chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and GABAPENTIN (NEURONTIN) for Blood pressure.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, 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 experienced FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings). At the time of the report, FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings) outcome was unknown.            No treatment medication were provided by the reporter.  Concomitant medication included: female hormone.   This case was linked to MOD-2021-306715 (Patient Link).
sore arm; itching like poison ivy; slight dull headache; chills; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She noted she never got a flu shot. The caller reported some events but she was not sure if they were an allergic reaction or side effects. On an unspecified date in 2021, the patient experienced the side effects sore arm, itching like poison ivy, slight dull headache and chills. The caller reported on the Pfizer COVID vaccine and explained she got the first shot 3 weeks ago and was due to get the second one but after 3 days, she of course had a sore arm, she incurred a lot of itching like going into poison ivy. The caller explained she was put on 7 days of prednisone for treatment. She had a slight, dull headache for 3-4 days and chills. Everything, after a period of time, went away but she was due to get the second shot tomorrow but wondered if she should, if these things were just side effects or an allergic reaction. The caller asked that if she was allergic to it would she have known after the first one. She received the response stating that they would not be able to say if she would have known about an allergy to the vaccine after the first dose and referred caller to HCP. She was due to receive the second dose tomorrow and she was concerned about getting the second one. She asked if she should get the second dose. The outcome of the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt became very pale, even lips;became very lethargic, hear rate dec;extremely diaphoretic;resp shallow;given epi;states feeling better;
Two hours post vax, developed rash - macular papular, and diarrhea. Returned to the physician's office on 02/29/00. Rash is abating. Physician has treated with Benadryl. Diarrhea abated. Is presently recovering.
WOKE UP 03-17-07 WITH PAIN IN ARM, LG AMT OF SWELLING IN UPPER ARM AND SHOULDER.  TENSE, HOT TO TOUCH, FEBRILE.  TOOK TO ER FOR EVALUATION.
Given second dose of covid vaccine on friday in the right arm 04/23/2021. The day after the covid vaccine I ran a high fever from about 7:30am until about 9pm on Saturday 04/24/2021.  During Saturday I drank lots of water to combat the fever but I noticed blood in my urine.  The blood got worse through out Saturday into Sunday and I noticed slight pain in my lower back and lower abdomen.  On Sunday morning (04/25/2021) my urine was a dark burgundy color.  This was quite alarming as it was very thick and not as light as the day before.  I drank lots of water on sunday and made sure to watch my urine.  The urine stayed red in color.  I called a telehealth nurse  on Sunday and they suggested I go to Urgent care in the morning.  I woke up on Monday (04/06/2021) with less blood in my urine but still went to urgent care to be safe.  At Urgent care I received a Urine analysis.  The doctor told me there was blood and protein in my urine.  He ruled out a UTI or an STD. The doctor said there may be kidney damage since there is protein present but it cannot be confirmed with the levels. The doctor advised that I continue to drink liquid and watch for worsening signs.  The doctor said I should contact him immediately if the blood or pain gets worse. The doctor also stated I should fill out this VAERS form. Today (04/27/2021) there has been less blood in my urine but there is still some pain in my lower abdomen.  I will contact the doctor at the end of the week to let him know what has happened to my symptoms, he requested I keep him informed.
PATIENT STARTED WITH A RASH ON TRUNK ON MARCH 25, 2021.  ON MARCH 26TH UPON REPORTING, THE RASH HAD NOT WORSENED.  PATIENT TOOK BENADARYL TO HELP WITH THE ITCHING AND SEEMED TO BE DOING OK.
Patient experienced Guillan Barre Syndrome/TIA on 5/12/2021 and was hospitalized at Deer Valley Medical Center (Honor Health) 5/12-5/15/2021
Received vaccine on 1/4/21 at 12:50.  On 1/5/21 at 3:00 called nurse line to report fever of 101.8, chills, cough, dizzy with standing.
** Did fine w the shot given by Dr. and then shortly later while leaving office pt had vasovagal syncope and was pale,  weak, then very transient seizure noted on rt side w decreased LOC while being attended to by myself and staff- he was given water, ice pack, legs elevated, vitals stable but 911 called and paramedics arrived - pt  will be taken to ER for eval. Note - mom reports he passed out after a blood draw in the past also.
