chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid with symptoms) in a female 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) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (Covid with symptoms). At the time of the report, COVID-19 (Covid with symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-027169 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Local reaction to right outer thigh. Warm to touch approx 3-4 cm in size infant pt fussy.  Afebrile. No other symptoms.
Chest pain and weakness on evening of 7/1/21 after working for 8 hours and while taking a bath. Chest pain worsened and went to ER.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 05-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Two days after receiving DTaP, IPV, Hep B (Pediarix) and a Varicella #1, pt broke out in a neck to navel light itchy red rash.  This was pt's 1st varicella vaccination.  No hx of allergies.
SORENESS; NUMBNESS; FEELING HOT; CHILLS; NAUSEA; MUSCLE ACHES; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included contrast dye allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced soreness. On 08-APR-2021, the subject experienced numbness. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and nausea, and had not recovered from soreness, feeling hot, muscle aches, and numbness. This report was non-serious.       T
I didn?t mention a side effect from my first shot because I didn?t realize it at the time I filled out the survey. Immediately after my first shot I experienced distorted tastes and smells. Lots of food still (after 5 weeks) taste nasty to me. Meats, fruits, and more. Hard to describe the smell and taste, sometimes soapy. My reactions to the second shot similar to first. Cold chills achey, feel really hot, fever, tingly arm, etc.
Redness, warmth, swelling immediately after injection on 11-30 seen by PCP 12.3 given ROCEPHIN injection along with oral AUGMENTIN.
Headache, Myalgia, Diarrhea, chills, fatigue Narrative:
Mildly itchy vaccination site, face, and hands.  This lasted approximately 2 days.   I also noticed a rash developed  (apx 4"X3") at the vaccination site.  The rash  is now, (6 days later) reduced significantly.
Respiratory distress and given 2 epi pens by home nurse, whom was present.
Pt with c/o increase pain to injection site (+)erythema and swelling at injection site.  Increase fluids, motrin, and benadryl prn.  F/u with patient provider prn.
First shot: visible swelling in arm & painful to the touch. Swollen lymph nodes 5 hours after administration of pfizer vaccine. Duration of about 2 days  Second shot: slight arm stiffness after administration of pfizer vaccine. Around 4 PM throat became dry & scratchy. Around 5:30 sore throat. Duration is 3 days and counting.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 32-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified), TWINRIX. On unspecified dates in 2010, after completing the vaccination series with Hepatitis B vaccine the subject experienced not responding to therapy. On 16 November 2010, the same day the subject received TWINRIX vaccination the subject experienced an extra dose administered. The subject reported receiving hepatitis B series in 2001 to 2002 and was tested for titers in 2010; the titers were undetectable. The subject stated that she also completed the hepatitis A series in the past and on 16 November 2010 she received TWINRIX "even though all she needed was just the hepatitis B vaccine". At the time of the report no other information was provided.
I had a cough, and congestion and it kept getting worse to the point that I was having shortness of breath. I never tested positive for COVID-19 though. I had 2 negative tests during that period. I went to the doctor and was prescribed albuterol, prednisone, and codeine with guaifenesin for cough. I am feeling much better now, but I still have an occasional cough.
got Coronavirus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got Coronavirus) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Coronavirus). At the time of the report, COVID-19 (got Coronavirus) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient received the 1st dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 2nd dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 1st booster dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 2nd booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8735) and on 07May2021 as dose 2, single (Lot number: ER8735) at the age of 33 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 066F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After testing negative, have been testing positive again for multiple days; Positive, notes: After testing negative, have been testing positive again for multiple days. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
TIA           cardiomyopathy, EF less tha 20%   new diagnosis   I DO NOT KNOW WHICH BRAND COVID VACCINE SHE RECEIVED ++++++++++     no other option above but to pick one,
This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:58 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the right arm (right deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Body aches, chills, fever, vertigo (accompanied by buzzing) - resolved 36 hours after onset
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
I had a headache and congestion. I had fever that was under 101 degrees, runny nose, hoarse voice, a lot of sneezing. Doctor prescribed PAXLOVID on Wednesday 12/21/2023-12/25/2023. Then I started to get better on 12/27/2023 and then on 12/29/2023 I experience a rebound experience same symptoms plus laryngitis but worse except I didn't have fever. While taking PAXLOVID, I was still taking all medications except.
Immediately -> pain at injection site, burning at injection site, dry throat, hoarseness, slight difficulty in swallowing, tightness in throat. Following with stomach upset, lightheadedness.
Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.
