chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
painful body aches/shooting pains; chills; skin tender to the touch; This is a spontaneous report from a contactable other hcp (reported for herself). A 50-years-old female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EN5318), via an unspecified route of administration on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included bifidobacterium lactis (PROBIOTIC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 19Feb2021 02:00 patient experienced painful body aches/shooting pains, chills, skin tender to the touch. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on unspecified date in Feb2021.
I had a headbanging headache. I still get them on and off. My headaches are usually associated with sinus pressure. My sinuses my eyebrows, cheeks, face everywhere hurt. I thought it was a sinus infection. The doctor was going to prescribe me medication. I did not experience green mucus that usually accompanies the sinus infection. In addition to that I had severe hives. It looked like someone had thrown boiling water at my torso. They were going to prescribe me prednisone. I  did not want that because I am a healthy person and they told me that the prednisone could compromise my immune system. I wound up with a dry mouth and the inside of my mouth hurt. I had talked to friends who had COVID and they said they experienced thrush. I did not have the white spots associated with thrush though. After 3 weeks, I went to the doctor and asked if it was possible I had a yeast infection in my body. They prescribed nystatin and from there things got worse. I went back in and they told me to stop the nystatin because my blood pressure was bottoming out. I have never had an issue with blood pressure before. I was experiencing dizziness after standing up. After stopping the nystatin, and getting the Holter monitor I experienced an episode of dizziness. I feel my mouth is starting to get better. I do have some tingling around my lips. I felt like I had Botox shots around my lips.
Information has been received from a physician concerning a 19 year old female who on 27-AUG-2009 was vaccinated with her first dose of GARDASIL (route and lot number not reported). There was no concomitant medication. On 27-AUG-2009, after vaccination, she was taken to the waiting room to sit and she felt "woozy". It was reported that it was unsure if the patient fainted or not. The patient was monitored at the office until she felt better. Subsequently, the patient recovered from patient felt "woozy". The patient sought unspecified medical attention. Additional information has been requested.
Eleven hours after receiving the influenza vaccine I started having pretty severe adverse reaction symptoms consisting of severe fatigue, moderately-severe whole-body aching, chills, sleeplessness, and minor aches at the injection site. There is no notable swelling or redness at the injection site. I have a mild temperature of 99.1 (mercury thermometer) 21 hours after injection. There is a notable increase in my resting HR to 88 (vs. 49 typical). I am also experiencing some moderate esophageal spasming. I took a diphenhydramine 25mg just in case. I am not experiencing any other allergic reactions such as itching, hives, flushing or facial swelling, breathing problems shortness of breath, wheezing, cough, confusion, disorientation, dizziness, lightheadedness, nausea, vomiting, stomach cramps, or diarrhea.  I have never had a reaction to a vaccination anywhere as intense as this.  My typical reaction to a vaccination is mild shoulder soreness for 48 hr.
Pfizer COVID-19 Vaccine EUA      Patient upon receiving vaccine 2 mins began feel nauseated and hot- provided ice pack wheelchair and got her to the provider where she was placed on gurney.vitals were taken please see chart. Epi pen was given when patient's lips started to turn red cough and stridor noted please see the notes. Ambulance was call and patient was taken to the hospital see chart. At approximately 0903 peri oral erythema was noted and patient reported chest tightness. Stridor was noted.  SpO2 remained stable at 97-98% on RA. EpiPen administered, 911 contacted for transport to ED. 0909 patient reports improved chest tightness, peri-oral erythema improving stridor.  EMS transported patient to ED for further evaluation and treatment.  ED - does not have chart access.      3/25: ED 3/23/21 Anaphylaxis after receiving Covid vaccine: chest tight, hot, and dizzy. Patient received epi at clinic and epi and benadryl in ambulance. Patient advised not to get 2nd dose. Patient states she picked up epi pens that were prescribed. She reports better. She is tired and has headache, her arm is red and bruised but it looks better. Patient states she will not be getting second dose.
Patient developed mild rash in two locations to left arm 2 days following first injection that was papular, pruritic and flaky. After second vaccination, rash progressed over the left arm and has increased size of lesions and spread to left upper lateral back. PAtient reports significant pruritis
I immediately tasted metal in my mouth.  I felt sick like I had a cold with a headache  12 hours following the shot.  48 hours after the shot I got extreme abdominal cramps and had both vomiting and diarrhea for a couple of hours.  I stayed in bed for about 3 days resting. I had a terrible headache on day 5.  Today is day 6 and I am feeling better.
