chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022 at 2:23 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 28-Mar-2022 at 2:23 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient received vaccine past its 30 day expiry date. Vaccine went into 2 to 8 C thaw state on or about 24-Dec-2021.  No treatment medication was reported by reporter.
Became very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's Comments: The reporter was an acquaintance of the patient. The reporter stated that the patient became very sick (undefined) after receiving the Shingrix vaccine. Reporter provided limited information. The reporter did not consent to follow-up. Additional Supportive Information: This case has been linked to US2022066904, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066904:Same reporter.
pt recv vax presented to ER w/a fever & an inj site rxn characterized by a rash, redness & swelling measuring 4 to 5 inches in diameter;the next day was seen by MD & treated w/Keflex & claritin;pt recovered @ the date of this report;
Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.
Right leg swollen, hard, red, warm to touch, from hip to calf, enlarged lymph nodes 15 cm groin
Her lips, or near where that filler was put in, had some swelling; chills; arm was swollen; arm was really painful; her face has swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful), SWELLING FACE (her face has swollen) and LIP SWELLING (Her lips, or near where that filler was put in, had some swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421-20A (2nd dose)) for COVID-19 vaccination.     No Medical History was provided by the reporter.  The patient's past medical history included Dermal filler injection (Patient had filler put in lips.).   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Jan-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful) and SWELLING FACE (her face has swollen). On an unknown date, the patient experienced LIP SWELLING (Her lips, or near where that filler was put in, had some swelling).   At the time of the report, CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful), SWELLING FACE (her face has swollen) and LIP SWELLING (Her lips, or near where that filler was put in, had some swelling) outcome was unknown.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Extreme fatigue after 2 weeks first shot. Shingles after 2nd shot.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
vaccination failure; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Heart" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 01Dec2022; CARVEDILOL; COSAMIN DS [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;MANGANESE ASCORBATE]; ISOSORBIDE; FOLIC ACID; LUBIPROSTONE; METHOTREXATE; PANTOPRAZOLE; PEARLS PROBIOTICS; PRASUGREL; PRESERVISION AREDS; REMICADE; VITAMIN D3. Past drug history included: Naproxen, reaction(s): "known allergies: naproxen". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid from 01Dec2022 to 06Dec2022.
Starting about 10 days after the booster I have been getting terribly itchy full body hives.  This has been ongoing for about two months and though the hives are starting to lessen, they are still horribly itchy.
About a week after vaccination, began experiencing abdominal pain in the stomach region. Began originally as a stomachache, but soon became burst of sharp pain and dull pain. This pain continued with episodes at least once a day for the next 3 months until the very end of August when it finally became less frequent, ending in the beginning of September. The pain was accompanied by gas, bloating of the stomach, and aggressive diarrhea at least twice per day, including blood in the stool in one instance.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Passed out two times and was shaking upon waking. I didn't wake up fully for almost 1 hour.
4yrold came in for WCC had proquad & kinnrix as part of his vaccine series. 20 min after shots developed sore throat, then cough, sneeze, returned to clinic was in clear distress w/ O2 sat 95%, breath sounds coarse & wheezing. Call 911. administered epi went to check on, resolved all symptoms 30 mis after epi
REDNESS, SWELLING, ITCHING, PAIN OCCURRED WITHIN 10 HOURS OF THE VACCINE. DIARRHEA, NAUSEA, FATIGUE
Tdap was given instead of hep b vaccine. Immediately called physician to report, another nurse called pharmacist to see if we needed to do anything or watch for anything. Physician reported to just monitor baby, but she didn?t anticipate for baby to have a reaction to the vaccine and to give hep b later in the day.
Pt experienced knots in thigh. Physician diagnosed cellulitis vs localized reaction. Pt treated with Benadryl and Keflex. Given Tylenol, Advil and Benadryl for pain.
Information has been received from a licensed practical nurse/immunization coordinator concerning a 61 year old female patient who on 25-MAR-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) instead of ZOSTAVAX (Merck). NO adverse effects were reported. The patient did not seek medical attention. Follow up information has been received from a licensed practical nurse who reported that on 25-MAR-2010 the patient with no pertinent medical history was vaccinated IM with a dose of VARIVAX (Merck) (Lot number 665418/1162Y, expiration date: August 2013) instead of ZOSTAVAX (Merck). No further information is available.
6/18/03 developed itching at injection site with some erythema. 6/23/03 itching and erythema. Erythema 24.5 x 8cm at widest point, sl. warm to touch, minimal induration. Temp 97.1, no SOB, dyspnea. Rx: Elocon BID prn itching, Benadryl 50mg q 4 prn, Aleve x 2 BID prn.