COVID-19 Pfizer dose given beyond-use-date. No signs or symptoms of side effects. No treatment necessary.
Began with feeling chilled and whole body shaking; muscles in legs tightened; at 9:30 pm fever of 100.5 F; by 10:00 pm was 103.8 F (Grad 3).  Took 1 Aleve at 9:45 and a second at 10:00.  Began cold compresses to reduce fever.  By 11:30 pm had reduced to 102.2 F.  Had sweats most of the night with fever of 98.0 F when awoke.  During 12/05 temperature fluctuated between 98.4 F and 99.4 F. Note:  I had had itching and redness at the injection site; minimal/expected of Grade 1.
The pt experienced pain at the injection site which increased to pain of the entire right arm with swelling. That night had chest pain and the next day this became more severe with swelling of the face. 2 days later the pt developed swelling of the right neck, nausea, blurred vision with the right arm still aching.
Started with the chills, could not get warm.  By the next day had chills , with body aches, sore throat, runny nose and cough.   Cough has gotten worse each day.  This is now 5th day of  feeling like a mild case of the flu.  Have taken Tylenol multiple times a day to help with achiness in joints.
tremendous chest pain laying down, less sitting up 1200mg Ibuprofen 3 times a day for 3 days... symptoms went away
Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.
The patient has received a J&J vaccine several months ago out of the country.  However, she told the pharmacy she had not received any covid vaccines. Only after receiving the second Moderna dose, did she disclose that she actively lied to the pharmacy because she wanted Moderna too.
Sore throat; This is a spontaneous report from a contactable consumer or other non-hcp. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included divalproex sodium, cilnidipine, valproate semisodium (DEPAKOTE), blood thinner (unspecified medication) and psychotropic medication (unspecified medication). On an unspecified date the patient experienced sore throat. It was reported that patient was taking Divalproex Sodium and Aspirin where it was not clarified. Outcome of the event sore throat was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt mom's states child has severe painful swelling on site that was given the Hep A right deltoid. Developed fever x1 day only on 9-18-09 at school, she called a nurse and was told to apply heat at 20min intervals, and gave him Tylenol and Benadryl. Swelling down child back to normal and in school today 9-21-09.
B cells low; This spontaneous case was reported by a consumer and describes the occurrence of B-LYMPHOCYTE COUNT DECREASED (B cells low) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    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 B-LYMPHOCYTE COUNT DECREASED (B cells low). At the time of the report, B-LYMPHOCYTE COUNT DECREASED (B cells low) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, B-lymphocyte count: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
briefly: cardiomyopathy, confirmed with echocardiogram.  05/09/2007  Additional records received from reporter. ID consult reveals pt reported for military duty with c/o fever x 2.  Typhoid vax given at that time.  That pm c/o worsening H/A and fatigue.  ER visit that night (03/03/2007) where pt. was febrile (101.7-102'F).  Pt. developed worsening dyspnea and fatigue. Pt was hospitalized again on 4/6/07 for new onset heart failure, cardioverted and worked up for a heart transplant. Otherwise txd medically. PMH: None. Flu shot x 2 this year. Allergies: NKDA.  Assessment:  New onset cardiomyopathy.  06/18/2007 MR received for hospitalization 4/6-19/2007 as above.  No new codes.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-079436 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079436:Cross link with Dose 2
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 75 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: 2016 (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; METFORMIN; TRULICITY; ATORVASTATIN, stop date: 22Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown", described as "COVID rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for Covid-19 treatment. Treatment start date was 22Dec2022 and treatment stop date was 27Dec2022. Patient had received other medications in two weeks.
Patient was vaccinate at 1410, in which at 1413 he stated he was feeling hot and light headed. Patient began sweating profusely. Cold compresses were applied to his neck and chest area. His blood pressure  was noted at 104/52 at 1413, and 144/98 at 1420. 911 was called at 1413. EMT arrived at 1430 and released client at 1435 with him agreeing to feeling better.  Client left our site at 1445 stating he was feeling OK.  Note: Client temporally lives in nearby apartment complex and walked back on his own.
Dump syndrome with recurrent flu vaccine x 3.  Interview with ER RN and review of medical records identified the following: He was seen on 11/10/2010 by Allergy Dept for report of 1999 flu shot reaction where he reported 6 hours later developing gas and a dumping syndrome reaction. He advised in 2000 he received another flu vaccine and again had reoccurrence of dumping syndrome requiring rehydration at nearby hospital. He has not received a flu shot since. He denied any rash, angioedema, headaches, myalgia/arthralgia, hives, or anaphylactic like symptoms. During his 11/10/2010 visit to allergy clinic, he received AFLURIA flu vaccine (lot # M54209) to his left arm. He and records advised he had no immediate reactions but later that evening (greater than 5hr) he was in a ER for IVF/rehydration and potassium replacement due to sudden onset of massive nausea and diarrhea. He reported it took 2 days for him to recover and was out of work. He advised he has an ileostomy bag due to prior intestinal surgery, and the sudden massive amount of fluid loss disconnected his ileostomy bag. On 11/10/2010 he was diagnosed with "idiosyncratic reaction to drug and was advised history was not consistent with an IgE mediated hypersensitivity and that providers were unclear as to why a flu shot would cause a dumping syndrome type of reaction". On 10/15/2010 providers documented he called back 6 hours later to report reoccurrence of dump syndrome and they recommended a permanent exemption from flu based on 3rd occurrence of this reaction. He advised other activities can also cause a dump like syndrome to include over-exertion, martial arts competition, and illnesses. He does hydrate prior to/after exercise and treats illness symptomatically.
The pt developed tingling of her tongue, face and neck 1/2 hour later. She states that it is itchy around her mouth and face. Rx'd Benadryl and Claritin and it improved within a few hours.
Client is a resident at the facility. Client had the first dose of Pfizer COVID vaccine (Lot #EW01071 expiration date 8/2021) on 6/28/2021. The Pfizer vaccine was given by RN in client?s left deltoid without incident. Client also received Hepatitis A vaccine (Lot #G99R2 expiration date 5/20/2022) and Hepislav-B (Lot # 934599 expiration date 2/22/2022) both in the right deltoid by RN.  Client was observed for 15 minutes per protocol without any side effects/adverse reactions. Upon return to facility on 7/27/2021 for second dose of Pfizer vaccine, Client informed this nurse of his hospitalization post first dose of Pfizer vaccine. According to client the morning of 6/30/2021 he was dizzy, with diaphoresis and nausea/vomiting. Client reports he was taken to ED and was admitted to the hospital. According to client?s hospital records client was diagnosed with bradycardia, hypotension and near syncope.  Client reports he had 2 stents placed in blocked arteries to the heart during his 6/30/21 stay at hospital. Client also reports he has a history of a previous heart attack. Client was discharged on 7/01/2021 to the care of his cardiologist. Client reports he is currently taking medications as prescribed by his cardiologist and client reports his cardiologist wants him (client) to follow up with his second dose of Pfizer COVID vaccine. Client reports he read in a journal it was best to wait 10 weeks for second dose of COVID vaccine (explained to client the CDC guidelines was 3 weeks apart).  Encouraged client to get a Rx from his cardiologist for the second dose of Pfizer vaccine.  Client reports he will get a Rx from his cardiologist for the second dose of Pfizer 10 weeks after the first dose. Client reports he will continue with his cardiologist for follow up and continue medications as prescribed. RN
This spontaneous report as received from a licensed practical nurse refers to an unspecified patient. The patient was vaccinated with the first dose of VAQTA 25/05 U/ml (lot number, dose, site, route not reported) at age 2, then received the second dose five months later. No other co-suspects or concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
On 02/12 at 4:30pm, child complained of his left shoulder feeling sore. Mother looked at his arm and found it to be red, edematous and firm from shoulder to just below the elbow. Mother noted that previous to this there was no redness or swelling, afebrile, totally resolved on 02/15/2003.
