chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough positive COVID case; Breakthrough positive COVID case; This is a spontaneous report from a contactable consumer or other non-hcp. An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration; in Mar2021 as dose 2, single; and in 2021 as dose 1, single; both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient experienced breakthrough positive COVID case. The patient underwent lab tests and procedures which included Breakthrough positive COVID case in Aug2021. It was unknown if the patient received any treatment for the event Breakthrough positive COVID case. The clinical outcome of "Breakthrough positive COVID case" was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19: 14-Nov: sore throat starts midday (keep mask on); slight nausea (start taking Zicam when I get back home); temp 97 according to scanner at work  15-Nov: sore throat still & more painful (still taking Zicam, but add Advil Sinus); temp still 97 according to scanner at work; chest feeling tight in afternoon & by evening can tell it?s chest congestion (typical cold symptom for me); start Robitussin, Vicks that night 16-Nov: sore throat abating but definitely chest congestion (phlegm is yellow); Test positive with home test; call doc for Paxlovid; use Vicks, Zicam, Robitussin, Advil sinus, CBD; felt nauseous, slightly achy & slightly chilled that night so add in Tylenol; temp at 99 17-nov: continue Zicam, Advil, Robitussin, Vicks, but feeling better than the day before; chest congestion still there but moving up to head; doc didn?t call in Paxlovid - still waiting 18-nov: go to urgent care for Paxlovid as my 5-day window was shrinking; temp 98.4; they confirm I?m positive; still taking Robitussin, Zicam, & Advil sinus 19-nov: Much less coughing, but keep up Med regimen; some nausea in the afternoon but attributing to a more stuffed head as my ears were clogged & my eye also was very itchy 20-nov: Day 6- rare coughs; little nasal congestion; still positive (at-home test) 21-nov: woke up feeling more congestion in my nose and chest like I slipped back a couple days; positive but the line was a little fainter-90% neg; chest/throat felt irritated;took no Advil today, just a little nighttime Robitussin 22-nov: still congested, but things are clear; rinsed 2x with Neti pot & got an almost negative test (could faintly see the line); started taking Robitussin again as the chest congestion is lingering; took Advil 1x; last day of Paxlovid 23-nov: woke up to Clear sinuses but still rinsed 2x with neti pot; solidly negative; took Rob today to try & get rid of chest congestion (although phlegm is very loose & clear) - chest is still burning; tried some breathing exercises which seem to have opened things up more 24-nov: didn?t rinse before testing today and was more like 80% neg; some nasal congestion; sinus pain & ear pressure on left; mild chest congestion; more breathing exercises  25-nov: Day 11-didn?t rinse first & was full negative again today; slight runny nose; ears plugged; rare cough [More detail, if wanted, as I tracked up to 10-Jan-2023, but didn't feel 100% until 8-Jan, however some of it could have been allergy related.]
Patient reported having difficulty breathing from about 1am to 7am the next morning.  Her arm was slightly sore on the 22nd, but after 7am on 10/23 she reported no other problems and she was feeling fine when I spoke with her on the 26th.
(Privacy) ,MD at 1/18/2022  2:30 PM New Patient Visit The patient is 73 y.o. male with history of HTN and episodic tachycardia referred by (Privacy), MD who presents for evaluation of hives and concern for an adverse reaction with beef.   In mid-November he developed intense itching associated with a rash, described as red raised itchy wheals. He recalls that this started around 6:30PM; for lunch the same day at 3:30 pm he had eaten beef (short rib pasta) for the first time in 6-7 months as he had been cutting back on red meat consumption. This rash was present for ~3 days prior to him going to urgent care; methylprednisone PO was prescribed but ultimately the hives returned when the steroids wore off. He did not try any OAH for this rash. At urgent care, alpha gal testing was ordered given the delayed presentation of hives after red meat consumption.   He notes that he has had dermatographism since mid-November. He still feels itchy 2-3x per day. Generally lesions last for approximately 1 hour or less before spontaneously resolving or migrating elsewhere. No residual bruising. He has not noted circular wheals in the last month, but continues to note linear wheals at the site of scratching or pressure. He denies sick contacts, URIs and fevers/chills. No COVID19 infection. He has received 3 doses of the Moderna COVID19 vaccine, last had his booster on 11/3. He takes aspirin 81 mg daily, but otherwise denies NSAID. No new medications. No history of hives or dermatographism prior to 11/2021.   Does not recall tick bites. He has eaten pork and lamb since the incident (last week) but not beef. Can eat dairy but trying to cut back on consumption.    He reports he has had 2 episodes of reaction with shellfish in the past (~20 years ago). He had whole body hives and passed out the first time when he was handling, not eating, a table full of crabs. Second time, while handling raw shrimp years ago he had hives all over the body associated with light headedness and used OAH with improvement.  He eats shrimp, mollusk once every 2-3 weeks. Has not had lobster or crab in the past couple years. Oysters, clams also fairly often, once a month.  Handling oysters, clams, lobsters- no reactions. He avoids touching uncooked shellfish though in general and will wear gloves.  Patient Instructions Start Allegra 180 mg once daily, and can increase to twice daily if not controlling hives with current dose.   Patient was seen and discussed with Dr. (Privacy) (Privacy), MD Allergy-Immunology Fellow   I performed a history and physical examination of the patient and discussed his management with the fellow. I reviewed and edited the fellow's note and agree with the documented findings and plan of care.   (Privacy), MD Allergy & Immunology
Second dose has been missed; Tested positive for COVID19; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose has been missed) and COVID-19 (Tested positive for COVID19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID19). On 07-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose has been missed). On 07-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Second dose has been missed) had resolved. At the time of the report, COVID-19 (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-Jun-2021 contains no significant information
Many bruises on back, neck, face, legs, petechiae on legs. Bruises on knees.
