chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- 22 year-old female  - Tested positive for COVID-19 on January 31, 2021. My symptoms lasted 21 days and started with major gastrointestinal issues, headache, and cough.  - Had a negative COVID-19 PCR test on February 25, 2021  - this negative PCR was needed to travel back. - Landed on February 28, 2021 and completed my quarantine at my parents house.  - I returned to work on the 15th of March, 2021.  - Over the weekend I traveled and flew back on April 5, 2021. Because I had flown, I was doing a courtesy and went to the local store to get a rapid antigen test.  APRIL 8, 2021 - left work at 12:30 and went to the store to get the rapid antigen test which came back positive. I was told by the nurses that it only came back positive because it has been less than 90 days since I initially tested positive. I was told I did not need to self-isolate and could go about as normal. I had my second dose of the Moderna vaccine on this day at 2:00 p.m. I went to get my second jab. Just to be safe, after my jab I went to the local urgent care where they took a nasal swab for a PCR test. The results of the PCR test came back Saturday, April 10 about 7:30 that evening and the result was "NOT DETECTED".  SYMPTOMS: Thursday, April 8th  about 8:00 pm I started to have difficulty breathing and taking a deep breath was difficult. I put it down to anxiety about the initial positive test. Saturday, the difficulty breathing continued, along with new pressure in my chest. I was unable to sleep Saturday night - as soon as I was nearly sleep, I would wake up gasping for a breath. Sunday, the pressure in my chest continued and so did the difficulty breathing. I went to the Emergency Room on Sunday, April 11 about 4:15 pm - they took a chest x-ray, ran blood tests, and did an EKG which all came back completely normal - no pneumonia, heart attack, or blood clots. The doctor gave me a 1 mg dose of an anti-anxiety medicine because he could tell I was very stressed. He later prescribed me Prednisone (3 tablets a day for 4 days). As of today, I am still having a very hard time taking a full, deep breath and continue to have pressure in my chest.
Pain; Redness; Swelling; Felt cold for half of the night; Rest of the night she had sweating; Headache; Muscle pains; Injection site appears bright red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), SWELLING (Swelling), FEELING COLD (Felt cold for half of the night) and HYPERHIDROSIS (Rest of the night she had sweating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CITALOPRAM, FENOFIBRIC ACID and COLESEVELAM HCL for an unknown indication.    On 12-Apr-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 (Pain), ERYTHEMA (Redness), SWELLING (Swelling), FEELING COLD (Felt cold for half of the night), HYPERHIDROSIS (Rest of the night she had sweating), HEADACHE (Headache), MYALGIA (Muscle pains) and INJECTION SITE ERYTHEMA (Injection site appears bright red). At the time of the report, PAIN (Pain), ERYTHEMA (Redness), SWELLING (Swelling), FEELING COLD (Felt cold for half of the night), HYPERHIDROSIS (Rest of the night she had sweating), HEADACHE (Headache), MYALGIA (Muscle pains) and INJECTION SITE ERYTHEMA (Injection site appears bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old non-pregnant female patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID 19 vaccine, Solution for injection, Lot number EN6200) via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00AM as dose 1, single (age at vaccination 73 years) for COVID-19 immunisation (Other). Medical history included atrial fibrillation, supraventricular tachycardia (SVT), asthma, hypothyroidism, dust and pollen allergy all from an unknown date and unknown if ongoing. Patient was taking other medications in two weeks. Patient was not taken any other vaccines in four weeks. On 18Feb2021 16:00 (04:00 pm) the patient experienced extreme fatigue, some nausea, body aches, overall muscle pain, injection site very sore. Most side effects lasted 3 plus days. No therapeutic measures were taken as result of events. Patient was not having covid prior vaccination and not tested post vaccination. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
104.2 FEVER, CHILLS, EXCRUCIATING PAIN IN THE UNDERARM WHERE THE INJECTION WAS GIVEN, DIZZINESS, LIGHT HEADNESS, GENERAL WEAKNESS, INABILITY TO KEEP BALANCE.
Within 4 minutes of receiving the dose I had tingling in my left facial cheek area, left orbital socket and towards the left ear; I can not feel it; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 08Nov2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR); both from an unknown date for an unknown indication and unknown if ongoing. On 08Nov2021 at 14:04, within 4 minutes of receiving the dose the patient had tingling in his left facial cheek area, left orbital socket and towards the left ear. It felt like "novacaine" was wearing off from the dentist office. He could move his face, smile frown etc. But he could not feel. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within 4 minutes of receiving the dose he had tingling in his left facial cheek area, left orbital socket and towards the left ear and he could not feel was resolving at the time of report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOCETIRIZINE; PANTOPRAZOLE; FISH OIL; CARVEDILOL; ATORVASTATIN; AMLODIPINE BENAZEPRIL; BAYER ASPIRIN. Past drug history included: Hydrocodone, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks included one a day multi vitamin. Therapeutic measures included anti viral Paxlovid from 23Nov2022 to 27Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
itchiness at site of injection, redness, hot to touch and welt at injection site all 1 week post injection
Started 11.3.16. Warm to touch. Pt. reported rash on left arm to Dr. on 11.4.16. Per MD said if not resolved within 5 days to make appointment for antibiotic.