syncope; was unconscious; Headache; dizziness; extreme fatigue; increased occurrence in hypotension; decreased heart rate; stabbing abdominal pain; vomiting; nausea; hands/feet feel asleep; feels like in a fog; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 47-year-old female patient who received HAB (Twinrix) (batch number 53AT5, expiry date 28th November 2020) for prophylaxis.   The patient's past medical history included syncope. Concurrent medical conditions included psoriatic arthritis and hypotension. Concomitant products included adalimumab (Humira), methotrexate and methocarbamol.   On 16th August 2019, the patient received the 3rd dose of Twinrix (intramuscular). On 20th August 2019, 4 days after receiving Twinrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head. On an unknown date, the outcome of the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, numbness of extremities and foggy feeling in head were not recovered/not resolved and the outcome of the abdominal pain, vomiting and nausea were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head to be related to Twinrix.  Additional details were provided as follows: The case was reported by patient for herself. The patient received Twinrix on left deltoid. On 20th August 2019, in the morning, the patient experienced stabbing abdominal pain and nausea.  She went to the restroom and vomited and after vomiting she experienced a syncopal episode. The patient did not knew how long she was unconscious.  Following the syncopal episode she checked her blood pressure and it was 80/50mm hg, her heart rate was in 50's.  The syncopal episodes were continued with the most recent episode being experienced on 22nd August 2019 that left the patient with a feeling of being in a fog, extreme fatigue, headaches, the feeling of her hands and feet being asleep, increased occurrence of hypotension and decreased heart rate. The patient did not seek medical attention and had driven to work. The reporter consented to follow up. Till the time of reporting, the patient had not received any medical treatment.
Facial weakness, tinnitus, limb weakness extensive neuro work up, felt to have AIDP.
Narrative:  44 yo male with PMH HLP, hypothyroidism, vitamin D deficiency, OCD, bipolar and impaired fasting glucose reported feeling dizzy and tachycardic during the observation period post covid19 vaccine injection. HR was 117 BP 155/93, RR 18 at the time pt reported feeling tachycardic. Baseline HR is in the 70s. Pt denied SOB and chest pain. He drank water and waited an additional 15 minutes. Prior to leaving, he was back to his baseline. Symptoms:  Dizziness & Tachycardic Treatment:
100.5 degree fever for 20 hours. Nausea, light vomiting. Chills, cold sweats. general lethargy. Headache, all for about 24 hours. Patient recovering nicely since.
Patient received FLUZONE HD in right arm on 9/3/13. That same day patient experienced swelling where the injection site was. It blistered and was red and raised. Blister popped and now it is about 1/4 inch raised and is still red by 9/6/13. Patient but BACTINE/NEOSPORIN on it but did not help.
Red rash approximately 4 inches in diameter at injection site. No swelling, pain, or itch.  Fading now.
Neck pain, chest pain, paresthesia, loss of appetite, intermittent palpitations
Routine screening. for Covid-19. Asymptomatic.   Date 2 developed shortness of breath with exertion, dry cough and afebrile.  Day 5 same symptoms, plus temperature of 100 to 101.1 F
Vertigo, unsteadiness when rising from sleep, awakened from sleep by sensation of room spinning, sensation of brain shaking, confusion, fatigue, headache, runny nose, runny eyes. Doctor advised to take Tylenol, stay hydrated and rest.
swelling under the armpit ~ like a soft tennis ball.   some discomfort in that area (beside the injection site).
REDNESS AND SWELLING AT INJECTION SITE APPROX 4-5 INCHES IN DIAMETER WAS ABOUT THE SIZE OF A QUARTER WHEN I WENT TO BED AND GREW LARGER OVER THE NEXT 24 HOURS AND REMAINED THAT SIZE FOR ABOUT 4 DAYS THEN SLOWLY WENT AWAY ABOUT A WEEK LATER.
Brief 1 second tonic extensions of arms and legs without change in mental status. Child remained alert, happy, playful and interactive. I think these are sterotypies and not related to the vaccine. I saw her within < 2 h of the onset.  This report is filed the day of onset and I don't have follow up yet.
Irregular period where it started on the second day of taking the vaccine even though I finished on July, 5th with a 9 days cycle, which is usually 21 or 24 or 28 days.
This spontaneous report was received from a company representative concerning a 76 year old female patient. On an unknown date, approximately in June 2012 (6 months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose route unspecified). No concomitant medications were reported. On 30-NOV-2012, the patient experienced shingles located on the buttocks and thighs. She went to the doctor office. No treatment was provided. It was unspecified if any laboratory diagnostic tests were performed. The outcome of the event was unknown. Additional information has been requested.
On 11Mar2018/ received the first dose/ 20Oct2019/ receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th March 2018).   On 20th October 2019, the patient received the 2nd dose of Shingrix. On 20th October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix exceeding the recommending dosing schedule, which led to lengthening of vaccine schedule. The reporter consent to follow up.
