chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, via a company representative, referring a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in August 2017, reported as "within the last month", the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and the patient was also administered "an unknown influenza virus vaccine (unknown manufacturer)" at the same visit. On an unknown date in 2017, after receiving the dose of ZOSTAVAX, she developed a nodule on her arm on an unknown date which had resolved on its own on an unknown date in 2017. She did not go to the doctor because of the nodule. There was not a significant disability or incapacity, no hospitalization was need and no life threatening was present. The causality between nodule and ZOSTAVAX was not reported.
Broke out in a rash on hands and stomach. Rash area scabbed over. Treated with CLARITIN and Hydrocortisone.
Slight dizziness and feeling little weak in both the arms/hands within 5min of injection and lasted about 5min
(R) arm hot, red, tender, swollen. Rx given: Triamcinolone 0.1% oint, KEFLEX suspension 1 1/2 tsp po BID x 10 days.
Migraine headache, including sensitiviity to light, throwing up. Treated with Tylenol.  90% gone by 8am the next morning, 9/20/2011.
Paxlovid:Treatment of COVID-19; Paxlovid:Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2 , single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Past Cancer Treatment" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; ENBREL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid:Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Fatigue in left arm, additional symptoms (fatigue, headache, sore throat, congestion, coughing, muscle soreness)
Patient experienced tingling, numbness, with pain and redness on both of the legs, more so above the knees. She also feel tingling on her arms, from elbow to fingers. She was concerning about the interaction between Moderna and her Invega sus t 234 mg that she inject once monthly shot We advised her to go to ER to check for blood clots. She called and ETM team came to check on her. According to patient, they did not screen her. They just checked on her and confirmed she did not have any blood clots and left.   Today, 6/14/21, patient experienced shortness of breath and symptoms described above did not relieve. We asked to speak to her mom. Her mom tried to talk to her yesterday and today to go to ER but she refused. We advised her mom to try to persuade her to go to ER to check. That is our recommendation because blood clots is very serious. We explained to her mom and let her know that they can contact us anytime with anyquestions they might have.
Pt recvd 1st dose of vax 26SEP91 & 3 hrs following vax pt exp low back pain, felt lightheaded & hot, devel a rash on trunk, had blurred vision & saw spots; Pt taken to ER & tx w/Adrenaline & DPH; sx resolved;
Rash appeared on feet, ankles, lower and upper legs. Dark red itchy blisters, then dark red painful spots. Appears to be vasculitis.
12/03/21 presents to ED for "increased confusion". PMHx of "hypertension, hyperlipidemia, dementia"
Redness and swelling at site of injection-(L) deltoid and down upper arm to elbow-left. Treatment supportive.
Information has been received from a physician via a company representative referring to a 60 year old female patient who was also a nurse practitioner. Concurrent condition and medical history of the patient were not reported. On 12-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014566, expiration date: 18-FEB-2015) (dose and route unspecified). On 23-MAR-2016, the patient got shingles and was still experiencing nerve pain. The outcome of the events was reported as no recovered/not resolved. Additional information has been requested.
C/o Arm pain, swelling, redness, loss of movement-started on 4/4/2019, went to doctor on 4/6/2019, recieved prednisone and mobic at that time, unsure of subsequent symptoms and timeline
The headaches started Friday (2 episodes - 01/15/2021) and on the 16th I probably had 6 headaches. It was just on one side of my brain (right) It started on the front and would go all the way to the back of my head. It would last about 3 seconds and it was extremely intense. I would come out of nowhere. It felt like an ice pick or something very sharp scraping inside of my brain. It was not like a regular headache or migraine, but like a spiky thing scraping my brain, it felt worse than birth contractions, and I have 5 kids! On the 17th I probably had again 6-7 of them so I went to see my PCP the next morning. Also, on Sunday night (the 17th) my arm started hurting, and it was weird, it was about 10 days after the vaccination but you could see it red, about the size of a quarter, it was red and hot and sure to the touch. On Monday the 18th I had an appt with my doctor (a telehealth visit) and she looked at my arm and went over the symptoms and she felt it could have been a side effect to the vaccine.  I felt good during the day (no headaches during the day) and about 4PM I noticed that I started with a cough. At 6:30 I started with a fever. and then all the covid symptoms came down, fever, body aches, cough, felt very weak, and then lost my taste the next day. I called work and they told me to get tested the next morning and I was tested Tuesday 01/19 was tested around 9AM I was tested by hospital. At 7 or 7:30 at night my results came back positive.
