chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed hives within a week of the second Moderna booster shot on May 23, 2022, accompanied by stomach pain, which I believe to be internal hives because it only happens during daily hives flareups.  I saw an allergist who diagnosed me with chronic spontaneous urticaria and told me to take three Allegra 180 allergy pills.  That kept hives away for 2 days and then they returned.  Allegra has since come out with a hives formula, which seems to help insofar as the itch, but the hives bumps, clusters and splotches remain.  Each daily hives flare is different and not precipitated by anything I can put my finger on.  Serious flares also cause swelling in my lips and the inside of my cheeks, and cause a medium asthma flareup requiring the use of my inhaler.  Prior to these hives, I hadn't needed my inhaler or had any asthma related symptoms in over 20 years.  I am also now very sensitive to ibuprofen, which is my go-to pain medicine.  When I take it, it causes certain parts of my throat to become inflamed and sore and makes my voice very hoarse for hours.
developed redness at injection site, which resolved. Then yesterday AM developed well demarcated erythematous rash with mild soft tissue swelling.
This case was reported by a nurse via sales rep and described the occurrence of chest pain in a female patient who received FLUARIX QUADRIVALENT. On 23rd September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced chest pain, facial flushing, neck pain and feeling abnormal. On an unknown date, the outcome of the chest pain and neck pain were recovered/resolved and the outcome of the facial flushing and feeling abnormal were unknown. It was unknown if the reporter considered the chest pain, facial flushing, neck pain and feeling abnormal to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chest pain that ran up neck, face flushed and felt icky after receiving FLUARIX QUADRIVALENT. No other information was provided.
100.3° fever and flu like symptoms including coughing runny nose, headache, fatigue and diarrhea.
"little welts, like big zits" coming up on her arm where she received the injection and noticed bumps all over body; She is still bruised from it around the injection site.; noticed bumps all over body; This is a spontaneous report from a contactable consumer (patient).  A 51-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EV-7176 and expiry date was not reported), via an unspecified route of administration into left arm on 11May2021 as Dose 1, single (Age at vaccination: 51-year-old) for COVID-19 immunization. Medical history included body aching and a panic attack and went to the hospital, but then remembered that was before the vaccine. Family history was not reported. The patient did not receive any concomitant medications. On 12May2021, the patient had "little welts, like big zits" coming up on her arm where she received the injection. She noticed the next day that she had bumps on her body. She is still getting more bumps which got worsened. They are like great big zits. The patient had bruise at injection site. The patient still had bruising at injection site. The patient did not had any lab test done. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt was very nervous before injection and experienced sweating and loss of vision 2-5 minutes immediately after administration. Patient calmed down after a few minutes and vision returned. Possible anxiety attack.
Right leg became swollen indurated and discolored around 10 inch diameter area of blanching around injection site.
Vaccine Vial was opened on 6/18/2021 and was not discarded at end of day.  Same vial was used on Monday 6/21/2021. to vaccinate patient with.
IRRITABLE BOWEL SYNDROME SYMPTOMS; LOWER BACK PAIN; SHORTNESS OF BREATH; HOT FLASHES; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 205 pounds, and height was 74 inches. The patient's concurrent conditions included: essential tremor, non alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient did not ingest caffeine or other drugs. Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, administered on 09-FEB-2022 for prophylactic vaccination. Concomitant medications included propranolol for essential tremor. On 11-FEB-2022, the patient experienced irritable bowel syndrome symptoms, lower back pain, shortness of breath, and hot flashes. Treatment medications (dates unspecified) included: buspirone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritable bowel syndrome symptoms, lower back pain, shortness of breath, and hot flashes. This report was non-serious.
Cellulitis - at injection site - 2 days post-immunization. Keflex 500mg. tid X 7 days
Body Aches, Fever (ear thermometer 101.8F), Chills.  Took Tylenol and symptoms were managed. No symptoms after 36 hours from time of injection.
01/22/2023, I had a cough, slight fever, nasal congestion. A terrible cough which lasted about 3 weeks altogether. I used over the counter medications. 02/03/2023, Medical office and spoke to the physician assistant. The PA said she had been seeing a lot of really bad colds. I also had a telehealth visit prior to going to the urgent care.