Faint erythematous rash under the skin on the anterior aspect of both lower legs, vaccine site normal. Rash was noticed right after vaccination. Observed baby for 30 min and discharged - rash fading at that time.
Complained of difficulty breathing at school. Taken to school clinic; nurses noted she was wheezing and flush. Paramedics arrived and her oxygen levels stabilized, however as she attempted to walk discovered her legs were painful and stiff below the knees.  She became unable to bear weight on legs, and paramedics took her to the hospital.  By that evening, following many horrifying hours of uncertainty, she regained function of her legs.
experiencing muscle pain to my upper right arm and to my right groin region which then began generating a strong pain to my quadricep leg muscle and down to the back of my right knee; This is a spontaneous report from a contactable health care professional. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: El 9266) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2, amoxicillin. The patient 24 Hours after having the 2nd vaccine I started experiencing muscle pain to my upper right arm and to my right groin region which then began generating a strong pain to my quadricep leg muscle and down to the back of my right knee. It is now 6 days after the vaccine, the arm pain has gone way, but the leg muscle pain persists. I have been limping from the pain and having difficulty stretching it out. The outcome of event was not recovered.
Right arm pain ad could only lift right arm 45degrees. Extreme abdominal pain and cramping. Nauseous . Diarrhea for 5 days. Abdominal and back muscle cramping 5 days post vaccine. 7 days post vaccine blood in stool. Abdominal pain ceased 12 days post vaccine.
A week after getting my vaccine, I got a very strange and strong headache on the left side of my head that persisted for the whole day. It was strange enough that I made a note to call my doctor if it persisted, but the headache was gone the day after.
Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress and was not in any way exerting herself. She described the attack as a feeling of someone sitting on her chest and began to hyperventilate. The color drained from her face and her hands felt numb. Her asthma attacks are generally exercise-induced, so this was highly unusual.  She took a dose of albuterol ( 2 puffs with a spacer) and followed her asthma action plan. She laid down and slowed her breathing. 20 minutes later her facial color returned to normal. Two hours later her hands returned to normal. She was disoriented for about 5 hours.
Developed red, raised, itchy splotches, similar to hives on multiple areas of the body, 2 days after receiving the vaccine. Splotches have started to go away on their own, without any medical intervention.
second dose of Covid vaccine and only had nausea; This is a spontaneous report from the non-Pfizer sponsored program received from a consumer (patient) via specialty pharmacy based on information received by Pfizer (manufacturer control number: UNT-2021-005877). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) via an unspecified route of administration from 10Mar2020 Inhalation at 0.6 mg/ml and currently at 60-120 ug (10-2- breaths) four times a day (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil (ADCIRCA). The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced blood pressure went up. The patient had nausea on an unspecified date. The outcome of event was unknown.    Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
1) Mild nausea within a few hours and lasting for 24 hours 2) mild headache within a few hours and lasting for 24 hours 3) significant fatigue within a few hours and lasting for 24 hours 4) flushed face within a few hours and lasting for 12 hours 5) severe chills from hours 8-10 6) severe overheating and sweating from hours 10-20 7) moderate body aches within a few hours and lasting for 24 hours
cold chills; her stool is going from caramel to darker color; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has compromised lungs" (unspecified if ongoing), notes: She has compromised lungs; "She has cataracts" (unspecified if ongoing), notes: She has cataracts; "she had high blood pressure" (unspecified if ongoing), notes: she had high blood pressure; "she is seeing physical therapy for her neck" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR, start date: Nov2021; NORVASC, start date: Nov2021; PLAVIX taken for cerebrovascular accident, start date: Nov2021; LIPITOR, start date: Nov2021. Past drug history included: Miralax for bowels don't empty, reaction(s): "Caller can't hold her muscles". Vaccination history included: BNT162b2 (Dose 1: 11Mar2021. No reaction and was fine, lot: EN6202.), administration date: 11Mar2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose 2: 01Apr2021, lot: ER2613. , The second shot she didn't feel like herself. She didn't feel sick, just not herself. She drank lots of water and slept. From that afternoon until the next day at noon time she didn't feel like herself. She doesn't know how to explain it.), administration date: 01Apr2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "She drank lots of water and slept", "She drank lots of water and slept"; BNT162b2 (First Booster: given on 10Dec2021, lot: 331308A, She got booster in early December and was fine. She had soreness in her left arm every time and she expected that and it didn't bother her.), administration date: 10Dec2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "She had soreness in her left arm every time", "She had small stroke".  The following information was reported: CHILLS (non-serious) with onset May2022, outcome "unknown", described as "cold chills"; FAECES DISCOLOURED (non-serious) with onset May2022, outcome "unknown", described as "her stool is going from caramel to darker color". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills.  Additional information: The second booster was the first time caller had chills out of all the shots. The chills were not continual, but off and on. Caller just tolerated it. Caller states her stool is going from caramel to darker color. It is not going through process. It could be normal. Caller doesn't think it has anything to do with booster. No one seems to be worried about it and it has nothing to do with Pfizer, but the little guys and long guys have points on them. Caller states she is referring to the stool. The little guys from top part are from small intestine and the long guys are from the long intestine and they all comes out together.
