL94; 26JUL94 MD ER repo showed react to HIB;
Myalgia, Arthralgia, FATIGUE Narrative:  Other Relevant History:
Sore arm. Sore shoulder. Can not lift her arm past her shoulder. Pain. Has a follow up with her PCP next week due to continued pain.
patient has a delayed 2nd dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received HAB (Twinrix adult) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix adult (1st dose administered in March 2023).   On 07-NOV-2023, the patient received the 2nd dose of Twinrix adult. On 07-NOV-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: patient has a delayed 2nd dose of Twinrix). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter was asking when the 3rd dose should be administered. The Pharmacist stated a patient has a delayed 2nd dose of Twinrix  administering today (on the day of reporting) after 1st dose administered which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Breakthrough case admission after three vaccines Moderna 2/26/21 Lot# 010A21A;  Moderna 0/26/21 Lot# 017B12A;  Moderna 11/12/21 Lot# 039F21A
On 11/3/2021 in the afternoon I began to experience significant fatigue.  On 11/4/2021, I have had malaise, myalgias, mild headache, nausea, skin sensitivity, feeling cold (but no fever or chills).  Symptoms are almost identical to those experienced the day after receiving my Moderna booster (10/23/2021)
he received series of vaccine and antibody testing negative; This is a spontaneous report from a contactable pharmacist (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on an unknown date at a single dose for COVID-19 immunisation. The relevant medical history was not reported. The concomitant medication included azathioprine sodium (IMURAN) and eculizumab (SOLIRIS). The patient underwent antibody testing which was negative on an unknown date. It was also reported that patient was asking for information on testing and those immunosuppressed (as reported) since patient was taking IMURAN and SOLIRIS. The outcome of the event was unknown.  Information on the lot/batch number has been requested
This spontaneous report as received from a health professional refers to a 3 year old patient. On 08-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 03-OCT-2015, dose and route not reported)   which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
7 days of explosive yellow/green diarrhea, over 6 times per day.
Nausea, Fever (100.9 is the highest), Chills, Injection site swelling and red to mid-arm level, headache.
urticaria onset 1 hr following vax inc severe over next 36 hrs despite DPH; t103; tx DPH, hydoxyzine; cortisone; MD to do measles titer in 6 wks;
Dose on 01Feb2021 at 11:25am.     feeling very tired on 01Feb2021 at 900pm.   Woke up on 02Feb2021 at 3:30am with chills, feeling hot, mild body aches, mild headache with 102 fever...took Tylenol and went back to sleep.  Woke up on 02Feb2021 at 9am with mild nausea, headache and feeling drained and tired.  No fever.   Spent all of 02Feb2021 feeling tired with slight nausea. No fever.  Took second dose of Tylenol at 3pm on 02Feb2021.  Went to bed that night and slept well.  Woke up on 03Feb2021 feeling fine with very mild sore arm.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant medication was not reported.  Patient received Moderna vaccine beyond the 30 day beyond use date. Beyond use date for lot was 01-Jul-2021 and patient received vaccine on 28-Jul-2021. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
The patient presented at the clinic on 12/19 with complaints of headache, nausea, neck ache, mild left arm numbness and fever.  Was diagnosed with a viral syndrome and sent home with symptomatic management.  She then presented to the ER on 12/20 with a left-sided hemiparesis and mental status changes.  She was admitted and started on antibiotics as well as acyclovir.  She was subsequently started on steroids after an MRI showed findings that suggested acute disseminated encephalomyelitis (ADEM).  During the course of the day on 12/20, the patient's status deteriorated as she developed unequal pupils and later required intubation for compromised respiratory status.  She then was put on an esmolol drip for tachycardia, but that was stopped when pt became hypotensive on the morning of 12/21.  She was then started on dopamine.  During this time course, her neurologic status also declined, and on the morning of 12/21, her pupils were fixed and dilated, and patient presented evidence of brain death with no spontaneous respirations and negative cold calorics. Brain death was pronounced on 12/22 after repeat evaluation, and life support was withdrawn. Medical Record received on 1/08/2004 states chills.
patient woke up on 11/11 ( day after vaccination) with paralysis and couldn't move,  began experiencing diarrhea and vomiting 11/11. 11/12 felt a little better. 11/15 she does not have full paralysis but does feel weak. She messaged her  Dr.  and her Dr. responded saying that she is doing better and if symptoms return to go to ER
Beginning later in the day, quickly developed fever of over 100.  Peaked at 102  about 22 hours after injection and finally fever went away after about 36 hours.  Then followed persistent headache and full body deep muscle soreness.
