chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Seasonal allergy and Food allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Mild fever). On 28-Feb-2021, PYREXIA (Mild fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medication was listed for treatment of the event.
I suffered from congestion, diarrhea, sniffles, and post-nasal drip. A couple of days later, I started having brain fog. On 12/20/2022, I took an at-home COVID-19 test which came back positive. I called my doctor who prescribed me PAXLOVID. After 12/25/2022, I finished my last dose and started feeling better. However, a couple of days later, my symptoms started to come back with body fatigue. On 01/01/2023, I took another home COVID-19 test which came back positive, and my doctor informed me I was suffering from rebound COVID-19. As of now, I'm doing better with just a mild cough and low-grade fever.
Developed Shingles (as have several of my friends after Vaccine) on the right side of my head and face. Bumps on head and face and extreme nerve pian in those areas. Went to ER and was diagnosed as having Shingles which has lasted now for16 days.
Large, erythematous, indurated lesion lateral (L) upper arm surrounding injection site. Warm to touch. Given prednisone 2 tsp of 5/5mL x 4 days, with instruction to return if lesion spreads.
pt exp fever 103 same day shots given; ER md said reaction to DTP; no convuls no fever on 5APR93;
Started feeling really tired and dizzy around noon time on 8/11/12.  Felt sick to my stomach; NO VOMITING OR DIARRHEA.  Symptoms continued on Sunday 8/12 as well.  Symptoms finally went away on Sunday evening.  I took a total of 1 dramamine during the symptoms to try and relieve the dizziness which helped only slightly.
stomach issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ABDOMINAL DISCOMFORT (stomach issues). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) outcome was unknown.
Chest pains, profuse sweating, low pulse, cold hands and feet, numbness in arms and legs, and fatigue.
they stored the vaccine improperly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (they stored the vaccine improperly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21A and o31a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (they stored the vaccine improperly). On 15-Apr-2021, PRODUCT STORAGE ERROR (they stored the vaccine improperly) had resolved. Not Provided           No concomitant medication information was provided No treatment medication information was provided
Swelling, erythema, pain, warmth, decreased mobility, streak from injection site to shoulder.
Today April 9 returned from getting 2nd dose. By 5pm exhaustion and sleepy. Slept for a few hours.  Around 8pm broke out in sweats, 9pm chills, backache
As soon as flu shot was injected the patients arm started to itch and turn red. Itching continued to get worse. The redness started spreading up patients arm and across shoulder. Patient was taken to emergency department.
Pt experienced vomiting at 12 am post vaccine dose 1. Pt was better by morning and is now only experiencing pain at injection site.
streptoccocal throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS (streptoccocal throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.    Co-suspect product included non-company product PENICILLIN NOS for an unknown indication.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PENICILLIN NOS (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced PHARYNGITIS (streptoccocal throat). At the time of the report, PHARYNGITIS (streptoccocal throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Patient felt like she was going to pass out after receiving vaccination. Patient was transferred to wheelchair and then placed on cot for observation from safety personnel- 10:09 120/59, p- 80, 10:24 106/65, p- 72, 10:32 BP 116/81 p- 60. 10:35 sitting up bp-115/57- standing was good denied any problems
patient was administered Adacel and was supposed to be administered with Pentacel with no AE; 5 years patient was administered Adacel and was supposed to be administered with Pentacel with no AE; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who administered 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6706AA, expiry date: 09-Jul-2022) via un unknown route on left deltoid on an 12-Oct-2020 for prophylactic vaccination and was supposed to be administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration (latency same day).  At the time of report no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Nine days after receiving the COVID vaccine I woke up with left leg pain and was unable to bear weight on my left leg while I was out of town camping in a trailer. The pain was 7-8/10 in my upper leg close to my pelvis and buttocks. It also felt like there was tight pressure in my calf and lower leg. I was concerned I had a blood clot in my left leg. I went to an Urgent care/Emergency facility. I had labwork and an X-ray performed. It was determined that I had tendonitis of the hip. I was prescribed Prednisone for 5 days and Ibuprofen as needed. The pain improved by the following day and was gone two days later. The pain reoccurred on 9/10/21. It was a 5/10 on the pain scale. I was able to walk but unable to perform exercise activities. I went to my chiropractor for an adjustment. The pain improved the following day but continues remain slightly in my hip. My chiropractor and I believe I have had a neurological side effect from the COVID vaccine.  I will be receiving my second dose on 9/15/21.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in right arm and experienced soreness of right arm. They still planned to get the 2nd dose of SHINGRIX. This case has been linked to case US2018078807, reported by same reporter, husband's case.
