chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Batch/Lot number: unknown), on 14Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Postive, notes: pos. Covid antigen test on 24May2022; (29May2022) Negative, notes: Patient had neg antigen test on 29May2022; (08Jun2022) Positive, notes: Tested positive again on 08Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Unknown if patient received Other medication in 2 weeks. Anti-viral details: Brand was Paxlovid, Treatment start date was 24May2022, Treatment stop date was 29May2022, Indication was Treatment of COVID-19, Administration route was Oral. For dose 1, dose 2 and dose 3, vaccine lot unknown reason was Not available/provided to reporter at the time of report completion. Adverse event: COVID-19 Rebound: pos. covid antigen test on 24May2022 followed by a 5-day dose pack of Paxlovid. Patient had neg antigen test on 29May2022. Became symptomatic 07Jun2022 and tested positive again on 08Jun2022.   The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (unknown strength, route and dose) lot # L002717 and expiry date of 02-JUN-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
L upper arm swelled, got red, developed large confluent raised hives below injection site over the upper arm. I had a tremendous amount of arm pain extending down to my L hand and upward into my neck muscles and shoulder.  This lasted for a week.  Cramps developed in medial upper arm into my lower forearm.   I had taken  two Tylenol arthritis tablets in the late day of the 27th but developed chills (no fever) by nightfall.  During the night, I felt restless, with diffuse muscle aches, and some nausea.  The next morning I was weak, dizzy, had chills and had to stay on the sofa all day.  The hives on my arm  were painful and slightly itchy.  The symptoms diminished over the third day. (Except for the arm pain).
Patient received first dose Pfizer on 12/14/20 then received the Moderna vaccine (lot #037K20A) on 01/04/2021.
got both shots last year, have the shingles/suspected vaccination failure; Shingles on face, hair and around eye/ for 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date:29-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both of the shots last year and guess what he/she have had shingles. The patient never ever had felt to bad.  The patient stated that they were on the face in his/her hair and around his/her eye. The patient stated that they said the patient was lucky, did not had a bad case. If this was not bad the patient did not want any worse. The patient have had been dealing with them for 2 months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient fainted 5-10 minutes after receiving vaccines, consequently falling to the floor.  Pt momentarily Lost consciousness, but fully awake and aware moments later.  Vital at time of event were @3:45pm B/P 98/70 HR 102, T97.6
pt devel thrombocytopenia w/platelet count as low as approx 79,000; pt seen by hematologist; pt was subsequently hospitalized for severe diarrhea?; traveler's diarrhea w/dehydration;
Information has been received from a consumer concerning his 68-year-old wife on on Friday, 30-NOV-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). On approximately 30-NOV-2007 the patient developed pain and redness at the injection site. No outcome was reported. Additional information is not expected.
I had a runny nose and had been in traveling for two weeks. I choose to use my home COVID-19 test that came positive. I decided not to call my Primary Care Physician since the only symptom I had was the runny nose. I chose to quarantine and do not feel that I need to get the PAXLOVID.
(1st dose)- headache only. sore arm. took Tylenol- headache went away. (2nd dose)- fatigue- onset 5 hrs later. Sore arm, chills, sweats, nausea, increased fatigue 17 hrs later (middle of the night for 5 hours). Woke up and all symptoms had exhausted except fatigue. Fatigued still 2 days later (5/12)- Tylenol every 6 hours. Water all day.
the patient received the vaccine on 1/8/21, her last day of work was on 1/11/21, patients family reported that she was hospitalized and on life suppose on 1/12/21. She suffers from severe asthma, has several asthma attacks and wound up on the life suppose. Patient passed away on 1/22/21
itchy arm at injection site 2/18/2021; arm red and hard near site 2/19/2021
COVID arm, erythema, inflammation and pruritis of deltoid on vaccinated arm which lasted approx 3 days
other zoster-related conditions; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Rash, blisters area surrounding injection site. No pain noticed the morning after injection. Was painful at first, then rash got bigger & form blisters. Now getting better and less red; blisters seem to be drying up.
Patient was given the 2nd dose of covid vaccine earlier than recommended by mistake. She was given the 2nd dose at day 14 instead of day 21. This was outside the recommended grace period of 4 days.
Confirmed Breakthrough  COVID-19 (Moderna) 1 02/04/2021 Moderna 007M20A   COVID-19 (Moderna) 2 03/06/2021 Moderna 015M20A   COVID-19 (Moderna) 3 12/13/2021 Moderna 041J21A
mild nausea; severe dizziness; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored Program. A female patient (reporter's niece) of an unspecified age (reported as 27, unit unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included vertigo. Concomitant medications were not reported. On 07Jan2021, the patient experienced mild nausea and severe dizziness. Dizziness got so severe that she couldn't get out of bed last night so she had to pee in a cup. Clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
pt recv vax 17JUL98 & thursday 23JUL98 lt arm swollen & red;pt was given a steroid inj on 24ht for rxn to tetanus by MD;improvement noted by end of day;
7 Days after vaccine injection,  pain around the injection site, redness the size of the palm of my hand and hardness developed.
COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction).  The patient's medical history was not provided. Concomitant medications reported were metoprolol.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
vaccine given to 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications reported.
A cute allergic reaction with hives, sweating. Diarrhea, vomiting, hives.
Rash that started the day I took the first shot. The rash started about an hour after taking the shot and it has gotten progressively worse over the last 6 days. The rash is very itchy, red and all over my body. Have tried creams, lotions, and steroid treatment with no improvement.
post vaccine syncope. no history of syncope with vaccines or blood draws. pt reports lightheadedness within minutes of vaccine and they passed out when transferred to chair. Given juice. Quickly felt better.
