chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/27/21, Client said she began feeling very dizzy as soon as she woke up that morning.  Episodes of vertigo were on and off all day, each time lasting several seconds. When this occurred, she needed to hold onto a fixed chair/table to steady herself. She has had NO headaches or nausea associated with this vertigo, and states she has never had vertigo in the past.  Each day since then, the vertigo has become less intense but the symptoms were still occurring at the time she called our agency to report it on 3/2/2021.  The vertigo caused her to not drive her car to work, but she has been able to go to work.
Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath.  The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. 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.
Pt received his vaccine at 1:22PM and he went to sit down and was noticed to turned light in color. Skin sweaty.  Pt asked to lie down.  BP 90/60, RR 18, OxSat 95% Pt remained alert, talkative, and hes color return to normal.  BP 121/74, HR 68, RR 18.  Pt stated he felt much better.  he was asked to stand up, and he did it w/o symptoms.  Pt was D/C.
Chills; Headache; Fever 101F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F). On 14-Apr-2021, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101 (High) fever 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
patient called pharmacy on 9/30/2020 at 4:35pm to report that she had a reaction to the pneumovax 23 IMZ she received on Monday 9/28. She says she had swelling on her arm from her elbow to her upper arm and all the way to her breasts. The skin was red and swollen, she also report of fever of 100.8. She said she took Ibuprofen to help with fever and body pain. Her fever is gone today and swelling  has gone down but she still has some redness, itching .
Her sister reported that on the 5th day she got a tremendous pain in her arm where she got the Pfizer COVID-19 Vaccine shot; Is almost like the flesh is being sucked underneath the titanium plate, there is like no blood or anything but there is a hole; This is a spontaneous report from a contactable consumer. This is report 2 of 2. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Her sister reported that on the 5th day, the patient experienced a tremendous pain in her arm where she got the Pfizer covid-19 vaccine shot, was almost like the flesh was being sucked underneath the titanium plate, there was like no blood or anything but there was a hole on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Not feeling okay; Feel like I have a cold; Arm extremely sore; Received vaccine while actively infected with COVID-19; Problems sleeping; A spontaneous report was received from a 75 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and received the vaccine while actively infected with COVID-19, and experienced arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold.   The patient's medical history included a COVID-19 test taken on 21 Dec 2020 with a positive result on 30 Dec 2020 at 20:00. Concomitant medications reported included levothyroxine sodium, vitamins, allergy medication (not specified), omega-3 fatty acids and calcium.   On 30 Dec 2020, several hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported that on 21 Dec 2020, she underwent COVID-19 testing and received positive test results, several hours after receiving the Moderna COVID vaccine on 30 Dec 2020. She also reported that her arm was extremely sore, problems sleeping, not feeling okay, and feeling like she had a cold. Treatment reported included oxymetazoline hydrochloride, pyrilamine / mepyramine / chlophedianol, and sulfamethoxazole / trimethoprim.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, received vaccine while actively infected with COVID-19, arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold, were not reported.; Reporter's Comments: This case concerns a 75-year-old female who experienced NS events of unexpected SARS-CoV-2 test positive, feeling abnormal, nasopharyngitis, insomnia, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of extremely sore arm, insomnia and feeling unwell,  like having a cold, a causal relationship cannot be excluded.
I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe headache. I was also having nausea.  I saw PCP on 01-06-2021 and he gave me Phenergan  6.25-10mL, 5mL syrup with codeine to help with my headache.  I only took the Phenergan one time in the evening before I went to bed.  I also got tested for a rapid Covid-19 test which was negative.
Starting 04/24/2022, when I woke up I felt fine, but by the end of the day, I was extremely fatigued. I would feel this fatigue for about 3 weeks. Just shortly after the fatigue started, the burning nerve pain sensation also started. It was more intense than the last time and it lasted longer than it did after the previous dose. I mentioned these symptoms to my doctor when I saw her via video for osteoporosis. She had prescribed a medication previously to me for the nerve pain (meloxicam) but I found out I was allergic to it. I had started it on 03/18/2022 but had to stop due to the allergy to it (rash).