Pt was transfered from urgent care to Covenant ER on 02/11/2022 with complaints of of breath, cough .  Chest x-ray showing possible developing right lower lobe pneumonia.  Patient admitted to the hospital with right lower lobe pneumonia/acute hypoxic respiratory failure secondary to COVID-19 pneumonia .    Patient treated with Remdesvir, Decadron. Elevated procalcitonin was also empirically treated with IV Rocephin.  CRP procalcitonin trending down. Afebrile. Patient seen by Infectious disease and cleared for discharge on ceftin 250mg BID for 5 days and to complete course of Decadron for 6 more days ( total 10 days). Patient did not qualify for Home o2. Advised RN to give COVID care kit  If Pulse ox less than 88% , recurrent SOB, chest pain fevers greater 101 seek immediate medical attention.
pt recv vax & devel petechial rash on both lower legs;pt crying on manipulation of the rt leg;t100.5, resp 26;around inj site there is local soft tissue swelling, but no signs of cellulitis;
Varivax given SQ left leg. Less than 5 minutes, noticed small raised areas near site of injection. Rechecked 2 minutes later - definite hive (red and raised) 2cm. Dr notified. Benadryl po given. 1700 pt playful, eating, drinking. Redden area decreasing. 36.8, 110/71-110. No resp problems. 1730 discharged home with mother and father, becoming sleepy from Benadryl. Induration markedly decreased, redness at site resolved.
Nurse called to report a patient who received a total of 4 doses of VAXNEUVANCE at age 2 months, 4 months, 6 months, and 7 months old; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. Patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not provided.  On an unknown dates the patient was vaccinated with four doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (exact dose, route and site of administration, lot# and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).
Very sore upper left arm- to touch and while using. Chills, skin "hurts" all over body, headache, tired, stomach cramps.
Severe headache onset 3 days post vaccine. Residual head pressure, nausea, brain fog, dizziness, extreme fatigue for 2 days following. Currently ongoing.
Pt reported that on May 13 she had recieved the SHINGRIX and 2 days later the site of injection was red and sore. However, on 6/12 she experienced swollen and pain on the upper part of the left arm where the injection was given. This pain occurs primary after she wakes up in the morning.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient was vaccinated with GARDASIL with the expiration date of 18-JUN-2016 (lot # K023432, dose, route of administration and injection site were not provided). No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
1/11/2021- noticed red erythematous, itchy severely  rash to Left forearm. Improved with otc antihistamines 1/11/2021- received 3 additional vaccines from PCP - MMR, Tdap and HPV- later that same evening rash developed to left arm where one vaccine provided our of 3. Resolved by 1/12/2021.
Approx 10-15 minutes after injection given employee became cool/clammy, face flushed, Rt arm red blotchy areas appeared. Stated "he felt dizzy and felt as if he was going to pass out". Sent to ER via 911.
