chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient's friend (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient went into a coma.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review the coma was considered to be an other important medical event.  Additional information is not available.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; Possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016B21A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 01 Apr 2022 and 04 Apr 2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C.  Between 22 Feb 2021 to 26 Apr 2022 there is no other temperature data available.  Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Lot numbers were provided include 057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A. Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Pericarditis; Damaged his vocal chords; Muscle wastage; This serious initial spontaneous safety report was received by Novavax on 06-OCT-2023 from a consumer, via social media monitoring.  A male of an unspecified age and race was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  The individual was reported as "healthy and well prior." No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced pericarditis (PT: Pericarditis) (Serious: Medically Significant), he damaged his vocal chords (PT: Vocal cord disorder), and he developed muscle wastage (PT: Muscle atrophy).  At the time of reporting, the event outcome of Pericarditis, Vocal cord disorder, and Muscle atrophy was unknown.  Lot number was not provided in the report.; Sender's Comments: This male of an unspecified age experienced: Pericarditis, Muscle atrophy and Vocal cord disorder after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Pericarditis was assessed as serious. The events Muscle atrophy and Vocal cord disorder were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Red, swollen area that spread to elbow after vaccine. Hot to touch & patient did not feel well next day.
Sz disorder developed & first noticed by parents 5 days p/receiving 2nd DTP shot.Dx Infantile spasms. Currently on sz meds & under care of peds neurologist.  Parents question their ability to identify spasms that may have occurred < 5 days.
extreme redness & swelling fr knee to buttocks, shrill scream, temp of 104;
4 hours after vaccine was given, vaccinee started having body aches and weakness, after 8 hours shivering started, and the shivering became very intense (like convulsions). Cold sweats started about 16 hours after the vaccine. All symptoms got worse until about the 36 hour mark, when symptoms started to resolve.
hot flashes,  problems with eating no appetite , very tired,  arms is swollen at site and feels very heavy. Vertigo and problems with Dizziness.
Information has been received from the mother of an approximately 8 week old female with a penicillin allergy who on 04/19/94 was vaccinated with MMR II. On approximately 05/03/94, two weeks after the vaccination, the pt developed a rash behind her ears and on the back of her neck, a high fever, vomiting and had bouts of screaming which lasted for about 9 days. The pt had received medical attention for her experience. The pt subsequently recovered. Additional info received from a physician indicated that he had no records on the pt. No additional info is expected.
5 days after receiving the shot, I experienced symptoms of Tinnitus for the first time in my life. My ears feel plugged up constantly and I have off and on ringing in my ears. Sometimes the ringing is associates with certain sounds coming from my vocals... other times it randomly shows up.
Boils appeared on my forehead, my jaw and face swelled up. Couldn?t open my mouth last a certain point. Swollen under right eye with burning sensation
She suffered and severe rash that spread over her entire body and up to her hair lines and turned her skin red.
Patient presented to BWH ED on 9/19/21 with fever, sore throat, cough and nasal congestion. Patient was fully vaccinated for covid. Covid test came back positive and patient was started on remdesivir. Patient was discharged on 9/21/21 with no chest pain or SOB.
kind of itchy; warm to the touch; tender and sore; arm is very red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (kind of itchy), VACCINATION SITE WARMTH (warm to the touch), TENDERNESS (tender and sore), VACCINATION SITE ERYTHEMA (arm is very red) and VACCINATION SITE SWELLING (swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (kind of itchy), VACCINATION SITE WARMTH (warm to the touch), TENDERNESS (tender and sore), VACCINATION SITE ERYTHEMA (arm is very red) and VACCINATION SITE SWELLING (swollen). At the time of the report, PRURITUS (kind of itchy), VACCINATION SITE WARMTH (warm to the touch), TENDERNESS (tender and sore), VACCINATION SITE ERYTHEMA (arm is very red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided. Upon in internal review on 04-Aug-2021, the age was corrected to 56 years
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 08Feb2021 as dose 2, single (Lot number: EI9769), in left arm, on 11Jan2022 as dose 4 (booster), single (Lot number: FJ1620), in left arm and on 31May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Jul2021 as dose 3 (booster), single (Lot number: FC378) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 05Oct2022; SULFASALAZINE, start date: 05Oct2022; HYDROXYCHLOROQUINE, start date: 05Oct2022; CYMBALTA, start date: 05Oct2022; ROSUVASTATIN, start date: 05Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID Rebound 7 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 covid-19 which was Paxlovid (Lot number: 149136) from 19Oct2022 to 23Oct2022. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 and EL3247 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507; lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
BURNING ON BACK OF THE HEAD; STINGING ON BACK OF THE HEAD; TINGLING ON BACK OF THE HEAD; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced burning on back of the head. On 10-APR-2021, the subject experienced stinging on back of the head. On 10-APR-2021, the subject experienced tingling on back of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning on back of the head, tingling on back of the head, and stinging on back of the head. This report was non-serious. This case, from the same reporter is linked to 20210810477.