21JUL94 fever6 100-102 red 4-5" x 2-3" area on left deltoid; 22JUL94 nausea, cramps, fever ; 23JUL94 n/cramps, fever-phoned MD-ordered Copazine for nausea-only took 1; 25JUL94 to MD has kidney infect;
Sore red arm at injection site. 11/02/12 stated having nausea, chills, memory loss, headache and felt miserable.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 14:30 as dose 1, single (Lot number: EN6201), in right arm, on 01Mar2021 at 14:00 as dose 2, single (Lot number: EN6198), in right arm, on 07Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FK9896), in right arm and on 21Apr2022 at 10:45 as dose 4 (booster), single (Lot number: KPSSF) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive other medication in 2 weeks. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Aug2022) Negative, notes: on day 8 after the start date, I tested negative; (16Aug2022) Positive, notes: I tested positive and had some symptoms reappear. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took a treatment of Paxlovid and on day 8 after the start date, she tested negative. On day 10, she tested positive and had some symptoms reappear, particularly the sore throat and hoarseness.
Patient states within 24-48 hours she developed a fever, arm became very sore, facial cheeks turned red, sore throat, numbness in toes and other cold like symptoms. No medical treatment occurred.
Other side effects after vaccination; Sore arm after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination). At the time of the report, VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.
Received Vaccine at 1545 - Reported symptoms of throat thickening consistent with her previous anaphylaxis reactions at 1553.  STAT team initiated at 1553, VSS, Benadryl 25mg PO given.  Transferred to ED by Wheelchair - ED course treated with Pepcid 40mg, solumedrol 125mg  and epinephrine 0.3mg IV at 1604 and given 1L bolus of 0.9 NaCl. Patient observed in the ED until all s/sx resolved.  Discharged Home with 40mg Prednisone PO daily x4 days.   Pt only complaint throughout was throat "thickening".  No other s/sx per chart review.
6 hours after receiving Shingrix Dose 1, patient experienced myalgia bilaterally in the pelvic region. After consulting with her PCP 2 days later, he advised her to take Advil 400 mg TID. Patient reported it provides some relief, but still experiences limping and pain. She said the pain is now radiating down her legs and around her hips over 3 weeks later. Pharmacist recommended patient to follow up with PCP for a more thorough evaluation and potential prescriptions for a muscle relaxant or stronger analgesic.
Patient's arm was still swollen after 3 days.  She said it was about 5 inches in size and ached but is getting better by the day.  She has no other symptoms, just felt lethargic for the first 2 days.
Soreness in arm as expected. 3 hours of intense chills with headache followed by tossing and turning all night and still woosey until about noon on the 23rd.
On 11/9/00 at 00:15, dyspnea, color blue, R-40, T-99 (ax), BP 176/54, P-68, and expiratory wheezes throughout. O2 started on 2L/NC, SpO2 67% without O2. Tylenol given at 05:30. Pt restless. At 09:20 SpO2 88% without O2 on 4L. Resp 36 and moist rales. Transferred to medical center per ambulance. Of the 21 individuals receiving immunizations, Friday 11/3/00, only 2 on prednisone and had sudden respiratory distress on 11/9/00, 6 days, post vax.  Diagnosed with pneumonia
Sore arm; Loss of energy; She felt like she had to lay down and rest.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.). At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned by the reporter.   This case was linked to INC.-MOD-2021-291257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  INC.-MOD-2021-291257:Dose 2 case
Child had 102 fever 3/20/04 in pm (5:00) Mom treated with Tylenol, full body rash developed 3/22/04 AM. Mom treated with Benadryl. Mom states rash and fever have lessened since 3/22/04 when she called to report on 3/24/04.
On august 26 2008 exactly a week from the injection(8/19) of the MMR, patient's injections site started to get red and swollen then he started to run a slight fever of 100.5. Called physcians office they said just to keep and eye on him give plenty of liquids. By thursday August 28th his fever had went up to 102 and started breaking out in a rash. Spoke with doctors office that evening and Dr stated it was a reaction to the shot and just to keep and eye on him if he got worse to call but that high fever should only last 1-3 days.
Dizzy, disorientation, vertigo, nauseous, fever, chills, shooting pains in side of head and arm that got injected, numbness and tingling in left arm and fingers, elevated liver levels (220 normal went to 1147) cold sweats.  No treatment. Was referred to a cardiologist a neurologist a liver specialist Mri but everything comes up normal. I still struggle with the effects today but after all this time with no way to control it, I have had to learn to cope with it.