Nausea and vomiting; left arm swollen, red and hot on 5/15/02. Went to bed. On 5/16/02, woke with "flu-like" symptoms (nasal stuffiness, SOB, nausea and vomiting). On 5/16/02, went to primary MD. No treatment needed. On 5/17/02, headache and ache over left arm.
Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL.  Subsequently the patient became dizzy and experienced a sharp pain in her arm.  Subsequently, the patient recovered from feeling dizzy and the sharp pain in arm.  The patient sought unspecified medical treatment.  Additional information has been requested.
Onset of extreme body aches,overwhelming fatigue onset 2/24/22 @ 1900 which have continued > 1 week after vaccine causing inability to work
flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body aches
This spontaneous report as received from a nurse refers to a 10 months 13 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Fever fever, chills, achy, cellulitis, lymph node swelling Narrative:  WENT TO URGENT CARE AND PRESCRIBED KEFLEX/STEROIDS X 7 DAYS
severe anaphylactic shock; Unconscious; This is a spontaneous report from a contactable consumer (patient). This 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 73-year-old) (Batch/Lot Number: EN6200) as single dose (unknown if first or second dose) for COVID-19 immunisation and bendamustine from an unspecified date, 5th dose in what was to be a series of 12, for Waldenstrom's macroglobulinaemia. Relevant medical history included Waldenstrom's macroglobulinaemia. The patient's concomitant medications were not reported.  The patient previously took bendamustine for Waldenstrom's macroglobulinaemia (the patient received 12 doses over 6 months 2 years ago). On 03Mar2021, the patient experienced severe anaphylactic shock and loss of consciousness; the events were considered serious as life-threatening. The patient specified that 5 days after the vaccine, the patient was undergoing chemotherapy with bendamustine. He had Waldenstrom's macroglobulenemia. This was his 5th dose in what was to be a series of 12. He had received 12 doses over 6 months 2 years prior to this report. During the treatment, the patient went into severe anaphylactic shock. He was unconscious in about 10 seconds from the onset of his first symptoms. He was treated on site and transferred to an E.R.  The severity of the event and the fact that both drugs were playing around with his immunoglobulins led him to file this report. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a nasal swab on an unspecified date which was negative. He recovered from the events on an unspecified date.
Continuous Respiratory Issues  -Cough  -Shortness of Breath  -Sore throat -Vomiting  -Headaches
Hot to Touch - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 26-Feb-2021, VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05 May 2021 included reporter information.
This report describes the occurrence of staring in an approximately 2- to 3- year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the subject's father and has not been verified by a physician or other healthcare professional. There was no reported medical history, concurrent conditions, or concurrent medications. Reportedly, one to two years ago, the subject received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The father reported that the subject was zombie-like on the same day he received the injection. Reportedly, the subject just stared for the first 18 hours. The father stated that after the 18 hour, his son started to return to normal. Reportedly, the following day, complete resolution occurred.
Right after the last vaccine was administered, the patient layed her head down on the desk. At first, she was replying to the father and the nurse talking to her, then became unresponsive. The initial vital signs were taken. The patient was lowered to the ground, and her feet were elevated. The vital signs were taken again, and then every 2-3 minutes until the ambulance arrived. Last set of vitals were taken at 9:18 am: BP 86/65, RR 22, HR 84, O2 99%.
No adverse event. Moderna booster for 18 years of age or older given. Moderna bivalent booster should have been given.
dizziness; 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 DIZZINESS (dizziness) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        AE submitted   Reporter did not allow further contact
Angioedema; Wheezing; throat pruritus; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), WHEEZING (Wheezing) (seriousness criterion medically significant) and THROAT IRRITATION (throat pruritus) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) to be possibly related.    Laboratory test included Polyethylene glycol and polysorbate skin testing with results not provided until FTA is available  Company Comment: This literature case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Angioedema, Wheezing and Throat irritation. A Polyethylene glycol and polysorbate skin testing was also reported (no results available). The events occurred at an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown since the events outcome was unknown and no information about other doses was available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-394128 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Angioedema, Wheezing and Throat irritation. A Polyethylene glycol and polysorbate skin testing was also reported (no results available). The events occurred at an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown since the events outcome was unknown and no information about other doses was available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Narrative: Patient received one dose of covid vaccine. Patient with PMH includingHLD, HTN, CDK3, HIV+, and left femoral below the knee popliteal bypass with PTEE and Linton patch c/b emergent fasciotomy for acute thrombosis on 6/2/20 c/b subsequent thrombosis and s/p thrombolytic therapy for acute limb ischemia and BKA. Patient was discharged to rehab with no further notes of cause of death. Reporting per facility instruction.
