chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died from Covid; died from Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 "died from Covid". The patient date of death was unknown. The reported cause of death was suspected covid-19, drug ineffective. It was not reported if an autopsy was performed. The consumer reported that she knew 3 people that have died from Covid, 1 wasn't vaccinated but 2 were.   The lot number for bnt162b2 was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760615 same reporter/drug/ AE, different patients;US-PFIZER INC-202101758340 same reporter/drug/ AE, different patients; Reported Cause(s) of Death: died from Covid; died from Covid
I've been informed by my MS Neurological Specialist,  that I have essentially 0% COVID-19 vaccine efficacy due to my current MS treatment of Ocrevus infusions because Ocrevus is a monoclonal antibody that uses the same cells to fight MS as the vaccine uses to protect against COVID. Ocrevus effectively overrides & nullifies the mRNA vaccines.
Patient's arm started to swell up and turn red just below the injection site. The area was about 6in by 5in. Patient complained that it was warm and sore to move her arm. She spoke with her doctor who instructed her to take some BENADRYL and keep an eye on it. She came into the pharmacy 4 days after injection and it appeared that the swollen area was getting smaller and not as painful. She was picking up BENADRYL that day and was going to start it when she got home.
Date Tested/Results: 8/28/21, POSITIVE Covid-19 Vaccine Yes/No: Yes      Date of last dose: 1/7/21 8/30: EE still symptomatic. Has a fever, cough, fatigue, congestion. EE reported that she is covid positive, 8/28/21. Discussed that she will need to quarantine x10 days since s/s first appeared and 24 hrs pased since last fever without fever reducing medications. EE instructed to call hotline back after she is released from quarantine. DOH to notify EE as well. EE will need to clear with clinic when cleared from quarantine and no longer having symptoms.
area where I received the shot on the left arm kept hurting for a week after second dose. Then the second week, it felt like my bone inside my left arm was hurting as well. It kept getting worse every week, and now I have issue holding anything with my left arm. The paint point is still the same where I received the shot.
viral sickness, headache, muscle ache, exhaustion, hot flashes, lasting several months,    exacerbated all existing conditions including my inflammatory disease creating chronic pain, and epstein barr,
I got the vaccine a week ago and I'm still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen does not help. Onl; I got the vaccine a week ago and I'm still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen does not help. Onl; Swollen and painful lymphnodes; shooting pains in centralized locations on arm, legs and feet; This is a spontaneous report from a contactable other healthcare professional. A 27-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 18:15 (Batch/Lot number and Expiry date was not reported) (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient had allergy to wellburtin. Concomitant medications included allergy medicines. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 18:15 (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. The patient did not have covid prior vaccination. On 13Feb2021, the patient experienced joint pain, muscle pain, swollen and painful lymphnodes and shooting pains in centralized locations on arm, legs and feet. It was reported that the patient got the vaccine a week ago and she was still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen did not help and only heat. The patient did not receive any treatment for the reported events. Laboratory tests on 20Feb2021 included: sars-cov-2 test (covid test type post vaccination (rapid test) and results were pending. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 4 (booster), single (Lot number: gh9694) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 03May2021 at 12:00 as dose 2, single (Lot number: EW0620) and on 18Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure abnormal; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment for the events. Outcome of the events was not recovered.
A nurse reported that a 28 month old female received a dose of Prevnar on 10/22/02 in her right leg. On 10/23/02 at 6am, the mother found that her child's leg was red and inflamed. The physician recommended Benadryl and Motrin. The child's leg "got worse" on 10/23/02, and the child was taken to the ER. The child's mother was told that the problem was not due to Prevnar, but to an infection caused by the injection. The ER physician prescribed amoxicillin and continuation of Benadryl and Motrin. The child recovered. This case was serious since this event was considered medically important (OMIC).
She started to feel like she was fainting; chest pain; she was seeing stars; she had trouble breathing; She was very hot; She also had a sore throat and some congestion; She also had a sore throat and some congestion; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 at 17:30 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first Pfizer covid-19 vaccine on 07Apr2021 and that night (as reported), patient had some troubling side effects; she had trouble breathing and was very hot. She also had a sore throat and some congestion. They thought these were very normal side effects; however, the side effects happened again on 12Apr2021, but it was worst. All of a sudden patient had trouble breathing, chest pain and she started to feel like she was fainting, she was seeing stars. She sat down, put her head down in her knees and the same thing stopped and it worked; it was about 5 to 10 minutes for her breathing to be okay again (for clarification). On an unspecified date, they called her health care providers and went to her urgent care location due to the events. They took her X-ray and EKG and was normal. They also did a Covid test which was negative. The reporter wanted to know if it is safe for the patient to get the second dose. The final outcome of the events she started to feel like she was fainting and she had trouble breathing was recovered (for clarification); while the other events was unknown.  Information on lot/batch number has been requested.
