chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine) was resolving.            Concomitant medications included Blood pressure medication, Diabetic medication, Post liver transplant medication and Cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-JUN-2021 contains no new information.
Had "4yr shots" on 2/15/21 and then 2 days later, got 'bump/swelling" on his L upper arm. Mom was using warm compresses and mom gave Motrin x1 yesterday for arm pain. Child also c/o itching to area.    mom advised to apply warm compress for at least 10mins (not a lukewarm wash cloth) or let him take a warm shower and focus on L arm, or bath OK to give OTC Motrin prn pain Monitor for worse swelling, pain or fever, drainage- then needs to call, RTO or ER
Patient was given Moderna Bivalent vaccine instead of Monovalient.  No treatment was needed. Pt had no adverse reactiion.  Pt will be given the Monovalent vaccination.
After two hours, began to get what seemed like a heart attack - Sharp pain in left chest, with pain on the lower left breast bone and sternum.     I checked blood pressure and it was fine so I determined it wasn't a heart attack and the pain would not subside so I thought it might be a very bad heart burn episode.  Took some antiacids like Mylanta and Tums and it did subside but not totally.  This went on for 4 hours of the intense pain.  At one point I noticed that my lower breast bone ribs and sternum on the left side were inflamed as compared to the right.  The pain lasted consistently 24 hours and on Sunday, it subsided and would come and go.  On day 3 (Monday), I have not felt pain.  My on line research indicates this might be costochondritis.
Severe neck/gland pain, swelling, throat pain. Called doc morning following vaccine, he called in a Z pak in case unrelated, we KNEW it was due to vaccine, but didn't see how it culd hurt. Fever today, 102 degrees. Constant pain with intermittent Severe Shooting pain in gland/neck area.
About 3 days after flu shot some cold/flu symptoms began. Runny nose/sneezing. The 4th and 5th day had heavy sneezing runny nose and sore throat. 6th and 7th day felt fatigue and coughing. About seven days later I began to recover, but still had some coughing and sore throat. Cold sores on lips.
Fatigue, soreness, tired. Pain on right back under shoulder blade, lung pain, hurt to take a deep breath. Lasted the second day into the night.
After each vaccine dose, the patient became weaker. He had more difficulty completing daily tasks. He complained of fatigue, nausea, weight loss, headaches, and weakness. He became sick often, without reason. Covid negative testing.  He was sick, respiratory virus, he thought he should get the booster since it was being recommended by the doctor on the news. He told me he got it on November 18, 2021. He felt worse, was trying to rest and sleep it off. He died in his sleep sometime on or about November 22, 2021.
At noon the day following my vaccination I started feeling fatigue and a headache.  At 24 hours after my vaccination, I had body aches and chills.  About 36 hours after my vaccination I felt better, but had a large lump under my underarm on the side I got my vaccine.  This lump was present for about 5 days.
Per parent report, patient had fever of 104 degrees F, headache, sensitivity to light, lethargy, unable to drink water. Symptoms lasted about 15 hours and resolved. Parent took patient to doctor for symptoms-stated nothing done. PHN became aware of this 10/2/07.
As per mother, baby vomited x3 on 7/23 & then was fine & kept Tylenol down. Mom called 7/24 because baby had reddness & swelling at injection site on left leg. She was instucuted to put a cool compress on leg & give Tylenol if a fever developed.If baby's condition worsened or developed a temp. of 105 F she should call the baby's PCP or take her to an ER. Mom states baby vomited x1 on 7/26, had a temp of 99.8 ax and was developing "blister-like bumps"on 1 leg, 1 arm and 1 on one foot.(She had had 1 on left arm prior to well-baby visit on 7/22/08)Mom took patient to an ER. She was not admitted and mom states that she was told "it was from the shots or was a combination of a virus & shots".Baby is acting normally, eating well with no vomiting on 7/29/08, but still has scattered clear papules on left arm, left leg & one on right foot. Mom states that they fade and then another may come. Mom denies pets with fleas and states that no one else has "bumps" at home.  No fever since 7/27/08. No treatment given.
Client received both flu and pneumonia shots in left arm.  Client states that around 1030pm he experienced heavy sweating, aches into his bones, a "bad" headache, and his left arm swelled up.  By 8am he sought assistance at ER where he received IV fluids, antibiotics and a breathing treatment.  Client states that Dr. was concerned about his blood work (WBC's per client) and wanted him to remain in the hospital but the client does not have insurance and wanted to leave.  Client reports that symptoms have subsided and he is "feeling better".