On 04/01/1999, the pt received first dose of vax. Twelve days later, on 04/13, the pt developed right Bell's Palsy. Two months later, on 06/15, the pt developed left Bell's Palsy. An emergency room or doctors visit was required. The pt was treated with prednisone and Famvir. Symptoms resolved. The most recent information, received on 07/09, reports the condition of the pt is resolved. Reported on 10/06/2000: "The patient has a history of psoriasis, gastroesophageal reflux disease and pension prostatic hypertrophy.  Concomitant medications were not provided.  On 05/01/1999, the patient received his first 30 mcg dose of Lymerix for prevention of Lyme disease.  Twelve days later, on 04/13/1999, the patient developed right Bell's palsy.  On 05/20/1999, the patient received his second dose of Lymerix.    Twenty five days later, on 06/14/1998, the patient developed left Bell's Palsy with left sided facial numbness and (facial)weakness.  An emergency room or doctor visit was required.  The patient was treated with prednisone tapering dose and Famvir.  The information received by the manufacturer on 07/09/1999 reported the condition of the patient as resolved.  However, information indicated that as of 07/16/1999, the facial weakness of the patient was improving.  The events of left and right sided Bell's Palsy with facial weakness and numbness do not meet ICM serious criteria but are being submitted expeditously for informational purposes per FDA request.
Pt is c/o severe pain in her (R) arm, especially at the shoulder. She needs a pillow under her arm in order to sleep. She needs to use her left arm to move her right arm. She cannot use her right arm much at all now. She is still having severe pain after a month. There is no redness or heat at the site.
Chills 14 hours later; diarrhea starting a few days later and going on for nearly two weeks.
1) Swollen gums. I cannot eat solid food because the pain that comes from many swollen areas in my gums makes it very difficult. I went to the dentist yesterday and he ruled out lodged food or other normal things. He seems to feel that I might just need to "ride it out".   2) A single shooting pain in my neck, jaw, ear, and head - Not exactly a "headache", but rather, about every 1.5 minutes, a pain shoots up to the top left of my skull, that has clear roots in my left ear and my jaw and neck. When I press on that part of my skull, the pain increases (it's tender ... like my gums if that makes sense). My left ear has a very light throbbing pain inside it that is in-sync with this spiking pain. It's also connected to a spot just behind the left jawbone. And it connects to down to the neck, just above the clavicle area. This is super weird. I'm pretty in touch with my body (I stretch, walk, do martial arts. This all started on it's own on Tuesday. My only activity up to that point was gentle stretching and walking.  Moving, my head, swallowing, listening, moving my eyes. Almost anything seems to trigger it.
Pt recvd vax & devel lightheadedness, n&v, h/a, light sensitivity; episode of diarrhea & dec appetite; fever 101, alk phos 217; culture of sinuses revealed 4+ staphylococcus aureus; migraine h/a w/tension component; depressed; hypoglycemia;
Pt states she had to go to ER because of high fever, vomiting, diarrhea, pain and bruising at injection site. Was told she had intestinal virus.
Employee states reaction to every vaccine she receives. Employee states ticks, perseveration, uncontrolled laughing and crying which resolve on own. This happened today immediately after vaccine administered. Employee given water, cold pack. Symptoms resolving on own as stated. Will keep longer for observation.
local reaction of redness 5cm, soreness & pain @ site of inject 7 days p/vax; 10FEB92 f/u pt was treated w/cold dry compress & APAP;
Heart palpitations, pain in chest while laying down and at rest, blood pressure 184/103 at its worst, broke out in hives, extreme tiredness and lethargy, muscle weakness and achiness, nausea, diarrhea, shortness of breath performing ADL's. Advised by PCP to go to ER if shortness of breath presented while at rest.
Pt's right deltoid became hot, red and swollen to size of "orange" per mother one day post vax. Pt taken to Urgent Care and MD said it looked like a cellulitis and gave her IV antibiotics to cover "staph" infection. Pt seen on Monday and was on Augmentin. The site was warm, pink, nontender and slightly edematous. MD thinks it may have been a local allergic rx. Site never was tender but did itch on 6/22. No pustule at injection site.
Elevated blood pressure w increase hourly til at 2 am dr said go to er blood pressure to high for my condition After the emergency room discharge I started w fever, as high 101.6  chills, body aches   So after consulting family doctor I was given COVID test which I?m awaiting results
started to wheeze, congested , tired, cough, ended up with croup after wards. was fine before the shot.
Headache, fatigue,  sore arm (difficult to raise arm), swelling at injection site, rash and itching  at injection site (raised hard welt).