Patient was seen by RN d/t lab work, noted that previous lab work Varicella was not immune. RN asked floor RN to give Varicella; reviewing patients chart nothing noted patient pregnant. Upon giving vaccine verified allergies, explained why patient was receiving. Patient understood and okay to receive vaccine. Patient given vaccine in left arm. Patient does not disclose that she is pregnant at time of vaccine. Patient left clinic messaging provider later asking if okay to have got vaccine cause she was pregnant. After review provider saw patient for PE; and incidental pregnancy. Was not noted in chart, except in providers visit note. Provider made aware. Provider contacted patient after consulting CDC website for risks. Patient okay at this time and understands. Clinic will continue to f/u with patient.
One of three pt who experienced swelling & redness fr the inject site to the elbow; Tx APAP, DPH & cold compresses;
Patient died at 5:15 the same day--- his wife performed cpr on patient until medical help arrived.
SUSPECTED COVID 19; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient experienced 2-3 weeks of covid and unknown drug abuse or illicit drug usage. It was unknown that patient consumed alcohol and smokes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced suspected covid 19. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative, Negative, On 15/Apr/2021, test returned Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid 19 was not reported. This report was non-serious.
Fever, hives/spots that eventually covered entire body, pain, stumbling/falling from what seemed like swollen joints.
CONCENTRATION IMPAIRED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced concentration impaired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of concentration impaired was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
submassive saddle pulmonary embolism; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "submassive saddle pulmonary embolism".; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
SOB. Afebrile HR 111; 101; 98. RR 24-30 BP 150/92, 148/101, 180/110. Pulse Ox 100% x3 BS CTA Dizzy, H/a, Nausea.
multiple sclerosis; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced multiple sclerosis. Patient wanted to get know if she can get revaccinated because of her current multiple sclerosis condition. She was quite concerned because she got her second shot of the vaccine 3 weeks after receiving the infusion for her multiple sclerosis condition. Patient stated she got the 2nd shot of the vaccine 3 weeks after the infusion for her multiple sclerosis medical condition. She wanted to get a yes or no answer if she can get revaccinated given that she got the 2nd shot of the Pfizer BioNTech Covid-19 Vaccine 3 weeks after the infusion for her multiple sclerosis medical condition. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sat AM, right arm, red, swollen, painful to child.  Warm area by touch.  Mom giving Motrin.
Stroke, hypertensive emergency, acute metabolic encephalopathy,acute respiratory failure with hypoxia, AMS airway compromise
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; & titer result was 2.5, indicating a low post response;
my armpit is swollen; my armpit is / tender; This case was reported by a consumer and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th December 2020, the patient received Shingles vaccine. In December 2020, less than a week after receiving Shingles vaccine, the patient experienced local swelling and axillary pain. On an unknown date, the outcome of the local swelling and axillary pain were unknown.   It was unknown if the reporter considered the local swelling and axillary pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. It was reported that patient received the Shingles vaccine and after that experienced swollen armpit with tenderness.
I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain Narrative: The chest pain felt like a muscle pull on left side of chest  according to the employee. She text her PCP who recommended that she go to the urgent care/hospital to be assessed.
On Feb 26, after my vaccine, I arrived home at 6:30 pm and told my wife my ears are ringing loudly. This lasted a few hours.   On March 26, after my vaccine, I arrived home at 6:30 pm and told my wife my ears are ringing loudly. This lasted a few hours.
The evening of the shot, around 10pm, I noticed that I was getting chills.  A hour or two later the fever started.  Sleep was difficult in bed because of pain in right arm.  Fever and chills continued Saturday, with a high temperature of 101.5F, along with body aches and pain.  Symptoms started to lessen on Sunday, chills first then fever, and finally disappeared on Sunday night.  Pain at injection site lasted for a few more days.
Fatigue then sudden onset dyspnea with exercise in previously well and athletic physician/ health care worker
Patient noted itching and hives approximately 3-4 hours after injection.  Presented at er, no hives noted, diagnoses:  Acute Diffuse Pruritis.  Given Prednisone, Atarax, Prilosec.  Experienced feeling restless, edgy, anxious, represented at ER, given imtramuscular decadron and morphine 4 mg for right upper quadrant pain, and sent home.
Chills, Fever, Headache.  Lasted from about 8:30pm on 7-May-2021 to about 1:00pm on 8-May-2021.
