chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood sugar" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: corn" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Empirin, reaction(s): "Known allergies: empirin". 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: Blood glucose: (unspecified date) High; SARS-CoV-2 test: (08Jun2022) Negative; (11Jun2022) Positive; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 01Jun2022 and stopped on 06Jun2022. Clinical course reported as, two days after testing negative on 08Jun2022, she started sneezing again on 10Jun2022. She took a Covid rapid test on 11Jun2022 and it was positive. Her symptoms had returned, sneezing, runny nose, tightness in the chest as well as a mostly dry cough that gets worse at night. Yesterday 15Jun2022, she was still testing positive and coughing, especially at night as well as some daytime coughing. Patient received no treatment for symptoms and not recovered from symptoms. Also patient received Tylenol (reported as other medication in two weeks) started on 01Jun2022 and stopped on 01Jun2022 (Lot number: SSC214) for unknown indication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea started one hour after shot administered. Emesis x 1 after 12 hours. Diarrhea 36 hours. No fever, no URI sxs, nor rash.
Well at about 130 am I had chills and jerky body movements which I liken to an anxiety attack.  I also had deep breathing sessions like it was hard to get enough air. I did calm myself down and get wa; Well at about 130 am I had chills and jerky body movements which I liken to an anxiety attack.  I also had deep breathing sessions like it was hard to get enough air. I did calm myself down and get wa; Well at about 130 am I had chills and jerky body movements which I liken to an anxiety attack.  I also had deep breathing sessions like it was hard to get enough air. I did calm myself down and get wa; Well at about 130 am I had chills and jerky body movements which I liken to an anxiety attack.  I also had deep breathing sessions like it was hard to get enough air. I did calm myself down and get wa; aches and pains back and shoulder especially; aches and pains back and shoulder especially; Lack of energy; This is a spontaneous report from a contactable consumer. This 59-year-old male consumer (patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6207) via an unspecified route of administration on 14Apr2021 at 11: 00AM (at 59-year-old) on left arm as dose 1, single for COVID-19 immunization. The medical history of the patient included Low thyroid or hypothyroid, Ragweed pollen and covid (prior to the vaccination). The patient did not receive any other vaccine in four weeks and received normal medications in two weeks. On 08Apr2021 the patient underwent nasal swab test for covid-19 and was tested negative. On an unknown date at about 01: 30 am, the patient had chills and jerky body movements which he took like an anxiety attack. He also had deep breathing sessions as it was hard to get enough air. He did calm himself down and got warm to help with the chills. He was up doing some cleanup work and would have been asleep at the time of the anxiety attack. This am after 8 hours of sleep with Tylenol pm I he felt warm and then chilly at times some aches and pains back and shoulder especially. He had lack of energy to get up and do things around the house but that may be the Tylenol pm groggy effect (1/2 pill diphenhydramine HCI 25mg or 12.5mg took plus tylenol250mg). The patient was recovering.  No follow up attempts were possible. No further information was expected.  Follow-Up (18Aug2021): Follow-up attempts were completed. No further information was expected.
31yr old male c/o itchy throat and lips.  25mg Benadryl given.  Initially gave him water stated he felt a little better, but symptoms continued. B/P taken 126/78 P62 R20  O2 sats 98.  reassessed in 10min. Stated Benadryl helped.  Released to girlfriend.
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Son of the patient called and informed us of the event.  Patient had bilateral paralysis of the lower extremeties.  The event happened the night of the injection at 2am, the patient was hospitalized and with 24 hours the symptoms had resolved.
Chills, fever of 101, oxygen level of 93, for 24 hours beginning 11 days after shot. Went to urgent care, rapid test for Covid and flu were negative, samples for strep and tick borne illnesses negative, pcr test for Covid on 1/22/21 negative.
The adverse affect was coughing tested positive for COVID19 after consultation with doctor no antiviral need lost taste only as a symptom.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunization; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "esophageal spasms" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "perioral dermatitis" (unspecified if ongoing); "MDD" (unspecified if ongoing); "known allergies: Almonds" (unspecified if ongoing); "known allergies: hazelnuts" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 07May2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication Bupropion in 2 weeks of vaccination. The patient received treatment with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Inflammation on injection site on her left arm. Checked temp, BP, pulse. Gave 4 tab. of diphenhydramine to take for 10/18 and 10/19.
