chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Dec 22, 2021 (two weeks after Covid booster), I started with pain in my lower back (left side). Pain went along left hip, left pelvis, left thigh. Numbness, tingling in left hip, pelvis and left thigh. I do not feel my pelvis area (left ingle) and left thigh. Left thigh is sensitive to touch, even my clothes sometimes hurt me. Sometimes I feel like sharp objects or coldness.  Weakness in left thigh. Heavy sensation in my lower left back and left side of pelvis. Walking and sitting is painful. I have to be most of the time in bed.   Doctor prescribed Prednisone 20mg, during 9 days, Tylenol, Cyclobenzaprine, Oneoprazole.  After taking the medication, pain continues, as well as numbness and tingling. Doctor recommended Norco for pain. I continued with Tylenol.  MRI spine lumbar wo contrast was done, with no evidence of cord compression and normal results.   Even though, pain and numbness continues. Today is January 13. Appointment with Neurologist is suggested.
Pt got Influenza injection on Thursday 11/11/2010. Called me at 1230 on Friday 11/12/10, complaining that arm was extremely sore and numb from injection site down past elbow. She said this started about 5 AM Friday.
Aches; Increased hunger; Fatigue; Some diarrhea; Dizzy; Lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route in left arm on 06Apr2021 (at the age of 31-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. On 06Apr2021 at 17:00 hours, the patient had fatigue, aches, increased hunger, some diarrhea and after first 24 hours these subsided. On an unknown date in Apr2021, the patient experienced light headedness and dizzy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of fatigue, aches, increased hunger, some diarrhea were recovered on 07Apr2021; while that of light headedness and dizzy was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
received first dose of Twinrix on 11Sep2023, and has yet to receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 11th September 2023 from batch number 2PG39, expiry date 19th September 2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Twinrix on 11Sep2023, and has yet to receive the second dose).  The outcome of the incomplete course of vaccination 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: 03-OCT-2023 Pharmacist reports a patient who was going to receive Twinrix accelerated dosing schedule received first dose of Twinrix on 11th September 2023, and has yet to receive the second dose. The patient needs to be on the accelerated schedule because he was going to travel in December. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. HCP gave permission for follow-up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
L arm pain starting at time of injection and increasing since December.  Decreased ROM.  Reported weakness and intermittent 5th L digit paresthesias.  Feeling of a nodule remaining at injection site.
body aches, chills, fever, headache, soreness/swelling/rash at injection site; acetaminophen taken
Fever 102, severe chills, headache , aches and pains, nausea   Tylenol , rest, water
Onset of redness, swelling at injection site 10/30/2007.  Fever 24 hours.  Redness, swelling lasted one month.  Slight "lump" remains at injection site. The reported injection site reaction occurred on the right leg.
DIAGNOSIS: 1. Superficial thrombophlebitis MEDICAL DECISION MAKING/DIFFERENTIAL DX: Differential diagnosis includes DVT, superficial thrombophlebitis, muscle strain, tendinitis. The patient presented to the emergency department with atraumatic left leg pain. An ultrasound reveals a fairly large blood clot in the greater saphenous vein. Although this is a superficial clot, given its extent, I think it warrants anticoagulation. Per the trial, the patient would benefit from 45 days of 10 mg Xarelto treatment. The patient was given good precautions regarding bleeding risk while on a blood thinner. He will schedule follow-up appoint with his primary care doctor. He will also use Tylenol and warm packs to help with the discomfort from the superficial thrombophlebitis. He was discharged in satisfactory condition.
This spontaneous report was received from a female pharmacist of unknown age, reporting on herself. Medical history, concurrent conditions, concomitant medications were not reported. On an unknown date, the pharmacist suffered an accidental topical to exposure to the powder from a vial of ZOSTAVAX, 19400 unit 1 standard package vial of 1, lot # K018175 and expiration date in January 2016, that may have been leaking. The pharmacist reported also that ZOSTAVAX was stored at room temperature, as it had already been pulled from the freezer some time ago, and was slated for return to the distributor (incorrect product storage). No adverse events were reported and Product Quality Control (PQC) was filled on 18-NOV-2015. This is one of two reports received from the same source (MARRS# 1512USA006659). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse called and reported that an unknown number of patients additionally were administered PROQUAD (Merck) which were improperly stored. The PROQUAD (Merck) exposed to -12.1 degrees Celsius for 21 hours (20 hours and 45 minutes). The excursion was supported. The nurse believed at least one or two individuals had received these various vaccines but did not have specific data. She had not received any reports of adverse effects to patients post vaccination (No adverse effects reported). Additional information has been requested.
Pt arm, erythema grapefruit size. Nickel size at injection site. Raised areas noted. Reddened & inflamed.
