chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the next day after my first Moderna COVID vaccine, my left arm was stiff and a little warm at the vaccine site.  Those symptoms resolved in 24 hours.  I had no other symptoms immediately after the vaccine. When I woke up on the 10th day after my first Moderna COVID vaccine, I just didn't feel well, so I went back to bed and slept a couple extra hours.  I felt a little better when I woke up, but then I noticed my left arm was itching and it was puffy, red and hot, very near where I got the COVID vaccine.  Probably about a 2" spot.  I treated it that night with a warm, moist compress which seemed to relieve some of the symptoms.   On the 11th day, it is still puffy, red and hot, but it's not itchy today.  I have not had any other noticeable symptoms in the past 2 days.
Extreme confusion and dizziness beginning approx 6 hours after vaccine.  Complete loss of memory for another six hours thereafter, including two blackouts or potential seizures that were not witnessed, where I came to on the floor.  I had no prior symptoms whatsoever from four prior Pfizer COVID vaccines and have no history of blackouts or seizures.  I'm ok but still quite dizzy the next day.  No more Moderna vaccines for me!
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case is linked to case 2018SA196604 for twin with initial CD. This case involves a 20 years old male patient who was given BEXSERO instead of [MENACTRA]. The patients past medical history, concomitant medication and family history were not provided. On 16-Jul-2018, the patient received a 0.5ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841Aa, expiry date 08 Mar 2019 via intramuscular route in the left deltoid instead of injection of BEXSERO not produced by Sanofi Pasteur lot number not reported. The patient had already had two doses of MENACTRA previously and this would have been a third unneeded dose. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Developed slight chest pains followed by heart palpitations.  Extreme tiredness for 3 weeks following.  Sleeping  4 hours  more than normal.  Heart palpitations are random and not as often after 1 month.
Pt developed weakness left leg with tingling . Similar occurred with Typhoid vaccine in past. Pt was taken to the ED by husband
rash in her face; up her left eye and swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her face) and SWELLING (up her left eye and swelling) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash in her face) and SWELLING (up her left eye and swelling). At the time of the report, RASH (rash in her face) and SWELLING (up her left eye and swelling) outcome was unknown. Unknown          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient was treated with Benadryl and topical.  The action taken with mRNA-1273 in response to the event was not applicable.
Fainting spell while standing, approximately 2 minutes after receiving vaccines. Client hit back of head against wall. Recovered in less then 5 minutes. Remained laying with lower extremities elevated. BP 102/82, HR-64, Resp. 20, Gave lollipops (suckers). Redness without edema to back of head. Ice pack applied to head. Refused further treatment (mother).
Hospital Course (Recall) 13-year-old male presenting with two days of intermittent chest pressure and an episode of tachycardia and shaking prompting EMS call and ER visit.    Patient afebrile.   Sinus tachy in ER.  Adenosine given without significant effect.   ER work up:  Chem-7 panel is unremarkable with a white count of 5.5, hemoglobin 16.2, platelets of 255.  Chemistry panel unremarkable with sodium 142, slightly low potassium of 3.0, and chloride 104.  Venous lactate was 2.1.  Troponin was less than 0.012.  CRP of 0.5.  BMP was 18.  Procalcitonin was slightly elevated 0.13.  CXR normal lung and heart appearance.   ER Treatment: Adenosine x 1.   Ativan 0.5 mg IV x 1.    Dad very concerned patient had reaction to Covid vaccine.   Work up not consistent at this time with myocarditis.
Pt recvd MMR vax as a child; pt currently exhibited a lack of response to rubella; No further details were provided;
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In November 2021, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, headache, ear pain and neck pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, headache, ear pain and neck pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain, headache, ear pain and neck pain to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's brother-in-law. The age at vaccination was not reported. The reporter stated that, the patient had the shingles shot several years ago but still got shingles anyway. The patient got the shingles 3 and a half weeks ago from the day of reporting. The patient had terrible pain on his head, ear and neck and had miserable sharp stabbing pain. The reporter hoped that the shingles get better soon. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Mangos" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received).  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.
Left arm went numb at the time shot was given. Neck became stiff and client c/o body aches during the evening that the shots were given. Client woke at 0300 with fever of 104 and chills. Was seen by MD at health dept 9/17/04.
