chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
local rxn lt thigh erythematous 8x5 x 4.25cm toward inner aspect;warm to touch, swelling;
Ringing in left ear; Bone pain; joint pain; tired; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced ringing in ears, bone pain, joint pain, tiredness and injection site pain. On an unknown date, the outcome of the ringing in ears, bone pain, joint pain, tiredness and injection site pain were recovering/resolving.   It was unknown if the reporter considered the ringing in ears, bone pain, joint pain, tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced ringing in ears, bone pain, joint pain, tiredness and injection site pain after vaccination. The reporter consented to follow up. This case has been linked with case US2019199338, reported by the same reporter.
s/p vaccine c/o pain and bruising at injection site and worsening pain - unable to lift, bear weight or rotate arm. On 1/25 seen by clinic physician and diagnosed with right shoulder contusion, likely related to hematoma
3/13 Swelling at site; rash, hives, welts. Seen on 3/24: rash, Aveeno baths, Benadryl every 6 hours. 3/28/03 Benadryl to Claritin; ongoing hives.
PT CAME IN TO GET HER FIRST COVID VACCINE AND WAS GIVEN A BIVALENT VACCINE. PT HAD  NOT PREVIOUSLY RECEIVED ANY COVID VACCINES
This spontaneous report as received from a nurse via the field representative refers to a 11 year old male patient. On 31-JUL-2014 the patient was vaccinated with the first dose of GARDASIL, lot# not reported, 1 single shot, intramuscular. Concomitant therapies included Tdap and meningococcal vaccine (unspecified). After receiving GARDASIL, the patient passed out and had a brief seizure. The field representative also reported "the patient had this reaction every time he received a vaccination (specific dates and products unknown). No medical attention was sought and no treatment was received. The outcome of the events was reported as recovered on 31-JUL-2014. Upon internal review, the events of "pass out" and "seizure" were considered to be medically significant. Additional information has been requested.
parent falsified dob   pt was under 12 years of age when received vaccine (both doses)
Local Redness, Warmth induration, and itching at injection site started yesterday (10/07) 5 days after receiving first vaccine dose
Pt came in 2/2/13 PM to tell me what happened. Patient said day after shot started experiencing pain & then couldn't lift arm (left arm). Went to MD b/c didn't improve & said he had a "frozen shoulder"; he was prescribed pain meds & did physical therapy x 6 weeks with minimal improvement. He had surgery the 1st wk of Dec - they cleaned out the joint - it was inflamed (they scraped out the joint). Pt still can't raise arm fully, states he has 65% functionality & loss of strength. MD recommended a 2nd surgery, pt states he's not going to do that.
Tingling/numbness in neck, throat and roof of the mouth.  Heart Palpitations
Vaccine given 8/9/11 in evening, and reported am of 8/12/11 localized swelling, redness, itching, blister. Pt has history of shingles.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 01-Mar-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
lt leg hard & slightly edematous; given APAP as needed; warm & cold compresses alternating;
flu like symptoms burning sensation on the right side of the head injection site elbow has a red circular raised area, almost the size of her fist slightly itchy
Injection site reaction. It was reported 2 days post vaccine the pt developed a big, red hard lump at the injection site. Follow up states the event has resolved.
Hives (urticaria) on abdomin, mostly symmetrical, starting at the hips and loving towards to armpits. Tasted with Prednisone.
A 1 year old female received MMR on 8/9/01 and on 8/19/01 she developed a rash on her face, head, neck and migrating down her body. No fever. She had a mild runny nose. Reassurance. Dx'd with measles rash secondary to vaccine.
