chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/28/2021: patient reports feeling muscle pain and soreness in injection site 12/29: fever of 100-103F and headache develops 1/1: fever subsides; blisters and pustules develop on both left and right soles of feet with slight itching and swelling 1/2: no fever; pustules similar to those on soles develop on left thumb 1/3: no change in condition from prior days
Patient brought to the ED by EMS on 11/2 with sudden onset of shortness of breath. She was brought in.  EMS placed patient on high flow O2 and she was satting at 93%. In the ED, patient tested positive for COVID-19 by PCR. She was ultimately admitted 11/2 - 11/9 with acute on chronic respiratory failure and COVID-19. Patient initially required BiPAP, and at discharge was on CPAP and required about 3-4 L of oxygen. At baseline she uses 2-3L O2. Patient has received the COVID-19 primary vaccine series and one booster.
Breathing problems -mucus spitting day night - choke on it about to lose breath mucus worse, eye dry skin keep peeling off. Weezing, arm hurt come and go. Muscle spasms in my back and neck - Foot hives come and go - Back itch come gos -breathing spasms, eyelid dry still
pain at injection site; pain in rib cage/pain shocks; Pain behind the ears and occipitals; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (10 years ago). Previously administered products included Zostavax. Concurrent medical conditions included post herpetic neuralgia.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, thoracic pain and pain localized. On an unknown date, the outcome of the injection site pain, thoracic pain and pain localized were recovering/resolving.   It was unknown if the reporter considered the injection site pain, thoracic pain and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient still has some post-herpatic pain from time to time. The patient states that later the same evening (less than a day after vaccination), she developed pain in her rib cage, pain behind the ears and the occipitals. The patient stated that it hurts to touch the area around her ribcage and she experiences painful shocks from time to time.  The pain that she was currently feeling, feels the same as the pain she felt when she had Shingles 10 years ago. The patient did not provide any additional details and did not have HCP's full address at the time of the call.
Thinks COVID-19 Vaccine triggered her lupus; It is lupus of the skin, not systemic.; Had a little nausea, but not as bad.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Dec2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Subacute Discoid Lupus", start date: 2012 (unspecified if ongoing), notes: lupus of the skin, not systemic. , Thinks the COVID-19 Vaccine triggered her lupus. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EN6199    , Dosage text: unknown dose amount; injected into the left arm; , Date of administration: 11Mar2021), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Tiredness", "The shoulder, where it was given on the left side, it swelled all the way up into her neck", "All of her lymph nodes on that side of the body were inflamed", "It hurt form her shoulder to her elbow."; Bnt162b2 (Dose: 1, Batch/lot number: EN6199    , Dosage text: unknown dose amount; injected into the left arm; , Date of administration: 11Mar2021), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunisation, reaction(s): "nausea feeling"; Bnt162b2 (COVID-19 Vaccine: Second Dose: , Manufacturer: Pfizer, Date: 01Apr2021, NDC/EXP: Unknown, LOT: ER8733, Dose: Unknown, Route: injected to left arm, Second dose COVID-19 Vaccine did bother her shoulder, but not as bad), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Second dose COVID-19 Vaccine did bother her shoulder, but not as bad"; Measles vaccine (When caller was 4-5 years old, she received the Measles vaccine. After vaccination, she contracted Measles NDC/LOT/EXP unknown), reaction(s): "she contracted Measles". The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021, outcome "unknown", described as "booster"; CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Thinks COVID-19 Vaccine triggered her lupus; It is lupus of the skin, not systemic."; NAUSEA (non-serious), outcome "unknown", described as "Had a little nausea, but not as bad.". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200063460 Same patient and drug, different event separated in time;US-PFIZER INC-202200063385 Same patient and drug, different event separated in time
Pounding palpitations with chest discomfort.  Continued despite no caffeine.  Developed shortness of breath Saturday morning and did go to local ED to ensure all was well.
a bad reaction to the booster; couldn't get out of bed; had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was), VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was). On an unknown date, the patient experienced VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed). At the time of the report, NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was) was resolving and VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed) outcome was unknown.            No relevant concomitant medications were reported. Patient used a compounded cream that she normally uses for neuropathy pain and it did not help at all.  She said that her rheumatologist said that the cream would not  have helped since it was a side effect of the vaccine.  She still has mild pain today but not like it was. She mentioned she did not have anything like this with the 1st two doses.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6202), at the age of 66, via an unspecified route of administration, in the left arm, on Mar 3, 2021, single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoarthritis, type 2 diabetes mellitus, gastroesophageal reflux disease and other unspecified conditions (as reported). The patient has some unspecified allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications not reported. On Mar 3, 2021, patient experienced extreme fatigue for three days (patient experienced lingering fatigue afterwards; as reported). The events did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of the event extreme fatigue resolved with sequelae on Mar 6, 2021. No follow-up attempts needed. No further information expected.