Case number PHEH2013US017763 is an initial spontaneous report received from a physician on 19 Aug 2013, with a follow-up received on 23 Sep 2013: This report refers to an 11-year-old male child. He was given only MenCYW liquid conjugate component of MENVEO (batch number: M12122) intramuscular on 16 Aug 2013, without being re-constituted with the powder component. The physician confirmed that patient would be revaccinated with the correctly constituted vaccine, as per the normal schedule. No adverse event was reported following this administration error. Follow-up received from a health care professional on 23 Sep 2013: Updated patient demographics and information about revaccination.
Per patient's description of the adverse event; over the 5 days following IM administration of Shingrix, patient gradually developed itching, rash, blisters around the injection site, which eventually spread beyond the injection area
Severe citrobacter induced sepsis complicating acute complicated  UTI, severe due to acute weakness, relative hypotension, slight AKI.  Patient who is a direct admission from an outside hospital because of symptomatic left flank pain due to 7 mm mid ureteral stone with left hydroureteronephrosis and a distended urinary bladder, required urology intervention, later turned to have +ve blood culture in outside facility, managed for this, managed for the above acute issues, improved, today he is cleared by all teams to dc, ID called in am, cleared by her to dc on po Cipro for 2 weeks, stable to dc to f/w ID, PMD, urology for further care after dc.  Hospital admission within 6 weeks of receiving the COVID vaccine.
12 hrs after injection woke up with severe body pain, scalp and forehead pain/tenderness, headache, lethargy & fever. 48 hrs after injection body aches gone but still had lethargy, sinus pain & scalp and forehead pain /tenderness. 72 hrs after the injection all symptoms were gone
all of the symptoms listed; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 8th July 2020 at 7:30 pm, the patient received the 2nd dose of Shingrix. After vaccination the patient experienced adverse events. The patient did not experience fever. The patient asked how long with this last. The callback to patient was made but unsuccessful.
decreased prothrombin level; decreased prothrombin level; PAIN IN ARM; Fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PROTHROMBIN LEVEL DECREASED (decreased prothrombin level), the second episode of PROTHROMBIN LEVEL DECREASED (decreased prothrombin level), PAIN IN EXTREMITY (PAIN IN ARM) and PYREXIA (Fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Coronary artery disease, Glaucoma since 2006, Enlarged prostate since 2015 and Restless leg syndrome since 2006. Concomitant products included WARFARIN and METOPROLOL for AFib, CYANOCOBALAMIN (B-12) for Bacterial infection NOS, FUROSEMIDE (LASIX P) and PRAVASTATIN for Coronary heart disease, TAMSULOSIN for Enlarged prostate, DORZOLAMIDE HCL for Glaucoma, DIGOXIN for Heart disorder, PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE [PRAMIPEXOLE DIHYDROCHLORIDE]) for Restless leg syndrome, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (PAIN IN ARM) and PYREXIA (Fever). On 28-May-2021, the patient experienced the first episode of PROTHROMBIN LEVEL DECREASED (decreased prothrombin level). On 11-Jun-2021, the patient experienced the second episode of PROTHROMBIN LEVEL DECREASED (decreased prothrombin level). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, last episode of PROTHROMBIN LEVEL DECREASED (decreased prothrombin level) had not resolved and PAIN IN EXTREMITY (PAIN IN ARM) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Prothrombin time (2.0-3.0): 1.4 (Low) Low.         Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Added height,weight,race,AE contact info and new events.
Pain, swelling and redness in and around injection site. Patient called to complain of these symptoms the day after vaccination and upon follow up the next day (2 days after vaccination), the symptoms were worse. Patient was advised to seek medical attention if redness continued to expand. At this time we are unsure if patient sought medical treatment and therefore have selected  "None of the Above" in Item 21 below.
CHILLS; HIVES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and hives was not reported. This report was non-serious.
Two swollen supraclavicular lymph nodes on the side of injection (left clavicle). Spots at first were painful, moveable, and soft. It's been four weeks and they are still present, but with less pain and movement. They only shrink in size when taking ibuprofen, but swell again when the medicine wears off.
arm soreness; She states she is in agony today; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On 30Jan2021, patient received her second covax and had some arm soreness for a few days and then it went away. A week later the soreness returned from elbow to neck left arm, she denies chest pain. She states she put a call in to her HCP and is waiting to hear from them. Patient denies redness or hot to the touch arm. Patient stated she was in agony today. The outcome of the event "arm discomfort" was not recovered and other event was unknown. Information about Lot/batch number has been requested.
