chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162b2, Formulation: Solution for injection, Batch/Lot number: not provided, expiration date not provided), via an unspecified route of administration, administered on 30Jun2021 as (at the age of 39-year-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty swallowing and feeling of a swollen throat on 30Jun2021. The patient wanted to know whether that was a common side effect of the vaccine. The patient reported that she scheduled to get the second dose and she was not sure what she should done. The outcome of events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Metallic taste on their mouth and throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste on their mouth and throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2IA) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Taste metallic with Flu shot. Concurrent medical conditions included Depression. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VITAMIN B12 NOS, ZINC, VITAMIN D NOS, CALCIUM, VITAMIN C [ASCORBIC ACID] and PROBIOTICS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste on their mouth and throat). On 03-Mar-2021, DYSGEUSIA (Metallic taste on their mouth and throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
The night of the vaccination, i developed a headache and my arm was very sore. By the next morning, my left arm was very painful and I developed a large lump, almost the size of a golf ball at the injection site.  I started to feel fatigue and bronchitis coming on.  By day 3, extreme fatigue, shortness of breath, headache, painful left arm.  Regular albuterol inhaler was not helping at all. I made an appointment  with my Dr because I was afraid of getting the second dose of the vaccine if it would make my symptoms worse.   I was prescribed a stronger inhaler, which helps a bit, but still have shortness of breath and fatigue.   The painful lump in my arm shrunk in size very slowly and is now (6 months later) about the size of a pea.  It hurts now only if I touch or bump it.  I have since developed occasional pain/cramps in my legs, chest, torso which had me worried about blood clots at first.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 13Jun2022, Treatment stop date: 18Jun2022, Indication: Treatment of COVID-19.  Rebound Covid 5 days after finishing paxlovid treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
None known as of yet, first set was administered on 3/8/17 and then was stopped before the second set advising to get clearance from my OBGYN, who then advised that the facility should have not recommended it or administered it in the first place, at all.
IT DID NOT WORK; This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age, sex, 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 admin, and batch number were not reported) 1 in total, 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 reported that, "I like their vaccine, but unfortunately it didn't work. I hope they are working on a new one I do not trust the antibodies in the other vaccines to be safe." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it did not work was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.; Sender's Comments: V0: 20220312412- covid-19 vaccine ad26.cov2.s-it did not work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Received shot in my left arm near my shoulder around 10:15am on Mon 3/29.  On Tue 3/30, I had mild pain under my left arm (I know that is common; didn't happen during first dose which was injected lower on my left arm).  On Wed night (3/31), I noticed a red rash on my chest, stomach, and lower back.  It is not painful or itchy.  [Note: while I do have sensitive skin, I have not changed laundry detergent or lotion which could explain this rash.]
Presented to our office with 1 day history of rash on scalp and back diagnosed with chicken pox
Night of vaccination: nausea and tremors Next day: headache, stomach pain, loss of appetite
One week after getting injection pt is still complaining of itching and irritated sensation at site (R delt) 4 x 9 cm area with very faint erythema and increased temp to touch (may be due to scratching/rubbing).  Does not appear cellulitic.  No systemic reaction.
Was given Pneumonia vaccine IM in RD on 10/22/07. Came back 10/23 with cellulitis from injection site down to mid forearm and elbow swollen hot and red. Area was marked and was told if it enlarged to go to ER, which she did. Was admitted. 11/5/07-records received for DOS 10/23-10/27/07-DC DX: Right arm cellulitis. Asthmatic bronchitis. Hyperlipidemia. Left forearm intravenous infiltration. Anxiety disorder. Seasonal allergic rhinitis. Evening after her injection developed pain redness and aching in right arm over the site of previous injection. Following morning noticed spreading erythema and pain in arm.
really bright spot under left wrist within first hour; ITchy; stingy; small pinpoint rash from breast down to legs; raised bumps on chest and arms,Some are a little red, most are little bumps; tingly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (really bright spot under left wrist within first hour), PRURITUS (ITchy), PAIN (stingy), RASH (small pinpoint rash from breast down to legs) and RASH PAPULAR (raised bumps on chest and arms,Some are a little red, most are little bumps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Histamine level increased (Has a history of high histamine levels; usually breaks out in summer. Broke out a couple of minutes after the shot.). Concomitant products included ESTROGENS CONJUGATED (PREMARIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ZINC, VITAMIN D3, DIGESTIVE ENZYMES [ALPHA-D-GALACTOSIDASE;AMYLASE;BROMELAINS;CELLULASE;LIPASE;MALTASE;PAPAIN;PHYTASE;PROTEASE NOS;TILACTASE], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), DICLOFENAC SODIUM and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH MACULAR (really bright spot under left wrist within first hour), PRURITUS (ITchy), PAIN (stingy), RASH (small pinpoint rash from breast down to legs), RASH PAPULAR (raised bumps on chest and arms,Some are a little red, most are little bumps) and PARAESTHESIA (tingly). At the time of the report, RASH MACULAR (really bright spot under left wrist within first hour), PRURITUS (ITchy), PAIN (stingy), RASH (small pinpoint rash from breast down to legs), RASH PAPULAR (raised bumps on chest and arms,Some are a little red, most are little bumps) and PARAESTHESIA (tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events included steroid (cortisone)  cream, a fungus cream. The fugus cream helped her a little. The dermatologist told her to take an extra cetirizine at night and hydrocortisone cream.
