chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, (Lot S815305, Expiry Date Oct 2018, NDC number 00005197102), via an unspecified route of administration on 19Oct2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm feels hot, redness at the injection site and her arm is swollen, on an unspecified date in Oct2017. She has been applying cold compresses and taking TYLENOL and it is not getting any better. She is still experiencing these symptoms after a week. All the events were non-serious with outcome of not recovered.
Pt c/o lightheadedness, pale, sick to stomach, within 5 mins after injection. Pt immediately layed down with cool compress on head. Pt layed for 30 mins. Then after being up for 10 mins c/o severe headache, vomiting. Pt layed back down with compress also gave pt apple juice and crackers. After waiting additional 30 mins pt states feels better.
Covid Positive; Covid Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "not recovered" and all described as "Covid Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Retested for Covid and positive again on home antigen test; (19Jun2022) Positive; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It is unknown if patient received any other medication in 2 weeks. Patient received treatment with Paxlovid from 19Jun2022 to 25Jun2022 (route of administration: oral) for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect  cannot be excluded for  reported events .The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Caller also stated that she "had shingles at the time of her second dose of the Pfizer COVID-19 vaccine; tingling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, administered on 21Feb2021 (age at vaccination 69 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263) via an unspecified route of administration, administered on 31Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The caller stated that she had shingles at the time of her second dose of the pfizer covid-19 vaccine and tingling on Feb2021. It was reported that she got shingles the same day as her second dose of Pfizer COVID-19 vaccine. Caller stated that she had the first 2 doses of the Pfizer COVID-19 vaccine and is planning to get a third or a booster dose. Caller is also planning to get a flu shot and a Shingles shot and wanted to know in which order should she get the vaccines. Caller also stated that she "had shingles at the time of her second dose of the Pfizer COVID-19 vaccine but was not sure if it was simultaneous with the dose or which came in first. Caller clarifies that she is not sure when she had shingles because it came on over a few days as tingling, which she is not sure which day it started, it was within a day or two before or after her second Pfizer COVID-19 shot, immediately in the vicinity. Caller says she didn't realize it was shingles, it felt like the label on her shirt was rubbing or something. As a treatment she received Zovirax 20mg four times a day by mouth. She says she took it three times later than she was supposed to have taken it, she took it for 5 days. The outcome of the event was unknown.  Follow-up activities closed as follow-up attempts are completed.
11:30 am single injection in right deltoid 3:30 pm patient's voice begins to get hoarse 4:30 pm patient completely loses voice and feel throat start to swell 5:00 pm arrive at ER, no voice and throat very swolen, patient is light headed and having difficulty breathing 5:30 pm Adreniliane is administered as single injection, Antihistimine is given via IV and breathing treatment of albutorol (or equivalent) given at hospital.  X-ray taken of throat 6:00 pm Patient starts to get voice back and swelling starts to go down. 7:30 pm Patient discharged from ER and given Rx for Steroids, antihistamine and anti-anxiety.
Nurse administered needles into patient's arm. As plunger pushed, vaccine sprayed out and needle disconnected from syringe. Patient did not receive dose, dose leaked out. Needle removed, pt educated, charge RN  notified, patient received new full dose. Patient held 30 minutes in observation, denies any signs or symptoms of allergic reaction, no apparent distress, education provided by charge RN to monitor for signs and symptoms of allergic reaction reaction. Pt left after 30 minutes without any complaints, charge nurse monitored patient.
Case number PHEH2016US010432, is an initial spontaneous report received from a health care professional via pharmaceutical company (Manufacturer ID: 2016224102) on 26 Apr 2016. This report refers to a adult female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination, the patient experienced allergy to flu vaccine. Outcome, seriousness and causality of the event was not reported.
5 cm induration, warmth, mild-moderate tenderness just below vaccine site beginning about 20 hours after vaccine. Given ibuprofen.
Patient administered pediatric Pfizer vaccine when the adult vaccine was indicated.  No reported adverse events.
This vaccine was administered after the beyond use date of 10 weeks in the refrigerator. There were no reactions to the vaccine.