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 16:30 as dose 1, single (Lot number: EN6202), in left arm, on 22Mar2021 at 15:30 as dose 2, single (Lot number: ER2613), in left arm, on 29Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 30135ba), in right arm and on 18May2022 at 13:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (Jul2022) positive, notes: I have tested positive for COVID after taking PAXLOVID treat as prescribed; (Jul2022) negative, notes: I tested negative after 6th day with a home test; (18Jul2022) positive, notes: I'm positive with home test this morning; (Jul2022) positive, notes: tested positive with PCR on the 7th day after starting treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The Patient had no known allergies. Patient had tested positive for COVID after taking PAXLOVID treat as prescribed. She tested negative after 6th day with a home test and tested positive with PCR on the 7th day after starting treatment. Today is 18Jul, she was positive with home test this morning and was experiencing mild symptoms, congestion and runny nose. No Fever. Adverse event start time: 10:00 AM. The patient did not receive other medications in two weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.   No treatment medication was given.   The box of vials was received on 14 Oct 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Ear pain; Seasonal allergy; Visual issues; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 08-Apr-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues). At the time of the report, EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I started getting a cough; I have been restless at sleeping at night when I lay down it's hard to breathe; I have been restless at sleeping at night when I lay down it's hard to breathe; This is a spontaneous report from a contactable consumer. A consumer (patient) of unknown age and gender reported that he/she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 08Mar2021 at 11:40 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Mar2021 the patient started getting side effects, he/she started getting cough and had been restless at sleeping at night when he/she layed down it was hard to breathe and in the daytime it felt fine. Patient would like to know do you have any idea and how long these symptoms would last. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Reports feelings of chest tightness, heart racing and palpitations which have been off and on since receiving the H1N1 and Seasonal flu vaccine on the same date.
Pt came in store today stating that he had atrial fib episode the next day after the shot. He said that he had the same problem on his 1st dose (he did not tell us about the 1st one), only now. But he said he was fine the next day.
localized cheek and tongue swelling, with some itching at same location, which began approx 10-12 after IM injectgion
arm became very red to elbow-very hard @ touch-very hot; administered ice-about 6 hrs p/shot did not help-did call ER & visited next day; nurse stated local rxn-cont w/vax next yr; itchy-swollen;
being sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "being sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Muscular Pain in extremties specially in upper arms. I used to lift weights before now it hurts to raise my arms parallel to the ground. Walking is a challenge, now I walk slow as a snail. Fatigue and  nervous stomach.  It has been a month , I thought this will go away  and I hope it does . Not sure if I should just wait to heal or get medical attention.
Gave COVID-19 BIV 12+ to an 11 y.o female instead of the 5-11 BIV. No symptoms or adverse reaction during her 15 minutes here. The CRNP spoke with family and informed of reactions and if she has symptoms to have her seen in office and or ER depending on severity of reaction.
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient came out of vaccine area to wait for 15 minutes to be monitored when he started sweating profusely, was pale white and asked for someone to come talk to him. After reviewing potential adverse effects, patient was able to breathe, no swelling or trouble breathing. But complained of arm tingling/dizziness/weakness at which point rescue squad was dispatched for further evaluation. I stayed with patient and reviewed symptoms with rescue squad, patient choose not to go with rescue squad.
injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; First dose of BNT162B2 on 22Dec2020 15:00 PM, second dose of BNT162B2 on 07Jan2021 08:00; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included known allergies to adhesive. Concomitant medication included duloxetine, ethinylestradiol, levonorgestrel (AMETHYST), bupropion, tizanidine. There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not COVID tested post vaccination. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies; tramadol and experienced allergies. The patient received the first dose of BNT162B2 on right arm on 22Dec2020 15:00 PM for COVID-19 immunization. The patient experienced injection site redness, swelling, lump, itching on 07Jan2021 22:00 with outcome of recovering. No treatment was received for the events (injection site redness, swelling, lump, itching). The patient also had first dose of BNT162B2 on 22Dec2020 15:00 PM, second dose of BNT162B2 on 07Jan2021 08:00.  Information on the lot/batch number has been requested.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a male patient of unknown age who received an expired dose of vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date (ADACEL was given seven days after it expired), the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5533BA (expiry date: 18-Jan-2019) via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient experienced any post vaccination reaction. 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 2001/83/EC 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.
