chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days post vaccine- extreme muscular and nerve pain in my left arm predominantly. Also noticed an extreme flare up in current RA active joints in various places in my body.  I developed severe limp in my left foot and a limp in addition to what I read the usual vaccine side effects. The diarrhea continued to get outrageously bad after the vaccine until now. Extreme abdominal pain round the clock, random explosive that is extremely painful.  I had nausea for at least 4 months, I was experiencing nausea in September.  I had a fever.  I still have a fever. My temperature reading is 99.8. I normally have low readings. By September,  I was having rectal pain and discomfort. I am in excruciating pain were I have to lie down and get off my feet. I developed a rectal fissure again beginning of October.  The hemorrhoids have been getting steadily worse. (I had surgery in 2002 that corrected the rectal surgery ). Treatment- hydrocortisone, I have had to add ibuprofen into the mix. I am going to require surgery. The earlies appoint I could get is 01/19/2022 with the gastroenterologist. The RA in the finger joint has continued to stay very hot and very red where I cannot make a fist.  This is 6 months later with all kinds of treatments. I have trouble doing personal grooming. The pain is severe and is impairing. The next step is to talk to a neurologist. 10/29/2021- I don't have the colon pain or nausea, so maybe the diarrhea will resolve and the pain is better and it is not waking me up in the middle of the night.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Axial spondyloarthritis" (unspecified if ongoing); "ulcerative proctitis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 06Jun2020, stop date: 08Apr2023; ORAL CONTRACEPTIVE NOS, start date: 01Sep2020, stop date: 08Apr2023; LEUCOVORIN [CALCIUM FOLINATE], start date: 06Sep2020, stop date: 09Apr2023; HUMIRA, start date: 26Jan2021, stop date: 29Mar2023. Past drug history included: Topical salicylic acid, reaction(s): "DRUG ALLERGY"; Cyclobenzaprine, reaction(s): "drug allergy". 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events,Linked Report(s) : US-PFIZER INC-202300175644 same  patient/reporter, different drug/AE;
1135am Nausea, dizzy, light headed, patients legs were elevated, ice pack given, water given, patient was fasting, father went and got patient food. 1205pm BP 115/74, pulse 72.  Patient eating, reports no nausea, dizziness, or lightheaded. 1215pm patient walked out with nurse practitioner. Patient verbalized understanding to call PCP and continue to eat and drink today
diffuse swelling & vax arm & welt same side as vax given.Admitted for IV steriods
arm "blew up like a balloon"; "rash up and down arm"; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb and rash were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her arm blew up like a balloon and she had a rash up and down her arm that lasted a long time. The reporter stated that the patient was not going to get dose 2 of Shingrix due to a bad reaction to dose1.  The reporter did not consent to follow up. The reporter did not have any further details for this adverse event.
Pt came into observation area after receiving the COVID-19 vaccine. Pt started complaining of chest pressure and palpitations. Vital signs were started on pt. Pt was given water, instructed to take deep breaths, and legs were elevated. Pt states that chest pressure was decreasing but was starting to feel ?heaviness? throughout her body. Vital signs were all in normal range. EMS was called when no relief was attained by the pt. Pt left by EMS with her mother at her side.
PATIENT EXPERIENCE ALLERGIC REACTION RESULTING IN SEVERE SWELLING AND REDNESS UNDERNEATH UPPER LEFT ARM
rash started @ umbilicus & spread over abd, neck upper thighs neck, & head;resolved completely by 4 days;probable viral exanthem per MD;
Pt complained of red bump at site of IZ. Pt saw physician who noted a 2.5 cm lump under the skin with minimal erythema and tenderness. Dx was sterile abscess to be treated with warm compresses and ibuprofen.
PATIENT STATES SHE WAS VERY HOT LAST NIGHT, AND WOKE UP TO A KNOT THE SIZE OF A PEA ABOUT 2-3 INCHES FROM THE SITE OF ADMINISTRATION. SHE RUBBED THE SITE, AND THEN THE KNOT BEGAN TO GET BIGGER. PATIENT ALSO NOTICED A LINE OF KNOTS DOWN HER ARM, AND THAT AREA IS RED. PATIENT STATED HER EYES ARE RED, SHE IS FEELING VERY RUN DOWN AS WELL.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified patients were vaccinated with doses of PROQUAD (Merck) (dose, dose number, route and lot number were not reported) that were stored improperly. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no permission to contact.
