chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up the next morning feeling weak, with full body aches, and sensitivity to coldness. I may have had a slight fever. These symptoms were gone by 2-3pm.
Bruise 2" wide brown spot on the right of injection site; Redness next to the injection site; Injection site was aching a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and ADMINISTRATION SITE BRUISE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included VITAMIN D.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA. On 15-Jan-2021, the patient experienced ADMINISTRATION SITE BRUISE. On 06-Jan-2021, VACCINATION SITE PAIN had resolved. On 07-Jan-2021, VACCINATION SITE ERYTHEMA had resolved. At the time of the report, ADMINISTRATION SITE BRUISE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ITCHY RASH NEAR DIAPHRAGM BETWEEN THORACIC AND ABDOMINAL CAVITY.
Several hours, post vax, arm started to hurt. Next morning, it was swollen and itchy. Hurts to move arm, joints ache (knees and elbows). No fever. Swelling 12cm X 11cm.
warm, red, itchy sensation @ site of inject 24 hrs p/inject; Cortaid/DPH recommended;
Patient stated at time of vaccination that she does sometimes get dizzy and faint during vaccines. After administration, she said she felt fine & sat near pharmacy. I went to give her a record card & noticed she didn't look well. I asked her if she felt ok; she said she felt very dizzy & then passed out. I ran out and caught her. She was shaking a bit too kind of like a seizure. One tech called EMS & one tech helped me. She woke up & said she was fine and then passed out again Again woke up, then said felt her tongue swelling, I ran to get an EpiPen and pulled it out of the box. Before admin, pt said tongue swelling is better so didn't administer. She couldn't hear properly, numbness in hands/legs, & stiff hands.
he was not feeling well; chest pain; anxiety; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 30Jul2021 (batch/lot number: EW0181) at 40 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history, no concomitant medications, and had no prior vaccinations. The patient experienced chest pain and anxiety on 03Aug2021 and was not feeling well on an unspecified date. The patient reported that 4 days after his first dose, on 03Aug2021, he started having chest pain and anxiety. He went to the ER and they checked his cardiovascular system and said everything was fine. He continued having chest pain and went back to the ED and had another check-up and did tests for acid reflux, results were unknown. He had pulse oximeter and a BP cuff at home, these have been normal. The patient went to the ED for a 3rd visit and did not stay since it was too crowded. The ED has provided a F/U appt in 4 weeks. Patient asked if other people had these same symptoms after getting the Pfizer COVID vaccine. The patient further stated that he had been experiencing constant chest pain, which comes and goes from taking the Pfizer Vaccine. He tried to see if reports of chest pain from getting the vaccine have been received. Therapeutic measures were taken as a result of chest pain and anxiety which included administration of ibuprofen (MOTRIN) and alprazolam (XANAX) and these did not work. Patient does not have the lot numbers of these medications. He was about to talk to the representative about this thing to healthcare person from Pfizer because he was not feeling well since an unknown date. So, he needed to talk to them. The outcome of the events was unknown. It was reported that the patient was scheduled for the second shot on 20Aug2021.  Follow-up attempts are completed. No further information is expected.
Pt reports experiencing palpitations and shortness of breath requiring EMS evaluation 5 minutes after vaccination. Heart rate measured at approximately 160bpm per EMS. Event resolved spontaneously during ongoing observation.
Symptoms were terrible headaches,  body aches, stomach pain,  stabbing pain, fever, chills, tired, sleepy, On August 25, 2021 was at working after taken shot when pain occurred had to leave work due to feeling pain and body just trying to shut down. I made it home around 1:48 pm I was so tired weak heart racing I laid in my bed 10 hours straight sleep when I awoke it was almost 1am on August 26, 2021 I was so weak I couldn't move  I was in so much pain I had to call out for work. I was scared sometimes to even fall asleep I had no appetite just started back eating as of last night on August 26, 2021 my mouth was so dry I was more thirsty for water than hungry for food. I can't afford to get sick missing out on work is like missing a days meal or a bill for my family. I don't ever want to experience that pain again
Information has been received from a practice manager and a healthcare worker, concerning 5 patients of unknown age and sex. On 11-MAY-2012, one of the patients was vaccinated with a dose of (Merck) VARIVAX (dose, route and frequency were not reported) (lot #: 1434AA Expiration date 13-SEP-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Severe swelling lymph nodes of left arm injected. Egg-sized. Flu-like symptoms lasting 36 hours.