No adverse event; 1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023; The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023), EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 15-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023), EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.).    It was unknown did patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 10-Mar-2023. The vial did not undergo any temperature excursions. Nurse has reported that only one expired dose was given. No treatment information was reported.
Pt has swollen and stiff left shoulder and arm; it is hot to touch; later she developed left side headache and left leg soreness (she is not sure whether is related to the vaccine or not). I reported it to her doctor's office and they made an appt for the afternoon. Pt later decicded not to go in today. I spoke to pt's daughter this evening and she said they will observe her over the weekend.  She will go in if it doesn't get better by Mon.
Fever, Chills, Body Aches, Exhausted, Bad taste in mouth.
Dizziness, Myalgia, NauseaVomiting, sweating Narrative:
p/vax pt devel T102, ear; next day, T104, ear; to clinic T102;
Mom reports large red welt and knot at injection site. In addition she reports baby completely stopped babbling and talking for 3 weeks after receiving the vaccine. He did begin babbling again but mom reports it is much less than what he was doing previously.
Fever fluctuating between 101 and 102, severe body aches especially in joints, dizziness, migraine, extreme exhaustion, brain fog (inability to think clearly or remember events).  Treatment was  Advil every 6 hrs
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with three doses of GARDASIL (doses, route of administration, lot numbers and expiration dates were not reported). On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported). There was no adverse event reported. Additional information is not expected because there was no consent to contact physician assistant.
Patient called and reported that developed a bruise, swelling at the sight. It was described as hard spot that is now resolving. There was an itchy rash surrounding  the area that was described as that the size of a dollar bill. Pt had taken Tylenol and was using a cool compress to treat. Pt in no distress. Instructed patient to take an antihistamine and use OTC hydrocortisone to treat the rash, and to seek medical attention if it didn't resolve in the next day or two.
DEVELOPED TONIC SEIZURE ACTIVITY X FEW MONTHS ON 1/24/07 AND ON 1/25/07-ADMIITED FOR EVALUATION ON 1/25/07-ANTIBIOTICS GIVEN PENDING NEGATIVE TESTS,EEG ABNORMAL(FOCAL ABNORMALITY)-NOT ON AMY MEDS AT THIS TIME 02/20/07-records received and reviewed for DOS 01/25/07-DX: Reflux vs Seizure. Possible seizures, Prior to ER visit patient had seizure that lasted for approximately 2 minutes, back arched, stiffened whole body, head deviated to left, eyes deviated to left. Second seizure morning of ER visit.  Temp 37. URI symptoms and loose stools 1-2/day for 7 weeks. 2 weeks ago changed formula. PE: WNL
Patient presented to the ED on 4/10/2021 , 4/18/2021 and 4/19/2021 for COPD with exacerbation. Patient presented to the ED on 4/26/2021 and was subsequently hospitalized for COPD exacerbation. These visits are within 6 weeks of receiving COVID vaccination.
Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Patient's medical history included No Adverse event.  The patient's past medical history included SARS-CoV-2 infection.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid-19). In April 2021, COVID-19 (Tested positive for Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Patient shown the symptoms include fever, feeling really sick, and fatigue. All are resolved except Fatigue. Treatment information not provided.
Had smallpox vaccine 3/5/03. On 10/6/03 I had the flu vaccine, which was given in very close proximity to my smallpox scar. On 10/8 around 7:30 AM, I noticed a reddened bum at the flu injection site and on 10/9 there was a small vesicle about (o) size noticeable in the mirror. Resolved by 10/11 with draining.
