chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. Patient received 2nd booster dose of Moderna COVID-19 Vaccine. No treatment medication reported by reporter.
DX SOB, COVID-19 pneumonia, elevated troponin, NSTEMI related to demand ischemia.Patient presented with acute hypoxic respiratory failure from COVID-19 pneumonia. ID and pulmonary were consulted. He completed course of Remdesivir, IV steroids. He clinically improved and was discharged home on room air once medically stable.  Readmitted on 12/14 with chest pain.  LHC showed severe triple vessels disease. Cardiology recommended transfer patient to Facility for CABG.
localized rxn to varicella vax 2wk p/vax @ site of vax w/erythema, few vesicles & warmth;
sick; Anemia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 "sick"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia".  Additional Information: Patent had been sick since he/she received our vaccine and developed Anemia from it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the event was unspecified. The sales representative was told all three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780845A and A0780846A for two additional reports of swelling.
Bexsero by mistake/ Menveo should have been administrated; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXD27AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th July 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 details were reported as follows: The case was reported by the patient's parent. The patient received the 3rd dose of Bexsero by mistake, when the dose of Menveo should had been administer, which led to wrong vaccine administered. The reporter consented to follow up.
Fever, chills, body pain, swollen arm, lump, big red spot on the arm, tenderness, constipation.
There is a small chickpea sized lump around my left side collarbone that I can move under my skin. It doesn?t hurt
Information has been received from a licensed practical nurse and a medical assistant concerning a 4 year old female patient. The patient had no relevant medical history, drug history, concomitant medications or laboratory data. On 14-APR-2017 the patient was vaccinated with PROQUAD (dose unknown, lot# M044018, expiration date 01-MAR-2018, rHA) subcutaneously to vaccinate against measles, mumps, rubella and varicella virus and sterile diluent(manufacturer unknown) (strength and dose unknown, once, lot# M029234, expiration date 12-MAR-2017) subcutaneously for prophylaxis (expired product administered). On 14-APR-2017, a certified medical assistant was attempting to give a vaccination to the patient. However, the needle separated from the syringe. Because of this, the reporter did not believe that the patient received much of the vaccination, but could not confirm that the patient received no medication. The patient was then given a successful vaccination of the PROQUAD from the same lot and expiration date (incorrect dose administered). It was unknown if the patient received more than the recommended dose of PROQUAD, but so far no issues had been reported. As of 14-APR-2017 it was unknown if the patient would receive future doses of PROQUAD, and the outcome of possibly receiving more than the recommended dose was unknown. Additional information has been requested.
Pt mom called on 10/11/2014 to inform that pt had had difficult night complaining of head and neck ache as well as "sensation of something traveling up her neck vessels"; on waking had "half-dollar sized warm red spot at injection site and arm swelling".  Advised to take Benadryl and ibuprofen and check back in 30 minutes.
April 6th, Sore arm at site of injection at 10pm, awakened at 3am with severe headache that lasted all day  took aspirin, headache was not relieved, experienced fatigue and body aches.These symptoms lasted 24 hours.   April 8th sore arm with no other problems, feeling great.
Narrative:  75-year-old male patient Covid vaccinated with PMH of essential hypertension, vitamin D deficiency, hyperlipidemia, glaucoma, bipolar disorder admitted after presented to ED with 1 week duration of shortness of breath and cough and COVID-19 detected with O2 sat at room air was 90% and CTA chest negative PE but with GGO's. #1. Acute hypoxic respiratory failure 2/2 COVID pneumonia -O2 sat at room air on admission:89 - 90% -->1-2 LPM NC sat at 98%-->(12/04)1 LPM NC O2 sat at 94%-->(12/05)95 to 97% at 2 LPM NC--> 12/06 at RA sats >93% patient is discharged home with no home oxygen needed. -Encourage use of incentive spirometry and self proning -Bronchodilator RTC #2. Acute Covid Pneumonia: Vaccinated with x2 Pfizer but no Booster yet -Continue IV remdesivir 11/30 - 12/04, dexamethasone 6 pm po 11/30 - 12/09 -Continue to trend inflammatory markers: Slightly elevated but stable -Continue supplements: Ascorbic acid, vitamin D and zinc oxide -Supportive treatment: Benzonatate - Serum procalcitonin: WNL, discontinue azithromycin Patient recovered and was discharged to home without need for supplemental oxygen.
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot # 641130? 116L). Subsequently the patient experienced injection site pain, injection site itching and redness and the site was warm to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow . The patient was afebrile. The nurse reported that the experience were severe and diphenhydramine (Benadryl) was needed to be given to the patient. It was in reported that the patient had previously received vaccination with pneumococcal vaccine 23 polyvalent and did not have a problem. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release  of this lot have been checked and found to be satisfactory. The lot complies with the standards and was release. Additional information has been requested. The nurse also reported that following vaccination with pneumococcal vaccine 23 polyvalent, two other females patient experienced injection site pain, swelling, itching, redness, pain and swelling (see WAES# 0204USA02065).
