chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist. On an unknown date PNEUMOVAX 23 (lot #, expiration date and dose unspecified) was stored in freezer, -2F for 36 hours. Pharmacist stated doses currently refrigerated and no doses were administered that were improperly stored yet pharmacist stated PNEUMOVAX 23 doses were mistakenly put in the freezer because unspecified staff thought the doses were ZOSTAVAX. Pharmacist stated PNEUMOVAX 23 cartons resemble ZOSTAVAX cartons. AE filed for potential doses that could be administered due to packaging. Additional information has been requested.
11/1/03: Pt developed severe varicella with secondary strep/staph infection and required acyclovir and Keflex therapy. Pt also had varicella lesion in eyes requiring opthmalogy visit.
I received the booster in February.  So the short version is over the past few months starting in May I have been in and out of emergency rooms 14 times for chest pain heart palpitations syncope and headaches. They continued to tell me there was nothing wrong and that it?s anxiety and follow up with your cardiologists and just kept waving me off and gave me the 35 and healthy speech over and over and over. Since this happened at work I was eventually advised to go to a different healthcare system all together where they quickly diagnosed me with dysautonomia, POTS, symptomatic bradycardia, orthostatic hypotension. I feel this is negligence and had this been caught earlier I might not be wheelchair bound. I believe all of this is directly related to the Covid Vaccine and specifically the booster. Prior to all of this I am a healthy 35 year old firefighter paramedic
Sore arm for 2 days which was expected but then a fairly large rash developed at the injection site over a week later.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: rash was behind knees
Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.
It seemed like a really bad cold with congestion and coughing fatigue and I felt like you had to be in bed for rest about a week. Wore mask and social distancing for about a couple additional weeks. Also experienced some diarrhea.
11MAY92 7AM c/o shoulders ache-knees aching & join discomfort; joint discomfort moves fr joint to joint 14MAY92; c/o discomfort lt side of neck; lymph glands swollen 15MAY92 rt side of neck glands swollen c/o sore throat; fever 102;
severe pain located proximal to the injection site; Can't move arm; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in an unknown arm. The reporter reported that, after vaccination, the patient developed severe pain located proximal to the injection site. The pain was not relieved by over the counter medication and the patient stated that, could not move their arm. The physician was at home at the time of the report and did not have specific records. The reporter consented to follow up.
Patient developed redness and swelling at injection site into armpit/lymph nodes and up shoulder lasting for 2 days.  No fever developed.  Area felt hot to touch.
CONFIRMED COVID-19 INFECTION; WHEEZING; RINGING IN EARS; EXPIRED VACCINE USED; This spontaneous report received from a patient concerned a 63 year old female. 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 not reported, batch number: 212AZ1A, expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 23-SEP-2021, the patient experienced expired vaccine used. On 17-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced confirmed covid-19 infection, wheezing, and ringing in ears. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, ringing in ears, wheezing and expired vaccine used was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000212682.
The vaccination exacerbated existing digestive tract issues. It had to change diet to low FODMAP Diet. I now, potentially, have IBS.
Left arm became hot to touch, headaches and sweating.  Started on 07/12/2021
No adverse event; Patient received the first two Moderna vaccines 6 months apart; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675038, US-MODERNATX, INC.-MOD-2022-675040 (E2B Linked Report). This case was linked to MOD-2022-675041 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675038:(Patient 1 male 2nd dose case) US-MODERNATX, INC.-MOD-2022-675040:(Patient 1 male booster dose case)
24 hrs p/vax 2 short episodes of fixation of eyes w/fast blinking & stiffening of the body followed by DTP vax;
Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.
Sinus pain and congestion, headache, fever, loss of smell and taste, infrequent cough
Fatigue, itching and swelling at the injection site. At 11 days post vaccination patient describes increased pain, redness, and itching that she feels has progressed to her armpit and breast.
it was rpt fr HCP concerning a pt who was vax & subsequently exp a lock of response. addl info requested
Pneumovax 23 given to pt. on 5/6/08.  On 5/7/08 she returned to the clinic for left upper arm (shoulder to elbow area) red and warm to touch.Physician evaluated pt. and gave instructions to use ice to area and Motrin prn.
Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating
Stroke like symptoms leading to hospitalization . Diagnosed with GBS. Continuing to have issues to present day with no explaination.
headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female consumer received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Jan2021 for Covid-19 immunization. Medical history included eczema and lowered the immune system. Concomitant drug included dupilumab (DUPIXENT) for eczema for 1.5 years (as of 02Feb2021) which she gives herself a shot in the stomach every 2 weeks.  She stated dupilumab affects the immune system and lowers the immune system.  She was previously unaware of this and took the first dose of the Pfizer Covid 19 vaccine and only had a headache as a side effect.   She took the dupixent either the day before, day of, or the day after the first dose of the vaccine, so the 25Jan2021, 26Jan2021, 27Jan2021, she had it on the 26Jan2021, and wondering if this impact the efficacy of the first dose. She was scheduled to take dupilumab on 09Feb2021 and second dose of the vaccine on 16Feb2021.  Patient had no kind of bad interactions, she had a headache which was her only symptom.  Outcome of the event was unknown.     Information on the Lot/Batch number has been requested.
This spontaneous prospective pregnancy report was received from a registered nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018 the patient was vaccinated with GARDASIL 9 (lot#, expiration date, strength, dosing details and route of administration were not reported) for prophylaxis. On 08-MAY-2018 (last menstrual period), the patient had menses and after that patient found out she was pregnant. The estimated date of conception was 22-MAY-2018 and expected due date (EDD) was 12-FEB-2019 (also reported as February 2019). No treatment was given for adverse event. No intervention was given to prevent serious criteria. The pregnancy outcome was unknown.
Initial case received from a health care professional on 07 January 2011. A 68-year-old female patient received an intramuscular right deltoid injection of FLUZONE (lot number U3737AA) on 06 January 2011. Approximately 2 hours post-vaccination, the patient presented to the emergency department with shortness of breath, increased heart rate ("to the 150's"), increased blood pressure, dizziness, confusion, and diaphoresis. She was hospitalized for unspecified treatment, and remained in the hospital at the time of the report on 07 January 2011. The patient was not ill at the time of vaccination, and medical history included an allergy to penicillin. In addition, she was taking metformin, hydrochlorothiazide, amitriptyline, "clonidin", metoprolol, pravastatin, ranitidine, and gemfibrozil concomitantly; indications were not reported. Per the reporter, the patient had previously received several INFLUENZA vaccinations. Documents held by sender: None.
Information has been received from a female RN who in September 2002 and October 2002 was vaccinated with the first and second dose of hep B virus vaccine. The reporter indicated the after the second dose, slightly elevated LFT's were noted in her lab work. No prescription drug was required. Unspecified medical attention was sought. Additional info has been requested.
Presented to ED, Hospital, with c/o cough and hypoxia.  Patient was diagnosed with Covid-19 on 04/10/2022.  Since then he has had SOB and nonproductive cough.  Chest Xray revealed some bilateral pulmnary infiltrates.  Patient was also found to have a UTI and started on Macrobid for 7 days.  Patient was discharged home with home health.  Patient expired on  05/13/2022.
This non-serious spontaneous case, initially received on 15-Mar-2018, reported by other health professional (nurse), concerning a 47-year-old, adult, female patient. On 19-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left thigh, batch number: XT59906, expiry date: 06-Jun-2018 and route of administration: not reported) after first temperature excursion. On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
pt recv vax & exp bilat stocking-glove neuropathy w/dec sensation in both hands & feet;addtl info was recv 2FEB96;pt was fully recovered as of 2FEB96;
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received SHINGRIX. On 25th April 2018 12:00, the patient received the 1st dose of SHINGRIX. On 25th April 2018 17:00, 5 hrs after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient who is reporter is also a nurse. The patient experienced pain in the left arm a few hours following the vaccination, which was intensified through the night. It lasted over a week and although it was resolving, the arm still aches. The patient gave consent to contact physician.
With the first vaccine I had a slight headache for about 2 1/2 days.; This is a spontaneous report from a contactable other HCP. This 67-year-old female other HCP reported. A 67-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ELO140), via an unspecified route of administration, in right arm on 04Jan2021 11:30 (at 67-years age) as single dose for covid-19 immunisation. Medical history included hypothyroidism and patient reported that she never was diagnosed with Covid, but she thought that she had on Feb2020. Patient had no known allergies. Concomitant medication(s) included thyroid (THYROID); vitamin b complex (VITAMIN B); zinc (ZINC); ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. With the first vaccine patient had a slight headache for about 2 1/2 days. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was recovered.
