chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up at approximately 4:00 am with an extremely dry mouth. I went into the bathroom and took a drink of water. I returned to bed. I noticed that my breathing was becoming more rapid. I had trouble catching my breath. I sat up on the side of the bed. My heart was pounding and quick. My breathing was difficult. I woke up my wife. After about 5 minutes my symptoms improved. She took my pulse which was now at 62ppm.  I laid back down in a reclined position. My symptoms of difficulty breathing and elevated heart rate quickly returned. My pulse was now up to 98 ppm.  I sat up again. My symptoms gradually improved. Being unsure of what was going on my wife called 911.  The ambulance arrived in about 8 minutes.  I was about 60% better. Vitals were improving other than my blood pressure which was 180/100 Being unsure of what was happening, I was transported to Hospital.   I  had a chest x-ray, a chest CT scan with contrast to rule out a blood clot, blood work including tests to rule out MI x2. All test were negative.  By about 6:30 am I was feeling at least 80% better. My breathing I felt had returned to normal. My pulse was down into the 50"s which is my normal range.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). The patient's past medical history included cancer (unknown type). Concurrent medical conditions included esophageal acid reflux. Concomitant products included Levothyroxine. On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 hrs after receiving SHINGRIX, the patient experienced itchy throat. On an unknown date, the patient experienced injection site swelling (serious criteria disability). On 10th April 2018, the outcome of the itchy throat was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site swelling and itchy throat to be almost certainly related to SHINGRIX. Additional details were reported as follows: The pharmacist stated that the patient was taking levothyroxine. The patient received the SHINGRIX vaccine in the left deltoid and she experienced throat itchiness two hours after receiving the vaccine, and it resolved by the end of the day. Less than a month after vaccination, the patient experienced injection site swelling, which lasted for 3 to 5 days. The pharmacist did not know the onset of that symptom. The pharmacist stated that the patient's arm swelling was a little bit disabling. The reporter was not aware of any medical intervention taken because of patient's experiences.
Injection site reaction NOS; Nasal congestion; Pyrexia. This report describes the occurrence of an injection site reaction in a 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis.  This report was received from a consumer and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject reportedly had no adverse experiences following receipt of prior immunizations.  On 01/28/2003, the subject received an injection of Pediarix as the fourth injection in the DTP immunization series.  Within three days post-immunization, she developed an injection site reaction characterized by swelling and soreness.  She also experienced congestion and a "slight" fever. These events were reported as "not major, and symptoms have gradually gone away."  The injection site remained "tender" as of 02/05/2003. On 3/18/2003, the mother stated that she had not taken the subject to the vaccine provider post-immunization. The mother declined to grant authorization to GlaxoSmithKline to contact the vaccine provider. Comment:  The reporter indicated that the subject received Pediarix from lot A58659; however, this is not a valid lot number.
severe h/a, swollen lymph node in lt arm, deep pain in shoulders & back;
~ 1am localized redness around injection sites; redness surrounds both sides. Small lump with warmth at site
Left leg was swollen and red. Saw pt 6/3/04 for follow up, no swelling inflammation.
Patient received the pediatric dosage of Pfizer vaccine when she should have received the adult dosage.
Patient woke up with a rash that started on her legs where the vaccines had been given. The rash spread to her trunk and some on her face. Some of the spots were big and red, looking like hives. The rash did not seem to be itchy. Patient had a temp of 100.3 and was fussy. No difficulties breathing or swallowing. Mom instructed to give a one time dose of Benadryl. Follow-up phone call later that afternoon, patient was feeling better and rash was resolving.
Site of PNEUMOVAX administration became extremely red, swollen and sore. Redness and induration spread over entire upper arm and pt had knot in armpit. Pt had fever and nausea. Pt's daughter had same rxn.
received COVID 19 Treatment; received COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022 at 14:00, outcome "not recovered" and all described as "received COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive; (16Jul2022) Positive. The testing kept showing Positive since 06Jul2022, and today's testing showed Positive as well (16Jul2022). The patient received COVID 19 Treatment Paxlovid from 06Jul2022 to 10Jul2022. No known allergies or other medical history, no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccination on 4/4/2019. Called provider on 4/11/19 to report his arm became red, warm, the size of half a melon, swelled from shoulder to elbow. Denies fever but positive for chills. Patient states reaction took place on 4/4/19 after getting home from appointment. Denies these symptoms at present. ErythemaMultiform & swelling
Injection was given in right gluteal muscle. Client presented 24 hours following injection (8/29/19) with a softball size area of localized redness around the injection site. Point of injection could be visualized within reddened area. Client did not report any itching at injection site. Client reported experiencing chills on 8/28/19 but did not take her temperature. It was recommended to client that she follow up with her doctor on 8/29/19.