About 20 minutes after I gave the Menactra vaccine was applying LMX cream to patients arm for a blood draw and she stated she didn't feel well. I told her to take some nice slow deep breathes, she then slumped slightly on the couch. Within a few seconds she opened her eyes stating she was ok. I asked if she was alright and feeling better she said yes, I put her feet up and got her apple juice and graham crackers. I also took her blood pressure and pulse which were within normal range. The patient at the crackers and drank the juice, one of our doctors assessed the patient, spoke with the patient and her mother. I rechecked on her after 15 minutes, she stated she felt better and was ready to leave. The patient and her mother left with no further incident.
Prolonged seizure (30-45 minutes) associated with fever 3 days after vaccine. No previous seizures. Two aunts had short febrile seizures in infancy. No local reaction. Probably viral.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patients received an expired dose of PNEUMOVAX 23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 08/09/2021 and 08/31/2021. Facility, lot number, and injection site were not entered into the immunization system. Discharge Notes: "This gentleman was initially admitted on 24 January [2022] secondary to his wife's inability to care for him adequately at home. His condition had gradually declined in respect to his large cell pulmonary carcinoma, COPD, and ASCVD. He was unable to perform duties of daily living and admission was suggested for further evaluation and possible physical therapy. On his admission, he was noted to be COVID-19 positive. He was placed in isolation for total of 10 days and then transferred to the regular floor. His condition gradually deteriorated and he passed away peacefully the morning of February 8, 2022." Clinical notes describe this COVID-19 detection as "incidental." Primary complaints were related to the underlying medical conditions the individual had.
mom noted pt turned head to rt side w/small jerks & cried;last only 3-4 seconds;fine immed p/;this repeated 3 times;
Had covid booster, then started feeling unwell a couple days later. Continued to have severe fatigue, decreased appetite, cough, decreased urination. Seen on 10/17/22 and found to have creatinine 6.47, BUN 71, Sodium 128, potassium 5.6. Was hospitalized. Had AKI, biopsy revealed acute interstitial granulomatous glomerulonephritis, felt to be due to covid vaccine. Treated with steroids and improving.
Nausea started during the m night with vomiting, had trouble breathing starting the next morning, Breathing got progressively worse and went to the ER.
Severe muscle weakness/malaise. Fever > 102. Arm soreness/redness.
Sick; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 degree Celsius.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant medication information was provided. No treatment medication were provided.
Report fever, HA left arm swelling itchy rash with lump at injection site. Treatment: Tylenol Outcome: Fever and HA resolved, itchy rash with lump at injection remains unchanged.
Mom noticed red area on right thigh the evening of 11/15/04. Brought patient to office on 11/16/04. 6x4cm area of erythema noted medial to the injection site. 6x1cm area of erythema noted lateral to the injection site.
This patient was given expired/Beyond Use Date Moderna Covid Vaccine. Patient states they have not had any adverse reactions. This was a booster dose.
Once, for a short time while performing a mild workout in the gym, and again a couple hours later, and for an extended duration (approximately 40 minutes),  while checking out at Costco I experienced what I believe to have been aura migraines without headache (or ocular migraines) in my right eye. What initially appeared to be a slight glare, I later determined was an obscuration of the lower half of my vision in that eye which could be described as a clouding effect.  While disorienting and concerning, with closing/covering that eye, the problem slowly resolved itself. Within about 20 minutes, I had enough vision to comfortably and safely drive home. Another 20 minutes after that and the event had ended as far as I could tell.  I have never experienced anything like this in the past. Doing some (dangerous, I know) searching online, I discovered what it might be called and learned that there were some reports of similar events occurring with other vaccine recipients. Since I don't have a primary care physician, I'm hoping it is directly related to the vaccine and I hope it doesn't happen again with the second dose since my eyes are a critical part of my job.