Information has been received from a physician and a health care worker concerning a 16 year old male patient who on 02-DEC-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot#661977/1275X). On 04-DEC-2008 the patient experienced cellulitis and was hospitalized. The patient's cellulitis persisted. Patient is still in the hospital as of 05-DEC-2008. It is unknown if the patient had a reaction to the first dose of VARIVAX (Oka/Merck). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Follow-up information was received from a healthcare worker who reported that the patient (weight: 204 pounds, Height 68 inches) with an allergy to penicillin/amoxicillin. The patient developed increase in redness, swelling and warmth at the injection site and was diagnosed with cellulitis on 04-DEC-2008. The patient was treated with cephalexin 500 mg every six hours per ten days with effect. However the patient went to the emergency room and was admitted for two days. The patient recovered on 14-DEC-2008. This is one of two reports received from the same source. No further information is available.
Office visit 12/6/05 - diagnosed with Chicken pox, confirmed with varicella culture. Received Varivax 4/5/01
Syncope without loss of consciousness. Lasted 25 minutes until back to baseline. Patient hit head against wall while fainting causing a superficial bruise without evidence of intracranial injury. Patient was tired, and somnolent but oriented to person, place, time and condition. All vitals were normal including HR and BP. A POCT glucose was normal. Patient was kept in a supine position until back to baseline and was able to walk out of the clinic unassisted.
pt recv vax 15OCT94 & on 16OCT94 pt exp fever of 102, muscle ache, low platelet count, sore throat & cervical adenopathy;pt stated that had an antigen count of 36,000;
Lung blood clot found after emergency room visit experiencing shortness of breath 03/04. Tennis ball size neck lymph node swelling starting 02/25. Joint pain and swelling starting 2/22
Pt had a fever of 104 F, 12 days post vax.  Taken to ER.
I received my 2nd dose of Moderna , which was still under EUA and MODERNA is the VACCINE I had injected. I have lost more than 1/2 of my range of motion in my right arm/shoulder ie: push-ups, weight lifting over head any  head range of motion,  so many range of motions are now difficult for my job due to this injection, and to the point writing is difficult as I AM A RIGHT handed dominant  I want answers as I can sue as Vaccination was not  FDA approved.
Moderate-severe low back pain, no precipitating trauma, no "reaching" or twisting or heavy lifting -- no instigating event. About 8 hours after flu shot. Generally very active, athletic, healthy retired medical doctor.
Perfuse vomiting and Diarrhea in PM following AM Anthrax and Smallpox Vaccination
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for the intended purpose of lifetime prevention from shingles and zoster related diseases. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 16-AUG-2016, the patient was diagnosed with shingles by a physician. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the lifetime prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
prediabetic; absolutely intense fatigue; Still a mess; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Still a mess), FATIGUE (absolutely intense fatigue) and GLUCOSE TOLERANCE IMPAIRED (prediabetic) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 16-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced CONFUSIONAL STATE (Still a mess). On 19-Oct-2021, the patient experienced FATIGUE (absolutely intense fatigue). On an unknown date, the patient experienced GLUCOSE TOLERANCE IMPAIRED (prediabetic). At the time of the report, CONFUSIONAL STATE (Still a mess) had not resolved and FATIGUE (absolutely intense fatigue) and GLUCOSE TOLERANCE IMPAIRED (prediabetic) outcome was unknown.            Concomitant medications were not provided. Treatment medications were not provided. Patient mentioned to discover to be prediabetic following the booster shot.
shortness of breath; Tightness in chest; Muscle soreness; Swollen joints; Swollen lymph nodes; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness), JOINT SWELLING (Swollen joints), LYMPHADENOPATHY (Swollen lymph nodes), NAUSEA (Nausea) and DYSPNOEA (shortness of breath) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis and Asthma. Concurrent medical conditions included Penicillin allergy.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (Muscle soreness), JOINT SWELLING (Swollen joints), LYMPHADENOPATHY (Swollen lymph nodes) and NAUSEA (Nausea). On 18-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST DISCOMFORT (Tightness in chest). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 19-Apr-2021, MYALGIA (Muscle soreness), JOINT SWELLING (Swollen joints) and NAUSEA (Nausea) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes), DYSPNOEA (shortness of breath) and CHEST DISCOMFORT (Tightness in chest) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Confirmed breakthrough case: COVID-19 Moderna; (1) 03/04/2021; hospital; batch/lot# 015M20A. COVID-19 Moderna (2) 04/01/2021; hospital; batch/lot# 002B21A.