chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatal fevers; Septic shock; Product contamination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fatal fevers), SEPTIC SHOCK (Septic shock) and PRODUCT CONTAMINATION (Product contamination) in an elderly patient of an unknown 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) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fatal fevers) (seriousness criterion death), SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (Product contamination) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided.  104 Patients received the vaccine.  Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
About 4-5 hours after receiving vaccine: Severe Chills- Arms shaking, freezing, hands like ice, Temp 99.6; Tylenol, to bed sleep 4-5 hrs, Temp 100.??; sleep; awoke middle of night Temp 107.2, legs very warm to touch; into shower; Temp came down to 99.??; sleep, Temp OK. Later in day Temp 100.4.  Some muscle pain but not too bad.  Didn't feel good rest of day/night.  Next day felt OK.  All lasted about 36 hours.  After 1st vaccine, I felt somewhat same as above - except Temp 104 and lower; Very sever muscle pain initially- hard to get out of bed and walk. Started 4-5 hours after injection and lasted about 36 hours. severe chills but not freezing. Taste and smell were not affected either time.
On call to car, pt fainted. Quickly aroused but diaphoretic and pale. Laid back in seat. Given cool air and compress. Color improved. Responded appropriately to questions. Briefly nauseated. Vss throughout.  After about 20 minutes patient reported well enough to leave. Driven by girlfriend.
I had a slight fever, bad headache, fever/chills, BAD joint and bone pain.  Lasted until about 8 pm that night. Had to call in sick at work.   Alternated Tylenol every 4 hours and Advil every 6 hours on the dot.
Right deltoid-red looks like sunburn from elbow to shoulder, painful to touch.  Started next day after immunization.
3min p/vax pt fainted falling backwards, opened eyes w/in 10 sec;when stable walked to waiting area, sat in a chair & started to faint again;called amb pt taken to hosp
5 hours after shot, fever, chills, body aches, nausea. Continued for 40 hours afterwards.
Quarter size bump at injection site for approx one month, with redness and swelling. Got the flu the 2 days later for 10 days with symptoms of Fever of 102, chills, aches, headache, congestion, sore throat.
Extreme tiredness, nausea and vomiting atleast 3 times weely, getting colds atleast 2 times monthly. Brain fog and dizziness, heart palpitations. Went to the hospital for heart palpitations and nothing was done. Was told that vaccine won't cause effects like this, but I have been perfectly healthy up until I have had this vaccine.And NO I am not pregnant.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 8-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 04-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Patient verbalizes she became ill about 4-6 hours post vaccine @ 11:00 AM on 11-3-08. Symptoms:fever, body aches, nausea, vomiting.etc.
My left arm is getting numb and then gets normal and then gets numb again every hour Sometime every two hour and then half hour and then my left hand feels very cold specially my fingers and then I feel normal it?s a very strange feeling All night long on and off
patient stated extremely sore arm starting the night of 10/3/23, the day she received vaccination. Still hurting and difficult to lift arm 3 days later.
Paralysis of his upper and lower extremities. This occurred just a few hours after vaccination. MRI spine, CT head, and results of lumbar puncture were unremarkable. He was treated with IV and oral steroids and discharged to home on 9/17/17.
I got little fuzzy; I got fuzzy head; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Lot number: HC3180) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: my blood pressure medicine and my water pill which I take; "water pill" (unspecified if ongoing), notes: my blood pressure medicine and my water pill which I take. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose), for Covid -19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 12Aug2021, outcome "recovered" (12Aug2021), described as "I got little fuzzy; I got fuzzy head"; DIZZINESS (non-serious) with onset 12Aug2021, outcome "recovered" (Aug2021), described as "dizzy".  Additional information: The patient got fuzzy head, it was gone away, but wondering if the patient should take blood pressure medicine or water pill or not because it (Clarification unknown) made the patient kind of fuzzy.  Follow-up attempts are completed. No further information is expected.
Pericarditis chest tightness... Pain... Weird pulse rates. Cant lie flat when sleeping.
I received the ZOSTAVAX on April 18, 2008. Two months ago, I started feeling a burning sensation in the skin on the left side of my back. It progressed around to the front with needle- like stabbings into my side and left breast. It didn't go away, so I saw my internist who, after my describing my pain, prescribed NEURONTIN. It has helped greatly -after 2 weeks-. Is it possible I had the shingles without the rash?
