chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/4/21 while hiking my heart started beating really fast, which is unusual, but chalked it up to the hiking. Then for several days after that, my heart would randomly ?flutter? but it only lasted a couple seconds, I assumed it was anxiety. 4/11/21 I was on a walk and my heart started beating really fast and it was hard to breathe. I went back home. 4/12/21 I was at work when suddenly my chest felt tight and  it was hard to breathe for a few seconds. Then following that for days it was the fluttering again, off and on, maybe once every other day, but now my chest had started hurting and feeling tight without the heart palpitations. Just all of a sudden a tight chest, this continues every day including today . 4/26/21 I was at work sitting at my desk when my heart started beating wildly, I?ve never experienced anything like that before. It lasted longer than the others and was stronger, and towards the end it was hard to breathe. I spoke to my doctor and she ordered bloodwork. I went to urgent care and they listened to my heart and lungs, and did an EKG and said everything looks good at the moment. I can still feel the chest tightness. I bought a heart monitor so I can track these flutters.
Moderna COVID-19 Vaccine EUA Around 6pm a week after I got my first COVID shot, a red circular rash began forming around the injection site. I have had a green small bruise the whole week from the shot, but the red circles didn't show up until a week later. They only lasted for about 24 hours before they faded away. I also had some irritation in the arm pit area of the same arm I got the shot in during the week after getting the shot.
lump in the injection site; warm to the touch/ heat; it's itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy). At the time of the report, VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by reporter.  No treatment information was provided by reporter.
Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random spots of rash on body
Breakthrough case admission after 2 vaccines Moderna 2/5/21 lot# 007M20A;  Moderna 3/5/21 lot# 023M20A
3 hours post vaccine- soreness of arm 3-24 hours: fatigue and sore arm 24-48 hours- sore arm 4 days post vaccine-5 days and counting-Nausea, Vomiting, Chills, Sweats, Diarrhea, Cramps
This case was reported by a healthcare professional and described the occurrence of leg pain in a 49-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous and/or concurrent vaccination included seasonal influenza vaccine (non-gsk) ;Sanofi Pasteur ;unknown;unknown given on 3 November 2009. There were no concurrent medications. On 3 November 2009 at 09:30 the subject received unspecified dose (booster) of ENGERIX B (1 ml, unknown, left arm). On 4 November 2009 in the morning, one day after vaccination with ENGERIX B, the subject experienced progressive leg pain, bone pain and foot pain. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were worse. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B. On 05 November 2009, the nurse reported that three subjects of ten total who were given ENGERIX B at the clinic on the vaccination date (03 November 2009) had called and reported similar events. As a result of these three reports, she had decided not to use the remaining doses until she further researched these events. The immunization series was discontinued. (Please see Case A0815433A and A0815453A for more details on the other two subjects, and A0815870A on a fourth subject). Follow up information was received on 06 November 2009. The health care professional wanted to file a QA (quality assurance) report. She received 20 ENGERIX vials in October 2009. She had distributed six of these vials and four subjects developed severe reactions to the vaccinations. She felt that these vaccines had a quality issue and she will not use the rest of the vials from this lot/shipment. She had the vaccines to return to GSK for investigation.
tightness in the chest; Lethargic; slight labored breathing/shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number : EN6206, Expiry Date: 30Jun2021), via an unspecified route of administration, administered in Left arm on 20Mar2021 11:00 (at the age of 49 year old) as dose 1, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none.  No history of previous immunisations. Prior vaccination, patient did not receive any other vaccines within four weeks. After receiving the vaccine on 20Mar2021, patient had a little bit of slight labored breathing. Then on 02Apr2021, friday, she had tightness in the chest, and was kind of lethargic and had a little more labored breathing than usual. Also on the days, 3rd, and 4th of April, she experienced all these events. At the time of report, she still kind of feels it, where It is so slight, but not usual for her at all. She confirms that her side effects have been stable, but out of the ordinary. They are noticeable, but slight, not enough for her to go to the doctor or hospital. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Within a month of receiving vaccine, experienced severe tonsil swelling leading to strep and tonsillitis that have been treated with antibiotics with no relief. Suspect immune system is not responding to sickness due to vaccine.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (dose and route not reported, lot number L008353 with expiration date 11-SEP-2016) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C for 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Pt recd 1st DPT/HIB/OPV in AM 8OCT91 mom called several hrs later-says pt has been crying/screaming since shot refuses to eat or to be comforted says has swelling @ DPT inject site; referred to MD & seen that afternoon; rx: Tempra q 2 hrs;
Severe headache; fever; chills; extreme fatigue; nausea; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 03Apr2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history, allergies and concomitant medications were not provided. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00 the patient experienced severe headache, fever, chills, extreme fatigue, nausea and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic and emergency room or department or urgent care. The clinical outcome of the events severe headache, fever, chills, extreme fatigue, nausea and loss of appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed hives and facial swelling the afternoon after receiving vaccines treated w/ BENADRYL and resolved w/i 8 hrs.