Headache 7 hours later - lasted about 48 hours Body aches 20 hours later - lasted about 24 hours Fever 24 hours later - lasted about 24 hours
COVID+ WITH MINIMUM SYMPTOMS    COUGH NASAL CONGESTION SORE THROAT
Swollen cervical lymph nodes on left side; 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 LYMPHADENOPATHY (Swollen cervical lymph nodes on left side) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen cervical lymph nodes on left side). At the time of the report, LYMPHADENOPATHY (Swollen cervical lymph nodes on left side) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-171223 (Patient Link).
I had a fever (101.5) off and on for 18 hours. Muscle aches, hot and cold sweats, extreme headache, nausea and vomiting. Those symptoms lasted until 9pm on 2/22/21. My injection site was sore and warm to the touch. That lasted 2 days total.
Vaccine reaction pt with left upper arm - red warm & swollen also burning & itchy. Dr. just reassure.
This spontaneous report as received from a nurse refers to multiple patients of an unknown gender and age. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of VAQTA (lot # L046953, expiration date 14-JAN-2017; LIQUID PEDVAXHIB (lot # L038501, expiry 16-AUG-2018 and lot L051124, expiry 14-OCT-2018; RECOMBIVAX HB (lot M010212, expiry 21-JAN-2019, lot L016427, expiry 13-APR-2017 and lot L045117, expiry 06-OCT-2018; ROTATEQ (lot M004890, expiry 10-NOV-2017 by oral route and GARDASIL (lot K010215, expiry 05-MAY-2017 and lot M014929, expiry 27-MAY-2017. The reporter stated that the vaccines were exposed for 15 hours and then they backed in range. There were no previous temperature excursion. There were no concomitant medications and adverse events reported. No product quality complaint was involved. Additional information has been requested.
Red injection site after 24 hours. Swollen lymph nodes in injection armpit and neck. Sore muscles across body. Sore joints. Fever after 24 hours post vaccine.
Chest pains: relieved after 45 minutes following dos of 2 aspirin and another dose of 2 aspirin after 30 minutes.
Flu like symptoms; All joints hurt/ joints were painful; Severe pain in left arm I got injection in/left arm was very painful and it was up underneath my armpit and down my arm; rash few days later and it's been itching; redness; Sunburn; Has sort of a "wound" (not clarified) on the injection "site wise"; arm is feeling itchy; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date: 30Apr2021), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included haemochromatosis and GERD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated, "I got the Injection, the second injection on Monday and Tuesday night I got the typical flu like symptoms. My joints were painful. I had severe pain in my left arm that I go the injection in and today like all day, my arm is feeling itchy on 14Jan2021 but I really didn't have any like redness around it but now there is like half of the side like redness on my shoulder. It feels like kind of a sunburn and has sort of a "wound" (not clarified) on the injection "site wise" (not clarified). I have been taking some Advil and I took some Benadryl the first night and I took the "Mucinex" (not clarified) (unspecified medication) it's like a "cough" medicine. The arm is getting as the days have gone on. It's just like first night the day after I got flu like symptoms, so like all of my joints hurt. The left arm was very painful and it was up underneath my armpit and down my arm and then that part improved but the left arm is now developing a rash few days later and it's been itching, like really itching." The patient considered that BNT162B2  is related to the events. The outcome of the event "pain in the left arm" was recovering while the outcome of the remaining events was unknown.
Myasthenia Exacerbation:  Left eyelid droop; Loss of speech; difficulty with swallowing. IVIG infusion 9/13/2021 and 9/15/2021. Episode of syncope due to dehydration on 9/14/2021. ER visit 9/14/2021 and 9/17/2021 for IV hydration. Increased prednisone to 40mg per day. Plan for IVIG in October. Continued difficulty with speech and swallowing as of 9/23/2021.
C/O diarrhea and aching approximately 2 hrs after Adacel shot given - symptom progressed with severe myalgias lasting approximately 72 hrs.
Pt. states that after receiving the 1st dose of Shingrix 02/08/2022, started experiencing symptoms that evening of soreness at the injection site, redness with swelling, fatigue/weakness, dizziness, and itchiness at the injection site. No noted Primary visit/communications. Pt. still continuing to experience symptoms. (Previous case of Shingles 06/2021)
Chest tightness without shortness of breath followed by angioedema of the lips and tongue -- symptoms progressed from 3:00 PM to 6:00 PM.  50 mg of diphenhydramine resolved symptoms 30 minutes after administration.  Symptoms resolved by 6:30 PM.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/10/2021. Symptom onset date is not available, but they tested positive for COVID-19 on 12/31/2021 and were admitted to hospital on the same day (12/31/2021). They were discharged to a skilled nursing facility on 01/05/2022 to continue palliative care (no CPR). They died later the same day, on 01/05/2022.