BODY ACHES; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. no medical history or diagnosis was reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced headaches. On 10-MAY-2021, Laboratory data included: Coronavirus test (NR: not provided) pending on results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and body aches. This report was non-serious.
a 6 month old female received Pentacel t was only given the Dtap-IPV portion and not the ActHIB; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past vaccination(s) included PENTACEL on 16-Apr-2019, Dose 2 and PENTACEL on 25-Feb-2019, Dose 1. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 19-Jun-2019, the patient received a third dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Dtap-IPV vial- LOT: 06216AB, expiry date 10-Oct-2020, ActHib (from the Pentacel Box that was not given: LOT: UJ013AA, expiry date 10-Oct-2020) via intramuscular route in left Vastus lateralis.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that a 6 month old female received Pentacel t was only given the Dtap-IPV portion and not the ActHIB.  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 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.
Within 30 minutes of receiving LAIV, patient experienced pervasive achiness.  She complained of fatigue about 4 hours later.  At 10:00 AM on 10/31/09 she awoke with a fever of 103.2, headache, and nasal congestion.  She was examined by the pediatrician at 11:00 AM.  Dr. prescribed Tamiflu and Tylenol for the fever. She ran a low-grade fever (99 - 100) through 11/1/09.   Nasal congestion, cough, and sore throat are still evident.
ROUND SMALL PATCH OF HIVES AT LEFT STOMACH AREA, WENT AWAY WITH BENADRYL
Patient had 20cm x 20cm redness +warmth, +edema at the injection site. Treatment; Augmentin 600mg x 10 days.
Pt recv vax on 9/15/98; on 10/13/98 pt exp fever & earache, right side neck swollen; dx=vax induced mumps
Administrative deviation only; no adverse event resulted from this deviation. This patient received a mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date of the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time second dose was due.We understand that the CDC provides consideration for a mixed series in exceptional circumstances (such as vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting. Note second vaccination date is listed.
fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.
Scratchy; Feeling tired; Headache; Chills; A spontaneous report was received from a healthcare professional concerning a 54-year-old female patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tiredness, headache,  scratchy throat, and chills.   The patient's medical history was not provided.  Concomitant medication included blood pressure medication.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in her left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced tiredness, headache, fatigue, scratchy throat, and chills.  The patient also tested negative for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events tiredness, headache, fatigue, scratchy throat, and chills was considered were not recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After a month of vaccine adm. pt complained of rash and tingling sensation all over his body. The pharmacist advised the pt to see a doctor. He went to see his PCP & PCP said he doesn't have shingles. Now patient is complaining joint pain and is convinced its from shingles shot.
Narrative:  Discharge DIAGNOSES: 1). CHF exacerbation 2). COVID 19 viral syndrome HPI: He reported several day history of increasing shortness of breath. He has a history of congestive heart failure and has been taking his medications intermittently. He did not take his medications today. He has some chest heaviness due to the swelling of his abdomen arms and legs. He has been seen here in December 2021 for similar problem. He continues to smoke tobacco products. He is on oxygen at home. History provided by: Patient, Medical Record PMH: CAD, CHF, Hypertension Obstructive sleep apnea
Vaccine was given in Left upper arm.  Slight Bleeding occurred after vaccination and brusing occured after vaccination. (patient states a hematoma)
01/05/2010 1400 scratchy throat. seen back in clinic. no treatment indicated. 01/05/2010 2000 at home injection site "very itchy, neck very itch", Benadryl taken. 01/06/2010 0530 at home "welts Benadryl taken. 01/06/2010 1345 "red splotches and itchy to body on and off all day" Benadryl taken and came to clinic. FNP prescribed prednisone to be taken x7 days.
Heat (around the injection site); Itching (around the injection site); Redness (around the injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)). At the time of the report, INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up information was receivcontained non significant information and the reporter information was updated
This spontaneous report as received from a physician assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 or GARDASIL (unspecified trade name) for prophylaxis. According to the physician assistant, the patient received the second dose of GARDASIL or GARDASIL 9 (trade name unspecified) 2 years after receiving the first dose. No adverse effect was reported. Additional information has been requested.