Upon second medical examination of the case during internal review, a significant correction performed on 3 February 2016 to update product screen, event screen, assessment screen and company narrative. Initial unsolicited report received from a pharmacist via other company (Merck) on 3 December 2015. Manufacturing report number: 1-14146974439. That report is from a Partner and contact information in based upon the location of our trading partner. This case involves a 72-year-old female patient who was vaccinated with a dose of Fluzone high dose (batch number, expiration date, dose, dose number and route of administration were not reported) and a dose of Pneumovax 23 (batch number, expiration date, dose, dose number and route of administration were not reported) both in same arm on 22 September 2015. The patient's medical history and concomitant medication were not reported. On 22 September 2015, same day following the vaccination, the patient develpoed unspecified reaction from shoulder to elbow on the unspecified arm that the patient received the Pneumovax 23 and Fluzone high dose. Laboratory investigation was not reported. The patient was treated with unspecified steroids. The outcome of the event was not reported. List of documents held by sender: none. Addendum 3 February 2016: Upon second medical examination of case at time of internal review, the following has been modified in this case: Administration site updated as arm. Manufacturer updated as Merck for PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE. Reaction site updated as shoulder to elbow. Required ER/Doctor Visit marked as "Y". Medically confirmed changed from "C" to blank. Corrective treatment updated in company narrative.
Gave patient Fluad Quad instead of Flucelvax Quad. No symptoms reported by patient
17 year-old patient was vaccinated with Moderna vaccine. Patient was scheduled to receive the 2nd dose at normal interval in accordance with CDC guidance.
Swollen, red, hot to touch and extremely painful entire left arm 13-18 days after injection.
1st, started with hiccups, GERD. Medicine worked, omeprazole Dr 40 milligram. No hiccups, will the 2nd vaccine and then got 2nd it got weird. 4hrs after the vaccine. The acid will come up and my esophagus tightened up and I can't breathe. I went to urgent care. Asked to go to emergency, gave Zofran and GI tonic for GERD.
This spontaneous report as received from a consumer refers to her husband, a 61 year old male patient with allergy to adenosine. Pertinent medical history was unspecified by the reporter. On 11-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were unspecified. On 16-SEP-2014, 6 days after onset of therapy the patient experienced hives spread to his head, both arms and now all over his body, having night sweats, head and body have been in pain (also reported as since September), rash spread to his head, both arms and now all over his body, and injection site reaction. The patient was on emergency room (ER) due to the events; the ER physician referred him to a dermatologist who performed a culture (unspecified) and unspecified lab/diagnostics tests (no results were provided for the tests). The patient received an unspecified treatment for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reproted. Additional information has been requested.
Chest tightness, fever, pain, redness, swelling at injection site, swelling at clavicle and arm pit Left side, hot flashes
Patient was inadvertently given Moderna vaccine for 2nd dose of mRNA COVID-19 vaccine series instead of Pfizer. 1st dose of vaccine given was Pfizer (Lot # EL9267) on 2/12/2021. Patient was notified of error.
Patient is a 68y.o. male with PMH significant for CVA, COPD, HTN, dyslipidemia and depression presents to ED via EMS for c/o SOB. History may be limited as pt is HOH. Poor historian. He states "unsure if I had covid vaccine".  His Imm record does indicate 2 shot covid PFE vaccine. Doubt he was boostered.   Pt states he has felt SOB over the last couple days with progressive worsening. Associated symptoms include fever and fatigue. Pt denies LOC, chest pain, palpitations, chest congestion, rhinorrhea, cough, sputum production, abdominal pain, N/V/D constipation or dysuria.  In the ED, pt was afebrile, normotensive and tachycardic with tachypnea. Pulse ox is 98% on heated high flow at FiO2 68%. Lactic acid 2.5, 1.6. Hgb 8.1. BNP 36. Troponin 0.01. Covid 19 detected. D-dimer 4,419. Chest xray - Multifocal consolidative opacities along the periphery of the lungs. No pneumothorax. No large effusion. The cardiomediastinal silhouette is stable. Right-sided shoulder arthroplasty. CTA PE protocol - 1. Subsegmental pulmonary embolus involving a left lower subsegmental branch without evidence of heart strain. 2. Peripheral groundglass and consolidative changes noted throughout the lungs, this can be seen in the setting of an atypical/viral pneumonia. 3. Prominent mediastinal and hilar lymph nodes, likely reactive to impression #2. 4. Trace right pleural effusion. 5. Moderate hiatal hernia. CT head - 1. No acute intracranial process. 2. Paranasal sinus disease. 3. Nonspecific white matter changes, likely secondary to chronic small vessel ischemic disease. In the ED, pt was given duoneb NMT, dexamethasone IV and pt was initiated on IV heparin.
Chills, fever, headache, muscle ache, swollen lymph nodes (deep pain in left breast)
nightmares, which lead to fighting in my sleep, as well as talking in my sleep.  when i open my eyes from waking up I see very vivid pictures of cartoon characters, people, scripts, moving objects that seem to be on the wall.  I spoke w/ my thereapist ref it, and she advised to try and touch it to see if its real.  (I know its not real) she said it could give me confirmation that its just an illusion.  IT IS NOT OK.