2.5 hours after vaccine administered: scratchy throat, swelling throat, itchy eyes, red sclera, wheezing, rash on chest (that went away). Pt initally took 25 mg of Benadryl followed up later with 50 mg Benadryl with some relief to symptoms. Came to the ER next day due to wheezing (as past hx of cold related asthma, but not recently).Was given a nebulizer in ER.
Arm swelled up below shot sight. Was red and hot to touch. Had a headache.
Itching white hives on back, abdomen and legs. 19 days post Inactivated Influenza virus Fluzones. No SOB
Loss of appetite; High fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 071F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, Irritable bowel syndrome, Blood pressure high, Mitral regurgitation and Drug allergy (codeine, Miralax, magnesium citrate.).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F.   This case was linked to US-MODERNATX, INC.-MOD-2023-747880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747880:Same patient (Different vaccine)
shingles rash on his back; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Last week before the time of reporting, the patient received a dose of Shingrix. At the time of reporting, the patient had developed a shingles rash on his back. The reporter wanted to know, what should do the patient. The reporter needed to know immediately because the shingles antiviral must be taken within first 72 hours.
This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored oral, ROTATEQ (dose, frequency and route of administration not reported) (lot # K004731, expiration date 10-DEC-2015; lot # K010221, expiration date 12-MAY-2016) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
slight earache in the left ear along with mild vertigo; slight earache in the left ear along with mild vertigo; a slightly stuffy nose the next morning; felt fatigued; This is a spontaneous report received from a contactable consumer who is also a Pfizer colleague. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 11:30 (Lot number: EN6203) at the age of 53 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies to latex" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medications included: OMEPRAZOLE; ZOLOFT; D3 VITAMIN; EXCEDRIN MIGRAINE. Past drug history included: Betadine, reaction(s): "allergy". The following information was reported: NASAL CONGESTION (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "a slightly stuffy nose the next morning"; FATIGUE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "felt fatigued"; EAR PAIN (non-serious), VERTIGO (non-serious) all with onset 03Mar2021 16:30, outcome "recovered" (05Mar2021) and all described as "slight earache in the left ear along with mild vertigo". Therapeutic measures were not taken as a result of nasal congestion, fatigue, ear pain, vertigo.  Additional information: The patient woke up with a slightly stuffy nose the next morning after the first dose vaccination (03Mar2021) and felt fatigued. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient also received the second dose of BNT162B2, administered in the left arm, administration date 26Mar2021 11:30 (Lot number: EL3248) for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
1 of 3 pts who exp a localized react which included swelling & tenderness; pt also recvd pneumovax (w/in past 4 wks) in the same arm as Td inject; pt recovered;
Patient was c/o tingling of the tongue, warmness and anxiety. She mentioned not taking her anxiety medication today. Patient was assessed at 1503 her BP =148/90, P=80 , O2= 95%, hydration protocol maintained a few minutes later patient voiced relief  she was reassessed at 1509 BP= 140/90, P=75, O2=95%. patient took half her anxiety medication and was approved to go home EOR
the night of vaccination, patient experienced severe itching in hands, feet and neck. she stated that she almost went to the er, however symptoms resolved in a matter of hours. patient was referred to allergist by primary care physician before she could receive second dose
Lymphnodes in my axillary space uder the injected arm. Swelled extremely and painfully. At one point the swelling under my arm was the size of soft ball, given my cancer history, my Dr. recommended an ultra sound to alley concerns I received 2 ultra sounds 25 days apart the first and second ultra sound both showed enlarged lymphnodes that had not completely resolved by April 27, 2021. Because most of the extreme swelling disapated the suggested that I just wait and watch.
Stiff arm and slight pain from roughly 2 hours post vaccination till the following morning. Uncomfortable throughout the night
Diarrhea approx. 3 hrs after immunization. On 4/8/03 approx. 10am developed hives. Denied shortness of breath of fever. Afternoon of 4/8/03 all symptoms resolved.
Received 1st Hepatitis B vaccine on 7/16/07 and next AM notice itching at injection site.