Coronavirus; Tiredness/ extreme tiredness; Temperature fluctuations; Rapid heart rate; Site of injection and the entire arm was painful; Site of injection and the entire arm was painful; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, between 3 and 5 months after receiving Shingrix, the patient experienced coronavirus infection (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased. On an unknown date, the outcome of the coronavirus infection was recovered/resolved and the outcome of the injection site pain and pain in arm were unknown and the outcome of the tiredness, body temperature fluctuation and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the coronavirus infection, injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine in left arm and her site of injection and the entire arm was painful after getting the first dose of Shingrix. This lasted for about 4 days. She came down with coronavirus in March of 2020, due to which she was hospitalized for a week. She recovered from coronavirus. After discharge from hospital she had been experiencing extreme tiredness, temperature fluctuations, and rapid heart rate. She stated it was getting better but at time of reporting she was still experiencing it. The reporter consented to follow up. The outcome for event coronavirus was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Pain & swelling on upper R arm to elbow the evening of injection. Worsened next day. Patient saw physician who prescribed LEVAQUIN 500mg daily for 10 days.
No adverse reaction. Reporting 2 Hep-B's given at same time. Haemophilus not given. No reaction.
Lt. deltoid below site of vaccine is red, painful with pressure and edema. Patient had a low grade fever the morning of 1-29-14 of 100.7 degrees. Resolved by 1:00 PM 1-29-14. Improved with time and ice applications. Pt. stated that she had a similar reaction to an Influenza vaccine and with infiltration of an IV - same area Lt. arm.
45 minutes after getting the vaccine I couldn't stand. My right leg felt like it was being sawed off from my hip. The pain would change from my foot, hand, etc.  It also caused me to be horribly inflamed. I was red and swelled for 2 weeks.  For 3 days the pain was so bad, I wanted to go to urgent care. I am very scared about the second vaccine.
Didn't have much energy; Upset stomach; Sick in bed all day; Nausea; Vomiting; Left arm pain/sore arm-left; Very Cold; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day) and FEELING COLD (Very Cold) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain/sore arm-left), FEELING COLD (Very Cold), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 23-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Oct-2021, the patient experienced ASTHENIA (Didn't have much energy). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 23-Oct-2021, MALAISE (Sick in bed all day), FEELING COLD (Very Cold), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) had resolved. On 26-Oct-2021, ABDOMINAL DISCOMFORT (Upset stomach) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.
Myalgia, Arthralgia, Fever, NauseaVomiting, hEADHEADACHE, FEVER, CHILLS, ALL OVER BODY ACHES, SWOLLEN LYMP NODES Narrative: HEADACHE, SWOLLEN LYMP NODES, FEVER/CHILLS, ALL OVER BODY ACHES, NAUSEA
Parent reports child c/o pain all over left side of her body - arm, shoulder, flank, buttocks and thigh upper abd pain and "swollen glands under her chin". Parent gave Ibuprofen says helped only small amount. Parent did not seek any medical attention until telling IZ clinic of symptoms today. Was referred to seek medical attention today/ options reviewed with parent for medical care facilities.
1wk following vax mom reported gen welt on body & in throat;rash accompanied by itching;no fever;pt was seen by MD & was treated for severe allerg rxn;
p/vax pt became pale & diaphoretic; laid down & immed had grand mal seizure; mom refused all med advice
VEINS APPEARING ON BODY/ ON THIGHS/ LOWER PARTS OF LEGS/ ON SHOULDER/ ON BOTH GROINS; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced veins appearing on body/ on thighs/ lower parts of legs/ on shoulder/ on both groins. The action taken with covid-19 vaccine  was not applicable. The outcome of veins appearing on body/ on thighs/ lower parts of legs/ on shoulder/ on both groins was not reported. This report was non-serious.
Redness, pain, warmth, swelling, induration; clinically consistent with cellulitis and treated as such