Arm sore, could not move it, swelling down to elbow and across chest, bright red rash. Sore for 3 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years, in left arm for covid-19 immunisation; 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 included: "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medications included: ODACTRA; GRASTEK. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
lt deltoid (site of injection) red, swollen, hot to touch; t99.8 PO; tx cool compresses to area; Atarax liquid;
When I took off my shirt last night my wife (who is an internal medicine physician) noticed I had morbiliform rash limited to my trunk both front and back. It did not itch or hurt and I hadn't noticed it. This occurred approximately 36 hours after my booster with Pfizer vaccine. My original two doses were modernal 2/12 and 3/12 of this year. The rash seems to be resolving itself as of the morning.
Developed hives from head to toe, with a more circular rash on my back(red circles with white rings around them), severe headache, swollen, watery eyes, and joint pain initially after my TDAP shot that day. By Wednesday 9/25/2013 developed sore throat, cough, severe joint pain that moved from place to place in my body. The joint pain is still present limiting my range of motion and ability to walk normally. I have also been diagnosed with Pneumonia at this time.
c/o dizziness x 2 hrs-started about 24 hrs p/1st vax 25JUN93;
Initial unsolicited report received from a pharmacist on 24 August 2016. This case involves a 44-year-old female patient who was vaccinated with a first dose of ADACEL batch number: U5318AA, (expiry date: 28-Apr-2018, dose, dose in series, route of administration were not reported), in the left deltoid on 06 August 2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions as none. Patient's medical history was reported as none and concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was reported as none. On 22 August 2016, sixteen days following the vaccination, the patient developed palpable lump in her left deltoid at the injection site. It's not warm discolored or painful. Lab data was reported as none and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
After receiving the 2nd Moderna Covid Vacine I noticed shortness of breath, chronic dry coughing and fatigue/tirdness. Each week was progressively getting worse and rapid declining in my ability to fuction.  I was gaining weigh and felt very tired, but thought it was respitory infection and tried to rest hoping it would clear up and improve. After several weeks, I noticed that both feet and legs started to swell and wouldnt return to normal. The decline was rapidly getting worse and I was not able to simply tasks. I tried to get an appointment at my primary physisan and was unable to get an appt, they recommeded I visit urgent care, so I went and was told to go to ER, where I was admitted to the hospital for congestive heart failure.
Pt received smallpox vaccine in left shoulder on 17 Mar 08. He Presented to day c/o dizziness, nausea, vomiting, frontal headaches pain level #4 for the past two days. Denies visual changes, and tinnitis. Vaccine site is tender and warm to touch. Firm underlying tissue circum: 50 mm around the injection site. Sites appears within normal variances according to smallpox trifold VIS dated 1 Aug 07. Physician ordered anti inflammatory meds. Pt is instructed to return to clinic on 31 Mar 2008 and or  to ER if symptons worsen over the weekend.  PT recieved Anthrax, Typhoid, PPD and Smallpox on 17 Mar 2008.
Ringing (Tinnitus) in both ears.  It has been continuous since the day after the first shot.
rash is blistering, bumpy, burning, itchy, and painful,  redness, constant, and itching
Site: Pain at Injection Site-Severe, Systemic: patient reported immediate pain upon vaccination and has since reported decreased use of left arm and continuing pain in arm-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient reported pain at injected arm as well as limited mobility of arm and decreased strength in arm
pt recvd vax;exp inject site rxn, swelling,erythema, induration;resolved w/in 48 hrs; fever of 100;pain persisted for 7 mon;pain radiated from shoulder to elbow;tx apap for pain;c/o persistent pain; no dx at time of rpt;
Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving.  No follow-up attempts are possible. No further information is expected.
Pt's (L) arm with increased erythema, warmth & swelling ~ 24 hrs after vaccination. 6 in x 5 1/4 in wide.