chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 331308A) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Lot number: 011Az1A) and on 01Apr2021 as dose 2, single (Lot number: 017B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile RA" (unspecified if ongoing), notes: Other medical history: Juvenile RA; "Psoriatic Arthritis", start date: 2019 (unspecified if ongoing), notes: Other medical history: Psoriatic Arthritis (2019); "ADHD" (unspecified if ongoing), notes: Other medical history: ADHD; "Reocurring Pregnancy Loss" (unspecified if ongoing), notes: Other medical history: Reocurring Pregnancy Loss; "POS" (unspecified if ongoing), notes: Other medical history: POS. Concomitant medication(s) included: PREDNISONE, start date: 19Apr2019; TIZANIDINE, start date: 01Apr2020; TRAZODONE, start date: 01Apr2021. Past drug history included: Plaquinil, reaction(s): "Allergy: PLAQUINIL", notes: Known allergies: PLAQUINIL; Methotrexate, reaction(s): "Allergy: Methotrexate", notes: Known allergies: Methotrexate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details for COVID 19 treatment included Paxlovid, Treatment start date: 26Jul2022, Treatment stop date: 30Jul2022.
2 days S/P Measles vaccine, pt. with "spacy" behavior, staring off, with developmental regression. Pt had 30 words, then lost them entirely. No speech and poor interaction.
pt reports  dx of erythema multiforme 10 day p/vax exp blistering rash of skin, widespread but sparing face-had fever tx w/pred;rash finally resolved 16FEB99 but evidence of rash sill present;
He received the vaccine along with the tdap around 2:30. At 5, he started coughing and feeling like throwing up. I went to check on him, he was completely red on his face, arms and stomach with raised bumps. He started feeling like his tongue was itchy and his lips were numb . Gave him Benadryl and too him to the ER, where they gave him methylprednisolone,  more Benedryl, famotidine and an epipen. He responded well but slept all weekend
shingles on face; Rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on face) and RASH (Rash on his face) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced HERPES ZOSTER (shingles on face) and RASH (Rash on his face). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles on face) and RASH (Rash on his face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the events was not applicable.
S: Patient is a 19 y/o male c/o odd sensation over his legs and arms lightheaded while he is walking out of the vaccination tent after 5 minutes of getting vaccine. Reports having history of lightheaded none with injections an appendectomy 2 years ago otherwise no other history . He did not eat or drink this morning. He did vape before taking vaccine.  Allergies: PCN, anesthesia hives post surgery  O:  1st reading 10:53 vitals BP 120/80 HR 92 Oxygen sat 99 pain 0/10 resp. 18 2nd reading 10:56 120/80 Hr 95 oxygen saturation 99 3rd reading standing after 5 minutes 110/80   Pale. Shivering. Weather is cold outside. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for n
Information has been received from a 25 year old female consumer for the Pregnancy Registry for GARDASIL, who in May 2009 was vaccinated with a first dose of GARDASIL and a second dose "around July or August 2009". There was no concomitant medication. It was reported that the consumer was "one week late" with her period. She did not know if she was pregnant. Her last menstrual period ended on 19-OCT-2009 and her estimated date of delivery was 26-Jul-2010. There was no adverse event reported. At the time of the report, the outcome of the consumer was unknown. No laboratory or diagnostic studies were performed. No further information is available.
Began to feel Unwell 01/06/2022  Diagnoised 01/10/2022 Covid Diagnoised  ran temp 99.8 went to pharmacy with nurse and PCR 01/11/2022. Sense of taste and smell stilll off and congesion in airway to noise still congested.
71y.o. male with multiple medical problems including BPH, chronic LBP with LLE radicular pain, DMII and PPN who was admitted to the hospital on 9/5/2022 for N/V and abdominal pain. Upon admission, lexiscan MPI showed a reversible perfusion defect. Cardiovascular surgery was consulted and performed CABG x3 on 9/13. Pts hospital course has been c/b acute hypoxic respiratory failure, post-op acute blood loss anemia, dysphagia and right forearm cellulitis with completion of abx courses. Corpak was pulled on 9/21 by the pt. SLP is following and have the pt on mechanical soft diet with thickened liquids. Psych was consulted for depression and started the pt on Wellbutrin. Pt with recent hx of (7/27/2022) lumbar laminectomy with medial facetectomy and foraminotomy with fusion at L4-5 on  by Dr., post-op course complicated by lethargy and confusion. Patient with unwitnessed fall with RRT activated on 9/26- no head trauma and no head CT required. He was transferred to the med ward for a dx of COVID with fever and anorexia.  He was treated with remdesivir - he did not have hypoxia. He had quite some anorexia and asthenia and some depressed mood.  He has been recovering and is now showing signs of resolution of these problems and we anticipated return to HCF, but he was denied by insurance, including a peer to peer.  Evaluation on Day of Discharge: Last night he had nausea and vomiting and could not eat dinner. Also did not eat lunch. This morning he felt good and ate the entire BKF. He has had multiple stools (constipation was an issue in the past days and received plenty of stool softners) - stool sfotners will be held now. Suspect component of gastroparesis - this should improve as he becomes more active.