16 hrs after vaccine (4:30 am Thursday) woke up needing to urinate, went to stand up, collapsed via legs folding in, fell into window, went to bathroom, realized I had nausea, headache, checked temp 101.1, felt beginning aches and pains all over, up all night with crazy frequent urination, every 15-20 minutes, freezing chills, burning up at the same time, disoriented, wobbly, runny nose, up and down all day and night urinating and diarrhea began, Friday 6 am fever 100.3 still aching all over, still frequent urination and diarrhea, freezing chills, Friday 7 pm fever 99.3, still feeling awful, started sneezing, Saturday am, sneezing attacks , low grade fever of 98.9- mine is usually 97.3 avg., started feeling better, started Pedialyte and Imodium, still have hardly any voice from sneezing attacks, still aching in back, feel wobbly and disoriented, Saturday afternoon 4 pm, woke up soaking wet, fever gone, still feeling nausea, disoriented, wobbly, Sunday, slowly getting better, back hurts really bad and I am still shaky
After 2 weeks from the date of vaccination, I started to notice ringing/humming in my right ear. This is a sign of Tinnitus which I had a mild form the begin with. The noise is more noticeable now post vaccine.
The evening after vaccine she was cool shaky pale gray, tired. They started to take her to ER, but she wanted to go home. She had been laying on the floor and "felt like she was going to die". By the time got to the ER felt better and went home. No fever HR ok.
This spontaneous report was received from a certified medical assistant, reporting that doses of GARDASIL 9 (which had the lot number of L016429, expiration date 09-AUG-2017) were improperly stored. No adverse effects were reported. Furthermore, the vaccines experienced temperature of 18.49F, the time frame was 30 days (1137 hours). The call was because a "data logger". There was not previous temperature excursion. And there was not product quality complaint involved. This is one several cases from the same reporter. Additional information has been requested.
Numbness and tingling in face within 30 min. after vaccine administration. No other symptoms; no difficulty breathing, shortness of breath or chest tightness, no facial swelling. Symptoms resolved after about 4 hrs. No medications taken and no treatment.
Pain at injection site for 48+ hours; Slight swelling of face; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0171) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and heart disorder. The patient had no known allergies to medications, food or other products not to his knowledge. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received other unspecified medications in two weeks of vaccination. On 19Apr2021 at 16:00, the patient experienced pain at injection site for 48+ hours and slight swelling of face. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site for 48+ hours and slight swelling of face were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt rcvd vax; 48 hrs after vax; pt devel sore arm;
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated subcutaneously with the first dose of both (Merck) PROQUAD and (Merck) VARIVAX on the same day, on 26-DEC-2012. No adverse effect reported. Additional information has been requested.
Per call from mother on 2/2/00, pt starting large, red, swollen knot, peripheral to injection site. At assessment, 2/3/00, parents state redness & knot have decreased, dramatically. Now 2-3 cm nodule.
Information has been received from a registered nurse concerning a 5 year old female patient with no past medical history who on 27 June 2000 at 15:00 was vaccinated SC in the left upper arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #632456/0173K).  Concomitant vaccinations on 27 June 2000 included a fifth dose IM in the right thigh of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (tripedia) and a fourth dose SC in the right arm of poliovirus vaccine (ipol).  There were no illnesses at the time of vaccination.  On 27 June 200 at 22:00 the patient experienced a fever of 100-101 degrees fahrenheit, accompained by fatigue for 5-6 days.  The patient's skin has noted to be hot to the touch with the upper arm, from the shoulder to below the elbow, to be swollen to twice the normal size.  The upper are was blood red looking for 5 days.  Subsequently a band of tissue 1 1/2 inches around the site appeared.  The skin around this area was black (bruised) for 10 days.  Unspecified medical attention was sought and the patient was treated with ice, diphenhydramine hydrachloride (benadryl) and ibuprofen (Motrin).  On an unspecified date the patient recovered from her experiences.  It was noted that the patient always has fever and 1-2 days of fatigue following vaccines.  No further information is expected.
High fever (103.7*F), chills, body aches, severe lower back pain, cold sweats, nausea, dizziness, abnormal heavy menstrual bleeding, fatigue, loss of appetite.
A dose of DTaP was administered intramuscular instead of a dose of TDaP to a 21 year old pregnant women, who was 31 weeks gestation on 1/6/17.
Case previously recorded as MA2009-5504. Initial case report received via healthcare professional on 19 Nov 2009. A 3-year-old male child was vaccinated with S-OIV FLUVIRIN (batch no. 10127803) on an unknown date. The recommended age is 4+. Nurse wanted to know, what she should do. The child tolerated vaccine and he was fine. Reference no.: NA09-008593.