Breakthrough COVID-19; Breakthrough COVID-19/She got the positive test results; Low grade fever; Congestions; Achiness; Loss of taste and smell; Loss of taste and smell; Headache; Itchiness; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: ER8732),via an unspecified route of administration, administered in Arm Left on 04Apr2021 15:00 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE and first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EN6208),via an unspecified route of administration, administered in Arm Left on 14Mar2021 as DOSE 1, SINGLE for covid-19 immunisation(at the age of 44 years). None medical history. No Prior Vaccinations within 4 weeks. No Adverse events following prior vaccinations. There were no concomitant medications. The patient experienced breakthrough covid-19 on an unspecified date, breakthrough covid-19/she got the positive test results on 12Oct2021, itchiness on Oct2021 with outcome of unknown , low grade fever on 12Oct2021, congestions on 12Oct2021, headache on Oct2021, achiness on 12Oct2021, loss of taste and smell on Oct2021.The patient underwent lab tests and procedures which included body temperature: 100 on 12Oct2021, body temperature: 101.1 on 13Oct2021, sars-cov-2 test: positive on 12Oct2021. It was reported that she was fully vaccinated on 04Apr2021 of this year. She had a breakthrough case of Covid last month and had mild symptoms. She had a mild fever that lasted for like 2 days and it was like 100 degrees, it was 101.1 and it was very mild. She had achiness and congestion. The congestion lasted probably like 10 to 12 days. She lost her sense of taste and smell. Clarified that all of these symptoms occurred last month in Oct2021. Caller states that it was 10Oct2021 or 12Oct2021. She got the positive test results 12Oct2021 and started to feel symptoms for Covid. Clarified that it was a PCR test because she was supposed to travel and did the test 2 days prior to traveling. Caller stated that the achiness and low grade fever occurred 12Oct2021 and 13Oct2021. She states that some time on 13Oct2021 or 14Oct2021, she lost her sense of taste and smell. She was congested for about 10 to 12 days. She had a headache probably every day. She states that she can't say definitively that it was due to Covid but she gets headaches every day anyways, in general. She took lozenges but, she didn't really take anything. The clinical outcome of the events was recovered for nasal congestion, pyrexia, on unspecified date in Oct2021 and for all other events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Post DTaP vax, child began crying and was inconsolable 72 hours after injection.
Acute myocarditis; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: Covid-19 vaccine - manufacturer unknown (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Acute myocarditis".; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300069723 Same article/ drug/event and different patient;
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm a little bit sore), feeling abnormal (my head not real good) and malaise (don't feel the best) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003A21A) for COVID-19 vaccination. The patient's past medical history included no adverse event. Concomitant products included high blood pressure and arthritis medication for an unknown indication. On Mar 10, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; at unspecified dose. On Apr 15, 2021, patient experienced pain in extremity (arm a little bit sore) and feeling abnormal (my head not real good). On an unknown date, patient experienced malaise (don't feel the best). At the time of the report, pain in extremity (arm a little bit sore), feeling abnormal (my head not real good) and malaise (don't feel the best) outcome: unknown/not provided. Reporter did not allow further contact.
can not stop shaking/tremors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "can not stop shaking/tremors".  Additional information: Caller stated there was a sulfa allergy involved for her son that was required to get the Pfizer covid 19 vaccine. Caller stated she was allergic to sulfa and experienced shortness of breath and had to go the the hospital. Caller stated she knows of two family members that had injuries from the Pfizer covid 19 noting that one was experiencing tremors and could not stop shaking. Caller stated a third member might be involved. Caller asked how can she feel better about this. Caller stated she knows of 58 people that died from other vaccines and the vaccines were pulled for much less noting the vaccines were studied for 10 years. Caller asked was there a threshold or level that Pfizer is looking for that would cause them to pull the vaccine. Caller had concerns about the safety of the vaccine. Caller did not want to be transferred to medical because she said it is not her place to report the AE for her family members, noting it was reported to the doctors Caller stated these AE of the family members were reported to VAERS.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives began day after immunization on bilateral arms. Topical Benadryl did not clear symptoms. Started on Zyrtec consistently two times daily along with oral Benadryl daily, will follow up with Dr next week if rash does not clear on its own.
13 weeks 6 days at time of injection, 14 weeks 0days at onset of symptoms. Body aches and chills started at 1am. Vomiting started at 2am and last until 4p. Was unable to keep food or liquids down during that period. Had highest fever of 100.7 F, as well as nausea, body aches, chills, fatigue and severe pain at injection site.  Nausea and fatigue continued into day 2 after getting vaccine (3/27).
LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80
pt recv vax; 5-7 min sz approx 5:30pm; seen in er; sent home p/ blood count,culture,chest x-ray & IM ATBs; good condition