A few minutes after receiving the vaccine, I got dizzy, then my tongue and back of my throat started to swell.  I could breathe, and that was great.  Swallowing was a bit difficult at first.  My throat stopped swelling and we left the vaccination site.  Later that night, very tired and my scalp itched.  Next day very tired, nauseous, headache, scalp itched very badly, a little dizzy and felt very "off".  All resolved by the 2nd day.
He sees a cardiologist every 6 months for pacemaker check , pacemaker was placed over 20 years ago for slow heart rate.  Been seeing cardiologist for over 20 years. Now first visit since vaccine and he has Atrial fibrillation. Never had it before.  Today there is reporting possible link between vaccine and myocarditis.  I look up can myocarditis cause Atrial Fibrillation.. answer YES.
Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report from a contactable consumer (Patient reported for himself). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 77-year-old), as First dose, single for Age/COVID-19 immunisation in clinic; warfarin, via oral route of administration from an unspecified date since 15-20 years ago (Batch/Lot number was not reported) and ongoing, at 7.5 mg, daily, (7.5mg by mouth daily) for Blood thinner (anticoagulant therapy). Medical history included cardiac disorder(bad heart) ,back disorder(bad back that is full of metal) from an unknown date and unknown if ongoing. No investigation assessment. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date of the Pfizer vaccine received. No history of all previous immunization with the Pfizer vaccine considered as suspect. Vaccine did not administer at military facility. The patient forgot and did not tell vaccine administrator that he was on a blood thinner prior to getting the vaccine and received the COVID-19 vaccine on Tuesday at clinic. He did not read the papers at first. Later he saw on the papers something that he did not tell them. "What does he need to do." On 03Feb2021, the patient had a fever of 100 degrees,It was down to 98.9 degrees ,He was dizzy. The gland under his arm was painful. He had muscle cramping in his legs. Adverse event did not require a visit to emergency room/physician office. The patient underwent lab tests and procedures which included on 03Feb2021, body temperature: 100 degrees and body temperature: 98.9 degrees. No relevant tests were performed. Therapeutic measure the patient took "Tylenol" as a result of fever, dizziness, gland under arm was painful, muscle cramping in legs and it helped. No product complaint was reported. The outcome of the event gland under arm was painful was resolved on 03Feb2021, outcome of the event fever was resolved on 04Feb2021 and outcome of the events dizziness and muscle cramping in legs was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Sore arm, pink/itchy area below where shot was given. Slight flu like symptoms: achy, slight fever, tired, but didn't feel bad enough to stay in bed. Two days after shot, all symptoms gone except sore arm and pink/itchy area below where shot was given.
Severe headaches, and also problems with dizziness to the point where i fall over and pass out.  my body aches to the point where i cant move anymore.  my asthma came back out of the blue after i got the shots.  i also have a rash on my arms now.  the pain has grown worse and worse.
After 24 hours of getting the shot I had a fever of 100.2 and chills.  It lasted throughout the night and the next morning I did not have a fever and felt fine.
First dose given below age of 18 (17 year old patient); This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)). On 20-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)) had resolved.        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.   No concomitant medications were reported. No treatment medications were reported.
flu-like symptoms; Product supply issue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and product supply issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional detials were provided as follows: The age at vaccination was not reported. Around April 2018, the patient received dose of Shingrix and experienced influenza-like symptoms. The patient reported that, she did not receive 2nd dose of Shingrix due to back order, which led to product supply issue. The patient did not consent to follow up.
Mother states the child had diarrhea prior to vaccine. Vaccine was given on 4/20/01 at 15:00. The child was fine initially following vax. At 03:00 AM woke with hives and at 4:00 am the child was brought to the ER where the MD related the symptoms to Prevnar vax.
Low fever, headache, neck ache, arm ache, generally felt badly 6 hrs after injection for about 12 more hours. Adverse event was to Typhoid Typhim-according to pt.