I was tired and coughing. I took the COVID-19 home test and it was positive. I contacted my doctor on that Monday and he prescribed PAXLOVID for 5 days. I lost my sense of taste and smell which I noticed when I started to take the medication. By Wednesday I felt like I was ok outside of the loss of taste or smell. I completely recovered since then.
~ 28 hrs after 2nd vaccine, developed fatigue, nausea, vomiting x 2. Difficult to arouse. To Emergency Department. Here, disoriented / confused. Admitted for overnight observation.
SkinRash, UrticariaPruritis, ITCHING, SWELLING AT INJECTION SITE AND JUST BELOW SITE. WARMTH TO TOUCH Narrative:
Swelling, dizziness, nausea, throat tightening, some difficulty breathing. Administered Epi Pen.
No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 12-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 12-Jan-2023, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    No concomitant and treatment information was reported.  Index number was reported as 29726665.   Reporter did not allow further contact; Reporter's Comments: This spontaneous prospective pregnancy case concerns a 28-year-old, female patient with no medical history information reported, who experienced the unexpected non serious event of maternal exposure during pregnancy after receiving third dose of mRNA-1273 bivalent BA.4/BA.5. Last menstrual period and estimated date of delivery were not provided. No adverse event was reported. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report
This case was reported by a physician via call center representative and described the occurrence of swollen joints in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX the patient experienced swollen joints, influenza-like symptoms and product supply issue. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and nsaid's (Non-Steroidal Anti-Inflammatory). On an unknown date, the outcome of the swollen joints and influenza-like symptoms were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the swollen joints and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The healthcare professional (HCP) reported that the patient developed significant swelling of entire left shoulder and flu-like symptoms after initial dose of SHINGRIX which was received 6 to 7 months ago.  The patient treated local reaction with ice packs and non-steroidal anti-inflammatory medications. Symptoms subsided over the course of 3 to 4 days.  The patient had yet to receive the 2nd dose due to vaccine shortage and concerned of possible reoccurring reaction. The reporter consented to follow up.
enlarged knuckles; burning legs,feet; fibromyalgia; football sized black and blue right arm; black and blue right arm; Neck pain; throbbing; Pain shot up arm to neck; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm) and CONTUSION (black and blue right arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck). At the time of the report, JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant FU- Contact information updated, Vaccine batch number added
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Injection site reaction; bruised for 2 weeks itching for few days (no rash); pain that radiates to shoulder (constant).
5 year male patient administered expired dose of Ipo, no AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 year old male patient who received 0.5 mL fourth expired dose of vaccine IPV (VERO) [IPOL] (lot N1K931M and expiry date: 18-Nov-2019) via an intramuscular route at an unknown administration site on 25-Aug-2020.  Medical history, medical treatment, vaccination and family history were not provided.  On 25-Aug-2020, concomitant medications included patient was treated with TUBERCULIN PPD (TUBERSOL) for Tuberculin test.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt got his immunization, when to sit in the lobby and passed out after sitting in the lobby for about 2 minutes. We were able to provide the appropriate medical care and pt regained consciousness quickly and didn't have any other issues/injuries.
large vaginal ulcerations appeared 24-48 hours after vaccine, pt is not sexually active and has never been
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 16-JUL-2015 the patient was vaccinated with improperly stored ZOSTAVAX (route, dose unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
pt recvd vax & was vomiting; had fever; stiff neck; shoulder pain;
the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022CCX00281 (ChemoCentryx).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021", "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021", "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021". The following information was reported: GLOMERULONEPHRITIS (medically significant), NEPHROPATHY (non-serious), VASCULITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021".  Clinical course: On 08Aug2022, it was reported that a patient started treatment on an unspecified date with the Covid vaccine and boosters (Mfr. Pfizer) at unreported doses and frequencies of administration for vaccination. It was reported the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021 (it had previously been diagnosed in 2013, then went into remission). They (not further clarified) thought the Covid vaccine and boosters caused the flare up and that it really messed with his immune system. No further follow-up is anticipated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 year female was vaccinated 2-4-14 with KINRIX in left lateral thigh, MMR in left arm. She woke 2-5-14 with "small amount" of redness and tenderness in left lateral thigh "quarter" sized. She woke 2-6-14, went to daycare, complained of pain, was noted to have larger area of redness. Exam of left lateral thigh revealed 2 inch area of erythema with darker red ring at outer edge, warm to touch and tender; no fluctuance. No limp. No fever.
I got the second dose of Moderna COVID-19 Vaccine EUA second dose. Besides the injection site pain and discomfort. I had a severe flu-like symptoms for about 24 hours there after. I also experienced mild sickle cell crisis pain. That incapacitated me from going to work the day after the injection.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 12-FEB-2014 the patients were vaccinated with VARIVAX (Merck) which was administered subcutaneously and underwent supported temperature excursions on unknown date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was in immunizations department when allergies were verified patient only reported penicillin. Patient received varicella vaccine as well Hep B, Flu and Meningococcal vaccine. Shortly after staff member noticed that patient had broken out in hives. Patient then taken to medical assessment department for further treatment where he received epi-pen and Benadryl. Patient afterwards revealed that he had a reaction to varicella in childhood but was not told he was allergic to it.
Headahe, soreness of the arm, dizziness, chills ,fever bodyaches,  Narrative:
found to be covid positive when admitted s/p fall, unwitnessed fall down stairs at home with prolonged downtime, lives alone, unable to obtain history. Mental status changes. NO other symptoms present. CXR lungs clear
Sore throat, sweats, coughing, nasal congestion, a lot of mucus build-up & chest ached.