Hours after receiving the shot, my body tensed up into a fetal position and was paralyzed for 30 minutes.    My body is still painful in the joints and muscles and makes daily life challenging.
Moderna COVID-19 Vaccine EUA At ~10 minutes into my 15 minute "observation" period post vaccine, I became extremely dizzy and weak; feeling as if I would fall out of my chair.  I gripped the chair with both hands and put my head down between my knees. 2 EMTs that were on-site came over and talked to me; put me into a wheel chair and took me to their "tent" area in the gym and had me lay down on a cot.  They kept me under observation (completing blood pressure, heart rate, pulse-ox, and temp monitoring) for ~1 hour/15 minutes.  I was somewhat recovered, and wanted to go home. They told me I should contact my doctor for evaluation before returning for the second dose, scheduled for 4 weeks out.   An EMT walked me to my car.  I drove myself home.  I continued to experience continuous (but milder) dizziness and weakness for the rest of the day,  mostly recovered by the following morning. (I also experienced typical side effects of soreness at the injection site, starting later that first day; and mild headache and fatigue the following day).
Patient presented for a "2nd dose" of Pfizer vaccination when it was discovered via database that the patients initial dose was Moderna 2/16/21.
6cm x 5cm area of erythema & swelling over (R) deltoid which is non-tender with a fine maculopapular eruption over the area. No discharge is noted. No fevers. No shortness of breath.
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
The patient received doses of GARDASIL 9 on 10-JUN-2019, 13-AUG-2019 and 21-OCT-2019.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported).      On 10-JUN-2019, 13-AUG-2019, and 21-OCT-2019 (inappropriate schedule of product administration), the patient received doses (also reported as 1 dose) of vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administrations, and anatomical location were not reported) (lot number N014464, expiration date 19-DEC-2019).
Aches and chills the next day   Shingles attack nearly 1 year later
sz cont;hyper extension of body;thrashing movements & repetitive blowing;attempting to walk;interacting w/other > a/;constipation;dilation of 3rd & lateral ventricles w/bowing of corpus callosum;optic nerves hypoplastic;septooptic dys
I experienced RIGORS (shaking chills beginning 11 hours after dose) severe muscle paon
Information has been received from a female RN who on an unspecified date was inadvertently splashed with Hep-B vaccine in her eye with administration of the vaccine. The pt sought medical attention. Additional information has been requested.
Patient developed lesions resembling blisters/pimples on face and red spots on legs.
The pt experienced a red papular rash over the trunk, arms, legs, face, and neck. Was presented to our office on 10/19/00. Vaccines were given at another facility.
Information has been received from a physician referring to a 2 month old patient. On 08-SEP-2015, the patient was inadvertently vaccinated with GARDASIL (confirmed not GARDASIL 9), dose, frequency and lot number not provided instead of LIQUID PEDVAXHIB. No adverse effects reported. Additional information has been requested.
FALL; WEIGHT GAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: depression, chipped bone thumb, gall stone, gall bladder removed, anxiety, shaking, urinary urgency, and pain, and concurrent conditions included: multiple sclerosis. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, clonazepam, cyanocobalamin, ergocalciferol, escitalopram, fish oil, naproxen sodium, ocrelizumab, and oxybutynin. On an unspecified date, the patient experienced fall, and weight gain. The action taken with covid-19 vaccine was not applicable. The outcome of the fall and weight gain was not reported. This report was non-serious.
Antibody test negative; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (Antibody test negative) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Waldenstrom's macroglobulinemia.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Antibody test negative). At the time of the report, ANTIBODY TEST NEGATIVE (Antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: unknown (Negative) Antibody test negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: The follow up received on 27 MAY 2021 contain non significant information
Hives on left jaw line area. Hive on both ulna bone area. Took 1 Benadryl tablet after one hour. Hives disapeared after one hour of taking Benadryl. Lethargic for two weeks following vaccine. Arm soreness on and off for two weeks.
Rash on palms and soles, urticaria, lip swelling one day after first dose.
Shortly after getting the flu vaccine, the shoulder where the vaccine has been administered began to get sore. Within one day, it was achy and is very painful when I try to use the arm/shoulder.  Lifting my arm to shoulder height causes pain and continues for the past 6 days with no relief.
Developed severe warmth & flushing of her face & neck, 20-30 mins after Flu vaccine. Resolved without treatment in about 15-20 mins.