Felt really bad that day, the next day he was fine.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really bad that day, the next day he was fine.) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt really bad that day, the next day he was fine.). At the time of the report, MALAISE (Felt really bad that day, the next day he was fine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-036175, MOD21-036103 (E2B Linked Report).; Sender's Comments:  MOD21-036175: MOD21-036103:
4 hours after injection:  Body ache.  Felt like body on fire Felt like sunburn Broke out in hives all over body.  Took tylenol and zyrtec - resolved by morning
Patient had a puffy rash below injection site that started the day after vaccination. Rash subsided after a  few days, then new rash started on left elbow and subsided after a few days. At time of reporting, a new rash had started on right hip area. Patient states rash does not itch, is just red. Only first rash was "puffy".  Patient has been using eczema relief cream to self treat.
This spontaneous report as received from a nurse refers to a 64 year old male patient with elevated blood pressure and hyperlipidemia and no drug reactions or allergies. On 20-MAY-2014 the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (dose was not reported, lot #K004207, expiration date 13-MAR-2015). Concomitant therapies included atorvastatin and aspirin. On 21-MAY-2014 the patient experienced pain at the site of PNEUMOVAX 23 injection. This pain spread down the arm from the site of PNEUMOVAX 23 injection on unspecified date, in 2014 and thus the patient had difficulty moving that arm. There were no lab diagnostic studies performed. The patient took either ibuprofen or ALEVE for the pain on unspecified dates, in 2014. The patient sought medical attention by calling the physician (date unspecified, in 2014). On 10-JUN-2014 the patient recovered. No PQC (product quality complaint) was involved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Headache, fatigue, sore at injection site, muscle and joint pain from evening of 1/21/2021 through 1/23/2021 AM.   Nausea the night of 1/21/2021.  Chills night of 1/21 through evening of 1/22.    Took Tylenol for headache.   Felt better 1/23/2021, appetite back.   Injection site sore through 1/24/2021. Called out sick from work on 1/22/2021.
PATIENT PASSED OUT & THEN HAD A SEIZURE TOTAL TIME LASTED LESS THAN 2 MINUTES
No adverse event; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    No concomitant medication was reported.  On 14-Oct-2022, the four people over the age of 18 were given 0.25 ml dose of the bivalent vaccine. No symptoms were reported.  No additional doses, medications or treatment was received.
My throat was swollen and sore, a rash on face and neck, runny nose, lost voice, SOB
This case was reported by a nurse via a sales representative and described the occurrence of injection site rash in a subject aged between 4 to 6 years old of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (manufacturer unspecified) and varicella virus vaccine (manufacturer unspecified) both given in 2012. In 2012 the subjects received unspecified dose of KINRIX in an unknown shoulder. An unspecified amount of time after vaccination with KINRIX (within a few months), the subject experienced injection site rash and swelling injection site. At the time of reporting the events were resolved. The sales representative indicated that a nurse reported 4 to 5 instances of rash and swelling at the injection site following administration of KINRIX. Specifics for each subject were not available. It was reported that the subjects were between 4 to 6 years of age and included males and females. There were 3 to 4 instances in 2011 and 1 in 2012. The KINRIX vaccinations were given in the right or left shoulder. The subjects all received MMR and Varicella vaccines concurrently, but the rash and swelling were only noticed with the KINRIX vaccine. Linked case for episodes in 2011 - A0973627A.
Pt received immunizations on Monday 3/8/04. On 3/9/04, L arm swollen. On 3/10/04, mom called our office and stated not swollen but very red and warm to touch-not painful. Seen by Dr on 3/10/04. Mom advised to apply ice, give Motrin and Benadryl.
whole body is aching; my lower body is throbbing/my whole body is aching, but especially my lower body; arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 09:15 (Lot number: EN 8730) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Only animal allergies" (unspecified if ongoing); "Moderate-severe asthma" (unspecified if ongoing). Concomitant medication(s) included: SPRINTEC; BUPROPION HYDROCHLORIDE. Vaccination history included: Bnt162b2 (dose 1, single, administration time: 09:15 AM, vaccine location: Right arm,), administration date: 12Mar2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "sore arm"; Tetanus shot (after tetanus shot in summer, her lower body was in extreme pain and even temperature changes or wind would cause pain in her legs), administration date: 2021, for Immunisation, reaction(s): "lower body was in extreme pain", "pain in my legs". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021 19:30, outcome "not recovered", described as "arm was sore"; PAIN (non-serious) with onset 02Apr2021 21:15, outcome "not recovered", described as "whole body is aching"; PAIN IN EXTREMITY (non-serious) with onset 02Apr2021 21:15, outcome "not recovered", described as "my lower body is throbbing/my whole body is aching, but especially my lower body". Therapeutic measures were not taken as a result of pain in extremity, pain, pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at time of 19:30, the patient experienced Within a few hours arm was sore. About 12 hours after second vaccine. Her whole body was aching, but especially lower body. Any movement hurts and she did not feel like she could warm up her legs. Even when she was not moving it feels like her lower body was throbbing. She was not experiencing a headache or any effects on her upper body. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit.  No follow-up attempts are possible. No further information is expected.