On 3/17/2023, I started to get a cough. By the next morning, I had cough and some fatigue. I did a home PCR test and got a positive result. I became increasingly fatigued. I started to wheeze and have asthma symptoms. I had continuous cough and shortness of breath. I had no fever, and my blood oxygen was never below 98%. On 3/18/2023, I began using PRN albuterol inhaler, a SEREVENT inhaler, and a QVAR inhaler. I continued to use these for the duration of my illness. On 3/19/2023, I pretty much had the same symptoms. On 3/20/2023, I had increasing fatigue and shortness of breath. I had to sleep sitting up on account of my trouble breathing. I called my doctor, who prescribed me PAXLOVID. I began taking PAXLOVID on the morning of 3/21/2023. I had begun to feel even worse that morning, with the cough and shortness of breath. After I began taking the PAXLOVID, I began to improve by the afternoon of 3/22/2023. I had less coughing and shortness of breath, plus I was able to lie flatter. I generally continued to improve. My cough almost resolved by 3/29/2023, and I was able to lie flat, but I was still very fatigued. I still experienced shortness of breath, but only with exertion. I saw the doctor on the early morning of 3/30/2023. I had a normal EKG and exam. I was sent for a chest CT scan, which I underwent that afternoon. The result of the CT scan was also normal. I was given metformin for possible long COVID-19 on 3/30/2023. I took the metformin for ten days, mainly to treat the shortness of breath and profound fatigue. It was effective. I had another two or three weeks of shortness of breath and fatigue, which have resolved at the time of this writing. Once I was able to be active again, which was around 4/19/2023, my proprioception was off. I really had no sense of my position in space. Today is the first day that I have had a marked improvement in my proprioception.
Pityriasis rosea: developed the herald patch near my collarbone about a week after the second dose of moderna, then slowly developed other pink/salmon-colored patches on my chest, arms, neck, and bikini line. They are slightly itchy and don't seem to be going away. Urgent care gave me the Diagnosis.
She received a booster dose of Pfizer/Biontech COVID-19 vaccine,; She received a booster dose of Pfizer/Biontech COVID-19 vaccine; She received a booster dose of Pfizer/Biontech COVID-19 vaccine; a flu shot was administered, instead of COVID-19; This is a spontaneous report from a contactable consumer or other non hcp.     A adult female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 3 intramuscularly, administered in Arm Left on 10Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, on 10Sep2021, The patient experienced she received a booster dose of pfizer/biontech covid-19 vaccine with outcome of unknown , she received a booster dose of pfizer/biontech covid-19 vaccine, interchange of vaccine products along with immunization, a flu shot was administered, instead of covid-19  on 10Sep2021 with outcome of unknown.  Therapeutic measures were taken as a result of she received a booster dose of pfizer/biontech covid-19 vaccine, (off label use), she received a booster dose of pfizer/biontech covid-19 vaccine (interchange of vaccine products), a flu shot was administered, instead of covid-19 (wrong product administered).case was assesses as non serious.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Case number PHEH2014US023177, is an initial spontaneous report received from a physician assistant on 17 Nov 2014. This report refers to 36 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 14511P) intramuscular on 03 Nov 2014. On the same day post vaccination later that evening she developed pain in the arm at the injection site. Pain fluctuating in intensity (sometimes severe) and was persisted since that time. She described the pain as a level 10 pain at times. Outcome of the event was unknown. Seriousness and causality assessment was not reported. Seriousness assessment of pain at the site was upgraded based on information available in the source documents.
(L) leg limp evening after DAPTACEL/ IPOL @ (L) leg HARVRIX to (R) leg. Also temp to 104 degrees F and recurrent emesis.
Experienced the left side of arm swollen and could barely raise arm. Stated having sinus allergies, and started coughing violently and went to the Urgent Care. Can't lay down without coughing and have to sleep sitting up.
Maculopapular rash involving the whole body beginning 10-15-06.  Saw ER physician 10-15-06 and was told it was a reaction to MMR that was given 13 days prior.  No treatment prescribed adn rash was completely resolved by 10-18-06
her blood sugar is high; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "her blood sugar is high".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
A friend had severe masseter muscle tightness to the extent that she could barely open her mouth after both of her vaccines.; This is a spontaneous report from a contactable consumer and reported for a female patient (her friend). A 67-years-old non pregnant female patient received first dose bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 29Jan2021 in left arm as DOSE 1, SINGLE and also received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and also for covid-19 immunization at other vaccine facility. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not experienced covid prior vaccination and no covid tested post vaccination. The patient did not received other vaccine in four weeks and also no other medications in two weeks. On 25feb2021, the patient had experienced severe masseter muscle tightness to the extent that she could barely open her mouth after administration of 2 dose. It was reported that, patient wondered if more people are reporting this kind of muscle tension and it has been more than 3 months muscle tensions persist. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.    Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected. Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
I was diagnosed with Covid on April 29; I was diagnosed with Covid on April 29; J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021;  Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Dec2021, outcome "unknown" and all described as "J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "I was diagnosed with Covid on April 29". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: diagnosed with Covid on 29Apr; (20May2022) Positive, notes: Today is day 21 and I am still testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was diagnosed with Covid on 29Apr. The doctor prescribed Paxlovid which patient took for 5 days. Today was day 21 and still testing positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
shingles / couple of bumps on her back and front; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 55, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the covid vaccine on 18Mar2021. She was due on 08Apr2021 for her next dose. Right now, she had shingles and got it this past week. Her symptoms started on Tuesday, 23Mar2021. The severity of her shingles symptoms was very mild. Only a couple of bumps on her back and front. She started the antiviral already, last time. The doctor explained that some people developed shingles after the flu vaccine. The outcome of the event was unknown. Event was reported as non-serious.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, sore arm at injection site, migraine Headache Narrative:
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions.  Provider will follow up in a few days to check on the patient.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently the patient developed "swollen lymph nodes". Unspecified medical attention was sought. The outcome was unknown. Additional information is not expected.
