chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller is receiving an infusion for her asthma after receiving her 2nd shot of  Pfizer BioNTech Covid-19 Vaccine. The infusion may be an immunosuppressant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Caller is receiving an infusion for her asthma after receiving her 2nd shot of Pfizer BioNTech Covid-19 Vaccine. The infusion may be an immunosuppressant". Therapeutic measures were taken as a result of asthma.  Additional information: The patient wanted to know if the current infusion that she was taking for her asthma may lower the protection that she got from her 2 doses of Pfizer BioNTech Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 inch diameter red rash and pain around the injection site, chills, lethargy, body aches, and dehydration. 24 hours later the rash was gone, but the other symptoms remained. 48 hours later all resolved except for lethargy.
BROKE OUT ON UPPER BODY LOOKED LIKE WELTS WHICH WAS SHOWING LIKE BODY REJECTING VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that the patient's doctor had told that the patient's immune system was good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced broke out on upper body looked like welts which was showing like body rejecting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out on upper body looked like welts which was showing like body rejecting vaccine was not reported. This report was non-serious.
sinus infection that has spread down to her chest; cough; coughing green phlegm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Blood pressure high (Low grade blood pressure). Concomitant products included IBUPROFEN for Fibromyalgia, FLUOXETINE HYDROCHLORIDE (PROZAC) for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3 Lesions filled with fluid with erythematous base 1 on abdomen, 1 under nose and 1 on cheek started 8/29/06. Varicella like lesions.
Area where vaccinated swollen and itchy 2 weeks post injection.  About 1.5 inches in diameter. Mildly itchy.
C/O- States SOB, "perhaps due to mask", feeling much better after sitting and receiving education on vaccine side effects.  Action- Monitored in OBS area, released after 30 minutes with no complaints
Information has been received from an office manager concerning a 51 year old female patient with no known drug allergies who on 07-OCT-2009 was vaccinated intramuscularly in the left arm with a 0.5ml dose of PNEUMOVAX 23 (Lot# 664653/1337Y). Concomitant therapy included aspirin, TRICOR, ADVAIR, CAMPRAL, LEXAPRO, melatonin, estrogens, PREMPRO and multivitamin. On 07-OCT-2009, the patient experienced erythema, pain, and swelling at the injection site after vaccination. The patient also felt clammy but did not know if the patient had a fever. The patient had sought medical attention via telephone. No laboratory diagnostic study was performed. The patient was treated with anti-inflammatory and cold compresses. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Pt experienced a rash and fever post vax. Medical attention was sought. No further info is available.
After getting 2nd booster (Dec 31,2022) around 21 days, I end up in ER for 3 days (Nov23-, Nov 24-25) due to dizziness and TIA! On end of November holiday 2022, instead of visiting my 2 weeks old first grandchild, I laid in hospital ER corridor for almost 6 hours waiting to be admitted to recovery room. (My responses to doctors are documented in files).
Dx cellulitis at injection site 10/4/16 seen at urgent care 10/4/16. Started on cephalexin.
Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R armpit
This spontaneous report was received from a patient of unknown age regarding himself/herself. Information regarding the patient's current conditions and medical history was not provided. It was reported that the RECOMBIVAX HB (dose, lot number unspecified) was given 0, 1 month and 11 weeks (dates unspecified) (inappropriate schedule of drug administration). No product quality complaint (PQC) was involved. No further information was provide. Additional information is not expected, no contact details were provided.
Swelling and pain - lymph nodes under the left axilla on to the left chest; I applied heat and took Motrin. Went to the doctor on the 6th;went for an ultrasound - January 8, 2021 ; no other treatment; repeat ultrasound to be done tomorrow 2/10/2021
Labored Breathing --> CTA in ER demonstrated bilateral ground glass consistent with inflammatory process-possible "viral pneumonia".