The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Patient developed severe thrombocytopenia, consistent with ITP. He was admitted to the hospital with this condition on 2/1/21 after developing diffuse petechiae, ecchymoses, epistaxis, and gingival bleeding over the preceding few days. He required steroids, IVIG, and rituximab. Initial platelet count on admission 2000, dropped as low as undetectable to 1000. Normalized/improved to 164,000 after 9 days in the hospital and multiple treatments. NOTE: patient had a prior episode of ITP in 2011. Please note date of Covid-19 vaccine and manufacturer are not certain.
Small rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on the chest) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH (Small rash on the chest). At the time of the report, RASH (Small rash on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded
weak, fatigue day after vaccine  Went to ER was told it was a reaction to vaccine and sent me home
Patient blacked out and appeared to have a seizure, 911 was called and evaluated patient. Patient recovered and did not go to hospital.
Information has been received from another physician (not the patient's physician) concerning a female who was vaccinated with a dose of GARDASIL (Lot # was not available). The patient experienced a "rash like bumps after receiving GARDASIL". The patient was seen by the physician to seek medical attention. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of limb discomfort (sore arm after the 1st dose) and pain in extremity (sore arm after the 2nd dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022C21A and 0B6C21A) for COVID-19 immunization. No medical history reported. On May 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient experienced limb discomfort (sore arm after the 1st dose). On Jun 7, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced pain in extremity (sore arm after the 2nd dose). The patient treated with Tylenol (paracetamol); 1 dosage form. At the time of the report, limb discomfort (sore arm after the 1st dose) and pain in extremity (sore arm after the 2nd dose) outcome: unknown. No concomitant medications reported.
I would like to register my pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I would like to register my pregnancy) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 031C20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) for Anxiety, QUETIAPINE FUMARATE (SEROQUEL) for Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Aug-2020 and the estimated date of delivery was 10-Jun-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (I would like to register my pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 13-Feb-2021, EXPOSURE DURING PREGNANCY (I would like to register my pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: (Inconclusive) Result not reported. On an unknown date, Prenatal screening test: (Inconclusive) Result not reported. On an unknown date, Ultrasound scan: (Inconclusive) 4 ultrasounds- Result not reported.         No treatment information was provided.
Started pain in the left leg after 3 weeks, Found DVT in left leg after ultrasound
Pt report body aches, headache and fever of 101.5. Treated with Tylenol with mild improvement
I got the second dose to the Pfizer vaccine on 1/12/2021at 11 AM. I felt throughout the day and was able to finish my shift. Later that night, I had very strong rigors, chills, severe headache and felt feverish. I took some Tyenol and felt a little better. I woke up at 5 AM to go to work, and my body was so fatigued and tired I couldn't move. My hands were shaking badly, and my whole body hurt. My joints hurt, my muscles, ect. I called out of work, as I work in the Micro lab doing COVID-19 PCR testing, I couldn't pipet correctly if I was shaking. I do not have any pre-existing conditions, and I have no allergies. I have never experienced an adverse reaction to a vaccine.
Bilateral dural sinus  and jugular vein thromboses.   Has viridans streptococcal bacteremia.  Thrombosis may be infected.  Patient also tested positive for SARS-CoV2 4/23/2021.  Being treated with antibiotics, Eliquis.  Not thrombocytopenic.  HIT studies pending.