1. Starting from the early morning of Jan 29th, started to get a fever(up to 37.5C) and the whole body feels muscle pain(left side was feeling worse). I took 750mg Tylenol to relieve the muscle pain and headache 2. At about 3:30 pm on Jan 29th, my 10 fingers suddenly feel paralysis for about 10 minutes which never happened in my whole life before. Then, at about 6 pm, I went up from my nap and my fever went up to 39C, and the left arm was feeling worse but whole body's muscle pain was feeling better. I took 750 mg Tylenol again to reduce the fever and headache 3. After taking Tylenol, my fever was reduced and did not go up again(highest is 37.3). But after getting up on Sunday morning(Jan 30th),  I think my armpit?s lymph node got inflammation, and the skin around the injection area starts to get redness 4. Monday morning(Jan 31th), I was woken up by the muscle aches for both arms, and my throat has a uncomfortable burning feeling. The redness around the injection area and the left arm pain including the lymph node inflammation stay the same I got a fever, headache, and redness/pain around the injection area for the second dose, but other symptoms are the first time for the third dose
Oct 22 PM - Chills, watery eyes, body aches. Oct 24 - Eyes started to bother, throbbing eye pain. Oct 25 - Went to optometrist - who said flu shot triggered herpes of the eye. Rx Atropine, Prednisolone, GENTAK.
Patient is a 82 y.o. female with a history of parkinsons disease, orthostatic hypotension, and NIDDM who presented to Hospital 9/17/2023 with AMS. She was found to be COVID positive. ID econsulted, after discussion with patient/ family elected to pursue remdesivir, 9/18- 9/20. She has symptomatically improved, worked with therapy and is medically stable for discharge to a SNF.    1. COVID 19 infection, Improving: No hypoxia. Complicated by encephalopathy, and appears to be fatigued and hypotensive. ID followed- Paxlovid would interact with patient's quietapine, this was not given. Discussed with family who favored remdesivir, 9/18- 9/20. Follow up outpatient for monitoring of symptom resolution. Tessalon pearls PRN at disscharge.  2. Sepsis, Resolved: Likely 2/2 above with hypotension exacerbated by history of autonomic dysfunction. However, Vanc & Zosyn started on admission given significant hypotension, sepsis fluids, lactate. Blood cultures 9/18 no growth. Urine cultures with coagulase negative staph likely contaminant. She was deescalated to doxy/ rocephin for CAP coverage 9/18. These were discontinued 9/19 due to low concern for bacterial infection. Follow up outpatient for monitoring of resolution of COVID symptoms as above.  3. Hypokalemia: K 3.0 on admit, repleted as needed. Recommend repeat BMP in one week. Encourage good PO intake.  4. Parkinsons disease with dementia: Patient able to ambulate and talk at baseline. Home medications continued.  5. Autonomic dysfunction: Previous hospital admissions for syncope within the past year. Home midodrine provided with hold parameters for SBP >140, continue on discharge. 6. Bacteriuria: With >100k colonies coagulase negative staph on urine culture. With possible symptoms including dysuria/ increased frequency. Repeat UA without evidence of infection. Continue to monitor for s/s dysuria in the outpatient and repeat UA if needed.  7. NIDDM: on metformin, continue to address outpatient.  8. HTN: held amlodipine, ok to continue on discharge with hold parameters. 9. Constipation: Significant hx of constipation, continue home meds on discharge.  10. Moderate/non-severe, protein calorie malnutrition: related to chronic illness, per RD assessment. BMI 17.45, daughter reports loss of 5lbs over the past week PTA, poor appetite. Recommend Boost glucose control with breakfast and dinner. Encourage good PO intake.
is pregnant: pregnant; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. Date of last menstrual period: 01Oct2022. The patient was 9 weeks pregnant at the time of exposure to BNT162b2, BNT162b2 omi ba.4-5. The patient was 10 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 08Jul2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Dec2022, outcome "unknown", described as "is pregnant: pregnant"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient has no other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events COVID-19, DRUG INEFFECTIVE and the suspect drug BNT162B2 cannot be excluded.