Pt felt feverish and lightheaded within 5 minutes of vaccine. He experienced sweating and chills. Administered one dose of acetaminophen. Pt was monitored for 30 minutes and felt better prior to leaving. We followed up later in the day and he did not experience any further symptoms.
p/vax pt exp inj site rxn including swelling of most of the upper arm in which vax recv;the areas were also hot & painful to the touch;pt sought unspecified medical attention;the reporter expressed a concern w/the specific lot of vax;
Extreme depression after vaccine Delayed period, spotty dark blood, very large blood clots and heavy cramping for over 3 days
Heart racing, severe sweating and dizziness, fatigue, brain fog.  Heart and sweating and dizziness lasted 2 hrs, fatigue and brain fog on going
Tiredness, extremely weak, dizziness, extreme chills, shivers, pain at injection site. This last until 04/04 when I started experiencing rashes from the left side of my shoulder to across my chest. Insomnia 04/05--AM.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown multiple dates, the patients were vaccinated with an improperly stored doses of ROTATEQ, orally, lot # L046319, expiration date 28-SEP-2017 (dose was not reported). The administered doses of vaccines were exposed to a temperature of 9 Celsius degrees, for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient had  chest pain,non-cardiac .  Onsite EMS was called vitals HR 84 BP 152/80  99% O2. Patient refused evaluation or care. Released against medical advise.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary immunization series complete; manufacturer uknown), for COVID-19 immunization. The patient experienced dysphagia and aphasia, with outcome of unknown. Additional information: She wanted to know if she can have the Paxlovid pill or not. She mentioned on Monday she was not able to talk or swallow. She recently took her Pfizer COVID-19 vaccine shots 2 weeks ago. The symptoms occurred 2 weeks after taking the COVID-19 vaccine booster shot. The medical inquiry was forwarded. Information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
vomited/T99-100;pain;to clinic-looked toxic;hosp for R/O sepsis; T102 in hosp; continued w/cranky, distressed abd pain;stool grew Aeromonas which may/may not have been cause of abd pain/toxicity
Hot feeling on vaccinated spot; arm swollen; Arm numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb) 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.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb). At the time of the report, VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb) outcome was unknown.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient's First, second and third dose details were not reported.   Reporter did not allow further contact
COVID-19 symptoms beginning night of 7/18/2022. Bad cough. Tested positive for COVID-19 on 7/19/2022. Low-grade fever 7/19/2022, 7/20/2022 and 7/21/2022. Started taking Paxlovid beginning 7/19/2022. No symptoms beginning 7/24/2022.
Patient was admitted with COVID-19 symptoms on 9/14/2021 after finishing second vaccine dose on 9/7/2021.  Patient has progressed to being intubated during this hospitalization and remains on the ventilator at this time of reporting this.  Patient continues to slowly improve with a positive outlook but a long road to recovery.
pt had previous hospitalization and was dx with COVID pneumonia; dc'd to rehab facility; pt's condition worsened and she was brought to Hosp; blood cultures found to be positive for enterococcus with endocarditis; respiratory status waxed and waned during hospitalization requiring intubation; pt received antibiotics, transfusions, antifungals; pt's mental status deteriorated; family chose to withdraw care; pt extubated and passed away in the hospital
Felt like I was coming down with a bad flu or cold. Had a slight fever, some diarrhea, and full body aches that lasted for about 24-36 hours.
Child complained of pain in left leg and did not want to bear weight (i.e., walk). Mother noted left leg swollen even down to the foot. Left thigh much bigger than R thigh. Stated not reddened and denied fever.  "Just painful, it hurt him and he wouldn't walk." Acetaminophen reportedly administered about 2 hrs after administration of vaccines and about every 4 hours, but not during sleep hours at night. When father called about 1:00 p.m. on 11/30/11, was advised to repeat analgesic if time and also try a warm (or cold) compress to toleration of child.  Mother stated he liked the frozen sponge they gave him and he held it to his thigh himself.  It did not worsen so they elected to not visit a healthcare provider. Next morning (today), leg was noticeably better but still swollen at thigh. Child is now walking and wanted to go to daycare today.
Pt experienced Arm numbness/tingling sensation on Left Arm, as well as a hot flash episode resulting in a brief episode of general weakness/malaise
Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant products were reported. The patient stated that he received monoclonal antibodies as treatment. The lab test included Monoclonal antibody test with inconclusive results. Rhinorrhoea and Nasopharyngitis are not coded as they are COVID-19 symptoms; Sender's Comments: This case concerns a 41-year-old male patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred approximately 5 months after second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given The The benefit-risk relationship of Spikevax is not affected by this report.
