chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 17-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Reports ? swelling, hives palms, legs evening of 10/29.  Resolving when seen 10/30 by provider.
Day after injection started with chills, pain at site, temp, welts on upper arm increased pain.
BRUISE ON HIS RIGHT UPPER ARM; LOOKED LIKE A PATCH OF RED BLOOD VESSELS, WHICH LOOKED LIKE RED THINGS UNDER HIS LEFT ARM; TURNED BLACK AND BLUE AFTER 1 WEEK LIKE  PUNCHED THERE; PAIN AT THE VACCINE SITE FOR A LONG TIME( 2 WEEKS); LEFT ARM WAS SWOLLEN FOR 2 WEEKS WITH AN ABNORMAL SHAPE; This spontaneous report received from a consumer concerned a 40 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: 004A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced left arm was swollen for 2 weeks with an abnormal shape. On 27-MAY-2021, the patient experienced pain at the vaccine site for a long time. On OCT-2021, the patient experienced turned black and blue after 1 week like punched there. On 09-OCT-2021, the patient experienced bruise on his right upper arm. On 09-OCT-2021, the patient experienced looked like a patch of red blood vessels, which looked like red things under his left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm was swollen for 2 weeks with an abnormal shape, and pain at the vaccine site for a long time on JUN-2021, and was recovering from bruise on his right upper arm, turned black and blue after 1 week like punched there, and looked like a patch of red blood vessels, which looked like red things under his left arm. This report was non-serious. This case, from the same reporter is linked to 20210555169.
unconsolable crying for more than 3 hrs; taken to ER; also t102-large swelling inject site;
Swelling around the base of the neck (left, right and front) and up the sides of the neck; initially treated with heat/cold therapy and ibuprofen; no impact on the swelling; visits to the primary physician, ER and referral to ENT all unable to explain or alleviate issue
2 days after vaccination the patient developed bilateral tinnitus, moderate intensity which has persisted.  He had subj. fever, body aches malaise day 1-2 of vaccination, then day 3 developed the tinnitus.
pt diagnosed COVID positive  2 days before hospital admission; admitted with increasing SOB and malaise; O2 saturations @ home were 85%; placed on O2, 8L via NC; cough, treated with dexamethasone and baricitinib; has AKI therefore didn't treat with remdesirvir; COVID pneumonia and ARF with hypoxia; placed on Vapotherm and eventually BiPAP; pt's condition worsened; palliative care was consulted; pt was taken off BiPAP and she was kept comfortable; pt expired in the hospital
Urticaria; hives started 4 hours after vaccine was administered; itchiness; low grade fever; Zyrtec and Prednisolone Sodium Phosphate Solution 15 mg/5 mL.
pt recvd shot @ 3PM on Thursday; In the middle of noc around MN t105 R, pt flaccid, moaning, not moving, dilirious; lasted for 2 days; got pedia Proten & fever broke p/2 days;
Warmth sensation came over her body; Burning lower back pain; Her legs feel tingly; Arms hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulosis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen Puffy Right upper eye lid  and lower eye sack Itchy Sides of mouth slightly inflamed
Immediate  pain in arm, later that evening around midnight had uncontrollable chills and heart racing throughout night, around 5/6 am had incredible body pains and weakness where I felt my legs could not support my weight, severe nausea, fatigue, headache, and low grade fever that lasted all day until about 10pm. It was one of the worst days of my life. Very intense pain all day. The next day my legs still feel weak though better, nausea persisted, as did arm pain. I took Tylenol every 4 hours.
woke w/fever 104.4;early Am 26DEC98;taken to MD 26DEC98 rash appeared & was seen by MD;MD felt that rash not due to MMR;child cont to run fever & break out;rash on face & chest;28DEC98 T102;MD feels viral infect;
Narrative:  Pt is a 66 yo gentleman with medical co-morbidities of poorly- controlled hypertension, ESRD HD (MWF, LUE AVF), Hep C s/p treatment w/ SVR, who presented to the ED for worsening shortness of breath after HID +UOP without dysuria, hematuria. NO fevers, chills, or night sweats. No chest pain, pressure, tightness or squeezing. No pain on deep inspiration, denies increased cough or sputum production, only shortness of breath. Date of onset of symptoms: 7/30/21. CRS grade 0 with need for 2L of O2.
