chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as receive from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-APR-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry Date of COVID-19 Vaccine: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, consumer stated, they got COVID the 1st shot and was feeling awful, whole body everything was hurting, could not walk, could not eat and was throwing up. Patient asked should they go to the hospital. When informed about Pfizer Medical Information Department and offered the number, consumer stated, Should they go to the hospital that was what they were asking. And asked for transfer. In response to further probing, consumer stated, they were hurting too bad, and need to get an ambulance or need help. Consumer was unwilling to share further information, hence, product details (LOT, expiration date, NDC, UPC) and other details were unknown. Limited information was available over the call. QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Event seriousness was not specified. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up attempts are completed. No further information is expected.
Information has been received from a licensed practical nurse concerning an 18 year old male patient who in July 2004, on 26-NOV-2004 was vaccinated with his first, second doses of RECOMBIVAX HB, lot number was not available. On 18-JUN-2010 the 18 year old patient was vaccinated two vials of RECOMBIVAX HB pediatric formulation (5 mcg) for his third dose of RECOMBIVAX HB (lot#664736/0715Y, thimerosal free, expiration date in March 2012). There was no adverse effect reported. The nurse also stated that the office's policy was to administer 10 mcg (adult dose) to patient over 16 years of age who weigh over 100 lbs. At the time of report the patient's status was unknown. Follow up information has been received from a physician concerning the patient who on 18-JUN-2010 was vaccinated IM with two vials of RECOMBIVAX HB pediatric formulation (5 mcg) for his third dose of RECOMBIVAX HB (lot number 664736/0715Y, thimerosal free). On an unspecified date the patient only complained of sore arm. At the time of report the patient's status was unknown. Follow up information was received which reported that the 18 year old male patient with penicillin allergy and no illness at time of vaccination or pertinent medical history. There was no adverse reaction reported to clinic after vaccination on 18-JUN-2010. Additional information is not expected.
2wk post vax pt exp a series of sz that have persisted & changed in nature;pt exp was considered an important medical event;
Took Moderna Shot first thing Wednesday, March 24,2021 9:00 am.  I was OK until about 7:00 pm when I started feeling chilly. I started running a fever at 8:30 pm of 100.4.  Went to bed and next morning, I had a temperature of 101.2 .  Laid in bed all day.  I started itching all over and have a bad rash that looks like hives or 3 day measles like I had as a child.  I felt bad on Thursday, Friday, Saturday.  No fever on Saturday.  Highest temp was 102.1. but have extreme rashes everywhere, on both arms, legs, torso.  I have used Benadryl, caladryl clear and vitamin e oil.  The itch is terrible, I have scratched until many of the places are raw.
12/28/20- shot administered I had symptoms consistent with the side effects anticipated 12/31/20 itching and swelling at site, hives on stomach and arms; called practice for consult- told no protocol for this. I took a Benadryl which helped; took Benadryl next night too - I have taken my regular allergy medication consistently 1/5/21- arm swollen, very hot to the touch; increased swelling and redness throughout day- arm begins to feel like gum in some parts, redness spreads; ER visit- Cellulitious- began antibiotics and advil 1/2/21- swelling decreasing, redness persists 1/7/21 significant improvement 1/15/21 continued improvement- I have a bruise at site
Severe migraines started after receiving the first dose and despite the doctor's best efforts they are still ongoing. The first migraine was so severe it mimicked the effects of a stroke. Hearing loss/ tinnitus started after receiving the 2nd dose and became worse after receiving the booster. The booster also had the effect of removing the benefits of the medications I was on and therefore setting back my recovery. I have been out of work since August of last year, I tried returning to work in January of this year but suffered another setback after only 3 shifts and have been out again since the first week of February.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 28-JUL-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
On 4/25/18 the client called the clinic complaining of pain to R arm, denied any redness or swelling. I told her to ice and apply warm compresses to her arm and follow up with her doctor if not better in the next couple of days. On 5/3/18 she left a voicemail at the clinic and it was received on 5/4/18 regarding still having sharp pain to R arm, that was keeping her up at night. I then referred the message to Dr., our clinic's medical director, who then returned the client's phone call. When he spoke with her on 5/4/18 at approximately 9:30 AM she stated she had been seen at Medical Center by Dr., and was given Prednisone for her R arm pain which is helping. She told him as of today her R arm is feeling better and still denies any redness or swelling to that arm. Dr. did tell her she may be allergic to the Pertussis part of the Tdap vaccine and recommended getting Td vaccine from now on, however it is impossible for us to know for sure which vaccine caused the R arm pain, as she received two vaccines in that arm.
