chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flashes; chills; chills got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Sep2021 18:00 (Lot number: FC3182) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no taste and smell", start date: 26Dec2020 (unspecified if ongoing); "no taste and smell", start date: 26Dec2020 (unspecified if ongoing); "nausea", start date: 26Dec2020 (unspecified if ongoing); "vomiting", start date: 26Dec2020 (unspecified if ongoing); "passing out", start date: 26Dec2020 (unspecified if ongoing); "hot flashes", start date: 26Dec2020 (unspecified if ongoing); "chills", start date: 26Dec2020 (unspecified if ongoing); "diarrhea", start date: 26Dec2020 (unspecified if ongoing); "abdominal pain", start date: 26Dec2020 (unspecified if ongoing); "headache", start date: 26Dec2020 (unspecified if ongoing); "cramps", start date: 26Dec2020 (unspecified if ongoing); "no period", start date: 26Dec2020 (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1.5/30 taken for contraception, start date: 2018 (ongoing). The following information was reported: HOT FLUSH (non-serious) with onset 01Sep2021 19:00, outcome "not recovered", described as "hot flashes"; CHILLS (non-serious) with onset 01Sep2021 19:00, outcome "not recovered", described as "chills"; CONDITION AGGRAVATED (non-serious) with onset 01Sep2021 19:00, outcome "not recovered", described as "chills got worse". The events "hot flashes", "chills" and "chills got worse" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hot flush, chills, condition aggravated.  Additional information: Other reported test were CBC, Celiac w reflux, IGA, TSH 3rd, ANA Screen, XR Chest, Lactate dehydrogenase and all are negative. Patient had not received any other vaccine within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.
12/27/2021- Started out just with nasal congestion, fatigue, and then over the next couple of days coughing, headache, and fever. 01/03/2022- Went to see doctor and she prescribed prednisone, cough syrup with codeine, and she performed a COVID-19 test - negative. I received the results on 01/05/2022, results were negative.
COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jan2022, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Reporter reported that it was Unknown if other vaccine was taken in four weeks. It is Yes if patient was Covid tested post vaccination. It was Unknown if covid was prior to vaccination. Privacy Policy consent was Yes. Device timestamp on 21Jan2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Pt presented the day after vaccine with redness and itching at injection site as well as other areas of chest, neck and back.
The patient reported that there was some irritation, itching, redness, and warmth that began under the injection site and spread to just under the bicep. She reported this today but she reported that it is getting better already.
Shoulder is still very sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder is still very sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ARTHRALGIA (Shoulder is still very sore). At the time of the report, ARTHRALGIA (Shoulder is still very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment medications were not mentioned   Reporter did not allow further contact
The evening of the injection patient spiked a fever of 106 and went into convulsions.
mild arm soreness 3 hours after shot. restless sleep. minor headache 12 hours after shot. 101.2 fever and body aches, headache, fatigue, arm soreness 24 hours after shot. persisted for 5 hours
throat feeling clogged or stuffed; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Aug2021 as dose 1, single for covid-19 immunisation. On an unspecified date in Aug2021, the patient experienced throat feeling clogged or stuffed. Reporter stated that "I was wondering if that one of the side effects that you all have been hearing about children because I don't have any side effects with myself and not the family members have any side effects". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, itching, swelling of arms, legs, back, hands. Tingling and itching throat and nose, shortness of breath. Rec'd BENADRYL / SOLU-MEDROL IM and BENADRYL - MEDROL Dose Pak.
patient received  dose of 0.2ml  of pediatric pfizer vaccine when he should have received the adult dose due to turning 12 recently.
She went to bed at 8:00 PM and had been acting normal since receiving the vaccination. She woke up at 9:45 crying uncontrollably, which is very unusual. We gave her Tylenol and she fell back to sleep around 10:15. She woke up again at about 12:15 AM crying uncontrollably again. She eventually fell back to sleep at about 1:30. I suspect that she had pain at the injection site.
Arm soreness from the vaccine; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021, the patient stated that he received his 1st dose yesterday, due to arm soreness from the vaccine, he took Naproxen 200mg. According to him, he already spoke to 2 nurses and they were unable to provide him an information regarding interaction of the vaccine and medicine. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information was expected.
Excessive pain/soreness/muscle fatigue at the injection site (left shoulder), including a "lump".  Pain lasting for greater than 5 weeks.
I got my period three hours after the vaccine and have not had it in over a year.  It lasted for five days where typically it would last one, no more than two.  The following day I got a urinary tract infection.  The doctor prescribed sulfamethoxazole-trime 800-160 tabs (six tabs).  After completing medicine, I can still feel the urinary infection symptoms and am going to call doctor for next step
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength. batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively in 2015, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.  On an unknown date, reported as subsequent to the vaccination, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).     The event shingles was serious due to hospitalization and life threatening.   Additional information has been requested.
Headache, Sedation, Arthralgia, HYPOtension, chills, swollen glands and fatigue. pain and swelling at the injection site. Narrative:  Other Relevant History:
Initial unsolicited report received from Consumer on 29-Oct-2015. This case involves female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date several weeks ago. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had had pain in my arm and the elbow till yesterday. Lab tests and corrective treatments were not reported. Patient was recovering from the event as it started to go away. Documents held by sender: none.