Tested positive for COVID-19 after primary series with NVX vaccine; Tested positive for COVID-19 after primary series with NVX vaccine; Like [you have the flu];never went into chest or lungs, just upper respiratory; Felt [tired and] not myself; Like you have the flu;[never went into chest or lungs, just upper respiratory]; Felt tired; This non-serious initial spontaneous safety report was received by Novavax on 15-MAY-2023 from a consumer via the contact center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 26-OCT-2022, intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on 28-NOV-2022 in the arm.  No medical history was reported. It was reported that the individual had allergies, but th caller was unwilling to share any more details.   No concomitant medications were reported.  On 26-OCT-2022, the individual was vaccinated with dose 1 of Novavax COVID-19 vaccine and later experienced covid-19 (PT: Vaccination failure). On 06-MAR-2023, 4 months 8 days after vaccination, the individual experienced breakthrough covid-19 (PT: Breakthrough COVID-19), she tested positive for COVID-19 on 06-MAR-2023. It lasted about 7 days and her symptoms were described as like the flu, it never went into her chest or lungs, just upper respiratory(PT:Influenza like illness) (PT: Respiratory symptom). She felt tired (PT: Fatigue) and not herself exactly for maybe the next week to 10 days (PT: Feeling abnormal).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 06-MAR-2023).  On 26-OCT-2022, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Breakthrough COVID-19, Respiratory symptom, Fatigue,Influenza like illness, and Feeling abnormal were recovered/resolved with unknow date in MAR-2023.  Lot number was requested but was unknown to the reporter.
Has red spots popping up everywhere, all over the back and front of her torso; Itching a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit). At the time of the report, ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Patient complained of right lower leg pain with shortness of breath and headache starting on 04/12. He was seen in the medical office for complaints along with malaise,  fatigue and muscle pain. Patient was diagnosed with acute vital syndrome
patient states side effects of trouble breathing with first vaccination on 3/31/2021 Moderna COVID 19 vaccine Lot number 025B21A.
The night after the injection I had a fever, chills, muscle aches and pains, joint stiffness, headache, and uncontrollable shivering.
Rashes started to develop on right side of lower abdomen, under arms and left leg. I applied cortisone 2.5 mg and gave Patient 10 ML of Benadryl allergy after her bath before bed when I saw the rashes.  Same this morning  but by the end of the day today she como long that other parts of her body were itching and when we took a bath around 9 pm before bed the rashes have spread to her bottom and back of her legs, the abdomen rash is bigger , on her left thigh, under her arm and sporadic bumps on torso and back.  Repeated same treatment as last evening/this morning. Wrote her doctor again (I had written in the morning) that if she doesn?t get better or if the rashes keep on spreading that I?ll take patient to be seen.
Sore arm; Started feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired). The patient was treated with VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   This case was linked to MOD-2021-378018, MOD-2021-378030 (Patient Link).
Chills, headache, lethargic.  Following day red hot spot the size of a softball 2 inches below injection site.  This lasted for 3 days before fading to just a red spot.
1 of 8 pts who recvd flu vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;
Patient received his first Shingrix vaccine on 11/07/2023 which resulted in development of Guillain Barre syndrome. He was hospitalized on 11/16/2023 with progressive ascending muscle weakness.
Patient woke up the next day to swollen red and tender area at injection site appr 3 x 2.5 inches. Patient came to pharmacy 12-14-14 pharmacist recommended Benadryl which brought itch, redness and swelling under control. Spoke to the patient 12-18-14 all is well except for slight tenderness at site all swelling and redness subsided.
Patient received vaccination, I explained the need to wait in the store for 15 minutes. Patient was ok as I returned to the pharmacy to prepare for the next vaccination. Pt left the waiting area to shop, then returned after about 2 minutes and sat down in one of our chairs. Pt then announced that he was feeling dizzy. I immediately tried to reach the patient, by the time I reached him he had collapsed to the floor. The patient was unconscious for about 1 to 2 minutes, I had my staff call 911. Then the patient regained consciousness. The paramedics arrived and checked his vitals and watch him. His father arrived and took him home. He was feeling ok when he left the store.