Patient developed a large 3-4 inch diameter redness around the injection site and complainted heavily that her arm was so sore and could hardly move it.  Adverse reaction stayed localized within 3-4 inches of the injection site.
About 5 minutes after receiving vaccine pt said she had intense itchiness and her chest was heavy and she was having a little difficulty breathing. RPh gave 50mg of liquid diphenhydramine for reaction. Patient rested about 20 min and felt better.
Inappropriate route of vaccination; Painful arm lasting more then a week; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received Shingrix (subcutaneous). On 5th October 2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In October 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist called and reported that she administered the Shingrix on right arm. She recalls that she gave it intramuscular but the patient claimed that they received the vaccine subcutaneously. She stated that she did not know if she did inadvertently give it subcutaneously, which led to intramuscular formulation administered by other route. The patient had painful arm lasting more than a week. The pharmacist would be following up with the patients. She also stated that GlaxoSmithKline can contact her if there are any additional questions. This case linked with US2019AMR190688, reported by same reporter.
Funny feeling in face numbness in face & jaw heart pounding lightheaded (L) sided chest tightness shooting pain in head depression w/all of this. Symptoms are intermittent. Heart pounding, lightheadedness, (heart) chest tightness all have subisded 1/25/11 face, jaw numbness are intermittent 1/25/11.
Injection site pain; induration and hardness upon palpation; This spontaneous report has been received from a nurse prescriber referring to a 17 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R000303 with expiration date of 29-AUG-2020, (strength, frequency, route, and anatomical location were not provided) for prophylaxis.      On an unknown date, the patient developed injection site pain and induration and hardness upon palpation, which lasted for one month. At the reporting time, outcome of injection site pain and induration was reported as resolved. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R000303; expirationdate: 29-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose and route were not reported), which underwent supported temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-NOV-2014, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
slow heart rate, since I have had vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE DECREASED (slow heart rate, since I have had vaccine) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE DECREASED (slow heart rate, since I have had vaccine). At the time of the report, HEART RATE DECREASED (slow heart rate, since I have had vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes back. Today in office it was indurated slightly. Reports on and off flushing and body aches that are new- feels like a toothache
This infant has urticaria / hives at 24 hours after taking Prevnar #1 dosage. Lasting for 4 days; severe so Prednisone started for 3 days resolved on Prednisone and 24-36 hours resumed. 2nd Prednisone started 03/23 and rash resolved 03/26. Completely gone 04/05/01.
not yet received the third dose; Drug dose administration interval too long; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on October 2017).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. In MAR-2018, the patient received the 2nd dose of Twinrix. In MAR-2018, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: not yet received the third dose).  The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2023 The pharmacist declined to provide details on the patient. The reporter was a pharmacist, reported a patient received the 1st dose of Twinrix October 2017, the 2nd dose March 2018,which led to the lengthening of vaccination schedule. Till the date of reporting the patient did not receive the 3rd dose, which led to incomplete course of vaccination. The patient did not consent to follow-up.
Fever 101.7 chills, nausea, malaise, injection site redness and swelling  Took 3 rounds of Advil, rest  and hydration  2 days later still malaise , no fever
Approx. 3 hours after receiving my flu vaccne, my left arm started to get stiff and sore. Knew this was normal, so I took Tylenol and applied an ice pack. Pain only worsened and did not go away. On 10/26/2009, I saw a dr. who prscribed Prednisone. I took that for one week and the pain went away, but returned when I tapered off the meds. Went back on Pred for another week, but again pain returned when finished with the meds. The pain is so bad I can't sleep at night, and it throbs all day long. Saw Dr. again and he diagnosed Myositis, and said I will need physical therapy to keep my shoulder from encapsulating and losing all range of motion. As of now, my range of motion is very limited and if I don't use my arm, it will freeze permanently due to scar tissue formation.
Felt a nodule in my supraclavicular lymph node  on my left side 5 days after receiving my 1st vaccine.  Made an appointment with my physician and had an office visit on the 6th day after vaccine.  Physician explained he felt like it was a side effect of the Moderna vaccine that I had received and told me to keep an eye on it.
Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K00A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized for 20 days) in July 2020.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2020, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. Patient tested positive for Covid-19 test on July2020 and was hospitalized for 20 days. Treatment for Covid 19 include Monoclonal antibodies, Plasma, Redemsivir, and Dexamethasone.  No treatment information were given.   This case was linked to MOD-2021-436130 (Patient Link).