The first doze made him tired and got back pain. Went to his Primary Doctor to see if it is okay to get the second dose. He got his blood work done, echo Cardiogram and all the necessary test have been done and he is okay to proceed by his Doctor. On the fourth day after he get the second dose of Pfizer-BioNTEch, in the afternoon, he couldn't get up from his bed that he had lay down. He experienced slur, facial droop and left side hand weekness. We called the paramedics right away and they checked him and took him to the nearest Emergency Hospital. They ran tests, did CT scan and diagnosed him with Ischemic Stroke on his right side which has effect on the left side of his body for facial droop and weekness and not being able to get up. He was threated with Mechanical Thromboctomy to remove the blood clot. He stayed in the hospital for 8 days and is bed bound up until now and is transferred to a re-hab. He still can't stand. Today is the 27th day since the adverse reaction started. His left hand has improved a little bit.
This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of VAQTA strength: 25/0.5 (units not involved), lot # L015460 with expiry date 20-JUL-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored VARIVAX (Merck) (lot #K018961, expiration date 15-OCT-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Vaccine given 1 day early (due 8/11/2021). No adverse symptoms reported as of 8/11/2021
About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, firm, swollen and red.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: ej11685), in right arm, on 12Jan2021 as dose 2, single (Lot number: ej1686), in left arm and on 19Aug2021 as dose 3 (booster), single (Lot number: fd8448) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "SLE Lupus" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: some cheeses" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment taken from 21Sep2023 to 25Sep2023. Very strong bitter metallic taste in mouth, feeling extremely weak, diarrhea multiple times, loss of appetite. On day 13 since start of symptoms, all COVID symptoms returned stronger than before.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315987 Same reporter/patient, different drug, different AE.;
This case was reported by a nurse and described the occurrence of worsening arthritis of the left knee in a 50 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history included arthritis of the left knee diagnosed following knee surgery in 1999 for a torn meniscus, and diabetes mellitus. No pt history of gout, Crohn's disease, or Lyme disease. The pt had no family history of rheumatoid arthritis or lupus. .The pt reported that she "has problems with vaccines" and "got a heart virus after the swine flu shot." She noted that she had received hep A vaccine without any problems. Concurrent medications were not reported. On 6/24/03, the pt received the first dose of Engerix B. Prior to receiving the 20mcg dose, the pt underwent a "two step" skin test for an unspecified reason. The pt reported that, within one day of immunization, she experienced worsening of arthritis in her left knee characterized by swelling and pain. The worsening of arthritis resolved after approximately 12 days, and she did not seek medical attention. The worsening of arthritis resolved after approximately six days. All joint complains resolved before the pt was evaluated by a physician. The nurse considered both episodes of worsening arthritis were possibly related to vaccination with Engerix B.
bad fall/fractures from her fall; bad fall/fractures from her fall; car accident; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Mar2021 (batch/lot number was not reported), as 1st dose, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first dose and then got in a car accident on an unspecified date. She missed her second dose. It was also reported that the patient had a bad fall due to other reasons and was in the hospital (unspecified date) to have a surgery because of fractures from her fall. The reporter asked if the patient should get the second dose even though it was almost 4 weeks since her first dose of should the patient start over. The outcome of the events was unknown.  Information about lot/batch number has been requested. Additional information has been expected.
Pt began crying @ 245PM on 2APR91 lt thigh tenderness & redness noted by mom unable to console child, apply compress to leg, or medicate w/APAP 2hrsto crying;
Itchy rash (hives) all over body. Started the day after receiving HPV vaccine. Treated with BENADRYL.
I?m 26.5 weeks pregnant. Getting a rash on my left hip. It?s getting bigger and spreading on hip. Irritating but not swollen.
A non-serious spontaneous report of inadvertent administration of FLUMIST to a person with asthma was received from a physician concerning an 11 year old male subsequent to the administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-Nov-2009, the patient received FLUMIST inadvertently. There was no adverse event associated with this vaccination error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
LOW PLATLET COUNT; BLACK AND BLUES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 194 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included blood work clean in september 2020,no drug allergies. The patient did not had any illness at the time of vaccination, no similar event in the past. He never had any adverse event in past for vaccination. The patient did not had family history of any disease or allergy. The patient did not had medical history of blood clots, heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: Unknown dose was not reported, administered on 12-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included doxycycline for drug used for unknown indication. On APR-2021,he noticed black and blues appearing randomly all over his body for no reason whatsoever. They continued to worsen until he went to primacy doctor who did blood work on 29-APR-2021. On 1-MAY-2021 doctor called about blood work to said that he had dangerously low platelet count and to make sure he did not fall and hurt himself. He was instructed to go to the emergency room where they were waiting for him. He was admitted that day. He was treated with steroids for two days with no response, 2 day plasma treatment with minimal response. On May 7-MAY-2021 he was discharged from hospital and was told to continue Doxycycline 2 weeks treatment course. He later had more blood work and the levels have radically dropped again. He had an appointment with a Hematologist/Oncologist specialist on Friday 12-MAY-2021., Laboratory data included: Blood test (NR: not provided) low platelet count. Laboratory data (dates unspecified) included: Blood test (NR: not provided) levels dropped. Treatment medications (dates unspecified) included: plasma, Steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and black and blues. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210536558.; Sender's Comments: V0: 20210535373-covid-19 vaccine ad26.cov2.s-low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient was given double dose of DTAP & IPOL because of being given Pentacel as well.  No issues as of now that we are aware of.