Patient felt injection site and it was warm, then noticed the redness and swelling. Patient also had pain around injection site and up the arm toward armpit.
Information has been received from a pharmacist concerning an 83 year old female who was vaccinated IM in the left deltoid with pneumococcal vaccine 23 polyvalent (lot #636849/0944K). On 10/30/01 the patient experienced pain at the injection site, and developed redness and swelling at the injection site. The patient was treated at a walk-in clinic for the local reaction (treatment not provided). At the time of this report, the outcome of the events was unknown. Additional information has been requested.
I had a bad traumatic headache from a car crash and after the 3rd Moderna vaccine. With a feeling of electrical zaps on my left eye and headaches. I did receive the shingle shot about 3 weeks after my 3rd vaccine on 11/2/2021. I still get deep pain from my elbow to my wrist from the shingle shot and a month after I was still experiencing these symptoms.
Left pleuritic chest pain starting 48 hours after immunizations with peak pain approx 60-72 hours after immunizations. EKG normal. CXR normal. Suspected pericorditis vs pleurisy. Treatment w/NSAIDS. Also significant muscle pain at injection site left deltoid 2-60 minutes after injection. No fever. No muscle swelling.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses 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.   Concomitant products were not provided.  Patient age was reported as 70.27 years.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was  8A, 9A and 10 A, temperature was 35 and 32, vaccine was not frozen prior to administration. Vaccine moved to fridge on 29-Sep-2021 and moved to clinic on 22-Oct-2021. 1 vials were sent to the clinic. BUD date was 29-Oct-2021. Vials only punctured right before administration.  Vaccine was stored in Cooler 1 on 22-OCT-2021.   Treatment medications were not reported.
02/25/2021 - 02/26/2021 Fever lasting approximately 18 hours 102* at peak.  2/272021 - approximately 6:00 pm getting progressively worse eyes were burning.  Continue through night, I did not associate this with vaccine and did not report.   02/28/2021 - continued burning sensation , blurred vision, unable to read print ( I do not need or use readers).  Sensitive to light.  Continuing to complete daily activities without problems.
Feeling a bit unwell/I am not feeling good; Chills; little weak; Little bit tired; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received the first dose of (Pfizer-BioNTech COVID-19 vaccine, lot# EK5730), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Medical history included allergy. Consumer stated, she guessed its environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for allergy. Patient had the vaccine on Sunday and was feeling a bit unwell on 22Dec2020. Consumer further stated, because she had the vaccine the first shot on Sunday and today (22Dec2020) she was not feeling good, she was wondering it could be a side effect. When probed for the adverse events, Consumer stated, she was feeling like little bit like chills, little bit tired and a little weak. Consumer stated she got it from work at the hospital. Outcome of events were unknown.
developed hallucinations that lasted for one day; This serious case was reported by a other health professional via sales rep and described the occurrence of hallucination in a 93-year-old female patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date 31-MAY-2024) for prophylaxis.   On 27-JAN-2023, the patient received the 1st dose of Shingrix. On 27-JAN-2023, less than a day after receiving Shingrix, the patient experienced hallucination (Verbatim: developed hallucinations that lasted for one day) (serious criteria GSK medically significant). On 28-JAN-2023, the outcome of the hallucination was resolved (duration 1 day).   It was unknown if the reporter considered the hallucination to be related to Shingrix.     It was unknown if the company considered the hallucination to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023. The reporter was a care coordinator who informed GSK sales representative that a patient received first dose of Shingrix and developed hallucinations that lasted for one day.  According to reporter doctor was not aware of the adverse event and adverse event filed.  The reporter consented to follow up
pt recv vax & exp herpes lt side of face w/severe vesicles;fever & devel pain in lt ear & surrounding area;had shooting pain in lt ear & could not sleep on lt side w/face or head on pillow;tender;lt side of face swollen;
Local rash and swelling about 4 hours after vaccination, lasted couple of days, (101 degrees temperature and lasting for that night only). Generalized aching especially around butt area. Used aspirin, patient felt 'lousy" the whole next day.
Sick; fever over 100; She had the flu; everything hurt; A little tired; All her bones hurt; She was in bed all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EM9810) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EL9264, Expiry: Unknown, Administered in left arm), administration date: 23Feb2021, when the patient was 81 years old, for COVID-19 immunization; Pneumonia shot, for Immunization, reaction(s): "Arm swelled up". The following information was reported: ILLNESS (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "Sick"; PYREXIA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "fever over 100"; INFLUENZA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "She had the flu"; PAIN (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "everything hurt"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "A little tired"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "All her bones hurt"; BEDRIDDEN (non-serious) with onset Mar2021, outcome "unknown", described as "She was in bed all day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She felt really sick and had fever over 100. She also felt like she had the flu and everything hurt but the day after that she felt fine. She had no fever anymore anything. She is asking if this is something like a harsh side effect that might indicate she has a higher immunity and might not need a booster dose. Caller commented she never gets the flu shot, she is not on any medication. She usually does all the natural stuff. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse events has not resulted in Emergency Room and Physician Office. Adverse events following prior vaccinations was yes. Many years ago she was talked into getting the pneumonia shot by a doctor. She had to go to the Emergency Room because arm swelled up really bad. Ever since then she never got a shot.   Follow-up attempts completed. No further information expected.
Day after left arm swoll for about 2 days. On or about 3 day the burning/stinging started. Had to apply medication and than take Benadryl. At this writing (10/18/2019) the symptoms are still present,more like itching.  I took the same injection last year and had the same problem, but I forgot and took it again.
Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting,  fatigue  missed a day of work
fungal infection; Arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm discomfort) and FUNGAL INFECTION (fungal infection) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03915120A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle weakness (Muscle problem).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On an unknown date, the patient experienced FUNGAL INFECTION (fungal infection). The patient was treated with TERBINAFINE (LAMISIL [TERBINAFINE]) at a dose of 250 mg. On 18-Jan-2021, LIMB DISCOMFORT (Arm discomfort) had resolved. At the time of the report, FUNGAL INFECTION (fungal infection) outcome was unknown.            No concomitant medication was reported.; Sender's Comments: Based on the known profile for mRNA1273, a causal relationship between the event of groin infection  and product use is assessed as unlikely.  The event of nausea is consistent with the product safety profile, and temporarily associated with product use and a causal relationship cannot be excluded.
Abdominal cramps, mild fever, diarrhea, lower back pain, headache and nausea for a period of 5 days.  Treatment = Pepto Bismol stopped diarrhea but cramps persisted.  Recovery occurred in 5 days.
Headache since 5/21, worsening over time, dull pain on top of head persistently, with sudden sharp pain on sides randomly come and go. Relief with painkiller 3 times a day.
No adverse event.  Reporting Medication Error Pt requested flu vaccine on discharge from hospital. RN asked pt the list of questions prior to receiving the flu vaccine. The pt had no contraindications and notified RN that he would like the flu vaccine prior to discharge as he has not had the flu shot yet this year. Flu shot given at 1232. Pt monitored up until discharge at approx. 1530. No adverse reactions noted. Pt VSS. At approx. 1445 pt told RN that he was mistaken and had already received flu shot this year a month or 2 prior to todays dose. Again, no adverse reactions noted.  MD notified. Pt still discharged at 1530.  Investigation showed Pt received Flucelvax at a Pharmacy on 10/13/22.  In System, there was record of it under section.  Missed by RN and Pharmacist during order verification.