Narrative:  87 yo M with h/o CAD s/p CABG (2012) and PCI (2018), severe AS s/p TAVR (2019), A-Fib (on apixaban), Factor V Leiden with DVT/PEs, SCC of lung s/p R upper lobe lobectomy (2015), COPD, DM2, and hypothyroidism. On 9/23/21, patient's Home Based Primary Care Nurse Practitioner visited his home for a checkup and noted that he was in a worse state of health than his baseline. Per note, "Primarily today he is dehydrated, hypotensive, tachypneic and tachycardic. He has been having worsened hyperglycemia and has been becoming more forgetful. has been too weak to eat or participate in ADLs or take meds since at least yesterday." Patient advised to go to ER. Patient presented to the agency ED the same day. In ED, patient was found to have newly reduced EF so taken to cath lab for NSTEMI. In the cath lab, patient went into cardiac arrest (PEA), an Impella was placed during the procedure. Patient was intubated, ROSC was eventually obtained and patient was transferred to the MSICU in critical condition. Per the 9/24/21 Medicine Discharge Summary: "In the MSCIU, patient was initially tenuously stable but then decompensated due to a probably internal bleed and groin hematoma, Hgb dropped from 12 to 6.5. Patient received IVF, was somewhat fluid responsive but no way to stop any coagulopathy and likely retroperitoneal bleeding due to the presence of the Impella (procoagulants would likely clot it off). Transfusion would be futile as bleeding could not be controlled." "MAPs downtrended down to the 30s and in the setting of poor organ perfusion, anoxic brain injury, and no further interventions that could improve patient status, the decision was made to make patient DNR and not initiate another code blue. MAPs decreased to 10s and patient eventually became bradycardic and eventually reached asystole." Patient's time of death was Sep 24,2021@00:41. Per Death note, immediate cause of death is listed as "acute non-ST elevation myocardial infarction." Of note, patient recently completed his COVID vaccination series. He received the Pfizer vaccines on 8/18/21 and 9/8/21. No known COVID contacts and covid-19 negative per test on 9/23/21. Unclear correlation between patient's passing and covid-19 vaccination. Reporting given proximity of the patient's death and COVID-19 vaccination. Symptoms:  Tachypnea, Tachycardia, HYPERglycemia & Dyspnea; NSTEMI; hospitalization Treatment:  EPINEPHRINE SODIUM CHLORIDE 0.9% IV SOLN INJ,SOLN 250 ml IV Conc=16,000ng/ml; drip , VASOPRESSIN SODIUM CHLORIDE 0.9% IV SOLN INJ,SOLN 250 ml IV Conc=0.24units/ml; drip
Worsening heart function; increased sx PVC burden and runs of VT. Drop in LVEF from 40% to 15%. Worsening CHF sx. Occured after the second COVID 19 Pfizer vaccine dose
patient felt chest tightness and dizziness about 10-15 minutes after receiving vaccine. Stayed in area for over 30 minutes and took one 25mg Benadryl and symptoms subsided.
erectile dysfunction; burning when urinating; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 30Jul2021 at 11:00 (at the age of 60-years-old) at dose 1, single for COVID-19 immunization. Medical history included COVID prior vaccination. COVID was not tested post vaccination. Known allergies reported as none; other medical history was reported as none. Concomitant medications were not reported. The patient did not receive other vaccine in four weeks and other medications in two weeks were reported as none. One week after, on 06Aug2021, patient began to experience burning when urinating and approximately 3 three afterward, on 27Aug2021 (as reported), he began experience erectile dysfunction. No treatment was administered for the events. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient was inadvertently given 0.2cc of regular Pfizer instead of Peds Pfizer. Mother notified and plans to contact doctor for further advice. Plans to bring pt. back in 21 days for second dose of Peds Pfizer. Patient has not experienced any adverse side effects.
Patient received yellow fever vaccine on 12/01/11 at 11:30 a.m. without any incident. Husband called today to report patient is complaining of facial swelling x3 days and slight general itching without respiratory distress. Denies any other symptoms. Instructed to go to ER ASAP. Saw PCP on 12/5/11. On ZYRTEC swelling decreasing. Feeling better today.
03/11/2009 13:45 Immunization administered. 13:55 Injection site red, puffy/size of quarter, painful. Cool compresses applied with no adverse symptoms noted. 03/12/2009 10:00 Child reports pain @ injection site. Grandmother home @ 12:30 and reports she gave her ibuprofen for discomfort. Reports no compresses applied today. 14:07 Presents to clinic requesting to have her arm looked at from injection given. Right arm reddened area approximately 1"width and 2" length @ injection site. Child reports pain @ site with no itching noted.
administrated with expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Boostrix and Boostrix 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 Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comments: The reporter reported that a patient was administrated with an expired dose of Boostrix and the vaccine expired on 30th September 2022.  No adverse event was reported. No patient's identifiers provided, no lot number and expiration date were provided. The reporter was consented to follow up. Additional supportive information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Had both vaccines, got shingles/Suspected vaccination failure; Shingles/Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both the vaccines and still got shingles. The patient reported that luckily he/she recognized them and went to the physician right away and got on the drugs to lessen the severity. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
14 yo Female client received Pfizer vaccine at 13:29.  Client reported feeling dizzy and light headed, appeared pale. Client escorted to the floow to lie down, father present BP 138/94, client reported feeling anxious Father gave client cookies, client reported feeling better but had a headache, color returned No EMS called Ambulatory upon leave with father
Sore muscles in the evening. Worst the next day 03//14/2015- with chills, fevers, sore muscles all over, stay in bed with banket. I was unable to meet my obligations.
Mild COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Mild COVID Arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Mild COVID Arm). On 01-May-2021, VACCINATION SITE REACTION (Mild COVID Arm) had resolved.            No concomitant medications were reported  No treatment information was provided  the patient had she had mild COVID Arm for 1 day   This case was linked to MOD-2022-447415, MOD-2022-447154 (Patient Link).
9/23 845 PM Patient reports lump at injection site, told to contact physician & call us. 9/24- Dr called in prednisone Rx. Patient say swelling down, feeling better.
Itchy red bumps on her torso (front and back); bumps on her torso (front and back); red bumps on her torso (front and back); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)). At the time of the report, PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Since April 17 I have a rash over both arms and itching. I thought this would pass by now. However it has not.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H015863, expiration 24-FEB-2015) (dose not reported), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
Red at injection site and dollar coin size warm lump around injection with red splotching throughout.  Applied warm pack and massaged.
Pt. states that after receiving the 3rd Booster of Moderna 11/09/2021, started experiencing symptoms that evening of pain in the left arm, fever (101.3), body chills, muscle aches, and fatigue. No noted Primary visit/communications.