Five minutes after receiving the vaccine, patient had to lean against the register counter of the store and close his eyes.  The pharmacist was called to examine the patient.  The patient had his eyes closed and he was breathing. 911 was called. The patient was asked if he had trouble breathing and he said no.  The patient was instructed to sit down but the patient refused.  The patient said "This is just how I am."  The patient and the patient's mother waived off any additional assistance and decided to leave.  The patient appeared normal and was speaking when he decided to leave.
a little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Lung cancer (Almost in her 11th year of lung cancer. She had chemo and some radiation and has been stable for some time now.), Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure abnormal, VITAMIN D NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little sore arm). At the time of the report, PAIN IN EXTREMITY (a little sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram thorax: normal (normal) CT scan for lung cancer a couple of weeks ago and it was okay.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided for this event.  Reportedly, the patient is due for a mammogram 6 weeks after the second dose.    This case was linked to US-MODERNATX, INC.-MOD-2021-075816 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Initial additional: non-significant updated appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075816:2nd dose case
Covid infection; Covid infection; Fatigue; Really bad headache; Shakes; Fever of 101 F.; This is a spontaneous report from a contactable consumer.   A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Apr2021 at 07:00 AM, as 2nd single dose, for COVI-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received the 1st dose of BNt162b2 on an unspecified date and had experienced a short period of dizziness (less than 30 seconds). After getting the 2nd dose, the patient experienced no symptoms for about 20 hours. But then, 20 hours later, which was around 02:00 AM on 06Apr2021, the patient woke up with shakes and fever of 101 Fahrenheit. The patient took 3 Advil to fall asleep, then woke up at about 05:00 AM with a really bad headache that lasted about 24 hours. On 07Apr2021, the patient woke up at 02:00 AM with no headache or any other symptoms except from some fatigue which was still present as of 08Apr2021. The patient was the diagnosed with a breakthrough Covid infection on 10Oct2021. The patient recovered from shakes, fever, and headache on 07Apr2021, while the outcome of the remaining events at the time of the last reporting on 18Oct2021 was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401210 Same reporter/drug/patient, different dose/event
This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VAQTA (lot # M022531, expiration date of 23-FEB-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sudden vaginal bleeding and spotting, not period; Spotting; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration on 18Aug2021 at 00:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Aug2021, the patient experienced sudden vaginal bleeding and spotting, not period. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event sudden vaginal bleeding and spotting, not period was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
received dose after more than 30 days refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were provided.
Approx. 5-10 mins after receiving vaccine and bicillin injection the Pt c/o of feet feeling funny and chest discomfort. Stated he felt like he was dying, coughing large amount of frosti sputum, c/o chest pain, capillary refill in fingers and toes 6-8 seconds. Sweaty and clammy decrease LOC. Labor breathing O2 10L given/non re-breather, Epi Pen adult given times, two, Benadryl given, Sol-u-medrol given. IV NS GIVEN PER EMS. 18 G LT ANTCUBITAL. 4:00PM TO 4:16PM. TRANSFERRED TO HOSPITAL.
Patient had a vasovagal vaccine reaction one minute after the vaccine was given. She started feeling dizzy and lightheadedness about half a minute after receiving the vaccine while seating down. I noticed her face color started to fade and turning to pale while, then began losing consciousness while seating down. I immediately called 911 and paramedics came within 5 minutes to check on patient. While waiting for paramedics to come, I noticed patient coming in and out of consciousness. She was able to verbal that she could not see but was breathing okay and able to make conversation with me and her mom. Paramedics came and checked vitals and made sure she was okay before they left. Vital signs were BP:108/78 mmHg, HR 78 bpm and Oxygen saturation 98%. The entire time from start to finish is about 30 minutes.
EXACERBATION OF MYASTHENIA GRAVIS:DOUBLE VISION, DIFFICULTY SWALLOWING, THROAT CLOSES UP,CHEWING DIFFICULTY, EXTREME WEAKNESS,BREATHING PROBLEMS DIAPHRAM GETS EXTREMELY WEAK, LEGS GIVE OUT WHILE WALKING, ARMS ARE WEAK, EYELIDS WONT STAY OPEN, CANTS HOLD MY HEAD UP MOST OF THE TIME, SLEEPLESSNESS, THESE SYMTOMS STARTED SLOWLY AND ADVANCED AS TIME WENT ON. I STILL STRUGGLE TO THIS DAY, CANT TAKE CARE OF MYSELF, CANT DRIVE, CAN'T WORK I WAS SENT TO THE EMERGENCY ROOM BY MY DOCTOR, THEY PUT ME IN THE ICU, WAS GIVEN 2 TRATMENTS OF IVIG IT DID NOT HELP. THIS FORM WILL NOT LET ME FILL IN NAME OF HOSPITAL: I WAS IN THE HOSPITAL FOR 3 DAYS. I HAD THIS CONDITION UNDER CONTROL FOR 12  yr
As per vaccinator, vaccination needle got separated from syringe and vaccination came all over patients arm. Patient didn?t receive vaccination. Dose was readministered to patient.
Erythema at left deltoid to elbow, chest, pruritis, non tender, and not nodular.