Fever, extreme chills, extreme body aches, muscle weakness, headache, sore injection site; ibuprofen every 6 hours; symptoms set in within 5 hours of injection
4/22/2021 Per EMT in First Aid area of Vaccine POD, 12:52 PM B/P 140/94 Pulse 68, 1:05 PM B/P 139/90 Pulse 78, Chief Complaint Syncope "due to anxiety", patient in observation area after receiving  vaccine, began to feel light headed, EMT went and got wheelchair, patient tried to stand up and became weak in the knees and began to pass out and fall to the ground.  EMT was able to grab patient and assist down to the ground without any injuries to patient or self, patient was able to answer questions, O2 was given by provider and cot was brought over to patient and patient  placed on cot,  EMS was called and patient refused medical assistance. Per Public Health Nurse who accompanied patient to appointment, patient became shaky, c/o nausea and lightheadedness, after receiving vaccine, shakiness began as tremors of fingers of right hand and progressed to right side, resolved within minutes, loss of consciousness less than one minute.
Information has been received from a medical assistant concerning an approximately 40 year old female with a history of recurring shingles who on 17-OCT-2007 was vaccinated with a dose of ZOSTAVAX. It was noted that the patient did not have an active case of shingles at the time of vaccination. On 18-OCT-2007 the patient experienced redness at the injection site and some dizziness. Subsequently, the patient recovered. Unspecified medial attention was ought. No product quality complaint was involved. Additional information has been requested.
MAJOR ADVERSE EVENT: After 1 week, patient had trouble swallowing, choking, cough with soreness, muscle pain and fatigue. Symptoms are still ongoing. The patient went to doctor and had chest x-ray and pulmonary function tests. He was diagnosed with ILD (interstitial lung disease) with polymyositis symptoms. He is currently on prednisone for his condition and will be going to the Clinic on approximately 12/5/17.
Since administration of vaccine, patient has had pain in her (R) arm, that radiates into her (R) shoulder to just below the elbow. She has an increased weakness in the arm and difficulty sleeping due to the pain. Symptoms do not seem to be improving.
pt recvd vax; eve presented to er p/ having sz & t of 101.4;told to see MD; no further complications;  was slightly lethargic for several days following rxn;
chest pain; Shortness of breath; Nerve shocks throughout her extremities and body; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; severe panic attacks; anxiety; burning sensation; constant headache; fatigue; had convulsions; almost blacking out but not fully; brain fog/felt very off, like a high feeling; she experienced chills; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration on 31Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Pfizer COVID-19 vaccine on 31Mar2021 and was still having severe reactions 5 months later. 20 minutes after receiving the vaccine felt very off, like a high feeling and later that night, the same day as she received the vaccine, she experienced chills, almost blacking out but not fully, she got in the shower shaking with chills and had convulsions while she was in the shower. For the next 2 weeks, she was very out of it, like a zombie state, constant headache, brain fog, chest pain, shortness of breath and fatigue. Nerve shocks throughout her extremities and body, when she would try to sleep her stomach, head, and chest would have a burning and buzzing, like someone hit her with a tuning fork, severe panic attacks throughout the night (all of this was persisting thus far except for the panic attacks and the brain fog). When dozing off her body would jerk, and she would wake gasping for air. She still had an extreme burning sensation in her chest, arms and stomach, and when it reaches her stomach, she had a doom like feeling, anxiety, and that burning sensation only comes on late evening and at night until starts to wear off around 11 or noon the next day. She could still get up and operate, she was a stat at home Mom, she really felt like she could not go on like this. Safety inquired if the patient had thoughts to hurt herself, because she did mention that she could not continue like this in front of her child she was very scared and in severe pain every morning. The patient wanted to know if there had been any reports of this and how long this last. She had been to multiple doctors, emergency room, currently any and all testing that has been done has came back normal, so the doctors had just diagnosed her with extreme/severe anxiety. The clinical outcome of the events constant headache, felt very off, she experienced chills, almost blacking out but not fully, constant headache, brain fog, chest pain, Shortness of breath, fatigue, Nerve shocks throughout her extremities and body was not recovered and remaining all other events were unknown.