2 days after injections, parent called pediatricians office with concerns about warmth, redness, pain, and swelling at the injection site. Pt came in for exam and was noted to have 7-8 cm diameter of erythema to right thigh. He  was diagnosed with cellulitis and given Keflex for 5 days
The night was annoying for him with the discomfort and had to endure this through the night; a little more reaction than normal as well; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night), IMMUNISATION REACTION (a little more reaction than normal as well) and INJECTION SITE PAIN (injection site pain) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Cardiovascular disorder. Previously administered products included for Product used for unknown indication: Flu shot (3 weeks ago) in October 2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Statin).    On 25-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night), IMMUNISATION REACTION (a little more reaction than normal as well) and INJECTION SITE PAIN (injection site pain). The patient was treated with PARACETAMOL (TYLENOL) in October 2023 for Pain, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night) and INJECTION SITE PAIN (injection site pain) was resolving and IMMUNISATION REACTION (a little more reaction than normal as well) outcome was unknown.            No concomitant medication was reported.
salivating around mouth became inconsolable, whimpering, seemed in discomfort, rx APAP x every 4hr devel high temp, pale, staring, not self, acting sick, seemed to be shaking a little;
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 39 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FFT8026), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient's current conditions included abnormal blood pressure and blood cholesterol. Patient was not allergic to any medication. On 06-OCT-2016 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # L044529, expiry date: 09-FEB-2017), once subcutaneously. Patient's concomitant medications included, unspecified blood pressure medicine and unspecified cholesterol medicine. The reporter stated that that patient immediately after vaccination experienced arm swelling and was painful. As of 2 days ago (on 16-OCT-2016), the welt-hard area continues on the left arm injection-site. The patient received treatment for the events. The pain went away the following day. The outcome of peripheral swelling is unknown. The outcome of injection site mass was reported as not recovered/not resolved. The reporter did not provided the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). No concomitant medication information was provided. The vial was initially stored in refrigerator on 07-Jun-2022. he vial did not undergo any temperature excursions. The patient was administered on any one of these dates (vaccine administration dates) of 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment information was provided.
Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swelling of right arm to hand, fluid in and around arm pit. Next day, fever 102.7 headache, joint pain, muscle pain, and arm still affected. Day 2, still fluid in arm pit area and headache.  Evening of day 2 ran fever of 102.6 with pain on right side of ne k and headache. Day 3 headache and fluid in and around arm pit has subsided a bit.
Pain on site of injection followed by redness. The site then developed a red circle that eventually went around the entire arm. Patient experienced these symptoms for 10 to 14 days. Patient started treating with BENADRYL upon pharmacist's recommendation and then followed with ibuprofen 400 mg daily for two days and intermittent ice on the site.
stiffness on right arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on right arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BROMELAINS (BROMELAIN), CALCIUM CITRATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DOXAZOSIN, BISACODYL (DULCOLAX [BISACODYL]), FLUTICASONE PROPIONATE (FLOVENT), FLUOROURACIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEUCOVORIN CALCIUM, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], OMEGA-3 FATTY ACIDS, OXALIPLATIN, POLICOSANOL, DABIGATRAN ETEXILATE MESILATE (PRADAXA), PROCHLORPERAZINE (COMPAZINE SPANSULE), TIOTROPIUM BROMIDE (SPIRIVA), CURCUMIN, VITAMIN C [ASCORBIC ACID] and VITAMIN D3 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on right arm). The patient was treated with CORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on right arm) outcome was unknown.            This case was linked to MOD-2021-222946 (Patient Link).
Dermatitis under breast left axilla and posterior left knee. Worse following vaccine. The follow up received on 5/27/03 states this vaccine was provided at a facility. I do not have access to that information.
I received my 1st of the 3 shot series for the HepB Vaccine on April 26th, 2004, in my right arm. I was told that my arm would feel some slight discomfort but would be fine in a couple days.  It most certainly was not.  I have been experiencing severe pain in my right arm where the shot was administered as well as pain up into my right shoulder.  I have limited mobility with that arm now and I no longer can lay on my right side when I sleep because of that pain.  Prior to receiving this shot, I NEVER had experienced any problems like this with my arm.  I did go ahead and get the 2nd shot on May 26th which increased the pain and symptoms in this arm.  I have tried confronting my provider but she dismisses my claim entirely WITHOUT doing any further testing or looking into the problems.  I most certainly would not have gotten the shots if I would have known this was a possible reaction.  I was only getting the shots in the first place to prepare for work in the medical field.  I am quite frustrated with the whole situation and I am quite certain I am not the first to have this problem.  I am very worried at this point that I am possibly going to be permanently affected in my right arm because of this shot.  In the next box, (#8) I have marked "None of the above." But as I said, I am worried that I am not going to get the use back in my arm. Thank you for listening.
Stomach starting hurting and then she passed out.  Checked her vitals. When she came to they got her up and gave her orange juice and crackers.  She then threw up.  Her eyes looked very glazed for a short time and she was very white and pale.  Put wet cloths on her head and checked her reflexes and eyes.  She got her coloring back and was fine.