My throat closed; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (My throat closed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (My throat closed). At the time of the report, THROAT TIGHTNESS (My throat closed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days.  Diarrhea stated at 6:00 am the day after my second shot and lasted  10 days.
Extreme pain in joints; chills; fever; migraine; swollen lymph nodes in underarm and groin; booster of Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 16:45 (Lot number: FJ8762) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: other medical history: Asthma allergies heart murmur; "heart murmur" (unspecified if ongoing); "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "known allergies: Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SINGULAIR; NASONEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 16:45, outcome "unknown", described as "booster of Pfizer vaccines"; ARTHRALGIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "Extreme pain in joints"; CHILLS (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "fever"; MIGRAINE (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "swollen lymph nodes in underarm and groin". Therapeutic measures were not taken as a result of arthralgia, chills, pyrexia, migraine, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders, On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL 9 (lot # M004116, expiry date: 12-OCT-2017; lot # L004475, expiry date: 12-MAY-2017). The vaccine was stored at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
At the clinic, this RN spoke with mother of patient who brought her son to clinic for a booster shot of Pfizer.  I informed the mother that her son was not yet eligible for the booster because he was under 18 years of age.  She reported that her daughter, the patient, had received the Pfizer booster at this clinic earlier in the day, and she is also under 18 years of age (and not immunocompromised).  I  informed the mother that the RN vaccinator had mistakenly given her daughter the booster, which is only approved for individuals 18 and older. This was a medication administration error.  I consulted with Dr., Deputy Public Health Officer on 11/22/21.  I followed up with mother of patient on 11/22/21 by phone. Mother reported that her daughter did not experience any side effects from the vaccine, and she felt fine.  I informed mother that this 3rd dose for her daughter is considered her booster shot, and that the booster should not be repeated.
Patient presented to BHC 237 with rash  24 hrs post multiple vaccinations.  Patient presented with urticaria with large red blotches with flat raised areas on the head and truck with no drainage or excoriation noted.  Patient states above presented on 21Jan09 2-3 hours before presenting to BHC 237.  Patient denied SOB/difficulty breathing upon examination.  Patient treated with Hydroxyzene.  Patient reported back to clinic on 22Jan09 with symptoms resolved.
Had Vx and still got shingles/Suspected Vaccination failure; Still got shingles; Not as painful since had shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Vx and still got shingles/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got shingles) and pain (Verbatim: Not as painful since had shot). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient interactive digital media. The patient had the shingle vaccines and still got shingles.  The patient stated that it was probably not as painful since he/she had the shot.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR064976, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR064976:Same reporter - Mother case
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-DEC-2014 the patient was inadvertently vaccinated with (Merck) VARIVAX, subcutaneously instead of (Merck) ZOSTAVAX. Concomitant medications were not reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX was not reported. Additional information has been requested.
TOOK THREE DOSES WITH FOOD; This spontaneous case report was received from a pharmacist (PVX2019-362) on 08-Feb-2019. The report describes a 72-year-old elderly male consumer who "took three doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took three doses of Vivotif with food.  The action taken with Vivotif with respect to the event "took three doses with food" was not applicable.  The clinical outcome of the event "took three doses with food" was unknown.  Company's Comment: The causality of the event "took three doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses with food" was considered as not applicable.
NauseaVomiting Chills, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
Initially started out as leg/ joint pain, insomnia and involuntary muscle spasms. Progressed into acute chorea. The muscle spasms became more painful. She describes them as her muscles trying to come out of her skin.