He ran a low-grade fever for one night and a cough with chest congestion. He tested positive on December 8, 2022 for COVID-19. Since then, he has been really tired and has a congested cough.
chills, headache, muscle soreness in arm, nausea, overall weakness; still has symptoms today, which are not subsiding  redness and swelling at site about 3 hrs after the vaccine, continues to be red and swollen and very painful  Has not taken any meds for the pain
Pt received Pediarix #1, Hib #1, PCV 7 #1 on 09/07/2005. He began the rash of erythema multiforme on 09/10/2005. No fever, URI sxs, vomiting, diarrhea. Rash still present.
Day after, significant arm soreness to right arm, difficulty moving right arm, redness the size of a quarter to right arm. 2 days after injection, fever of 103, arm redness getting larger, double in size from day 2. 3 days after, fever resolved, arm soreness improved with arm mobility almost to baseline, but redness, swelling, warmth worsening to size of palm. Was seen at local urgent care on day 2 and given cephalexin 500mg TID. Was seen by urgent care  above on day 3 and advised conservative measures and that remaining symptoms will resolve on own with no further treatment required.
10 days following vaccine administration patient developed rash, fever and cough and her oxygen saturation dropped to 85% at least 3 times in the following week
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
Few pimple like lesions around immunization site (lat) noted 1/29/03.
CHILLS FOR LIKE 12 HOURS; SORE ARM FOR ABOUT A WEEK; FEVER FOR LIKE 12 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills for like 12 hours, sore arm for about a week, and fever for like 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills for like 12 hours, sore arm for about a week, and fever for like 12 hours. This report was non-serious.
Several days p/recvd 2nd shot of Hep B recomb pt exp severe flu like sx, e.g. bilateral shoulder pain, generalized body aches, feeling generally bad or severe flu sx;
Initial unsolicited report received from a nurse on 11-Jul-2018. This case involves a child patient (age and gender were not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Inappropriate reconstitution technique. It was reported that patient was inadvertently given the DTAP and Polio part of the PENTACEL and did not mix it with the HIB portion. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt recvd 1st dose of Hep B vax 30JUN91 & approx 2 wks later exp intense fatigue; 31JUL91 itching hands, following day nausea, weakness, fever, vomiting, swelling of lips, & hives; also exp tightness of throat;
Local pain level 3 to 4, that evening I started to feel weak and chills and shivering. Then I started to feel nausea and then I vomited.  Day 2  stomach upset and diareahha, pain level diminished to 2 to 3 Day 3 pain level reduced to 2 and general feeling of weakness.
Temperature of up to 102; violently puking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of up to 102) and VOMITING (violently puking) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of up to 102) and VOMITING (violently puking). At the time of the report, PYREXIA (Temperature of up to 102) and VOMITING (violently puking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
blurred vision & itchy eyes - this actually started yesterday afternoon and is continuing today  severe joint and muscle pain - took aleve - did not help - so far all morning  shortness of breath and chest pains - so far all morning - don't know of anything to do  lethargy and brain fog - so far all morning - don't know of anything to do  severe pain at injection site
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient got light-headed after the vaccine, fall as getting into chair.
1/13/21 4:00PM arm pain, advil for relief. Next day 1/14/21 04:30 AM dizzy, chills, fever temp 99.8,  hives on stomach, neck tightness all day. All symptoms have resolved today 1/15/2021, hives still present some
11/24 12pm:   Booster dose of Pfizer mRNA after first two of Moderna (finished 5/5)] 11/26:   6:20pm - Photo evidence of hip welt?pretty sure it began there either 24th or 25th, but have no photos.   Left hip welt began to grow?.I thought it might go to face.  11/26 11:30pm:   Video - hip growing, spread and height, and appears to be non-pitting, blanching. 11/27 2:20am:   Facial swelling begins on the left side of lips - lower more prominent but upper had begun.  Took 20mg of Cetirizine quick dissolving tabs (2) 11/27 7:25am:   Facial swelling has spread to both sides of upper and lower lips and cheek/upper chin/Jowl on left side?maybe a little on right. 11/27 8:15am:   Blood draw for C1/C4 tests.  Needle goes in without issue?I?m sure there was latex gloves, but I don?t recall?rubbing alcohol, gauze and red wrap...nothing I'd think would cause a reaction. 11/27 1pm:   Slight itch at draw site has me notice the ?hive? around the draw site?PHOTOS 11/27 2:15pm:   Another 20mgs of quick dissolving Cetirizine  11/27 4:40pm:   Lips draining a little, cheeks still strong, especially the left one.  Draw site has really spread and raised.  Left hip welt is still present but might be going away a bit.  PHOTOS 11/28 2:15am:   Swelling is still present, but does seems to be getting better in lips?10mg of Cetirizine 11/28 10:30am:   Swelling is still present but is draining?left cheek is really still solid.   Took 10mg of Cetirizine.