My vision has become so blurry that the glasses I was able to see out of are no longer adequate.
Absolute ZERO side effects from first dose, not even a sore spot on injection location.  Migraine intensity headaches started 4 hours after injection of the second dose and lasted for approx. 40 hours. Went to sleep at 10:30 PM the night of the second dose and woke up in a startled state every half hour until I got out of bed at 5:30 AM.   From 5:30 AM until approx. 10 PM the day after my second dose I experienced seizure-like symptoms where I would seem to fall asleep while in a sitting position and awake just a minute(s) later in a confused state of mind. This would happen frequently and stopped its frequency slowly and stopped entirely late that same night.   I experienced eye pain to the point I had to apply ice bags to my face the entire day after the second dose. Body pain was so sever I cannot compare it to any other flu-like symptoms I've ever had.   Totally recovered after 48 hours.
edema of face around mouth & eyes, also extremities;resp distress began w/in 25 min of recv vax;pt went to local ER where given steroids, oral DPH & NMT;
Developed an encephalitis - presented as seizure and AMS with diffuse slowing on EEG - culture negative (viral and bacterial) with normal imaging - no cells (few RBCs) and elevated CSF protein - started 2 weeks after vaccine administered.
patient experienced itchy rash and small bumps near the injection site area about one week after the vaccine
Trouble speaking (Aphasia) for 1 minute; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Trouble speaking (Aphasia) for 1 minute) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination.     The patient's past medical history included Brain tumor (brain tumor-1972 removed.)  Concomitant products included ENOXOLONE, GLYCOL SALICYLATE, LEVOMENTHOL, TOCOPHERYL ACETATE (SALONPAS 30).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APHASIA (Trouble speaking (Aphasia) for 1 minute). On 16-Jan-2021, APHASIA (Trouble speaking (Aphasia) for 1 minute) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   Reporter did not allow further contact; 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.  However, very limited information have been provided about the history of the brain tumor and it could be a confounder for this event.
they got COVID, and then they were killed; they got COVID, and then they were killed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP)  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "they got COVID, and then they were killed". Caller's Concern: A caller said that she heard our commercials on the radio all the time, and she wants us to know that she wouldn't buy our product if it was the last thing if it would save her life because she doesn't trust our company. She said that's how much she has hated the COVID vaccine that we forced on them, and we didn't give them all the negative inner reactions to it. She said she wouldn't buy anything from Pfizer. She and her husband didn't take anything from Pfizer because a friend of theirs rushed to the hospital or the doctor's office to get the shot, and then they got COVID, and then they were killed, and the doctor is asking them why they shouldn't take it. She said they didn't take it because it doesn't work and she is not a stupid person. She mentioned that Pfizer are all crooks, thieves, and murderers. Inform the caller that I have documented this and make sure it goes to the appropriate department. I needed to end the call because the caller didn't stop talking bad things about Pfizer. The patient date of death was unknown. Reported cause of death: "got COVID, and then they were killed". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: got COVID, and then they were killed; got COVID, and then they were killed
Raised area at the site, larger than a silver dollar; Itching at the site; Large soft swollen area at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site). At the time of the report, VACCINATION SITE MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported Treatment medication were not provided by the reporter.
the arm on the intake side felt heavy and dull pain; the arm on the intake side felt heavy and dull pain; swelling in my arms; This is a spontaneous report from a contactable physician (patient), mail trail received in response to the query sent regarding the translation of language. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The 1st dose of COVID-19 vaccine (COMIRNATY) was inoculated at noon on 10Feb2021, immediately felt swelling in arms and after 4 hours later, the patient felt mild heavy sensation and dull pain in the vaccinated arm. Now, the patient had recovered and had no problem. A doctor who was personal in "PRIVACY" went to the United States to study abroad at "PRIVACY" the other day. At the university, the patient received the community as a preliminary intake for medical staff. The patient received a comment in a chat online with the intention of giving an impression after ingestion. The patient was reconfirmed the date of occurrence of the event with the reporter's doctor. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and soreness that was persistent about a week after. The outcome of the events was recovered two weeks after. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018282314 same reporter, suspect product, event, and different patient.