Moderna COVID-19 vaccine had a storage excursion and was kept in the fridge for 31 days instead of the recommended 30 days.  Analysis by Moderna indicated the lot of vaccine maintained the activity necessary to protect against SARS-Cov2 at the time of administration.  No adverse events reported beyond normal s/e from the vaccine.
PATIENT RECEIVED INFLUENZA AND TDAP ON SAME DAY. DEVELOPED CHILLS AND MYLAGIAS THAT NIGHT-RESOLVED BY NEXT AM.  FOLLOWING AM PATIENT DEVELOPED CONFLUENT ASYMTOMATIC RED RASH THAT BLANCHED WITH PRESSURE AROUND HER NECK,ON HER SHOULDERS AND DOWN THE MIDDLE OF HER BACK OVER THE SPINOUS PROCESSES.
Patient received VARIVAX #2 in office - seemed fine. 15-20 min later developed itching & rash was in local pharmacy at the time, given BENADRYL & EMS called, treated at local ER for allergic reaction & released.
Asthmatic reaction; Sore throat; She felt sleepy; A runny nose; Felt achy; Fatigue; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (Patient) reported.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported, Expiration date was not reported) as 1st DOSE, SINGLE DOSE for an unspecified indication.  Medical history included asthma from an unknown date and she was to have a colonoscopy and is considered high risk due to a past history of asthma. The patient's concomitant medications were not reported. First dose of the covid-19 vaccine on 24Jan2021, that night and the next day patient felt sleepy. As the week went on patient had a runny nose ,, sore throat , fatigue, and felt achy 28Jan2021 caller had an asthmatic reaction  went to the ER for a breathing treatment. On 29Jan2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. she has albuterol and nebulizer treatments that she hasn't had to use in the past year, but now is using, on 14Feb2021 caller is scheduled to have her second dose. Outcome of events was unknown.   Relayed PMI phone number for future reference, transferred to PSCC Covid AE/PCOM, relayed 11 callers ahead, will fax AE side eff  Information about lot/batch number has been requested.  Follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made
Patient mother called pcp last night to inform that he developed a high fever 105F less than 1 hr. after LD shot.
Dose 1  Extreme pain and swelling at injection site and then moving down arm and underneath arm down right side of body.  Right leg hot an painful in front thigh area.  This whole effect lasted 10 days  Fever up to 101 approximately 3 hours later lasting 2 days (up and down fever)  Chills lasting 2 days starting late the night of injection  Migraine headache - Debilitating for 3 days and still have daily migraines.  Painful lower neck that has not gone away  Shoulders and legs hot and feel numb at times - Leggs lasting approximately 14 days; arms still feel this way  Blurry vision off an on for 13 days  Dose 2 So far same as above although legnth unknow as I just recieved the shot on 4/13/2021
Major hairloss,fungal infection of scalp,left ear,metalic particles coming out of scalp,hands,arms. Headache, tingling in arms,itchy rash on scalp and arms.
A lump appeared after the first shot in my left breast. It is still slightly present but has since diminished   Ongoing aide effect is tinnitus. Following second dose. Approximately 24-48 hours later ringing began. I had no ringing of anything noticeable before. Ringing gets severe and very loud. On June 14 I lost hearing in left ear for 15 seconds completely. Another time since the second a similar incident occurred. Ringing also resulted in curtail today June 16 which required myself to lay down due to being so dizzy.
Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tingling in arm".  After waiting approximately 30 minutes after first report of tingling, patient stated tingling resolved with no other signs/symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 81-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th May 2018, several hours after receiving SHINGRIX, the patient experienced chills. On 8th May 2018, the patient experienced chest tightness. On 8th May 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the chest tightness was not recovered/not resolved. The reporter considered the chills to be almost certainly related to SHINGRIX. The reporter considered the chest tightness to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's received unknown concomitant product. At 11:15, the patient received SHINGRIX on left deltoid. Last night from the reporting date, the patient experienced chills, but they had resolved by morning of the reporting date. One day after receiving SHINGRIX, the patient experienced tightness in her chest. The reporter was not sure if it was due to SHINGRIX or more of a panic reaction after reading the literature for SHINGRIX and becoming concerned.