11/05/07 Client was administered flu vaccine to left deltoid.  11/08/07 Client presented to office with redness swelling on the inner aspect of left arm where flu shot was given.  Encouraged client to apply ice pack if she felt it was needed and to take tylenol for pain.  Instructed client to call our office if swelling did not subside in a couple of days.
Pfizer on 1/26 and . Positive on 8/10 admitted 8/7-8/11
A itchy rash  appeared around the injection site a week after the injection.  The area felt warm to the touch and itchy.  Treated with oral antihistamine (Benadryl) and application of cortisone cream.
Swelling at vaccine site greater than 3 inches in diameter. Diarrhea and nausea that has lasted from 11/8/2021 until today, 11/10/2021.
GREAT AMOUNT OF HAIR LOSS; BUNION IN THE SECOND TOE OF RIGHT FOOT; GOUT; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced gout. On an unspecified date, the patient experienced great amount of hair loss, and bunion in the second toe of right foot. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from great amount of hair loss, and gout, and the outcome of bunion in the second toe of right foot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220157663.
Severe redness swelling in arm where influenza vax given. Resolved p/72 hrs.
Night sweats; Extreme nausea; Chills; Fever; Itch; This is a spontaneous report from a contactable Nurse (patient) reported for self. 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 an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse was asking for recommendations if she could get the 2nd dose of the vaccine after having adverse reactions on the 1st dose - experienced night sweats, extreme nausea, chills, fever, and itch. Nurse was also asking what are the signs of severe allergic reactions. The outcome of the events was not reported.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported and inadvertently the patient was administered a second dose of ZOSTAVAX) (dose, route, lot # and expiration date were not reported). 2 years later (exact date unspecified). No adverse effects were reported. No PQC  (product quality complaint) was involved. Additional information has been requested.
I also had the Flu shot the same day as  I had the Covid Booster.  A few days later I noticed a painful small area in the right side of my neck near my right collerbone. It did not feel like a swollen gland. it was painful if i touched it. I decided to leave it alone. Within a week or two It had changed to a more solid feeling lump with out much pain. I did notice pain in my right ear off and on.  I did see my Dr yesterday and  after examining the area he said it was not a lymph gland but more like my thyroid. He has ordered an ultrasound for next thursday.
Tested positive with PCR test; Tested positive with PCR test; sneezing; slight headache; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EP6995) via intramuscular, administered in Arm Right on 30Mar2021 at 14:00 (at the age of 48-year-old) as dose 2, single and dose 1, bnt162b2 (BNT162B2, Solution for injection, Lot Number:EL3247) via intramuscular, administered in Arm Right on 09Mar2021 at 14:45 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Hashimoto Disease (thyroid) and  the patient was allergic to dairy, wheat, egg white, soy, corn. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19. Patient stated that he tested positive with PCR test taken on 05Sep2021,no symptoms other than some sneezing, slight headache evening of 05Sep. Since the vaccination in 2021, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 05Sep2021(Nasal Swab). The outcome of the event events was recovered on unknown date in Sep2021.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
On 3/31/2021, I had a menstrual cycle when I previously had been in Menopause for the past 16 months. The menstrual cycle started on 3/31/2021 and as of today (4/10/2021) it is starting to taper down and be finished in the next day or two.
Dizziness and weakness. Able to ambulate, but does not feel if she will fall, no nausea, SOB, Edema or rash.  Mentating well and does not sound ill when speaking with on call MD.  Advised to take b/p and call back with reading if SBP <100 or if sx worsen.  Observation suggested at time of phone call.
insomnia; soreness in the arm; nausea; vomiting; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 15:00 (Lot number: EN6199) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EN5318), administration date: 04Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "insomnia"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "soreness in the arm"; NAUSEA (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "nausea"; VOMITING (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "vomiting"; CHILLS (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "chills". Therapeutic measures were not taken as a result of insomnia, pain in extremity, nausea, vomiting, chills.  Additional information: Other medications in two weeks reported centrum vitamins. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since vaccination. Patient had not any allergies to medications, food, or other products. Patient received centrum vitamins in two weeks of vaccination.Vaccine Facility information available.The patient became aware of the 1st side effect (soreness in the arm) when it started at 9pm on 23Mar. She didn't keep track on when the other side effects (insomnia, nausea and vomiting, chills) started but they came in during the night. On Thursday morning (25Mar), all the side effects were gone.  No follow-up attempts are possible. No further information is expected.
Vaccine administered 9/24 at 4 pm, pt noticed full body rash at 9/25, and presented to the pharmacy after it worsened overnight (0/26 at 4 pm). No itching/pain, just full-body redness. Will take diphenhydramine tonight.
A few minutes after vaccination, patient began to feel dizzy. Then fainted and lost consciousness. Was supported to the floor in supine position. Patient regained consciousness with a minute of time and quickly recovered.
Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration at left arm on 05Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products (unspecified allergies). The patient's concomitant medications were not reported. The patient experienced red bumps and itching to arms, legs and belly at 12:30 on 05Jan2021. The patient received the Benadryl as treatment. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient complains of erythema and pain at injection site. Patient states the vaccine was administered in the subcutaneous layer above deltoid. Administering provider used a 1 inch needle and states patient grabbed hand/wrist and self administered vaccine.
The injection site immediately became sore. Within 24 hours a bruise developed with several red streaks. This has lasted 14 days, but the severity has decreased. Also within 24 hours of injection, I developed a severe headache, body aches and chills. The headache and body aches have persisted for 14 days, but are now subsiding. I developed a severe cough 4 days after the injection, which currently persists.
Slight fever and chills, followed by muscle soreness and weakness in the upper arm into the neck and across the back that lasted about 7 days.