TRANSIENT CEREBRAL ISCHEMIA 10/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (route and administrating site not reported). The patient experienced arm pain, weakness, headache and local reaction after administration. The patient's sister also had an adverse experience after vaccination with GARDASIL vaccine (yeast) (WAES# 0806USA08872). Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for truncal ataxia, dizziness, and vertigo within 6 weeks of receiving COVID vaccination
Typical immediate symptoms of sore, tender at injection site. Within 8 hours also became red and warm.  Those typical reactions lasted the typical 3 days. Just as they were subsiding the following reactions appeared at the injection site and spread down to approximately the crux of my elbow and up to the top of my shoulder and my clavicle; increased redness, itchy, slight headache.  The itchiness was also in my left eye and left armpit but no pain or redness. All that seemed to be subsiding on the 7th day after the shot, but then a rash and hives appeared (again starting at the injection site and spreading to the same places) It got worse and worse for another week and finally at 2 weeks out (yesterday) it is about 95% back to normal. Still some rash and itchy near shoulder.
Covid arm appeared 2 weeks after first dose. Raised red, itchy rash around site of injection. Took a few doses of benadryl and rash was gone after a few days
woke up with a massive headache, then had nausea since then, my body aches all over, and the injection site has turned to a yellow bruise.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown). The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: positive for COVID for more than 1 week. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014666 202300011385 ;
A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case from the  was received on 11-Dec-2020 via The Agency (reference number: SEQW20-05712), reported by a physician and concerned a 28-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007627, 202007628 and 202007631 due to the same reporter.  Company comment: A 28-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 28-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
None from vaccines except sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324615 Same patient/vaccine, different vaccine dose/event;
1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) 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 EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 06-May-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions. Vial size 5.5 ml red cap. Reporter stated that, since they did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time. They are still investigating and does not have any patient identifiers at this point. Treatment medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2022-682174, MODERNATX, INC.-MOD-2022-682176, MODERNATX, INC.-MOD-2022-682038 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up added. Reporter added and narrative updated.; Sender's Comments:  MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) MODERNATX, INC.-MOD-2022-682038:Same reporter case/master case
Flu-like sx and nodules at injection site post each of 4 anthrax shots. Extreme fatigue, joint pain, muscle pain, pericarditis (that progressed today) post #4 anthrax. Dx with lupus in 2001. In July 2001 pt sought treatment with rheumatologist. His ANA came back as positive with a speckled pattern and he was diagnosed with autoimmune and connective tissue disorder. he was prescribed Flexeril and Celebrex and a decrease in prednisone to 40mg. The Celebrex did not provide relief. Pt also was experiencing a sore throaat and palatal ulcers. He was treated with antibiotics but the symptoms did not resolved. Within few weeks the throat pain reduced but never subsided. The pail will increase on the left side when he has a flare up of symptoms. Shortly after discovering his inability to return to either job he began experiencing sleeplessness, depression and anxiety. Ambien was prescribed for his sleeplessness and he was able to sleep thee full hours per night and awaken feeling rested. Through October and November he was still depressed and the pain had progressed to the point where he could only walk a few days without being exhausted. He began taking Xanax and weaning off Prednisone and stopped taking Ambien. He was officially diagnosed wtih Systemic Lupus Erythematosus in November. He began taking Plaquenil and continued to wean off Prednisone.
The patient presented to the pharmacy the day after her vaccination with Pneumovax 23 with a rash surrounding injection site.  The rash was around the injection site and extended around the underside of the arm but did not extend below the elbow.  The patient also stated that her arm was very sore but she was able to move and lift her arm.  I advised the patient to apply cool compresses and acetaminophen for the pain.  I advised her to check with her doctor if the symptoms worsened or if she experienced limited mobility.
Menstrual cycle active bleeding lengthened to 13 days. Bleeding started a week earlier than due and was very heavy.  This occurred for three cycles in a row.  Two of the cycles were anovulatory for no other reason. Ovulation resumed in early September.
Patient reported spots of itchiness at various sites of body (legs, back, torso) beginning 24 hours after vaccination. Patient contacted PCP (at clinic) and was still waiting for a response at the time he visited the pharmacy on 8/1/18. Recommended for patient to get in touch with PCP as soon as possible and take antihistamines in the meantime to alleviate the itchiness.