Sore arm at injection site; Slightly dizzy for about 1 h after vaccination; This is a spontaneous report from a contactable consumer (patient himself).  57-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EL3247), via an unspecified route of administration on the left arm, first dose on 12Feb2021 09:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021, the patient experienced sore arm at injection site (24 to 48 h post injection) and was slightly dizzy for about 1 h after vaccination. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Case was reported as non-serious.
My mother Received vaccine on 3/18/21. Approximately the week of 4/4/21 she started to experience shortness of breath and got progressively worse. On 4/9/2021 she was admitted to hospital and diagnosed with extensive clot burden within the interlobal pulmonary arteries bilaterally as well as upper lobar branches. Venous Doppler was a performed on 4/10/21 blood clots found in both lower legs Please note that I attempted several times to report this to Pfizer, I was disconnected once and was on hold for over hour with the same automated message replaying that there were 6 callers ahead of me. There was no option to leave a message for a return call to share what I feel is important safety information.
Redness, swelling and pain at site (R arm). 10 x 17 cm erythematous area with patches of induration. No pustules, discharge or streaking.
My arm is little sore; This is a spontaneous report from a contactable consumer reporting for himself. A 95-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient also received apixaban (ELIQUIS), 2 dose forms (DF) every day, via an unspecified route of administration from an unspecified date at an unknown dose as blood thinner. Medical history included a bone spur in the left foot that causes the patient to limp a bit, although he is still able to move around a little bit ("he is surprised that he is still plodding along"), cardiac pacemaker insertion, body weight sometimes increasing, a trouble with his vision, so he has a restricted driver's license: he can only drive during the day time. The patient is also a hearing aid user from an unknown date and has central nervous system stimulation from an unknown date ("I have Neuraxis"). His wife says that "he has them every day". Past drug history included warfarin sodium (COUMADIN) used for years as blood thinner. The patient's concomitant medications were not reported, although the patient stated he takes a lot of medications. The patient reported that the vaccine "worked beautifully", but only after the shot he could read on the information sheet that the he should have told the provider about all his medical conditions, if he has a bleeding disorder or is on a blood thinner. Now he's reluctant to take his pills because of this warning. He feels fine, he doesn't have any problems with the shot. He only stated that his arm was little sore but that's to be expected. The patient would like to know if he can continue to take his blood thinner. On an unknown date the patient underwent lab tests connected with some kind of surgery or his pacemaker whose results were unknown. The action taken with apixaban in response to the event was unknown. The event outcome was unknown at the time of the report.  Information on the lot/batch number has been requested.
About 10 days after the first shot on 3/8/21, there was blood in stool. It went away after about a week, And roughly 2 weeks after the second shot 3/29/21, a hard lump near the anus area is discovered. Now the lump is leaking small amount of puss, almost gone.
Hives, welt at injection site. Achy joints/muscles. Dizzy. Low grade fever.  Started 12 hours after injection. Ongoing 48 hours after.
Administered an expired dose of Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 24th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The patient administered an expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2016, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the 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. Causality assessment was related. Additional information has been requested.
Pt presents to ER with symptoms of CHF. Patient had no history of any heart problems.
Reported itching all over body. Reported welts, "hives" over trunk, arms, legs and all over body. "My skin is on fire".  Started afternoon of 5/18. Continuing this morning 5/19/2021. No reports of breathing issues. No reports of other symptoms.
Noticeable area L posterior upper arm measuring 14cm X 15cm of erythema with induration of 5cm X 4cm. Pt c/o itching & discomfort to site but denies any numbness or tingling. Pt also received a TB skin test in L forearm same day.
(OMIC). Pt was administered pneumococcal vaccine IM 4/3/06. Pt experienced severe swelling/edema left arm muscle post injection. Local redness and increased skin temp. Complaint of pain. Medication for pain with relief. Ice/warm soaks applied to swelling as needed. Benadryl given as needed. 01/17/07-records received and reviewed. DC Summary for DOS 04/04-04/05/06 During hospitalization, patient received Pneumo vaccine to which she developed a localized reaction and resolved with cold and warm compresses provided by nursing staff.
Large, red, raised, painful injection site reaction with bruising up to 2 weeks later Narrative: