chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 56-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular 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), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: She tested positive for Covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10 hours post vaccination, chills, joint and muscle pain, intense thirst, severe fatigue, headache, and slept 8 hours  following morning  still muscle and joint pain, fatigue improved, and remained tired throughout the  day.
Patient reported that after 5 minutes of receiving the vaccine, he felt as though his throat was closing and had difficulty swallowing but denies difficulty breathing.  He stated that his symptoms went away after approximately 15 minutes.  He did not seek medical attention and did not report the reaction until prior to receiving his second dose when asked about prior vaccine reaction.
Immediately following the injection my daughter felt dizzy, nauseous, weak and like she was going to pass out. The nurse gave her a ice pack for her head and we waited a few minutes. By the time we got home about 2:40 PM she had a severe headache, along with the above symptoms. The headache pain radiated back behind her ears when she sat up.
2 days, post vax, the vaccinee complained of chills, myalgias and shortness of breath. 3 days, post vax, his temperature was 102F; CXR with infiltrate and pulse ox 85%. He was admitted and rx'd with Zithromax, O2 and steroids. CXR and clinical determination to ARDS, mechanical ventilation and death. Autopsy findings state cardiomegaly and left and right ventricular hypertrophy; focally calcified mitral valve. Secondary findings: ascites.
Pt. felt lightheaded after receiving vaccine. BP 130/88 - HR =88 reg.
Mild maculopapular rash to chest, face both legs and feet 2 wks after MMRV given.
PMR (Polymyalgia rheumatica); awful; This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and feels awful. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica and feels awful were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that shortly after second Shingrix shot the patient came down with PMR (Polymyalgia rheumatica).  It had taken one year to get better after a long regiment of Prednisone. The patient asked if any other reported cases of PMR after taking Shingrix? The patient reported that It was an awful experience.
Patient started breaking out in urticaria on cheeks and neck about 28 hours after vaccination dose (on 1/20/22). Family gave benadryl and she went to sleep. She woke up on 1/21/22 with persistent urticaria and chest, neck, and cheeks, as well as under eye, for which they gave another dose of benadryl which calmed down the rash. She did complain of a slight headache and sore throat on the morning of 1/21/22 but no other symptoms. By the time she came to our office (1/21/22 at about 1100 am) she only had one small urticaria under her left eye. Patient was negative for COVID and strep in office. Patient and parent were told to give Zyrtec 5 mL daily until hives stay away for 24 hours and Benadryl PRN for itching.
Information has been received from a health professional concerning a 4 year old male with no known illness at the time of vaccination who on 05/26/93 was vaccinated with the first dose of varicella virus vaccine vaccine live, administered SC, in the  right arm. On 07/11/01, the patient presented with chicken pox and was reported to have approximately 36 lesions on his head, trunk, and extremities. It was also reported that he developed a temperarure of 100.5 degrees F. Subsequently, on 07/20/01, the patient recovered. It was reported that the patient's sibling had a varicella infection 2 wks prior to the outbreak. Unspecified medical attention was sought. No further information is expected.
Given history of anxiety around needles, visual aura, paleness after episode, and quick recovery to baseline presentation most consistent with syncope with myoclonus. Seizure less likely given that this is different than his typical semiology and he has been well controlled on his current AED regimen. Discussed with the Neurology attending of the week who was in agreement. Point of care blood glucose was found to be 111. Per neurology recommendations, Trileptal level was drawn. Patient was observed for 1hr and remained at baseline with no additional events concerning for seizure. Patient and mother were informed about vasovagal syncope and instructed on precautionary measures to take with future shots. Given return precautions.
Information has been received from a registered nurse concerning a 6 year old white female, with no known allergies, who on 10-APR-2002 was vaccinated SQ, in the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 638816/1236L). There was no illness at the time of vaccination. On 01-MAY-2007 the patient started with lesions. On 02-MAY-2007 the patient was seen in the office with less than 25 red papules, in various stages. The patient recovered on 04-MAY-2007. Patient was not hospitalized, and no laboratory tests were performed. No further information is expected.
Sore arm at injection site Swollen, sore armpit (left) Low fever, chills Soreness in hips and legs
MD reports 9 pts who were non-responders; recvd vax @ different facilities; all were in the funeral business;
Pt came to report event on 20Jan2012 of adverse reaction to final dose in series of anthrax.  He has experienced pain and soreness at the site of injection for over a month.  He has also experienced migraines unlike previous migraines prior to vacinnation.  He has experienced joint pain, right eye vision changes, and lethargy.
Was not able to walk/He could not move his legs, but now he is able to stand; His knees were hurting; This is a spontaneous report from a contactable consumer. A 75-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL9262), via intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included 2 heart attacks, stroke, she said that he had had numerous other things. His physician said that he was doing fine with all of the different things that he had. She said that he did not get enough oxygen when he was born and was a little slow because of that. There were no concomitant medications. The caller said that her brother today 25Jan2021 got up after doing a few little things and said that the paperwork talks about joint discomfort. He was not able to walk after a little while. This was something new. She said that his knees were hurting. She had to use a wheelchair to get him to the car. The cardiologist said that there was nothing wrong with his heart when and said that she made an appointment with his primary care doctor as well. She said that she made an appointment with his primary care for tomorrow evening 26Jan2021. Caller said that she was not saying that it was from the vaccine. She said that he could not move his legs, but now he was able to stand. At 15:00 central time 25Jan2021, he was able to stand up and walk to the chair. She said that it was an improvement. The caller said that her brother took the shot on Friday 22Jan2021. He got up did his regular routine and at about 11:50, he was in the den and was standing with a cane and was holding on to the cane and was not moving his legs. They got the wheelchair out of the car and sat him down. He said that his knees were hurting at that time. He was not able to move his feet at all. She said that he does not complain at all. Caller said that when this happened, her bother He was not slurring his words or having any other symptoms. The outcome of the events was recovering.
7 days after vaccination start getting rashes  and itching  on my feet, arms  and legs, went to urgent care, have a steroid injection and  methylphednisolone 4mg and Zyrtec,one week already taking the medication and still have rashes on my feet .
9 days after vaccine my skin has broken out in a red rash on the arms and upper legs.
Instead of having one cycle per month, she has two; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Instead of having one cycle per month, she has two) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMENORRHOEA (Instead of having one cycle per month, she has two). At the time of the report, POLYMENORRHOEA (Instead of having one cycle per month, she has two) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Reporter was not sure if patient received the Moderna vaccine or another one.  Concomitant medication was not provided.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received and contained no significant new information. (Quality complaints team updated that, this report was received on 18Mar2022 & will be processed for cancellation under QE-016290 and QE-016291).
Intense body aches, pain from arm caused to wake from sleep, difficultly raising arm above head, strong headache that did not go away with Tylenol
Pt received the pneumonia vaccine on 10/29/10 between 10 AM-12 noon. He noted the area on his (R) arm becoming sore around 3:30 and it became progressively more painful that night. On 11/30 his arm was swollen, red, hot & painful. He went to the Emergency room & started Cephalexin 500mg which resulted in full recovery.
Patient developed hives with blisters and inflammation in her entire body that started later the same day of vaccination and continued for 18 months. Her family practice doctor and dermatologist did not believe these effects were due to the vaccine. After 18 months, she found an allergist whom told her that the vaccine had created environmental allergies and lowered her immune system. He put her on a gluten-free, wheat-free, and dairy free diet and then her rash and blisters resolved, though she says she has on-going pain.
Left arm - very large red area, swollen and itchy covering a large part of upper arm and an even redder area in the middle of this area. Started the day after vaccine and still worsening 3 days after.
A report was received from a health care professional on 11/10/03, concerning an 88 year old female vaccinee who received a dose of Fluvirin on 10/16/03 and inadvertently received a second dose on 11/10/03. No adverse events were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Headache, fatigue, nausea, low abdominal cramping, bloating abdomen, back ache, muscle pain, fever 100 on day 12 post-vaccine.
Symptoms for first 3 days: very swollen arm down to wrist, muscle aches in arm, shoulder and chest, bright red arm and shoulder. Symptoms days 4 - 7: pink arm area down to wrist, sore to touch, itchy arm, shoulder and chest.
Vasovagal reaction with near miss syncope.  10-15 mmHg drop in BP
Covid arm - red rash on upper left arm, pruritis, warm to the touch & tender. Self limiting, no treatment; resolved in 3 days.
It started off with a burning sensation in my throat that work it way down to my Adams apple. I started having chest pains and felt like I was being stabbed with a knife. On a scale to 1-10 the pain was a sharp 5.
She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications include unspecified medications for diabetes and low pressure.   Reporter further explained the event  as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home.  The treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Company Comment Very limited information regarding this events has been provided at this time.   Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 008B21-2A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site). On 03-May-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient concerned that after second shot the nurse used her two fingers down firm massage technique in injection site. The patient reported that, she had concerns of effectiveness of second injection as she read that due to big size of mRNA the rubbing of injection site can destroy the vaccine. Concomitant medications were not reported. No treatment details were provided.
No other adverse events reported; PROQUAD was administered to a 16 year old in error on 31Aug2022; patient should have received MMR and Varicella vaccines; This spontaneous report was received from a registered nurse concerning a 16-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 31-AUG-2022, the patient was vaccinated in error with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W019631 with expiration date 19-DEC-2023 (route of administration was not provided) (Inappropriate age at vaccine administration). The nurse reported that the medical assistant that administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) did not know it was not indicated for patients less than 12 months of age or 13 years and older, the patient should have received Measles, Mumps, Rubella (MMR) and varicella vaccines (Wrong product administered). No other adverse events were reported (No adverse event).