during our covid site visit from the department on 12.15.22, it was discovered that we had a pfizer batch in the frig past BUD date. During the investigation they went back through all the covid injections that were given and saw this patients lot number was given past BUD date. patient has been contacted and revaccination was offered. manufacture was notified and reports were filed pending outcome.
Recd 2nd dose on 2/10/21 at 11am. No soreness or reaction until around pm headache and slight soreness. In the middle of the night, felt soreness on right side. When I got up in morning, had throbbing pain near hip in front. It has persisted all day and cannot lift right leg unless I pull my pants leg up slowly. Extremely painful when trying to do this to get up. Took Aleve 2X but has not helped.
Body aches since 8 pm, 10 hours after vaccination.   Chills at 3 am when I woke up.   15 hours after vaccination.   No fever as of 5 a.m.  17 hours after vaccination.
This case was reported by a healthcare professional via a sales representative and described the occurrence of vaccine exposure during pregnancy in a male neonate exposed to TWINRIX (GlaxoSmithKline) given to the mother while pregnant. The case was also reported by the subject. Previous vaccination received by the mother included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 March 2008. From 04 to 06 December 2007, the mother had received Ofloxacin, 0.3 percent daily for pink eye. On 10 April 2008, at 09:30, the 23 year old mother received 2nd dose of TWINRIX at 1.0 ml intramuscularly in the left arm. Thus, the baby (the subject) was exposed to TWINRIX transplacentary. This was at approximately four weeks gestation. Information received on 10 February 2009 via a Pregnancy Registry Outcome Form indicated that the male, neonate subject was born premature (36 weeks gestation) on 24 January 2009, via induced vaginal delivery with vacuum extraction. The infant weighed 6 pounds and 13 ounces and was 19 inches in length. It was reported that the mother had been on bed rest for 10 days prior to delivery due to preterm labor. Labor was induced due to extreme back pain in the mother. The neonate was born with hyperbilirubinemia and lung immaturity. The outcome of the events was not reported. For details concerning the mother case, please refer to A0724362A.
Severe joint pain, nausea, chills, fatigue, sweats lasting 48 hours, symptoms eased slightly with ibuprofen.
I had an irregular heart beat and had a telehealth visit and was directed to urgent care and I was taken by ambulance to emergency room. It was over 166 bpm, I was given drugs to reduce it and the next day it went back up to over 180bpm. I went back to the hospital, I was given medication to reduce it again by a cardiologist. I have an appointment on March 24th for a 5 hour procedure I'll have to stay over night for and I've been told there isn't a cure but a progressive problem. The medications I'm currently on have huge side effects.
Pt developed knots on both thighs at injection sites. Pt also experienced redness and swelling.
Patient presented to ER complaining of a rash that started the day after he had received a Fluzone HD and a Pneumovax-23 immunization in the left arm. The rash was encircling the deltoid area and was erythematous & hot. May have had a fever.
Information has been received from a physician concerning a female with rheumatoid arthritis who on 21-JUN-2007 was vaccinated with a single 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 657559/0462U).  On approximately 21-JUN-2007 the patient experienced ill feeling with arthralgia and skin rash.  Unspecified medical attention was undertaken.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.
Fever 100 by 9pm,  102 by Midnight, which progressed to 105 by 4AM.   ER visit malaise, back & neck pain, and headache.
fatigue - 3/25/21 @ 5 pm and all day Friday and Saturday. - slept majority of the 2 days body aches, chills, hot,,  - 3/26/21 starting at 2 pm until Saturday around noon - slept dizzy - 3/27 - am and happened just a couple times. headache - 3/26, 27  - on and off through out the day.  pain, redness, swelling/tender at the injection site and surrounding area - started 3/25 at 8 pm and still continueing. - tried ice, ibuprophen, gentle massage. nothing seems to work.