fatigue, low grade fever, muscle aches about 36 hours Day 3 - slight red rash on injected arm about a 4 inch diameter circle, slightly itchy
Patient recieved a expired vaccine with no reported adverse event; Initial information was received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist and non-healthcare professional via Agency (00784201).  This case involves an unknown age of female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.  There will be no information available on batch number for this case.
nausea a 2-3 days by day 5 post shot experience lung spasms or fluttering in chest (on and off for a week now) chest pain that has lasted approximately 8 days
Deloped large hives on left arm at site of injection then over the next 2 hrs developed two small hives on right leg and one small hive on right arm-then they went away. The large hive on left arm resolved on the 4th day.
Pt started having febrile seizures on 6/19/01, lasting over 1 hour, originally. Dx'd as a Urinary Tract Infection. Original urine results were lost by hospital. All subsequent tests, including urine cultures-neg. The hospital believes seizures are from Prevnar.
Initial unsolicited report received from a nurse on 18 November 2016. This case involves a 32-years-old of male patient who was vaccinated with a dose of Fluzone QIV intramuscularly (Batch number: UI684AA, expiration date of product: 30-JUN-2017, dose, dose in series were not reported) in right deltoid on 24 October 2016 and with HEP A intramuscularly (Batch number: L02773, expiration date of product, dose, dose in series were not reported) in left deltoid on 04 November 2016. The reporter denied the patient having any illness at time of vaccination. Patient's medical history included asthma and abdominal hernia. Concomitant medications were not reported. On an unknown day, unspecified timeframe following the vaccinations, the patient had developed Guillain-Barre syndrome (GBS) and numbness in both legs. Numbness in both legs occurred sometime after the 4th of November and it progressed for 2 days post onset of symptoms. The patient was hospitalized on an unknown day and discharged after 7 days. The patient required doctor visit for follow up on 18 November 2016. Laboratory investigations were reported as unknown. Corrective treatment included phenergan for nausea and occupational, physical and speech therapy. The outcome of events was reported as unknown. List of documents held by sender: none. Sender's Comments: GBS was suspected in this cases after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and HEPATITIS A VACCINE, however diagnosis was not confirmed. Time to onset (Approximately 11-12 days post INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED) is compatible with a role of the vaccine. To be noted that GBS is often preceded by an gastrointestinal or respiratory infection which was not ruled out in this case. Details regarding infectious work-up and information on infections occurring prior to vaccination are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Pt called the office on 10/12/09 to report joint pain, no other symptoms that she felt may be related to MMR vaccine she received on 9/23/09.
Rash to arm and legs 7-19-07. Swelling of hands and joint pain 7-20-07.
Symptoms began at approx. 8pm with a severe headache. 2 hours later, mouth, tongue, throat very swollen. Unable to take deep breaths, wheezing and very bad chest pain. Dizziness while standing and nausea. Fever of 102.2. Very difficult to breathe, called nurse line and was instructed to go immediately to emergency. Was given an IV and administered Benadryl and Toradol. Discharged from ER at approx 2am. Arrived at 11pm.
Patient states that Pneumovax 23 vaccine was given "too high up in left arm" and that she felt the serum "going in".  States she cannot lift her left arm above her shoulder.  Complains of severe pain and tenderness.  Denies redness or swelling.  No numbness or tingling reported.