Painful left axillary lymph node - 4 days. Extreme drowsiness 3 -4 days, lightheadness 3-4 days, feeling faint (stopped what I was doing)- brief transient on two or three occasions over 1 week,  mild altered sensation left lower leg most noticeable for two days, 1 week after flu shot.
pt recvd vax; 12 days later red rash appeared on body that was itchy; 14 days after vax swollen & sore neck,  eyes are red & sore, throat is sore; stuffy nose & body aches especially in joints;
COVID-19 breakthrough case requiring hospitalization   The individual was hospitalized due to an Irregular Heart Beat. Other COVID-19 symptoms included Fever (100.4) Chills, Rigors, Rhinorrhea/Sinus Congestion, Sore Throat, Headache, Fatigue, Cough, shortness of breath, Ear Pain, Irregular Heart Beat.   The case was admitted 12/6/21 and discharged 12/7/21.  The individual is also a health care worker at Medical Facility
My supraclavicular lymph node on the same side as the vaccine (left) got enlarged after the first vaccine in about a week. I had it checked  (sonogram and blood work) and it was a healthy swollen node most definitely a side effect of the vaccine. The lymph node started to get smaller but after I got my second vaccine it got even larger than it was before.   I didn't feel sick after the first shot, but was sick after the second - I experienced weakness and body aches for one day.
After 15 minutes post Tdap immunization - patient reports itching, feeling hot. She reports she has already taken a Benadryl 2 hours prior. Reported to Dr. who reports for patient to continue to wait and monitor patient for continued reaction. ...........December  4, 2010 3:43 PM
Dose 3: Full dose Moderna, 08/20/2021, 088D21A. I had double vision, noticed around the first of the year. I made an appoint to see ophthalmologist and I was referred on to a specialist 01/10//022, provided the diagnosis of  Diagnosed as 6 nerve palsy. Diagnosis of New onset Esotropia was Dr. (Privacy) was referred to the Nero-Ophthalmology Dr. (Privacy).
Patient states reaction of swelling, itching, redness, rash, discomfort and lasted about 2 weeks. Patient spoke with PCP/NP and has had similar incidents with previous vaccines and patient reports that she has sensitivity with low tolerance and wants to continue receiving vaccinations routinely because these reactions are localized.
Symptoms-fever 103 degrees F, pale skin, constricted pupils lasted for 24 hrs took him to nurse in clinic. He tested positive for influenza received TAMIFLU for 10 days, after 10 days recovered completely.
Had pretty significant muscle aches, tenderness all over, achy neck, headache. Resolved after about 48hrs.  The last thre days, 12-14 day after received have severe muscle and joint pain like did after first received. Having to take advil to help relieve and then comes back. I haven?t ever had this type of joint pain or muscle aches like this. It hasn?t gone away.  I hurt all over.
Information has been received from certified medical assistants concerning a 51 yr old white male (281.5lb, 6'4") factory worker with allergies to aspirin and NSAID (not specified) who on 02Oct05 (also reported as 12Oct05), at 16:15, was vaccinated IM, into deltoid muscle, with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0709P). On the next morning (also reported within the next several hours), at 7:30AM, the pt developed angioedema of face and head (also reported as swelling of his face and head). By the next afternoon, the swelling was reported by the pt as being much better. The pt was reported as recovered. There was no product quality complaint involved. Additional information is not expected.
Headache 36 hours; Chills 36 hours so far; Muscle/joint pain (the worst 24 hours) still aching at 36 hours; Fatigue ( the worst 24 hours- slept most of the day) still fatigued at 36 hours; Redness and swelling at injection site  - the injection site continues to be very tender and the redness and warmth is continuing to get worse
61 y/o F, BIB ALS, with hx of asthma, presents for evaluation of worsening shortness of breath beginning 1 month ago. Pt has been evaluated by his PMD multiple times and had a chest x-ray done with no clear etiology for her sx, but found something cardiovascular related and had an EKG done which came back normal. Pt used her inhaler at home with minimal sx improvement yesterday. Sx aggravated with any exertion/ambulation. Reports associated intermittent cough. Denies chest pain, LE edema, or fever. Pt is fully Pfizer COVID-19 vaccinated in May 2021.  PMH: Asthma, HTN  Social Hx: Denies tobacco use.
Vaccine administered to the patient, was given in error beyond the recommended expiration date. We are consulting with Moderna manuf if it is advised to have the patient repeat vaccine dose.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, HYDRALAZINE and AMLODIPINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient vaccinated in Left Shoulder.  Laboratory details was not provided. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Pt has half dollar-sized red elevation on (R) arm, quarter-sized lesion (L) arm.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-NOV-2015, the patient was vaccinated with improperly stored oral, ROTATEQ, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.