After my vaccine there was just a little tenderness for a few days and about 10 days later I woke up and there was this red circle on my arm and did a Teladoc visit and they told me it was a reaction to the vaccine and then I developed on my collar bone this painful knot and I ended up going to the ER for that and they concluded it was related to the vaccine and my lymph nodes were reacting to it. I still have the nodule but it's no longer a painful nodule and not as big as it was. Then things were okay until July when I had taken a driving trip and back and when I returned I wasn't feeling quite well, and in about 3-4 days my leg started cramping and I thought it was a pulled muscle because of the drive and 3 days after that my calve was swollen and you could physically see the green mark and that's the day (July 15) that I was diagnosed with a DVT and I was kept in the ER overnight and given blood thinners and when I was discharged I had a prescription of Xarelto medication and in the beginning of August I went back to the DR for clearance and she readmitted me to get a full exam and the blood clot was completely gone. So, in a matter of 1 month, I had developed a blood clot, took medications for it, and it was completely gone by August 4 or 5th. I had coughing fits as well in the beginning and every now and again I will have it and my Teladoc wants me to get tested for COVID-19 because it's more often and I have shortness of breath doing things that I normally have energy for. They kept me overnight again in the ER. I did have fatigue and that just kicked in last week and I've been struggling ever since probably Thursday or Friday last week and when I did a Teladoc visit on Monday she wanted me to go straight to the ER, but I can't keep taking time off work. I did take 1/2 a day off today to try and get everything situated before I go to the ER and get tested for COVID-19. When I got diagnosed with my DVT Dr. thinks it was from the drive, but this drive wasn't new to me and I don't think that's what it was from, and the ER nurse thought it was from the vaccine. Around the same time of trop (first part of July) I was supposed to start my cycle and 2-3 days later I started cramping like it was about to start over and it was gut wrenching cramps I've never had before. The Teladoc told me to go t ER again because she thought I was pregnant and had a tubal pregnancy, so I went to the ER, and I had every type of ultrasound possible and wasn't pregnant. They couldn't find out why I was having these issues. 4 days before I ended up in the ER for DVT at this time I had uterine bleeding and I thought I had a pulled muscle, so I didn't mention it to the ER staff. Right now, I'm dealing with the breathing difficulties, shortness of breath, coughing fits, and fatigue. With the fatigue I haven't regained my full energy back since. My mind also feels clouded, and I feel like I'm struggling at work because I can't remember certain things and my mom told me to go straight home but that's been since the vaccine. I'm normally OCD and I remember things very well and I've been struggling really badly.
Itchy welts over forearms (both) and calf of one leg over last 4-5 days. Customer states started 5 days after injection. Pt stated has been working in the yard and MD diagnosed contact dermatitis. Not due to vaccine.
(On 4/3/12) The morning after receiving a vaccination (Varicella), patient presented with swollen, red, hard lump. At site of injection. By the following day, symptoms had spread, extending length of under side of upper arm. Itchy, hot to the touch. Given BENADRYL and started on BACTRIM D.S, symptoms resolved by 4/9/12.
Pt recvd vax & devel swelling to below the elbow which lasted for 10 days & pain @ the inject site, flu-like sx including fever, myalgia & h/a for 3 to 5 days;
Can "feel throat" and ears feel stuffy.  Occurred 30 minutes after vaccination. Patient took 25mg of Benadryl and went to the ER to be observed.
Extreme muscle pain in left hip and thigh region; has worsened over the first three days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 at 18:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Vaccination history included: Bnt162b2 (DOSE 3, SINGLE, Lot number: 32030BD, Anatomical location: Right arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8734, Anatomical location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8727, Anatomical location: Right Arm), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Jun2022 at 07:00, outcome "not recovered", described as "Extreme muscle pain in left hip and thigh region"; PAIN (non-serious) with onset 04Jun2022 at 07:00, outcome "not recovered", described as "has worsened over the first three days". Therapeutic measures were not taken as a result of myalgia, pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within 4 weeks of vaccination. Post vaccination, the patient had not been tested for COVID-19.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JUL-2016, the patient was vaccinated with a dose of M-M-R II lot # L030162 (dose, route of administration, albumin status and expiry date were not reported). On 01-AUG-2016, the patient was vaccinated with a dose of VARIVAX lot # reported as L048466 (dose, route of administration and expiry date were not reported). Concomitant therapies included sterile diluent. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Report 20010085541 described muscle pains in a vaccinee of unspecified age and gender who received hep B vaccine (brand unknown). Allergies, medical history, and concomitant medications were not specified. On an unspecified date "a couple of years ago," the vaccinee received the unspecified dose of hep B vaccine. Subsequently, the vaccinee experienced muscle pains for about six months. As of 03/30/2001, the outcome of the event is unknown.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
This case was reported by a physician via call center representative and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was not reported. The patient received 1st dose and had some systemic side effects. For tolerance to 2nd dose, refer case US2019GSK030801.
Local reaction noted following morning, firm tender oval nodule, no fevers, bruising note 48 hrs later.