30 hours after shot #2 I developed a large red spot on my bicep around 2 inches below the injection site. It was sore and very hot. My body has reacted this way before when I get bee stings. I iced the spot on and off for two days. Day 4 the redness and swelling went away. There was a small bruise and knot under the skin.  This reaction seemed weird because it was below the injection site, not on or near it. Day 5 all signs of reaction were gone.
Child complained of last night right arm feeling heavy and itching and no temp elevation noted. 7/31/02 1:30pm, Mother and child presented at health department. Site on upper right arm red, swollen, hard, hot to the touch and approximate size of an orange. No temp elevated or rash. Complained of itching at site only.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Elderly patient (age and gender was not reported) who reported that MD was administering the dose when the syringe leaked from the hub, unclear if patient received a partial dose and syringe at the needle point was leaking at the neck, syringe leaked from the hub while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ047AB and expiry date: 28-May-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose and syringe issue. Patient involved reported no known symptoms. 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. List of documents held by sender: none.
weight loss, nausea, vomiting, dizziness, palpitations, fatigue-started a week before being diagnosed with COVID
I was supposed to start my period around March 25, 2021 and I did not get it. I have since gotten my second vaccine, and it has been 5 weeks since my first. I am on my 73rd day of my cycle, and still no period. I have been experiencing fatigue, lots of discomfort around my ability to regulate my temperature, and general discomfort and aches.
During 15 minute window pt states her lip was tingling and both her hands were shaking. Denies any trouble breathing or other symptoms.
I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night with nausea and when I woke in the morning I was having both dizziness and Nausea. The nausea has subsided but I am still experience waves of dizziness.
Localized erythema gradually worsening to raised 3 x 2 cm with central pallor.
Narrative:  Following the second dose of COVID-19 vaccine (2/22), patient was seen at a hospital emergency room on 5/2/2021 for a DVT in the right leg. Initially treated starting on 5/3/21 with Apixaban 10 mg BID x 7 days and is completing 3 months of treatment with Apixaban 5 mg BID. As of 6/17/2021, swelling and pain is resolving, but not completely gone.
Blurred vision; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "Blurred vision".  Additional information: Pharmacist stated, "So its regarding adverse event for the COVID Vaccine. I have a patient that called me, and expressed concern about she experiencing Blurred Vision, like an hour after she received the first shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a 73 year old female patient, with no drug reactions/allergies and no pertinent medical history, who in 2012 (on an unspecified date), was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). There was no concomitant medication involved. On 12-JUN-2013, the patient developed shingles on unspecified areas of the body. The patient was given VALTREX and TYLENOL #3. The outcome of shingles on unspecified areas of the body was reported as recovering. The relatedness between shingles on unspecified areas of the body and therapy with ZOSTAVAX was unknown. No laboratory diagnostic studies were performed. The patient sought medical attention - she came to the physician's office. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 reported as 74.21.  No concomitant medications were reported.  The vial was initially stored in the fridge on 23-Mar-2021, moved to clinic on 30-Mar-2021 and proposed beyond use date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 27-Mar-2021, at 09:00 A.M and at 10:00 A.M. the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On 28-Mar-2021 and 29-Mar-2021, at 10:00 A.M, the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On the date of administration, at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Dizziness and intermittent headaches. A feeling of shaking in my body, and unsteady on my feet much of the time. Occurs also when I'm sitting or lying down. Sensations of waves in my body. No treatment.  I went to urgent care and spoke to 2 different doctors virtually. I have an upcoming physical exam and my doctor may order a head CT scan.
On April 3rd 2022, I started coming down with a scratchy throat that progressed throughout the day, so I took an at home COVID-19 test which was negative. The next day, I felt like I had a cold but I disregarded it because my test had come back negative. When I realized I was running a fever, I made an appointment to be tested for COVID-19 at the Clinic on April 5th and was notified that evening that it had come back positive. I was treated with MAB therapy on April 7th. My symptoms lasted, but decreased over time, for around 10-12 days with the exception of some fatigue that I'm still experiencing.
Fever, body aches, headache, redness swelling and firmness at injection site (resembling cellulitis) as well as lymphedema to right armpit.
Stabbing headache, random, not constant, very painful, all areas of head - every day Low grade fever for approx 6 months (Aug. 2021 - Jan. 2022) Red dots on stomach - went away after 4 months Joint pain - constant Confusion, memory loss, low grade fever  - occurs if i dont take Diclofenac daliy Extreme Fatigue - occurs every day Sleeping sickness- difficult to stay awake more than 8 hours a day Freezing Feet - occurs daliy (rest of body is normal temp) Kidney issues for a few months Suseptable to illness/colds - poor immune system 10/18/21 (headaches, fever);12/20/21 (headaches, fever);1/1/22 (pnuemonia); 3/21/22 Vaccine injury
Vaccine DTaP #5/IPV #4 given about 9:35 AM. Per mom about 15-20 min started to cough, worsening with time until brought back to office about 10:30AM. Positive wheezing. O2 sat 91%. Within 10 min, received ORAPRED, XOPENEX Neb tx, O2, Epi 1:1000 0.12cc SQ with immediate relief.
Patient had fever several days after receiving the vaccine then started with a rash on her back that quickly spread to  other parts of her body (Chest, arms, legs)