Presented w/ cough, fever, sore throat, confusion, hypoxia. Tested covid+, pneumonia. Tx w/ Redesivir, O2, Dexamthasone
pt recvd flu vax 9OCT93 approx 24 hrs later pt devel fever & nausea; died in the ambulance on the way to the hosp;
Immunization was given 12 hours after the vial was punctured for the first and only time.
Information has been received from a pharmacist concerning a 66 year old patient of unknown gender with allergic reaction to ROCEPHIN and BIAXIN who on 03-MAR-2011 was vaccinated with 0.65ml ZOSTAVAX (Merck) in the right arm. The patient's relevant concomitant medications were unknown. On 03-MAR-2011, 10-15 minutes after receiving ZOSTAVAX (Merck), the patient experienced soreness, swelling and itching at the injection site. The affected area was about 4 inches by 2 inches. The patient had had no laboratory testing performed. As of 05-MAR-2011, it was unknown if the patient would continue ZOSTAVAX (Merck) and the events continued. This pharmacist advised that the patient use cold compresses, an antihistamine, and a pain reliever for events. Follow-up information has been received from the pharmacist concerning with female patient with no illness at the time of vaccination who on 03-MAR-2011 PM 5:15, was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z) in left arm (previously reported as "in right arm"). The pharmacist reported that on 03-MAR-2011 at 17:15 the patient experienced 5x2 inches redness raised and rash immediately after getting vaccination. On 21-MAR-2011, the patient had recovered. Follow-up information has been received from the pharmacist indicating that the patient experienced approximately 4x1 inches red area raised immediately. The patient had no shingles prevention. There were no diagnostic and laboratory tests performed. The adverse event lasted for 3 weeks. On 24-MAR-2011 (previously reported as "21-MAR-2011"), the patient had recovered. No further information is available.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 76-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, at the age of approximately 70-year-old, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (lot#, expiration date, dose, dose# and route not specified). On an unknown date, the patient was treated in a dermatology center for the following injuries resulting from the patient's ZOSTAVAX use: herpes zoster with ophthalmic complications. At the time of the report, the outcome of ophthalmic herpes zoster and herpes zoster was unknown. The reporter considered that herpes zoster and ophthalmic herpes zoster were related to ZOSTAVAX. Upon internal review, ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
elevated liver function tests; very high lymphocytes; nausea; vomiting; constitutionally ill; shaking chills; joint and muscle pain; headache; maintained her temperature at around 100.5-101.5; This is a spontaneous report from a contactable physician.    A 67-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 27Jan2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration (Batch/Lot Number was unknown) as single dose for covid-19 immunisation.It was Reported, Caller received the second Pfizer shot on 27JAN. A day after she experienced some nausea and vomiting which immediately resolved. Two days after, she was "very constitutionally ill" with shaking chills, joint and muscle pain, and headache centred behind the eye. This lasted severely for 12 days. She took 1 Advil or Tylenol every 6-8 hours and maintained her temperature at around 100.5-101.5. She consulted with her primary physician and she was given a number of tests. She came back with elevated liver function tests (6 times the upper limit) as well as very high lymphocytes. Her physician stated that it may be a reaction to the vaccine, and they are hoping that it will resolve within a month. The outcome of the events Nausea and vomiting on 28Jan2021 with outcome of recovered, constitutionally ill on Jan2021 with outcome of recovered, Rest all other events are on an unspecified date with outcome of unknown  Information about Lot/Batch requested  Follow-up attempts are completed. No further information is expected.
pt recv vax 2MAR98 & T99.1, rt arm swelled;it was red & swollen;tender 10-12cm;pt was checked by MD who advised DPH & ice pack;
10:10 AM rec'd flu vac 9/1/09. 4:00 pm LA aches, pain, 8:15 pm redness, fever 101 degrees. Pain up into neck. Pt. took TYLENOL 9/16/09 then again 9/17/09 AM. 9/17/09 saw Dr. - given ZYZAL x 3 days. RTC PRN.
He had a mild fever/sweat; He had a mild fever/sweat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat) in a 3-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Ear infection (Fighting an ear infection and on antibiotics).    On 21-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat). On 23-Jun-2022, HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications included unspecified antibiotics.  It was reported that, in the middle of night of 22-Jun-2022 (early hours of 23-Jun-2022), patient had mild fever and sweat. The fever and sweat did not last that long and patient woke up fine.  Patient was not sure if it was related to the vaccine or not.  Patient was simultaneously fighting an ear infection and on antibiotic, though there was no fever associated with the ear infection over the prior week.  No treatment medications were reported.