I was hospitalized, I was put on IV antibiotics for pneumonia, oxygen. Rapid heart rate 174 bpm. Metoprolol, diltiazem, Eliquis. Eventually they put me on pacemaker. I'm on ENTRESTO, NATOPHEROL, warfarin. Since I have been home since the pacemaker I have felt pretty normal.
@ 11am the next day after receiving vaccine pt had a headache that lasted an hour; @ 7pm that day he started having blurry vision and floaters on right eye; pt came to clinic 8/26/17 to be evaluated.
Patient received expired Covid vaccine in our office by our medical assistant 12/01/2022. No adverse effects noted by the patient.
Brachial plexus injury. Numbness and pain in the arm. Weakness.
Information has been received concerning an approximately 75 year old male patient who in "early summer 2008" (in June 2008), was vaccinated with ZOSTAVAX (Lot # not available) and subsequently the patient broke out with shingles along his back and shoulders shortly afterward. The patient's persisted. The patient sought medical attention. No further information is available.
NIGHTMARES; SLEPT A LOT; BODY HURT A LOT; THE ARM THAT GOT INJECTED KIND OF HURT TO MOVE; FEVER; REALLY TIRED/FELT FATIGUED FOR LIKE A WEEK; HEAD HURT A LOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported 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 experienced nightmares, slept a lot, body hurt a lot, the arm that got injected kind of hurt to move, fever, really tired/felt fatigued for like a week, and head hurt a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hurt a lot, really tired/felt fatigued for like a week, and head hurt a lot, and the outcome of fever, nightmares, slept a lot and the arm that got injected kind of hurt to move was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist refers to a 63 year old male patient. Patient has no drug allergies or reactions. The patient's medical history included ulcerative colitis. On 13-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), subcutaneously. No concomitant medications were reported. On an unknown date in June 2013, the patient experienced a flare up of his ulcerative colitis shortly after receiving the ZOSTAVAX. Patient sought medical attention (called the pharmacist). The outcome of flare up of his ulcerative colitis was unknown. Additional information has been requested.
Patient states symptoms such as anxiety and panic attacks started day after receiving dose #2 of Covid-19 vaccine. She also states that insomnia, agitation, lack of focus, mood swings , and increased hair loss. Patient states that symptoms are similar to previous autoimmune "flares" she has experienced and adds that symptoms have not yet subsided completely.
ADMINISTRATION ERROR: PATIENT RECEIVES THE FIRST DOSE OF MODERN AT 16 YEARS OLD. ACCORDING TO THE INDICATION OF THE VACCINE, IT IS AUTHORIZED FOR EMERGENCY USE IN PATIENTS 18 YEARS OR OLDER.
Patient admitted reporting Moderna Covid-19 vaccine dose #1 in community. Patient provided Moderna dose #2 at  based on patient disclosure. Verification revealed patient received Pfizer for #1 dose in community. Information disclosed regarding mixed series dosing. Evaluated and monitored in medical unit for adverse reactions. None were noted or assessed.
Headache lasted 5 hrs. Large (5" x 3 1/2") hard area, hot, red and very painful to the touch. This has started to lessen but is still warm, red and sore on day 7.
COVID Breakthrough Case  J&J Dose 3/16/21 1805018 COVID Positive 11/3/21  11/7/21: The patient is a 49 year old male from who presented to ED with complaints of shortness of breath. He started feeling ill early last week with fevers, headache, fatigue and body aches. He was tested for Covid-19 on Wednesday with positive results. He did received J&J vaccination. He was treated with a Z-pack with no improvements in his symptoms. His symptoms have progressively gotten worse. He began having nausea and vomiting yesterday. Today he developed severe shortness of breath with activity and at rest. He denies chest pain. He has "chest tightness" when he coughs.  He has a past medical history significant for hypertension.  On arrival to ED the patient was hypoxic on room air at 87%, 2 L supplemental oxygen was applied with improvement in oxygenation saturations to 94%.  Laboratory findings were significant for hypokalemia 3.3.  Hypocalcemia 8.6. Anemia HGB 12.9.  C reactive 13.30.  Chest x-ray showed bilateral lung infiltrates.  Rocephin and doxycycline were initiated in ED.  Dexamethasone given. NS 0.9% 500 mL bolus given.  11/13/21: Patient is a 49yo male who presented and was managed for COVID 19 pneumonia  He completed course of IV remdesivir  He received IV decadron and discharged on 3 days decadron PO to complete 10 day course  He was on Ceftriaxone and Doxycycline for possible underlying bacterial pneumonia  His symptoms improved and he was able wean off oxygen  He had complaints of bruising and soreness in his abdomen but US soft tissue was negative for hematoma  He had O2 walk test and does not require supplemental oxygen upon discharge