1 min: Metallic taste. 3 min: very mild tingling to lips. 40 min while driving: Pronounced tingling to lips spreading to face, squeezing feeling to center upper chest, sensation of not being able to breathe, tight/wheezy/labored breathing, sensation of being about to become unconscious. 911 called.  Squeezing sensation self-resolved after call. Paramedics arrived about 1 hr post-vaccination. BP 89/66. (Note my normal BP runs 90-110s/50s-70s.) HR 70s-90s. Pulse Ox high 90s. Paramedics not concerned that reaction was allergic, no rescue meds advised. I felt well enough to drive home despite persisting facial tingling and tight breathing. Allegra and albuterol taken upon arrival home, resolved breathing but not facial tingling. Facial tingling better but not resolved after about 24 hrs.
Information has been received from a medical student concerning an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed.  On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M018453, expiration date 28-JUN-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. No adverse events were reported. The doses of ZOSTAVAX were exposed to a temperature  > 5F but < 14F and were out of range for 15 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.; Sender's comments: US-009507513-1702USA003007:
Initial report was received from a health care professional on 03 Dec 2009: This patient (3 years old) received S-OIV FLUVIRIN (lot 102130P1) 0.5 ml, intramuscular vaccination on 03 Dec 2009. No adverse were reported.
headache; This is a spontaneous report from a contactable consumer (patient), Pfizer sponsored Program via medical information team. The female patient at the age of 80 (unit unknown) reported for herself.  A female patient at the age of 80 (unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced headache. Patient stated that she took her first dose of the vaccine yesterday and today she has a headache, and she would like to know if she can take Tylenol and how many milligrams. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mild SOB. Mild rash. Mild difficulty swallowing. Treated with IV BENADRYL and IV SOLUMEDROL with improvement in condition.
Halo pink sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Halo pink sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Halo pink sore). At the time of the report, VACCINATION SITE ERYTHEMA (Halo pink sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient took Benadryl as treatment for their symptoms.    This case was linked to MOD-2021-013030 (Patient Link).
right arm is visibly pulsating and twitching; Arm is throbbing; right arm was getting sore; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217 and Expiration Date: 30Sep2021), via an unknown route of administration, administered in right arm on 30Jun2021 at 11:00 (at the age of 44-years-old) as dose 2, single for covid-19 immunisation. The patient has no medical history. Patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 via an unknown route of administration in right arm on 06Jun2021 (at the age of 44-years-old) (Lot number: EW0177 and Expiration date: 31Aug2021) and got period again and arm was a little sore. Prior vaccination, patient has not received any other vaccine within 4 weeks. Patient has no family history relevant to adverse event. On 30Jun2021, the patient reported that within 4-5 hours after vaccination the right arm was getting sore, later in the evening there was minor soreness. She was knowing that the second shot would be worse. She reported that with the soreness, it kind of hurts to move her arm but it's nothing excruciating. She cannot really lift her arm up high or anything, but its getting better. She was able to deal with the discomfort through the night. On 01Jul2021, she reported that her arm was throbbing. At time of call on 01Jul2021, she had her arm and its totally relaxed. She reported that her arm was pulsing and it just started happening. She said that her right arm was visibly pulsating and twitching even her child can see it. She had never seen anything like that. Her daughter stated that her arm was pulsating almost as fast as she is blinking. She explained that she can move her arm halfway up "freely", otherwise if she moves it up any further the pulsating was worse. She said that pain really was not an issue. Emergency room visit was not required for adverse event. Outcome of event right arm was getting sore was recovering and outcome of other events was unknown.