Patient stated on consent form that she had not had a previous dose of COVID-19 Vaccine. Her daughter called the pharmacy to report that she had already completed the 2 dose series of Pfizer at a different pharmacy. She received dose number one on February 25, 2021 and dose number 2 on March 25, 2021.  Patient's daughter states that she has had no adverse symptoms.
I was on a hiking trip. When I was about at the fifth mile, I didn't feel well and had indigestion. At about mile seven, I had tightness in the chest. I walked another mile and a half before I had to sit down. I had to have someone else carry my pack for the rest of the trip, and I didn't feel well for 24 hours. I went to an urgent care 48 hours later. They ran an EKG, and no abnormalities were detected. They then told me to just come back if it happens again. I was fine afterwards. I'm a very active person. I rode my bike regularly all that summer without any trouble.
Moderate headache, chills, intense fatigue, feeling unwell/sick.  All lasting from 2;00pm- present (11:50pm).  My jaw was clenched. .  I took Tylenol and an Ativan at 7:00 for my headache and jaw clenching but it did not seem to help.  I put a heating pad on my neck and back of my head for the past two hours and this helped the pain.
Patient is reporting this adverse event. Therefore, some technical and outcome information is missing.  In addition to side effects listed on info sheet, a red intensely itchy rash appeared on 6-22-2019 on both arms from injection site on left upper arm (same location on right arm) to wrists. Also a 1.5" red patch four inches above left wrist adjacent to a previously healed scratch that became red and blistered. Rash has moved to legs, noticed at 9 p.m. 6-23-2019 (Sunday). I will go to the clinic early 6-24-2019 to advise and seek help for this concerning side effect.
Three days after shingles shot, got shingles; painful, constant pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media Three days after getting the shingles shot, the patient got shingles, so painful and the bad thing was that this was a constant pain still after about 6 years. Additional supportive information: Follow-up would not possible as no contact details were available.
arm started to itch at injection spot; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 07Aug2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control and caffeine, paracetamol (EXCEDRIN); both started on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FA6780) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 07Aug2021 at 16:00, later on the same day as second shot, the patient's arm started to itch at injection spot and noticed by the end of the night it was red and a little puffy and sore and as days went on the area continued to get bigger and it was the size of fist on fourth day but it did seem less defined on current date. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arm started to itch at injection spot, arm red, puffy arm and sore arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected
This spontaneous report was received from a consumer referring to her 22 months old female daughter with none drug reactions or allergies and a history of an ear infection which was treated with an unspecified regimen of amoxicillin for an unspecified number of days until 27-FEB-2013. On 04-MAR-2013 the patient was vaccinated with an unspecified dose number in series of MMR II (lot number and expiration date not specified) (dose and route not reported). The consumer reported that on 10-MAR-2013 her daughter developed a "stutter when talking". At the time of the report the patient has not recovered from the "stutter when talking". The reporter stated that no treatment was given for the "stutter when talking". No laboratory diagnostic studies were performed. The reporter stated she sought medical attention by a phone call to the physician's office. Additional information has been requested.
6 SHARP PAINS IN MY LEFT POSTERIOR BACK MEDIAL OF MY FLOATING RIBS; MUSCLE PAIN ON TOUCH FROM THE SHOT; FEELING COLD; FEELING OF BEING INTOXICATED; FELT LIKE SUPERWOMAN/URGENCY TO TAKE OFF RUNNING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 29-JUL-2021 14:21 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced feeling of being intoxicated. On 29-JUL-2021, the subject experienced felt like an urgency to take off running. On 29-JUL-2021, the subject experienced feeling cold. Laboratory data included: Body temperature (NR: not provided) Low, 97.6, and Heart rate (NR: not provided) 76, 61. On 30-JUL-2021, the subject experienced 6 sharp pains in my left posterior back medial of my floating ribs. On 30-JUL-2021, the subject experienced muscle pain on touch from the shot. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling of being intoxicated, felt like an urgency to take off running, feeling cold, muscle pain on touch from the shot and 6 sharp pains in my left posterior back medial of my floating ribs was not reported. This report was non-serious.
Patient presented to the ED and was subsequently hospitalized for orthostatic hypotension within 6 weeks of receiving COVID vaccination.
This is a spontaneous report received from a contactable consumer or other non-HCP (parent), for a Pfizer sponsored program (159558). A 33-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity (experienced arm pain), with outcome of unknown. The batch/lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up. Follow-up (Oct 18, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.