p/vax pt having swelling & pain;went to MD office started on augmentin;dx 2 days w/area of erythema;
Headache, fever, malaise. Fever in ED=100.5 F. Seen at hospital ED.
fever; sweating.; This is a spontaneous report from a contactable consumer. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 28Feb2021 17:30 (age at vaccination: 64 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included overweight, was a smoker, diabetic, blood pressure, thyroid disorder and several back surgeries. Patient is fused front, back, and sideways. The patient takes blood pressure and thyroid medicine. On 04Mar2021, 3 days after, the patient experienced fever, sweating. On an unknown date, the patient's body temperature was 99.5. The events did not require physician's office or emergency room visit. The patient had no prior vaccinations within 4 weeks: but had flu shot months ago. The outcome of the events was unknown. There was no product quality complaint (PQC) present.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt recv vax on 10/19/98; on 10/20/98 pt exp itchy palms of hands, fingers, toes & scalp, hives under LA & torso area; tx=Hydroxyzine
Within 30 minutes, I started to have a very mild headache. It felt like a pressure headache. I took Motrin. About 6 hours later that was gone. That night, about 8 hours after vaccine, I began to have muscle aches - whole body. I was very sore. I went to bed. Next day, I had severe joint and muscle aches and pains. The Motrin did not help that. Ice did not help, heat did not help and rest did not help. No headache. I wasn't red in face etc. Over the next week, I the muscle aches and joint aches were varying between moderate to severe. Some days it did restrict my activity completely. It started to get better week two - but still moderate to severe. I had some abdominal pain on upper left side and my right side (upper, as well) The upper right side pain would go away with ice but the upper left side wasn't helped with that. The only thing in those two weeks that helped was Celebrex (Motrin stopped helping). After two weeks - around 2/5/2021, I saw my Dr - a virtual visit. He told me to double up on the dose of Celebrex to help with muscle aches, joint aches and right side abdominal pain. Heart palpitations - irregular heartbeat. On 2/7/2021, I took a test for COVID and it was negative.  The joint and muscle aches were moderate to mild the third week. There was no more abdominal pain in third week. Week 4 - mild joint and muscle aches - only a few days that week and that was it. Last week was the first week where I had a few days that were fine. And this week, I have been completely fine. Had general malaise for three weeks solid. And now it's gone.
Pt recv vax on 10/7/97; approx 1 1/2 hr post vax pt exp bronchial spasms, sweats & malaise; tx=Epinephrine
Within the first 24 hrs. of my 1st shot on 3-19-2021, I began to get sick and experienced: chills, sweating, headaches, nausea and vomiting.  Then on 3-29-21 i woke up with red itchy patch (2x3) on my left arm at the vaccination site.  As the day progressed the red itchy burning feeling began to move down my arm to my elbow area, then eventually the palm of my hand. As it moved down the arm my arm became weak.  My hand/palm became red itchy, the swelling began to cut off the circulation in my hand, causing my hand to tingle, became cold.  I went to Urgent care facility, and doctor prescribed Steriods and antihisimines. Doctor also gave my a Steroid shot, and advised that I consider NOT getting the 2nd shot due to my adverse reaction on my first shot.
After taking the 3rd dose, I had a low grade fever, chills, severe injection site pain, headache, nausea, and dizziness. These symptoms persisted for three days. On July 21, 2022, I experienced difficultly breathing, chest tightness, mucus drainage, severe cough, and headache. I went to my doctor. On July 25, 2022, I was diagnosed with acute bronchitis. I received a Z-PAK, albuterol inhaler, nasal spray, and bromphen PSE DM for coughing. The drainage and headache symptoms improved, but my lung issues did not. I later went back to the doctor and I was a prescribed ADVAIR inhaler. I got better for a little bit but I was still dealing with health problems. On September 7, 2022, I went to the clinic on my campus and I was prescribed PREVACID and an albuterol inhaler as needed. I was then diagnosed with Shingles in August 2022. I was prescribed VALTREX for it. I will soon be tested for Asthma.
High fever, lethargic behavior after 4 days  - lasted approx 24 hours Broke out in rash covering entire body after 1 week - rash remains after 24 hours
Tightening of throat, tingling of tongue and lips, rapid heart rate, shortness of breath, numbness of face and very high blood pressure.
Mild erythema surrounding injection site, 5" x 3". tender to palpation. No fever, no angioedema. Tx: ZYRTEC and NSKID.
After receiving the 2nd dose he complained of feeling anxious and started to feel like he was having difficulty breathing. He started hyperventilating, then feeling faint. He loss consciousness and was unaware of how he made it to the ground. While placed on his back with his feet was raised he was able regain consciousness immediately. He complained of tingling and weakness to his leg, he had a brace on his left leg from a surfing injury.
I received my first dose of the Pfizer vaccine on June 16th, the day after I started menstruating.  My period did not end until July 3rd resulting in 19 days of bleeding.
A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200749, PJP200200742, PJP200200741, PJP200200720, PJP200200745, PJP200200690, PJP200200743.