Localized swelling, redness, warmth, and itching at the injection site. Swelling 4cm round. BENADRYL 50 mg given IM and monitored for 30 minutes.
knots on the injection side that wen from below her ear to her elbow and down the side of her leg; itchy; allergic reaction to the vaccine; she had lumps down arm and around ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN MASS (knots on the injection side that wen from below her ear to her elbow and down the side of her leg), PRURITUS (itchy), HYPERSENSITIVITY (allergic reaction to the vaccine) and SWELLING (she had lumps down arm and around ear) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (knots on the injection side that wen from below her ear to her elbow and down the side of her leg), PRURITUS (itchy), HYPERSENSITIVITY (allergic reaction to the vaccine) and SWELLING (she had lumps down arm and around ear). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SKIN MASS (knots on the injection side that wen from below her ear to her elbow and down the side of her leg), PRURITUS (itchy), HYPERSENSITIVITY (allergic reaction to the vaccine) and SWELLING (she had lumps down arm and around ear) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include lotion.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: significant follow up appended on 16  April 2021. Added information about concomitant medication and an event (swelling)
Patient was feeling dizzy and nauseous after receiving vaccine. He did vomit once. The patient was monitored and given water. After about 10minutes he felt better. He stated he hadn't eaten and was nervous which he said may be why he felt sick after getting vaccinated.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:45 as dose 5 (booster), single (Lot number: 6H9693) at the age of 70 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 06Jun2022 at 15:15 as dose 4 (booster), single (Lot number: FP4554), in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: (26Oct2022) Negative; (30Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Oct2022 to 25Oct2022.
Tingling in left hand and upper lip, left deltoid has dime size induration and redness around area.  6/29/10 - spoke w/ patient took BENADRYL feeling better MP.
Extreme tiredness, swelling, redness and hot to touch at site. Stopped walking, talking and started to grunt only. Started having extreme meltdowns, confusion, and give breakouts on body. Just used baths, TYLENOL ect to help. Sought dr help and prescribed 24 hr BENADRYL and CLARITIN to be taken everyday (no word to when to stop). Lead results in blood from 2014 to 2016.
only administered the adjuvant; only administered the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate dose of vaccine administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The reporter stated that she was dispensed Shingrix by her pharmacy to be administered at her doctor's office. The nurse at the doctor's office only administered the adjuvant, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
A non-serious spontaneous report of administration of H1N1 vaccine to pregnant female was received from a registered nurse/health professional concerning a 36-year-old female. The patient's medical history included seasonal allergies and concomitant medication included fexofenadine HCl for relief of her seasonal allergies symptoms. Obstetrical history included gravida five, term birth four, para four, pre term birth none and abortion one. The patient was in her 23rd week of gestation during vaccination. The LMP of the patient was 15-Jun-2009 and the expected delivery date was 21-March-2010. On 24-Nov-2009, the patient received H1N1, Intranasal via nasal route. There was no adverse event associated with this pregnancy. On 20-Apr-2010, the patient gave birth to a male child. It was a spontaneous, normal, vaginal, term delivery without complications. Resuscitation was not necessary. The patient hasn't experienced any medical complication during pregnancy, amniocentesis was not performed and any other prenatal testing was not performed. Child's gestational age was 40 weeks, wt: 9.3 lbs, length: 22 inch, Head circumference: 13.78 inch, Apgar score one minute: seven and five minute: nine. The outcome of the event of vaccine exposure during pregnancy was considered recovered. Treatment was not provided to the patient and reporter causality assessments are not applicable. Additional information was received on 07-Dec-2009 and incorporated into the narrative: gestation period, medical history, obstetrical history and concomitant medication. Additional information was received on 08-Dec-2009 and incorporated into the narrative: medical history, obstetrical history and concomitant medication added. Additional information was received on 21-Apr-2010 and incorporated into the narrative: Pregnancy outcome, child information and obstetrical history added.
Patient was given DTAP, MMR/Varicella (combined vaccine), IPV and Hepatitis A.  Approximately 15min after injections developed swelling of eyes and lips. He developed hives and diffuse erythema.  No skin changes at the local sites of injections.