chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upper respiratory tract congestion; voice congestion with postnasal drip; Drug ineffective; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4433494-00.  Solicited report by a consumer of an 82-year-old female with events of non-serious voice congestion with post nasal drip and Covid-19 with Humira (ADALIMUMAB). The patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 82 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162124) at citrate free, subcutaneous for rheumatoid arthritis. There was no reported medical history and concomitant medications. On an unknown date, the patient experienced voice congestion/Upper respiratory tract congestion with post nasal drip/ Upper-airway cough syndrome. In Mar2021, the patient experienced Covid-19 and Drug ineffective. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken for adalimumab was unknown. The reporter's causality for event(s) of voice congestion with post nasal drip unknown onset and voice congestion with post nasal drip unknown onset with Humira (ADALIMUMAB) was no reasonable possibility (Not Related) and not reported for event Covid-19 and Drug ineffective. The reporter's causality for the event(s) "covid-19", "upper respiratory tract congestion" and "voice congestion with postnasal drip with BNT162b2 was Possible and not reported for Drug ineffective.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Moderna Arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm). At the time of the report, LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) outcome was unknown.            No concomitant medications were provided. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow-up received contains reporter details, patient details,events were updated.; Sender's Comments: This case concerns a unknown-year-old, female patient with no reported medical history. The patient experienced unlisted non-serious events of Limb discomfort peripheral swelling pain in extremity and vaccination site reaction unspecified days after third dose  (booster dose) of spikevax. Patient experienced AEs after the third dose and no information about first and second dose is available rechallenge not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Presented with increasing SOB, worsening cough and ongoing fever; + covid PTA; Rec'd antiviral PTA; CXR groundglass opacities bilat; Labs: D dimer 0.72; CRP 6.8; Ferritin 140; Tx: Intitiated on Decadron, Lovenox, Remdesivir, Vit C, Vit D3, doxycycline, singulair, zinc; O2 @ 2 LPM initially, down to room air by d/c
20 hours after the shot I experienced Nausea, Vertigo, Headache, Dizzy, watery eyes. My arm was Sore all over.  40 hour's after shot I woke up to sore arm and large red patch at injection site. The area is swollen and hard, hot to touch and red, very itchy.  Pain in my arm, and shoulder. Injection site is painful to touch.
malaise, nausea, sore arm, extremely swollen arm, redness, fatigue
Dose Number: 4; Treatment of COVID-19; Dose Number: 4; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Asthma" (ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Dose Number: 4; Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (20Jun2022) Negative, notes: Tested negative on antigen test last day of treatment; (25Jun2022) worse COVID symptoms than with initial infection, notes: Antigen test 5 days after completing paxlovid with worse COVID symptoms than with initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Headache started a few hours after shot ... Muscle aches, headache, chills, could not sleep, lethargy,  starting 8pm day of shot/ 12 hours after injection. Continue until about 4 pm next day - started feeling better around noon.
Patient presented with an itchy, red, and bumpy rash on her arms and back beginning 2 days after receiving the 2nd dose of the COVID-19 vaccination. The vaccination occurred on Saturday (2/13/21) and the rash began on Monday. She reports this being the only contact change in the previous week. She saw us for a visit on 2/18/21.  Treatment: Triamcinolone twice daily, thick moisturizing cream, avoid long, hot showers, take an antihistamine, cool compresses, and a biopsy was taken.
Irregular labs indicated a liver issue; Covid vaccine issue/ Injection site pain; removed a piece of intestine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358536-00 (Agency).  A 67-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTESTINAL RESECTION (medically significant) with onset 2021, outcome "unknown", described as "removed a piece of intestine"; LIVER DISORDER (non-serious), outcome "unknown", described as "Irregular labs indicated a liver issue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Covid vaccine issue/ Injection site pain". The patient underwent the following laboratory tests and procedures: Endoscopy: (2021) No problems were found; Lab test: (unspecified date) Liver issue. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intestinal resection.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue and Covid Vaccine Issue/Injection Site Pain was not provided.Agency's opinion is that there is no reasonable possibility that the events of Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue and Covid Vaccine Issue/Injection Site Pain are related to Humira (Adalimumab). Agency's opinion is that the event of Irregular Labs Indicated a Liver issue is not assessable.  Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): Reporters causality for the events Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue were not reported and for event Covid Vaccine Issue/Injection Site Pain was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
PATIENT REPORTS GETTING DIZZY AND HAVING A HEADACHE 24 HOURS AFTER VACCINE, WENT TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH VERTIGO, STATES DR STATED IT WAS BROUGHT ON BY THE VACCINE
malaise; Muscle ache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever) had not resolved.            No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.
Moderna COVID?19 Vaccine EUA  Arm pain (unable to lift arm up over shoulder for 24h) Headache
Approximately 2-3 minutes after receiving FLUMIST pt. started complaining of severe dizziness. We had pt. sit down, gave him some water & had him to sit still. After about 15 minutes pt said that he felt normal again. Vital signs were normal. Pt left clinic in NAD.
Red plaque 4"X 6" right thigh with induration 1.5' X 3"
Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant medication information was provided.  The vaccine BUD was reported as 2Sep2021.  Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:master case
Admitted with pyelonephritis and found to be pseudomonas which is only sensitive to Fortaz. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
One week after shot she ran a 102 fever.  Then seem to have a virus.  Saw pediatrician twice.  She then seemed to feel better for 2-3 days.  Then her left side of cheek/jaw swelled causing pain.  Took her to pediatrician and she was diagnosed with mumps.
This non-serious, spontaneous case, initially received on 20-Oct-2018, reported by a pharmacist, concerns an adult of an unspecified age and gender. On an unspecified date, the patient (under the age of 65 years) was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported. This case was considered as lost to follow since the reporter has not given consent to provide further information.
Rash across the chest (collar bone) itchy, red, itchy all over the body from head to toe, muscle aches, irritated left arm.
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 2013-05188, 2013-05251-05256, 2013- 05258-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved an 87 year-old male patient who had received Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 18 days later reported the onset of GBS. No further information was provided. Outcome were not reported. Documents held by sender: none.
Bronchitis; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Asking if it's safe to take the second dose even if he was advised to take steroids due to his bronchitis. As per the caller he was scheduled 27Jan2021 for his second dose. The outcome pf event was unknown.   Information about lot and batch number was requested.
I wore hearing aids before this incident. Three weeks after my second vaccine I got an ear infection. I am 55 years old and have never had an ear infection in my life. I was given antibiotic but then I lost most of my hearing in my left ear. The ENT said the hearing loss was not caused by a bacterial infection. They started me on a series of steroid injections in my inner ear. I can't take steroids orally due to internal bleeding issues. After the steroid shots, my word recognition improved by 20% in my left ear.
On April 18th around 12:15 I was scratching my right thigh, when I looked a notices some red bumps (rash).  I stopped scratching it since I didn't want to irritate it.  I then noticed the rash forming on my left thigh and eventually to my stomach.  It looked like hives so I thought it may be an allergic reactions but I didn't know for sure.  The back of both hands eventually started to feel warm and started to turn red and eventually showed what almost looked like welts.  I again didn't scratch any of the rash and eventually in the evening they disappeared and there was not a trace of the bumps or redness.   When I woke up on April 19th, I immediately checked to make sure the rash was gone and it was.  As the morning progressed I noticed a burning sensation on the back of both my hands, both my legs and feet, stomach and the left and right side of my waste.  I was concerned and immediately started checking online about the possible side effects of the vaccine.  Both of my feet were so red that my toes looked almost blue/purple and both my legs were covered in red spots which looked almost like the measles or the shingles.  I called my doctor to try and get an appointment but she didn't have anything available.  By the end of the day,  the rash was gone and again there was no trace that they were ever there except for the pictures that I took.   On the morning of April 20th, I again checked to see if there was any sign of the rash and thankfully there was none.  As the day progressed I noticed a burning sensation on both my elbows and forearm areas and there it was again.  The rash was also on both of my knees but not as bad the the previous day.  As the day progressed, the rash again disappeared without a trace.  By evening I noticed my hands were irritated and  I saw red bumps again but not as bad.  I also noticed the bumps returned to both my knees and around my feet.  This is very uncomfortable and I hope they finally go away for good but the fact that they keep coming back has me concerned since I am scheduled to receive my 2nd dose of Pfizer on April 27th and I'm not sure if I should get it since I don't want to aggravate my current rash.
Covid-19; Eczema; heartbeat problems; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems). At the time of the report, COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems) outcome was unknown.            No concomitant medications were reported. It was reported that patient had skin problems and itching and patient went to dermatologist to get the medication to treat the itching and was diagnosed with eczema. Symptoms of COVID-19 was reported as breathing problems. Symptoms of Eczema were reported as hives, itching, skin problems and rash problem. No treatment medications were reported.  Company Comment This spontaneous case concerns an unknown-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of eczema, cardiac disorder and other expected event  unknown days after 2nd. dose of  mRNA-1273 vaccine.  Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of eczema, cardiac disorder and other expected event  unknown days after 2nd. dose of  mRNA-1273 vaccine.  Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelling lasted for about a week and the spot faded after time.