75 year old male who presents with  Weakness and altered mental status after second covid vaccine. Patient with advanced dementia, at baseline ambulatory , follows some direction and able to feed himself , but since second vaccine worsening weakness, stopped walking and communicating and today was too lethargic for family to wake him up, thus 911 called.  Patient had similar but less severe reaction after first vaccine, and had covid disease earlier this year . Normally cared for at home by wife and son .  Patient unable to give any history , awake but not coherent.
Round red rash at the injection site; Round red rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site). At the time of the report, VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: TCR received- Email id received On 18-Jun-2021: TCR received- Follow up denied
Spotty Rashes on both arms and legs. Benedril helped rash to calm down for a few hours but rashes came back for 3 days.; Palms and Feet are tingling and itchy; Palms and Feet are tingling and itchy.; This is a spontaneous report from a contactable consumer. A 23-year-old male consumer (patient) reported for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 15:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included Benefiber (DEXTRIN) taken in two weeks. No known allergies reported. No other vaccine was taken in four weeks. No COVID prior to vaccination. No COVID tested post vaccination. The patient experienced spotty rashes on both arms and legs on 29Apr2021 at 8:00PM. Benedril helped rash to calm down for a few hours but rashes came back for 3 days. Palms and feet were tingling and itchy. No treatment received for "palms and feet were tingling and itchy". Outcome of rash macular was Recovered/Resolved with Sequel. The outcome of other events was not recovered.   Follow-up attempts are needed. Further information is requested.
shortness of breath, chest pain, rash, hives,  throat swelling, feeling flushed, dizzy, injection site swelling
local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); This spontaneous report was received from a patient of unknown age and gender reporting on him/herself, through Pfizer. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  In approximately 2016 (reported as "some 5 years ago"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On an unknown date, the patient experienced local skin reaction reported as warm, red and swollen (skin reaction, injection site erythema, injection site swelling and injection site warmth). The primary care physician advised the patient not to obtain the Pneumococcal Vaccine, Polyvalent (23-valent) anymore.  The outcome of skin reaction, injection site erythema, injection site swelling, and injection site warmth was unknown. Additionally, the causality assessment between skin reaction, injection site erythema, injection site swelling and injection site warmth with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was not provided.
Guilliain Barre Syndrome diagnosed  Hospital, 11/2/2021.  He received Influenza vaccine at Health Services on 10/2/2021.  I don't have access to which Influenza vaccine or lot number.   EMG/NCV was consistent with GBS as was clinical picture.  Treated with steroids and IVG.  Myasthenia gravis considered but ruled out.  Now back at Health Services.    He has NOT yet received Covid booster.   (note item #17, I started to enter the influenza vaccine but didn't notice you are asking for vaccine same day as Covid vaccine.  He DID not receive another vaccine on 3/4/2021.  I could not remove my error on #17.  )
Cutaneous Hyperaesthesia Response  Feels like an extremely bad sunburn that is sensitive to the slightest brush of fabric - temperature sensitive as well.  My skin feels warm to the touch, but no visible rash or redness or swelling. Pain is intensifying and affected area gradually increasing over the last 8 days - goose bumps are incredibly painful.  Started on the outside edge of thighs and hips, moved up my trunk, mostly on the edges about a hands width wide then merged, migrating up my lower back toward to my shoulder blades and down the arms.  It?s fully wrapped around my chest and abdomen. Currently, my legs are fine from mid-thigh down to toes and my neck and head also remain unaffected.
1 month old was given expired Pentacel/ No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an eight weeks old female patient who received 0.5 mL expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5593AA, expiry date 27-Oct-2019, via intramuscular route in the right thigh on 04-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  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.
"Just wanted to report I had a reaction to the flu shot I got yesterday. I received it around 3pm.  Around 9pm, my entire left side was tingly, numb, my heart was racing, I was extremely sore, and I was very disoriented. I had no fever, nausea, or vomiting. I was able to sleep it off with my husband keeping an eye on me. By 9am this morning, I felt fine and had absolutely no side effects at all. I?ve honestly never had a reaction to the flu shot ever before. Not sure if I needed to report it at all. "  reported by this individual.
Swelling left deltoid, red, warm.  No tenderness no nodes. Elevation/ice, no fever.
After getting the Covid 19 Booster injection I had symptoms of headaches, fever of 102.1(before taking Tylenol), felt unbalanced, diarrhea for a day, arm hurt to touch, and have lymph nodes under the  right arm.
Patient states he had a typical reaction the day of the vaccine (low fever, chills, aches, injection site pain) and when to bed earlier than usual because he was tired.  He didn't sleep well, and this morning his sleep app indicated his heart rate during the night was between 100-110.  After noticing his heart rate was between 130-140, he called the clinic and was told to go to the ER.  Hospital ER administered several tests and did blood work. The MD's determined his heart was fine and it is likely vaccine related.  He is home again and is feeling better (no chills, etc.) and his resting heart rate is now in the low-90's.