COVID-19 DISEASE (2/26/2023)  ACUTE HYPOXEMIC RESPIRATORY FAILURE (2/26/2023)   Assessment: Not quite clear if hypoxemia due to COVID-19 versus aspiration.   Plan: DC remdesivir since patient will be discharged today.
dry throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat) and COUGH (cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011O21A) for COVID-19 vaccination.  Concomitant products included VALSARTAN for Blood pressure, APIXABAN (ELIQUIS) for an unknown indication.On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (dry throat) and COUGH (cough). At the time of the report, DRY THROAT (dry throat) and COUGH (cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.The patient said that she takes Eliquis and Valsartan for blood pressure as regular medication. This case was linked to MOD-2021-386475 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Non significant follow up appended.
A pharmacist reported that a 69-year-old male received an injection of Flu Shield and subsequently developed Guillain Barre Syndrome. No further information was available at the date of this report. This report of a labeled event is being submitted in a 15-day time frame requested by the FDA.
This spontaneous report was received from a physician regarding a male patient of unknown age with no pertinent medical history reported. Approximately on 01-JUN-2013 (reported as "about 10 days ago") the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) 0.65 ml, subcutaneous, once) for prevention. No other suspect therapies or concomitant medications were reported. Approximately on 01-JUN-2013 (reported as "about 10 days ago") the patient presented with "shingle-like" symptoms after receiving ZOSTAVAX. The outcome for "shingle-like" symptoms was unknown at the time of the report. No treatment information was reported. Additional information is not expected.
STROKE; This spontaneous report received from a consumer via a company representative via social media  concerned a male of an unspecified age, race and ethnic origin. 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 administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220230564 and 20220230385.; Sender's Comments: V0-20220230560- covid-19 vaccine ad26.cov2.s- Stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I also had an allergy shot and the same day. I have chills, aching body, feels like the flu. I feel horrible.
This initial spontaneous report was received from a registered nurse (also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of GARDASIL 9 injection (lot # L007560 with expiration date 15-JUN-2017, lot # L013429 with expiration date 1-JUL-2017, lot# L017407 with expiration date 15-AUG-2017 and lot# reported as L030869 with expiration date 18-JUN-2018; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
fatigue immediately following then loss of appetite, muscle aches, headache, abdominal pain, lightheadedness, fever, and chills 30min later
Vaccine given 2/18/10, pt noticed next-day redness, itchiness, warn to touch. 2/24/2010 arm started feeling stiff.
Headache; fatigue; nausea; This is a spontaneous report from a contactable nurse or other hcp (patient).   A 66-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot number: EN6200, Expiration date was not reported) via an unspecified route of administration, administered in left arm on 18Feb2021 at 09:15 AM (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing and patient had no known allergies. The patient's concomitant medications included lisinopril and metoprolol both taken for an unspecified indication, start and stop date were not reported. patient did not tested COVID prior vaccination. patient did not received any other vaccine within four weeks. On 19Feb2021 at 12:00PM, 1 day after first dose the patient experienced headache, nausea and fatigue. The patient underwent lab tests and procedures which included nasal swab or qualitative PCR sars-cov-2 test on 19Feb2021 which result was pending. Therapeutic measures were taken as a result of headache however not relieved by Advil and no treatment received for nausea and fatigue. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Multi-lobe pulmonary embolism. Only symptom was shortness of breath doing household chores. I had a nearly identical event nine years prior. Reported to ER. CT scan with contrast confirmed diagnosis. Started on Eliquis anticoagulation. Ultrasound of legs showed non-occlusive clot in posterior tibial vein in right calf. Stayed overnight in hospital. Released the next day. This event is likely not related to the Covid vaccine, but I reported this to V-Safe, and they called back and asked me to fill out this form.
I was vaccinated with the first dose of the Pfizer vaccine on 3/3/21. I started experiencing itching on my chest and back on 3/4/21. The itching sensation increased and I broke out in hives on the evening of 3/5/21.  I took an antihistamine and the hives subsided. The itching and hives started near the vaccine injection site on my left arm and spread across my chest, back, and to my right arm.
Immediate tingling in injection site arm. Following day experiences coldness and tingling in lower extremities.
Fever to 103, headache, myalgias, local redness and pain at injection site.
Pain at injection site, fever, chills, body aches, headache, fatigue Treatment: NSAIDs for 24 hours, fluids