I have allergies all the time.  I have a cough with my asthma.  I did have a cough and fever of 104 degrees.  I took ibuprofen and put cold compresses on me which worked to bring the fever down.  The next morning my fever was 100, achiness, dry cough, soreness, and fatigue.  I was mainly exhausted and rested the whole day. I had more of a cough than my regular asthma.  I was prescribed Paxlovid.  I was functional like I took my son to school and came home and went to bed.
Weeks later, I woke up with cramps in my wrist and it went up to my shoulder, through my back making it very difficult to lift and move. I took Tylenol and practice stretching but nothing worked. Now as days go on, I'm having trouble walking.  A month later I finally decided to call my doctor and went in, she took X rays and said muscles in my neck and back were really tight. She only recommended me to physical therapy as the X rays came back ok.
I had a mammogram 23JAN2023 it was noted that a small 4mm lump was detected in my left breast. A follow up ultrasound and views will be completed on 10FEB2023.
Intense chills, weakness, headache, lightheaded, muscle aches, very short, but very intense sharp stabbing muscle pains
Patient's first moderna vaccination was 2/8/21 and received 2 nd dose 3/3/2021 -- timeframe 23 days this is less than recommended by the manufacture and CDC guidelines.  Patient could not come back to the clinic as he was traveling.   He acknowledged the timing, the risks and strongly wanted to provide with vaccination.
NAUSEA; BODY PAIN; CHILLS; LEGS HURT; FEVER 102 DEGREE F; BAD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. 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, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced legs hurt. On 10-APR-2021, the subject experienced fever 102 degree F. On 10-APR-2021, the subject experienced bad headache. On 10-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102 degree F, chills, bad headache, nausea, body pain and legs hurt was not reported. This report was non-serious.
Patient was a resident of a facility.  Patient had hx of thoracic spinal mass and not being able to walk.  Patient tested positive for Covid-19 at the facility on 02/08/2022.  CXR obtained at the facility came back clear.  On 02/17/2022 patient c/o SOB with exertion and positional changes.  Patient expired at facility on 02/22/2022.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Feb-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.27  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 14-Feb-2021, no hourly temperature recordings available  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant product was not provided by the reporter Treatment medications were not reported.
Within 4 hours my left pinky was swollen.  By the next day (Sat.) my arm was tingling. Sunday my left leg was slow to keep up with my pace when I was walking. Monday I got real tired. Tuesday my left arm could not grab the steering wheel or type on the computer. My co-worker told me I was slurring my words, that's when I went to the hospital. They told me I had 3 blood clots in my right brain. I had a stroke.
not received her second dose in the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator   Patient has not received her second dose in the recommended interval. As of 11May2021, it has been 48 days since her first dose.
The patient developed a rash 2 inches around in the vaccine site.  The patient also reports tingling from shoulder to elbow for approximately 1 week.  The patient could not straighten arm due to pain.  Patient can still feel pain upon movement.
I had vaccination on 10/22/2022. I had a slight fever having both vaccinations of about 100 for 2 days. On 04/03/2023 I started to experience dry cough headache dizziness and fever. I tested COVID-19 positive on 04/04/2023 and I called my doctor office. I was prescribed PAXLOVID. I feel ok but still feel wiped out a little bit and I still have a cough.
FELT LIKE SHE HAD BEEN HIT BY A TON OF BRICKS, LETHARGY
About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme muscle aches and headache.  My fever lasted about 12 hours running between 100 and 102 (on tylenol)  Headache continues. Muscle aches and fever subsided about 24 hours after onset.
Stinging and pain when administered. Within a couple of hours following receipt of the shot arm became red, swollen, hot, and itchy.  Woke up the following morning with hoarseness and coughing.  Arm very red, swollen, hot, and itchy. Took Benadryl, which helped relieve some of the intense itching.  All adverse events listed persisted for approximately 52 hours with the swelling beginning to go down after this and itching lessened.  After 5 days all adverse effects disappeared.
Pt complained of swollen tongue, tasting "medicine" at the back of throat, numbness, dry throat, 10-15 min after getting the vaccine, was asked if she wanted an epipen adminstered but declined, she accepted a water bottle but said it did not help with the dryness, when asked if she wanted 911 called she said yes and emt was called to the pharmacy, upon EMT arrival she was still conscious and able to talk, complained of weakness when escorted to ambulance.