chest pain, felt like I couldnt get my breath , indigestion, abominal discomfort
itching (internally & externally), h/a, tachycardia, palpitations, mild SOB; tx w/DPH;
Bilateral axillary lymphadenopathy, sore throat Narrative:  Symptoms started after the over a week after the initial dose. COVID testing performed and negative
This spontaneous report was received from an approximately 55 years old male patient of unknown age regarding himself via twitter (social media). It was reported that the patient had no pertinent medical history and drug allergies/reactions. On an unknown date approximately in 2012 (reported as around 4 to 5 years ago), the patient was vaccinated with ZOSTAVAX, 1 dose (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prevention of shingles. It was reported that the patient was not taking any medications concomitantly. On an unknown date approximately in 2015 ( reported as around two years ago), the patient developed shingles (herpes zoster) after receiving ZOSTAVAX and the patient further stated that it was "the most painful experience of my life" (pain). It was reported that the patient sought medical attention and visited office with the physician. The patient received treatment. On an unknown date a routine blood test was performed results and values were not reported. The outcome of herpes zoster was reported as recovered and the outcome of pain was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
dizziness since day after the first dose with Pfizer (Covid vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 14Mar2021, outcome "unknown", described as "dizziness since day after the first dose with Pfizer (Covid vaccine) ". The event "dizziness since day after the first dose with pfizer (covid vaccine) " was evaluated at the physician office visit.  Additional information: Patient has had vertigo before the patient knew how vertigo feels like. Patient has been to the doctor specialist for that and was told that this was not vertigo. Patient wanted to know if (the patient) should get the second shot (due on 03Apr2021) or not because (the patient) has not been able to work due to the dizziness.   No follow-up attempts are possible. No further information is expected.
This non-serious medically confirmed spontaneous report (initial receipt 05-Dec-2014) concerns an unknown demographics patient. On 12-Nov-2014, the patient received intramuscular AFLURIA (batch number T58406). The patient was administered less than 0.5mL dose of AFLURIA. It was reported that the needle was not fastened to the prefilled syringe which resulted in leakage of the dose. No adverse events were reported since administration. Outcome was unknown.
Shooting pains through arms and legs; Muscle aches; Nausea; Fever of 102.5 Degrees Fahrenheit; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Shooting pains through arms and legs), MYALGIA (Muscle aches), NAUSEA (Nausea), PYREXIA (Fever of 102.5 Degrees Fahrenheit) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included RIVAROXABAN (XARELTO), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Shooting pains through arms and legs), MYALGIA (Muscle aches), NAUSEA (Nausea), PYREXIA (Fever of 102.5 Degrees Fahrenheit) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Shooting pains through arms and legs), MYALGIA (Muscle aches), NAUSEA (Nausea), PYREXIA (Fever of 102.5 Degrees Fahrenheit) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102.5 (High) 102.5 Degrees Fahrenheit and 102.5 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Nausea-Mild, Additional Details: pt called the pharmacy stating that after her booster shot she felt nauseous the next day and was burning up with slight fever, also had large rash at the injection site that is hot to the touch, not going away with benadryl
Patient received first dose on 12/23/20.  Patient received the second dose on 1/8/21.  This date was out of the recommended 21 day revaccination (+/- 4).
Approximately 36 hours after injection, patient started spotting menstrual blood. Patient?s cycle is extremely regular, starting  on day 28 or 29 every cycle. This spotting is chalky blood and not like her normal cycle. It also began on day 21 of her cycle. It is 7 days early. This is not a common occurrence for this patient. It is important to look at this side effect of the vaccine.
First day bad headache, neck and spine were sore. Second day my entire body is in pain, my brain hurts, my kidneys hurt . I?m I excruciating pain. No energy been sleeping off and on since the vaccine. My arm where I got this injection is swollen hot to touch and in extreme pain.