Malaise, Fatigue, Fever to 103.4; all lasting 18 hours; significantly sore L arm for 3 days Of note, patient had COVID-19 infection April 2, 2020 lasting 12 days.
Itchy really red, got worse the 2nd day, 01.22.21.  Getting redder with bigger circle each day.
She initially had localized arm pain for the first couple of days. She states she was sick around the same time as the COVID vaccine and felt achy on Friday, so it took her a little bit of time to realize it was just in her shoulder.  Since she filed the incident report on 10/30/23, she states her shoulder is exactly the same. She filed the incident on day 4 of 4 shifts in a row, and works in the ICU. She has been off the last few days, starts her week again on Sat for 4 shifts in a row.  Patient states it hurts to raise her arm above the level of shoulder in any direction ? laterally, in front, behind. She states it is the worst when crossing her arms in front of her as if she is taking off a sweatshirt. Over the 10/28 weekend, it now hurts when her arm is hanging down from her shoulder, when pulling the joint downward. She states that sleeping is okay.  She has applied heat, which feels better than ice. She has tried to do stretching, but painful to do ROM with rotation. Provided ROM exercises. Referred to Physical Therapy.
About 3 hours later started feeling nausea then vomiting. Inside of mouth, below tongue, behind lower teeth was swollen . Vomiting continued for about 2-3 hours. Overnight there was some discharge from the eyes resulting in crusty in AM.
This case meets criteria for vaccine breakthrough review. Patient admitted for acute respiratory failure secondary to choking episode followed by PEA arrest.  Unknown if COVID SxS prior.
Edema of eyes and mouth and itchy skin in axilla and blotchy rash right chest, voice hoarse.
Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as: hepatitis B Vaccine (30-AUG-2006, 25-OCT-2006, 03-JAN-2007, 04-JUN-2007), Meningococcal Protein Conjugate (25-OCT-2006, 03-JAN-2007), ROTATEQ (25-OCT-2006), poliovirus vaccine inactivated (unspecified) (25-OCT-2006, 03-JAN-2007 04-JUN-2007), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck) (09-OCT-2007), hepatitis A vaccine, inactivated (07-OCT-2007, 19-AUG-2008, 09-OCT-2007), measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (09-OCT-2007, influenza virus A vaccine (unspecified) (H1N1) (09-OCT-2007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headache, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with x-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, blackberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information for ROTATEQ, MARRS #1207USA008778. Additional information has been requested.
I developed shingles within 2 days of getting the shingrix vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: I developed shingles within 2 days of getting the shingrix vaccine). The outcome of the shingles was not reported.   The reporter considered the shingles to be possibly related to Shingrix.     The company considered the shingles to be possibly related to Shingrix.   Additional Information: GSK receipt date: 08-JUL-2023 This case was reported by a patient via interactive digital media. The reporter reported that within 2 days of receiving Shingrix vaccine, she developed Shingles. The follow-up could not be possible as no contact details were available.
105.4 rectal temp about 12 hours after vaccine. Tylenol given.
Local redness greater than puncture site with distal streaking > 50 mm obvious infection, secondary cellulitis Tx: Septra OS, Rifampin 300 mg. Resolving
PATIENT FELT DIZZY, FAINTED AND BECAME UNCONCIOUS (FOR ABOUT 1 MINUTE). WE THEN CALLED 911 AND PATIENT WENT TO ER. SHE STAYED FOR SEVERAL HOURS AND RECEIVED HEADACHE MEDICATION AND IV FLUIDS.
I started on 04MAY2023 with a sore throat, headache, chills, temperature of 100.4, musdcle aches headache, back ache as well, (not sure if it was from Paxlovid causiong this pain) back of my throat was sore and itchy, diarrhea, vomiting, metallic taste, slight loss of taste and smell.  I called my  Doctors office and saw him 06MAY2023 and I was prescribed Paxlovid and will test again after my regiment is finished and time is allowed.
Three days after injection, patient felt he could not think clearly. Four days after injection he experienced tremors involved his arms and head and upper body. These tremors lasted about 48 hours then went away.