Hives that occurred 10 days following Moderna booster shot Hives have persisted now x 1 month
21JAN95 pt became irritable-fever 103.1 devel 22JAN95; mom took pt to ER-petechial rash also present-blood work & spinal tap done-tx w/Rocephin & Ampicillin; sent to Hosp 22JAN95 dx Neisseria Meningitis; pt cont to be hospitalized;
felt hot; eyeball pain; painful headache/"odd little headache"; fever/99.8 Fahrenheit temperature; chills was shaking and teeth were chattering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Laryngopharyngeal reflux (diagnosed with laryngopharynx reflux 17 years ago.). Concurrent medical conditions included Arthritis and Seafood allergy (allergic to mussels.).  Concomitant products included OMEPRAZOLE, METOCLOPRAMIDE HYDROCHLORIDE (VOMISTOP [METOCLOPRAMIDE HYDROCHLORIDE]), CELECOXIB, AZELASTINE and FLUTICASONE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 27-Nov-2021 at 3:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form three times a day. At the time of the report, FEELING HOT (felt hot), EYE PAIN (eyeball pain), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) outcome was unknown and HEADACHE (painful headache/"odd little headache") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Body temperature: 99.8 (High) 99.8 Fahrenheit.   It was reported that patient received half dose of Moderna booster.   This case was linked to MOD-2021-399992 (Patient Link).
AFTER RECEIVING HIS 2ND DOSE HE FELD ANXIOUS. ON SITE EMS RESPONDED AND VITALS ARE BELOW AFTER THE INITIAL EVAUATION HE HE SAID HE FELT BETTER AND WAS RELEASED TO GO HOME
Tight, hot red circle around the injection site more than 24 hours later. Severe pain in my left arm. Low grade fever, diarrhea and body aches beginning approximately 20 minutes after the vaccine was administered.
3 hours after receiving booster pt developed bells palsy. Being tx with prednisone and acyclovir
Shot one I was extremely tired and in a lot of pain. I went to the dr. or urgent care because my breathing got really bad. Shot two was as bad as shot one and I again went to dr. or urgent care because of breathing, I also was in pain and my head hurt both times had trouble waking up and staying awake. Third shot I had a sore arm day one, extreme body pain days two and three four and five. Diarrhea and pain headache all days but at about 9:30 pm on Friday I had a massive sharp pain in my head and instant migraine and nausea. By 4 am Saturday I couldn't handle and went to ER. First shots given didn't work then was given a narcotic it helped a little but it was gone until I took my migraine pills again later Saturday evening I have not been allowed back to work yet due to having the fentanyl.
The next morning after the vaccine I had a high fever, chills, and headache. Shoulders hurt. The muscular area around where the vaccine was injected also hurt. Burning sensation when urinating.
Swollen lymph node in armpit of arm that received shot; woke in morning with acute tenderness that persisted for 3 days, with discomfort moving that arm and sleeping on that side; symptom gradually receded; no detectable pain after 8 days
Patient reports mild soreness in her left arm after receiving the vaccine. Reports mild fatigue but this was expected due to pharmacy consultation prior to administration. She states she experienced vision loss in her right eye that developed a day or two after receiving the shot. Vision returned in about 24 hours.
This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# not reported, expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient vomited after receiving the BNT162B2 vaccine. The caller reported she might not be able to get her second dose of the BNT162B2 vaccine at 21 days due to a transportation issue. The caller wanted to know if she got the vaccine at 19 days, would that be ok. The caller reported the logistics for scheduling her vaccine appointment put the elderly and those without computers at a huge disadvantage. The caller heard from a healthcare worker that he vomited after receiving the BNT162B2 vaccine. The caller wanted to know more information on the side effect and wondered how long it would take for a severe allergic reaction to occur after the vaccine was administered. The caller heard on the news that patients are being watched for 15 minutes after the vaccine was given. The outcome of the event: unknown. Batch/lot number requested. Follow-up attempts completed. No further information expected.
Playing, smiling, interactive toddler with around 9 cm erythematous, edematous, well circular scabbed area with induration to the right ant, slightly lateral thigh with central ecchymosis around 3cmx2cm, minimally warm to touch and not apparently tender to squeezing. Walking well with groin adenopathy. Rectal temp 99.7. tX: Wait and watch. If increased erythema or new fever or new pain to go to PMD tomorrow. If related to IZ expectation for beginning resolution within 24 hours. Mother with return statement of when to go to PMD.
Hives around her neck; Temperature of 101 degrees Fahrenheit; Arm was aching; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy), URTICARIA (Hives around her neck) and PYREXIA (Temperature of 101 degrees Fahrenheit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy) and PYREXIA (Temperature of 101 degrees Fahrenheit). On 13-Mar-2021, the patient experienced URTICARIA (Hives around her neck). At the time of the report, PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy), URTICARIA (Hives around her neck) and PYREXIA (Temperature of 101 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 degrees Fahrenheit.         Action taken for mRNA-1273 was Not Applicable.   Information on concomitant product use was not provided by the reporter.  No treatment information was provided.