Dizziness, Sedations, Diarrhea, NauseaVomiting, Chills Narrative:
Symptom are significant upper arm pain like a strained muscle or bruised bone. Pain increases when moving arm. Upper arm has burning feeling in the middle of the night enough to wake me up and take pain relievers. It's been 7 days since the shot and the pain does not show signs of subsiding.
Injection site swollen, red, itchy and painful to the touch. Redness has not went away it periodically will change between painful and itchy. So far its been a little over a week and been consistently.
Vesicular rash at right thigh and right nares noted. Acute respiratory decompensation requiring ICU admission on 9/23/00. Dx'd with akinesia-dyskinesia sequence, myopathy, respiratory failure s/p trach and ventilation, GE reflux on meds, poor POs s/p G-tube and developmental delay with steady progress. Please see medical records for more detailed information.
Fever x 24 hours Temperature max 103.5, treated with Over The Counter MOTRIN.
C/O pain, redness, inability to perform R.O.M. with affected arm.  Diagnosis Brachial Neuritis post TD for adults 2 days.  Treatment per pcp Ibuprofen & Vicodin.
11/30 79-year-old male with a history of asthma, atrial fibrillation, CHF, COPD, CAD, diabetes mellitus, inflammatory bowel syndrome, kidney stones, reports she's been short of breath with cough and congestion over the last week. He denies any chest pain. His cough is productive of thick yellow sputum. No fever. Denies any leg swelling or pain. He is immunized against Covid 19. EMS was called. His SPO2 is 85% on room air. He does not use oxygen at home. He was placed on 6 L and his SPO2 is 93% here. No distress on arrival 12/1 COVID-19 pneumonia, on hiflo O2. Vaccinated earlier this year. Cont decadron, Start remdesivir & baricitinib 12/3 Patient complaining of pain, requested several pain meds, including high dose Patient complaining of pain, requested several pain meds, including high dose of Neurontin, Norco, dilaudid.  12/4 discontinue all antidiabetic oral medication.    We will adjust meds as needed.   - Resume home dose of Creon.  - Hyponatremia likely due to hypovolemic hyponatremia.   Fluid management per Nephro.  - We will avoid nephrotoxic medication, adjust meds per GFR.  Consult to Nephrology.  - Patient has suprapubic catheter - Anemia likely secondary to chronic disease anemia.  - The patient is currently on PPI.  - PT/OT.  12/6 Patient once again was asking for more pain medication, asking for Dilaudid. Patient was informed we will try to get pain specialist 12/7 O2 supplement to maintain SPO2 > 92%,  with weaning attempts as tolerate... Patient recently transferred down to ICU for intubation for failure to maintain saturations on BiPAP. See RRT note for details. Cardiac arrest occurred post-intubation  Initial Rhythm: PEA after patient was noted to brady down. 1 round of CPR with 1 mg of epinephrine before achieving ROSC. Details in code sheet.  Intubation : yes Person responsible for intubation: CRNA Verification of Correct Placement:  End tidal CO2  12/8 Last night RRT was called due to hypoxia and agitation, the patient was intubated and sent to the ICU, the patient did have cardiac arrest, and after one round of CPR and epinephrine, the patient's ROSC was obtained, the patient did have another code, and discussion was held with the family. Ultimately, family made the patient DNR and patient passed just after midnight at 0011.
Pt recv vax on 4/15/99; on 4/21/99 pt exp concentric red morbilliform raised rash on rt arm
Sore arm, Headache, Body aches, Severe fatigue, Abdominal cramping, Brain fog (disconnected feeling)
Vaccine given on 9/17/2018. Symptoms of numbness, burning, and tingling in bilaterally lower extremities developed on 9/27/18. These symptoms spread to the upper extremities and left side of face. No issues with respiratory complications.
covid-19 came never received my 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Original Shingles vaccine (had gotten the original 1 shot).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported this case. The age at the vaccination was not applicable. The patient received 1st Shingrix shot about the time COVID-19 came into country so never received his/her 2nd shot within 6 months, which led social problem. Till the time of reporting, it had been 12 + months since 1st shot,  so the patient enquired if he/she could still get the booster shot.
Patient describes extreme redness and inflammation (swelling the size of a tennis ball) on arm, low grade (mild) fever, chills
I was pregnant at the time, EDD 6/23/22.  Received booster several weeks pregnant and several weeks later developed severe chronic urticaria/dermatographia. Dermatologist suspects is it a booster side effect possibly worsened by immune state in pregnant. It has been 3 months and I?m taking two anti histamines and it is improved but not resolved.
Fever, body aches, weariness, sleepiness, headache. Treated with test and fluids.