Rash on back of legs to begin. Subsequent spots were arms and legs. Rash got considerably worse after boost in November.
No additional adverse effects reported; Patient received her first dose of GARDASIL 9 in February 2020 - Second ose of GARDASIL 9 on 13-SEP-2020; This spontaneous report was received from a pharmacist, refers to a 24 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      In February 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, dose, lot # and expiration date were not provided) for prophylaxis.  The pharmacist reported that, on 13-SEP-2020, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, dose, lot # and expiration date were not provided) for prophylaxis. No additional adverse effects were reported.
I began feeling pain in the left upper quadrant / lower chest area while lying in bed April 3 morning. During the course of the day, the pain continued and felt worse when breathing in or taking a deep breath. That night, it was very painful to lie down to sleep. It helped to sleep in a recliner and keep my head and chest elevated. April 4 morning, I went to convenient care and they recommended I take Tylenol and follow up with my primary care physician. On April 6, my primary care doctor diagnosed it as pleurisy and said to take NSAIDs. The pain improved but persisted for over a week. On April 12 I had a chest x-ray which was clear.
On 04/15/2021, I experienced an extreme amount of joint pain all over my body, my feet ankle, knees, wrist, shoulders. I was gradually having the pain from the time I received the vaccination on 03/10/2021 to 04/15/2021. I initially saw my PCP, who sent me to the rheumatologist. The Rheumatologist diagnosed me with rheumatoid arthritis. I was put on prednisone a day, and methotrexate a week.
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th November 2018, 1 days after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), headache and activities of daily living impaired. On an unknown date, the outcome of the loss of consciousness and activities of daily living impaired were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the loss of consciousness, headache and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. She had a bad headache the day after receiving the first SHINGRIX vaccine. She was unable to do anything that whole day - she was knocked out. This case has been linked with case US2019GSK032783, reported by same reporter.
In the middle part of her breast, had a little rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (In the middle part of her breast, had a little rash) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (ibuprofen). Concomitant products included BIOTIN and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (In the middle part of her breast, had a little rash). On 16-Mar-2021, RASH (In the middle part of her breast, had a little rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient received the vaccine 13Mar2021 and Monday 15Mar2021 had a rash in the middle of her breast. Wonder if that is an allergic reaction to the vaccine. In the middle part of her breast, had a little rash. The rash has gone today. The vaccine was administered in the right arm. Caller is allergic to ibuprofen and is currently taking vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Email updated. No new significant information recieved
Racing heart; Shortness of breath if over assert self; nausea; High fever; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache). At the time of the report, PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The treatment reported as Tylenol.
Initial unsolicited report received from a nurse on 28 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient had major neurosurgery less than 5 years ago. Concomitant medications were not reported. On an unspecified date, few minutes (reported that the patient returned 15 minutes later) following the vaccination patient experienced headache and was lightheaded. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. It was reported that, patient did not believe her episode was related to the vaccine, but rather her anxiety about getting the flu shot. Follow up information received from a nurse on 28 December 2015. The patient age was reported as 66 years. The patient had received a "0.5" dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (SANOFI QIV/ SANOFI MDV) (manufacturer: Sanofi Pasteur, batch number UI446AA) in the left arm on 08 October 2015. It was reported that patient had not had breakfast prior to injection. The events occurred on 08 October 2015. It was reported that the ambulance was called. The patient walked into ambulance by self and was taken to the hospital and was released (not admitted). It was reported that the patient was fine. On an unspecified date, the patient recovered from the above mentioned events. List of documents held by sender: none.
MODERATE-SEVERE FLU-LIKE SYMPTOMS SEVERE CHILLS AND MUSCLE ACHES NUMBING OF HAND AND FEET TO THE POINT OF TURNING BLUE/PURPLE
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: en6198), on 15Mar2021 as dose 2, single (Lot number: EN6208) and on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer - Remission" (unspecified if ongoing), notes: Prostate Cancer - Remission. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Negative, notes: tested Negative twice 07Feb2023 and 09Feb2023; (09Feb2023) Negative, notes: tested Negative twice 07Feb2023 and 09Feb2023; (11Feb2023) Positive, notes: tested Positive 11Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid..
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose, 1 total, dose number in series 1, 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, (six or seven weeks after shot) the patient got COVID (suspected covid-19 infection and suspected clinical vaccination failure). Patient was just as sick as if patient never got the vaccine. As per reporter, "Don't be so sure about fully protected. You can still get COVID. My friend got the J&J shot and 6 or 7 weeks later she got COVID. She was just as sick as if she never got the vaccine, so be careful. Pretend you never got the shot. That way you will be diligent about staying safe." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000206783.; Sender's Comments: V0: 20211229553-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS