chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 27 Jan 2017. This case involves 42 year old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date, dose in series was not reported) via intramuscularly in left deltoid on 12 Sep 2016, a dose of INFLUENZA VACCINE (batch number, expiry date, dose in series was not reported) via intramuscularly in left deltoid on an unknown date. (Reported as 10 days later). The patient had no illness at time of vaccination, the patient has an autoimmune syndrome that has been in remission for 1 year. The patient concomitant medications were not reported. On 13 Sep 2016, within 24 hours after the vaccination with ADACEL, the patient developed pain at the injection site, that woke her up at night and her whole body ached. On an unknown date, few days after the vaccination with influenza vaccine and ADACEL the patient had lymph node swelling and a fever of 103 F, on an unknown date the patient was seen by her MD (medical doctor), blood work showed an elevated rheumatoid factor and the patient was diagnosed as inflammatory reaction to vaccine, on 09 Nov 2016, 1 month 28 days after the vaccination with ADACEL the patient Thumb swelled on left hand and left foot swelling. Seen by MD rheumatoid factor was 24, again on 20 Dec 2016, the patient Left thumb and foot had swelling, on 26 Dec 2016, the patient top of the left foot very swollen and a lump about the size of two peas developed, causing her pinky toe to be pushed away from her other toes, on 29 Dec 2016, the patient was seen by a rheumatologist and put on high dose of steroids. Rheumatoid factor was 38, and diagnosed as Early Rheumatoid arthritis. On an unspecified date, following vaccination, the patient had swelling in her right hand to the middle index finger, and left hand the thumb was swollen. She is also experiencing pain in her joints and uncomfortable feeling. The patient other lab tests were not reported. The patient had corrective treatment with Prednisone, Zovalax 35 mg 2 times per day and a steroid daily. The outcome of the events were reported as not recovered. Upon internal review the company decided to consider the events serious because of important medical events Rheumatoid arthritis, Peripheral swelling, inflammatory reaction to vaccine, joints a painful, fever of 103F, uncomfortable feeling, lymph node swelling. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with ADACEL and presented with vaccination site pain and whole body ache with 24 hours and 10 days later she was vaccinated with influenza after both vaccine she presented Rheumatoid arthritis and associated symptoms. Time to onset is compatible, in this case patient has been positive for RA factor, rheumatoid arthritis is autoimmune disease which has genetic correlation and idiopathic in nature, past vaccination status, any similar complain are needed to further assess the case. Based on available information the role of vaccine in rheumatoid arthritis is unlikely, but for vaccination site pain and whole body ache cannot be ruled out.
21 y.o. female, no pertinent hx, presents for chest pain and SOB. The patient states yesterday while riding a motorcycle with her boyfriend, she had gradual onset of central chest pain that is described as a sharp ache. The pain is worse with deep inhalation and is slightly improved with leaning forward. Additionally she notes feeling chilled, having a dry cough, and feeling intermittently short of breath, but notes she has not taken her temperature. Patient also attests she recently received her Covid Vaccine on 10/7, but has felt well since that time.  COVID vaccine was NOT administered at this facility..
fever up to 102,  severe headache and neckache, nausea, vomiting and diarrhea, chills, body aches. recovered in 10 days
flu; Initial information was received on 12-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
red welt left arm; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 1977, Drug allergy (sulfa drugs), Bee sting, Drug allergy (dilaudid), Allergic reaction to antibiotics (erythromycin), Allergic reaction to antibiotics (tobramycin), Prehypertension since 2001, High cholesterol and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LISINOPRIL for Blood pressure management, CEFIXIME (FLEXERIL [CEFIXIME]) for Fibromyalgia, LOVASTATIN for High cholesterol, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE WITH VITAMIN D3) for Osteoporosis, UBIDECARENONE (COQ 10) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm). The patient was treated with Manual therapy (Iced left arm) for Urticaria and Manual therapy (Iced left arm) for Pain in extremity. On 16-Feb-2021, URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-046218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow information included Medical history.
Pt reported headache, chills, nausea, bodyaches and lightheadness about 1-3 hours after the injection.
Their vaccines / exposed to freezing temperatures / administered to several patients; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced incorrect storage of drug. The action taken with Havrix Pre-Filled Syringe Device was unknown. The action taken with Boostrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The nurse reported they had a temperature excursion for their vaccines Pediarix, Havrix, Kinrix, Infanrix, Boostrix, Menveo, Bexsero, Engerix-B, all of them were exposed to freezing temperatures and were no longer good to use, and then were administered to several patients which led to inappropriate storage of drug. The reporter had no data about the patients or the vaccines. The reporter consented to follow up.
Feeling Sick; Nausea; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concomitant products included DILTIAZEM, ACETYLSALICYLIC ACID (BABY ASPIRIN), FUROSEMIDE, METOPROLOL, CLOPIDOGREL, POTASSIUM, VITAMIN D3 and OMEPRAZOLE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling). On 11-Mar-2021, MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment taken.
Mouth is drooping; Feeling numb; Walking is off; Eye is dropping/ Eye was not close all; Achy/Flu; Achy/Flu; Feeling of stroke on left side; I am not feeling good; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 08Nov2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3182) intramuscularly in arm left on 29Sep2021 15:45 (at the age of 28-year-old) at single dose for COVID-19 immunisation. Relevant medical history included attention deficit hyperactivity disorder (AHDH). Family medical history included throat cancer, lung cancer, dementia and alcoholism. Concomitant medications included oral amfetamine (ADZENYS XR ODT) ongoing since Aug2021 for ADHD, oral norethindrone acetate ongoing since an unspecified date for birth control and unspecified steroids. On 29Sep2021 18:30, few hours later lock jaw the patient felt stroke on left side. On 29Sep2021 she was not feeling good. All next day she was achy and had flu line symptoms. On 01Oct2021 the patient had left side still feeling numb, walking was off, eye was dropping and mouth was drooping. Eye was not close all the way, eye drops were needed. The patient used eye patch for relief. Three weeks later the patient still had the same symptoms with no relief. Second should would be due on 20Oct2021. Not feeling good required physician office visit and was treated with 5-day steroid pack. Not feeling good was not resolved, outcome for the other events was unknown.  Follow-up attempts are completed. No further information is expected.
hives and rash on arms and chest  fever and headache  nausea  injection site pain and swelling
Patient felt like she was going to pass out, did not want to lie on the ground as instructed. Patient passed out in her chair, provider was next to patient and lowered patient to the ground. Patient was unconscious and not alert for a few seconds. When patient came to, she was alert and oriented, answered questions appropriately. Patient's BP was 118/82, HR 80, BG 63 (after a large lunch 2 hours prior). EMS was called, patient felt fine. Decided not to go to the hospital. Patient waited at vaccine clinic, BG 110 after an apple juice.
3" x 3" erythremic swollen warm/tender area (R) deltoid. Fatigue, fever, headache, nausea.
The patient is pregnant and received FLUBLOK QUADRIVALENT with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in context of the patient is pregnant and received flublok quadrivalent with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported The patient is pregnant and received FLUBLOK QUADRIVALENT with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for Immunisation. Information regarding batch number details has been requested.  On an unknown date the patient was pregnant and received flublok quadrivalent with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (The patient is pregnant and received FLUBLOK QUADRIVALENT with no reported adverse event).  Outcome: Unknown.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Severe lump in leg and very red and swollen.  Fever & vomiting.
I had no adverse reaction to the vaccine that I know of. However I was contacted because March 29, 2023 I tested positive for covid (home test) and the next day tested positive for Strep throat, which was treated with Zithromax 500 po daily for 5 days with complete resolution
Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2010, the patient was treated by a healthcare provider at a health center or shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Hives 24 hours after Td injection. Self medicated with Benadryl, hives resolved.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the viral or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to a patient of unknown age. On 12-SEP-2014, the patient was vaccinated with M-M-R II vaccine (0.5 ml, subcutaneously). No concomitant medication was reported. It was noticed that on 12-SEP-2014, the patient was administered with a dose that had been improperly stored. No adverse effects were reported. The outcomes of the event were unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
I had a total hip replacement on Thursday, Feb. 27th 2019. The pain was at my new hip joint and the muscules surrounding the area. This continued for (3) three days. Resulting in having to take Aleve during that time
Child began to stutter within 24 hrs of vaccine, forgetting words and pronouncing words strangely. Marked change over 24 hrs according to mother.
sterile abscess @ inject site; serum sickness-arthralgia, macular rash on extremities, malaise; treated w/Atarax then Pred;
This is a spontaneous report from a contactable consumer and from a contactable physician. A 67-year-old male patient received PREVNAR 13, via an unspecified route in right shoulder of administration on 06Mar2016 at 15:00 single dose. Medical history included ongoing hypothyroidism diagnosed about 6 years before this report, ongoing prostatic specific antigen (PSA was 1.8) and urine flow/prostate. Concomitant medication included SYNTHROID, tablet orally at 56 ug daily for hypothyroidism, liothyronine orally at 20 ug daily for hypothyroidism and alfuzosin tablet at 10 mg daily for urine flow/prostate all ongoing. In 2008, at 59-year-old, the patient received influenza vaccine and experienced influenza and malaise. On 06Mar2016 the patient experienced soreness, like someone hit him in the arm both. The patient was recovering from the event. The physician confirmed that the patient provided to him/her information regarding the reported events with the use of the vaccine. The physician considered the vaccine had a causal effect to the adverse events. Follow-up (02May2016): New information reported from a contactable physician includes: confirmation that the patient provided to the physician information regarding the reported events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
bumpy, itchy rash on forearms, hips, back of knees and legs. symmetrical on both sides of body.
Severe neuropathic foot pain. Severe joint and muscle pain requiring pain meds. Unable to sleep using zolpidem. When starting to fall asleep body twitches to wake up.   Headache. No appetite. Severe chills.  Had to use electric blanket.
Received a second dose Moderna on 3/3/21 and a first dose Pfizer on 2/10/21
2 hours of inconsolable crying; onset about 4 hours, post vax, then continued to be fussy but consolable.
every time had flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who experienced flu (influenza), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient only got a flu shot a few times, and every time he/she had flu. The last time was quite severe. He/she had not got flu shot in many years and had no flu. Maybe he/she was just the exception to the rule.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for influenza was unknown.  There will be no information on the batch number for this case.
Mild pain , deep erythema and warmth with swelling about right arm: the next day after Motrin, Zyrtec and ice packs, swelling much decreased.