HPV vaccine given by mistake instead of the correctly ordered PCV15  No adverse reactions noted on day of vaccination.
No additional AE; first dose of Gardasil 9 on 24-AUG-2021/ home pregnancy test yesterday (20OCT2021) that came back positive; This spontaneous prospective pregnancy report was received from a female patient of unknown age, reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-AUG-2021, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for immunization (vaccine exposure during pregnancy). On an unknown date in 2021, she became pregnant with last menstrual period (LMP) estimated as unknown date in 2021. It was reported that the patient was not pregnant when she received first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On an unknown date in October 2021, she took home pregnancy test that came back positive. The pregnancy outcome was pending. There was no additional adverse event.
Information has been received from a 60 year old female with sulfonamide, morphine, DEMEROL and CELEBREX allergy who on 02-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck), lot number unknown. Concomitant therapy included VALTREX, simvastatin (manufacturer not reported), PLAVIX, DIAZIDE, fluconazole and omeprazole (manufacturer not reported). On 03-JAN-2009 the patient experienced warmth, redness, swelling, and itching at the injection site. Patient then developed bruising. Patient stated that she received vaginal herpes after the vaccine and as of 14-JAN-2009 has developed shingles. It was reported that she usually develops a case of the shingles at 3-4 times a year. "Routine labs" were performed (results not provided). Patient not recovered. Additional information has been requested.
-pruritic rash which started 01/11/2010 No SOB No fever No arthralgias - hydroxyzine 25 mg 1-2 by mouth as needed for itching # 30 , OTC CLARITIN PRN
I did not have an adverse reaction to the vaccine. I had strep throat in 02/2023 and I was tested for COVID-19, but it was negative. I saw my doctor and was prescribed an antibiotic and a cough syrup. I got exposed to strep throat from my grandsons. I have recovered with no lingering symptoms.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves two- patients (gender and age at the time of reaction were not reported) who were vaccinated with a dose (reported as invalid doses) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, dose in series, site and route of administration were unknown) on an unspecified date. The patient's medical history, concomitant diseases, family history, risk factors and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that two patient received invalid doses of flu vaccine, package of vaccines shipped on 30 Aug 2018 that arrived on 04 Sept 2018. It was not reported whether the patients experienced any adverse events or not. 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. Documents held by sender: none
Report mild sore throat on 11/10/11 and resolved 11/11/11. Acquire info by contact client.
Rec'd shingles vacination.  Developed a red and inflammed tennis ball size lump at the injection site (right arm).  Lymphnodes under the same arm swollen and painful.  Two red patches of skin on the side of the right breast.
This spontaneous case reported by a consumer, describes the occurrence of swelling (whenever she itches, she feels a bump is coming out) and rash (all over body except face and feet/really itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced swelling (whenever she itches, she feels a bump is coming out) and rash (all over body except face and feet/really itch). The patient treated with cortisone for itching, at a dose of 1 dosage form. At the time of the report, swelling (whenever she itches, she feels a bump is coming out) outcome: unknown; and rash (all over body except face and feet/really itch): not resolved. The patient stated when she applied OTC cortisone cream; it helped a little bit but after she washed her body, itching came back again. Concomitant medications not provided. This case linked to MOD-2021-197793 (patient link).
renal failure; hard to catch my breath/SOB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to catch my breath/SOB". Clinical course: The patient did not have Dyspnea, Tachypnea, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome, Cardiovascular, Heart failure, Cardiogenic shock, Arrhythmia, Myocarditis, Vomiting , Abdominal pain, Jaundice, Acute liver failure, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Renal, Acute kidney injury, Neurological, Altered consciousness: No, Convulsions/seizures Encephalopathy, Meningitis, Cerebrovascular accident, Hematological Thrombocytopenia, Disseminated intravascular coagulation, Dermatological, Chilblain, Erythema multiforme: No OTHER (e.g. multisystem inflammatory syndrome [MIS]: No and it was unknown the patient had Hypoxemia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash started around injection site of Pediarix then rash and swelling spread over most of body resulting in trip to hospital - still on oral prednisone at follow-up appointment with MD on 12/10/07.  01/25/2008 MR received for 2 ER visits 12/7/2007 and 12/8/2007 with D/C DX: Allergic Reaction  Systemic-probably reaction to immunizations and Rash likely 2' to medication reaction.  PE (+) for red, macular papular rash  to legs, torso, and arms, otherwise WNL except infant fussy. D/C on benadryl and prednisolone.  Returned to ER next day with worsening sx including puffiness of the cheeks and eyelids and reduced appetite. D/C to f/u with PCP.
Patient may have received Pfizer vaccine instead of Moderna for the second dose in their series. Patient completed observation without incident.