This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number, expiration date: unknown), via an unspecified route of administration, administered in Left arm on 20Apr2021 18:00 as 2ND DOSE, SINGLE DOSE, for covid-19 immunization. Medical history included herpes simplex from an unknown date. Concomitant medication included sertraline HCL (SERTRALINE HCL), Ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 30 Mar 2021 (Batch/Lot number was not reported) as for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. on 23Apr2021 05:00 the patient stated that patient developed a cold sore the day after my fever from the shot subsided, or three days following the shot. Patient had HSV1 since childhood, but only develop cold sores occasionally. It stood out to me because I had one in mid-March for the first time in a few years, which was normal. Having a second so close to the vaccine made me think it was a secondary effect, or potential reaction to the fever. The patient had no Allergies to medications, food, or other products. Outcome for the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a 74 years old female patient regarding herself with no drug reactions/allergies. On an unknown date (reported as more than 15 years ago) the patient had outbreak of shingles. The patients current conditions included blood pressure and asthma. Approximately on an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported)as told by her HCP(health care professional). Concomitant medications included losartan potassium (reported as losartan 100) and fluticasone propionate, ADVAIR (reported as ADVAIR DISCUS 150). Approximately on an unknown date in October 2012 (reported as end of October), the patient had another outbreak of shingles and does not feel that this was a milder case of shingles as told by her HCP. A culture of the shingles was taken. The patient sought medical attention (details unspecified). The outcome of the event was unknown. Additional information has been requested.
Pain, redness, soreness, swelling at site and down arm  Day 1 and 2 Headache, muscle aches, fever, shivering, fatigue Temp. Days 2 and 3 and 4 Felt Faint - Day 4 Arthritic type aches continued for the duration of 18 days - took Aleve or arthritis pain formula which helped
had troubles hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (had troubles hearing) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A8BZ, 026L20A and 172267) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN CALCIUM (LIPITOR), MIDODRINE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), TAMSULOSIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (had troubles hearing). At the time of the report, HYPOACUSIS (had troubles hearing) outcome was unknown.            Concomitant medication also includes Supplements. No treatment medication provided.  On 24-Sep-2021, patient had blood draw for blood tests, 14 vials of blood were taken due to that patient was worried it might effect the efficacy of the vaccine.  It was unknown if the patient was immunocompromised or not. patient took the third dose of the vaccine as his doctor told him to get it.  Patient had an unspecified coronary sugary 5 years ago for  atrial stimulation. Another unspecified coronary surgery was planned at the end of October. It was planed before prior to getting the vaccines.
Patient did not receive  second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive  second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive  second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive  second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided. No concomitant medications were reported
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: camphor/eucalyptus spp. oil/menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
Minimal reaction at time of shot, salivary glands shut down 30 hours later, lasted 11 days, tongue swelling, could not swallow. Contacted ENT and allergist (allergist found no food allergy). Dissipated after 11 days. No medicine administered, specialists had her chew gum to produce some saliva, lost 12 pounds because hardly eat. Went to two specialists and an allergist
Within 15 min of vax a small wheal appeared around injection site. Then sever wheals appeared just under injection site. 24 hours later the pt developed erythema with increased warmth around site. The pt was diagnosed with allergic reaction. Treated with Benadryl
Diagnosed with 20 percent hearing loss in the left ear /  significant difficult hearing phone calls through the left ear; Constant and ongoing ringing in the left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone propionate (Flonase), methylprednisolone (Medrol) and sulfamethoxazole + trimethoprim (Bactrim Ds).   On 29th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a constant and ongoing ringing in the left ear approximately 2 to 3 days after receiving Shingrix.  The patient had significant difficulty in hearing phone calls through the left ear. The patient was diagnosed with 20 percent hearing loss in the left ear by audiologist.  The reporter consented to follow up. For tolerance of 2nd dose refer case, US2021AMR022441.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR022441:Same reporter.
Diagnosed with myasthenia gravis 5/7/21.  Left eye ptsosis and left arm weakness started 5/4/21.  Currently on Imuran, Ultomiris, pred 30mg QD with significant disability.
Blood in Stool, continue feeding and routine infant care and return in 1 week to recheck stool for blood.