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 29-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
patient was inadvertently administered an expired Menveo vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA097A, expiry date 31st March 2020) for prophylaxis.   On 8th April 2020, the patient received Menveo. On 8th April 2020, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The Medical Assistant (MA) reported that on 8th April  2020, their patient was inadvertently administered an Menveo vaccine which was already expired on 31 March 2020. The MA reported that the patient experienced no issues.  The MA was transferred to GSK Medical Information for additional information. This case was considered as medication error without harm.
CHILLS; BODY ACHES; HEADACHE; Fatigue; TINGLING IN BOTH HANDS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling in both hands. On MAR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in both hands, and fatigue on MAR-2021, and chills, body aches, and headache on 08-MAR-2021. This report was non-serious.
Pfizer Dose 1 9/12/21 (lot NA) Pfizer Dose 2 10/29/21 (301308A) COVID Positive 1/17/22  1/24/22: Patient is a 69 male who presented to ED with a chief complaint of generalized weakness.  Patient tested positive for COVID-19 on 01/17.  He has been fully vaccinated against COVID-19 but has not received his booster. He reports insomnia for the past week. Ongoing decreased appetite and oral intake. He has a past medical history of COPD chronically on 2 L NC, anxiety, hypertension, chronic pain, and former tobacco user. He has a LUL cavitary lung nodule that was discovered back in July. He has had multiple hospitalizations since. CT guided biopsy on 11/5 showed necrosis and reactive fibrosis, acute on chronic inflammation but no malignancy.  Sputum cultures on 10/23, 11/4 and 11/6 were positive for aspergillus and the patient was treated with Zosyn, vancomycin and micafungin. He reports significant weight loss over the past months, approximately 40 lb. He has decreased appetite and oral intake. No recent fevers, nausea, vomiting or diarrhea.  He was seen at HC on 1/13, advised to stop IV antibacterials and consider low dose azithromycin and repeating imaging in a few months, if no improvement repeat biopsy. Additional recommendations were to collect more sputa for AFB to exclude missed NTM and repeat blood work for histo AG, galactomannan, and fungal antibodies.   On arrival to ED patient was hypertensive 151/90. Laboratory findings were significant for CKD stage G 3A BUN 39 and creatinine 1.51.  Transaminitis AST 52 in ALP 252. ProBNP 1393. CT chest small thrombus in left upper lobe pulmonary artery.  Slightly increased size of the back wall cavitary lesion in the left upper lobe, most suggestive of aspergilloma.  New multifocal airspace disease most prominent in the lung periphery.  1/28/22: Patient was admitted for shortness of breath, CT pulmonary angiogram showed small PE, also has changes consistent with aspergilloma from before.  Patient was started on anticoagulation with Eliquis.  Patient was hemodynamically stable.  Also patient was diagnosed with COVID before.  Patient was asymptomatic from COVID. Patient was seen by Pulmonary and Infectious Disease specialist. Advised to continue with micafungin till May 22nd as prescribed.  Patient remained hemodynamically stable.  Patient continued on micafungin. On Eliquis which patient is tolerating well.  Patient discharged home today.
Patient received the flu vaccine in left deltoid on 9/22/2009. On 9/24/2009 patient developed a local blistering rash diagnosed as an allergy to the flu vaccine by Dermatologist and Allergist. Patient recovered with hyperpigmentation in the area.
shaking chills for about 1 hr (10-11PM); 1240AM on 18NOV t102.9; took 1 extra strength APAP; 225AM temp 101.5, 415AM 99.4; pt awoke w/swelling lt lower leg, tenderness inner calf (takes lasix); calling MD today re leg;
reported by pt on 7/22/99 states had a bad rxn, T100 1/2hr p/dose of APAP;c/o feeling feverish joints hurt, hip & knees, can't put pressure on legs-calves et muscles hurt;
Pt's arm became sore, swollen and red on 9/28/00. Pt did not develope fever. Encouraged to come to office to be examined. Pt unable to get transportation. Called pt on 9/29/00 and arm was less swollen and red and the pain was completely gone. Condition is improving on date this form was filled out.
Hives, swelling on face, itching approximately 5 min after injection. Hives around MMR injection site. Rash on arms and back. Epinephrine .2cc administered to arm. BP 104/60. Symptoms began to subside within approximately 5 min. BP taken again 102/60. Patient released in care of parents at 5:00 pm with no symptoms.