chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and swelling at DTaP injection site with heat, redness and severe hives. Oral Benadryl giving immediately and hives improved within 15 minutes. Hives never fully resolved until 10-11 days later. Patient had to recieve oral Benadryl every 6-8 hours during this time. A mild temperature (never exceeding 101.5deg) happened 24 hours after the vaccine and lasted 2 days. Only the DTaP injection site had this reaction. The other 3 vaccine injection sites were normal.
Inability to sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (Inability to sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LISINOPRIL for an unknown indication.    The patient's past medical history included No adverse event (No Medical History reported). Concomitant products included METFORMIN, TRAMADOL and TRAZODONE for an unknown indication.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On an unknown date, the patient started LISINOPRIL (unknown route) dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headaches and headpains started 36 hours after the shot and lasted over 3 weeks
This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 year old female pt who received lyme disease vaccine recombinant (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unk time after receiving Lymerix, the pt experienced fatigue,arthralgias, headaches, and loss of concentration. Time to onset, treatment, and outcome were not reported.
Fever 100 degrees fahrenheit, joint aches, fatigue. 8 hours after onset took 2 ADVIL ibuprofen. Symptoms subsided for 8 hours then took 2 more Advil. Symptoms subsided and 3 hours later felt symptoms disappeared.
Headache, Muscle aches, and Fatigue for about 24 hours. I also had pain at the injection site for a week. I self treated at home with Tylenol.
This spontaneous report as received from consumer concerning her 13 year old grand daughter with no pertinent medical history and no drug reactions/allergies who on an unspecified date when she was a child was vaccinated with a dose of VARIVAX (Merck) (route and lot# not provided). The consumer stated that her grand daughter developed shingles over this past weekend on 12-JUL-2012. Her grand daughter came down with a rash around her neck, face, ear and eye and first it was thought to be impetigo and was prescribed antibiotic (unspecified) by her family physician, but her symptoms did not improve and came down with more rash. Her grand daughter was taken to a dermatologist and was diagnosed with shingles and prescribed an antiviral medication (name unspecified). As of today 17-JUL-2012, the patient's condition was improving with no new rash appearing. At the time of the report, the patient was recovering. The patient sought medical attention. The relatedness for shingles is unknown for (Merck) VARIVAX. Additional information has been requested.
did not feel 100 percent; typical sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 06Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing); "immune suppressed" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EL9263), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent"; BNT162b2 (Dose 2, Single, Lot: EN6201), administration date: 15Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "typical sore arm"; MALAISE (non-serious), outcome "unknown", described as "did not feel 100 percent".  Additional information: The patient had a typical sore arm for 48 hours and did not feel 100 percent but felt ok and had nothing major.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, same event, different dose;US-PFIZER INC-202300215226 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Patient is a 69 y.o. female patient of local MD with history of COPD with previous use of oxygen at home, tobacco use disorder, hyperlipidemia, presented to Hospital with shortness of breath and found to have COVID-19 virus infection.   Acute Respiratory Failure with Hypoxia and Hypercapnia  Initially on BiPAP ; weaned down to nasal cannula 4L Last VBG 7.26/56.5/30 on high flow 30/50 Continue to wean off O2 as tolerated to baseline 3L DuoNebs as needed. Improving   Covid-19 Virus Infection with pneumonia Date of onset of symptoms: A week ago Symptoms present on admission: Shortness of breath Date of covid positive test: 1/13/2023 Vaccination status: vaccinated Imaging: CT pulmonary artery; no evidence of pulmonary embolism.  Multifocal pneumonia in the lingula and lower lobes Oxygen requirements on admission: BiPAP Current oxygen requirements: 4L NC. Used 3L at baseline  Continue to wean to 3L baseline. Feeling much better. Medical therapy: steroids. Abx stopped. Consultants following:  eID Incentive spirometry, inhalers. Encouraging proning as tolerated Medically much better, ok to dc today once back on 3L baseline O2.   Suspected PNA CT chest as above, PCT wnl. Ok to stop abx, await ID recs   Hypertension Continue home toprol and cardizem. Stable BP   Tobacco use disorder, dependence moderate Spent 5 minutes counseling patient on cessation   Pulmonary nodule, solid 8 mm in size Recommend CT in 6 to 12 months   Hyperlipidemia Continue home simvastatin   History of rib fracture Subacute right lower lateral rib fracture noted on x-ray Continue to monitor   Anxiety Disorder Benzo dependence Chronically on Xanax, resumed
30 minutes after administration of flu and pneumovax vaccines both into left arm, patient began to feel achiness in the left arm and took 2 Advil at 5:30 pm. She then began to feel nausea, itchiness on shot site, chills and throbbing headache of pain level 7 so she laid down. Began to feel heat in her left arm. A friend stayed with her through the night during which time the patient experienced fever and chills until 3:30 a.m. Late evening on 9/14, patient called 911 and was transferred to a hospital. This hospital sent the patient to call another hospital who transferred her from one extension to another and the patient never spoke with anyone who could help her and no emergency team or transport was sent to her. On the morning of 9/15 around 11 am the patient and her friend walked to a nearby physician's office. Doctor diagnosed the patient with cellulitis that is spreading. The doctor prescribed Avelox 400mg.
Patient received 2 doses of  Sinovac  1st dose 3/4/2021 and  second dose on 4/7/2021 and on 8/8/2021 she receive 1 dose of Pfizer
Breathing, leg pain, stomach pain, walking, talking, etc. Diagnosed with Guillain-Barre Syndrome
severe local reactions with pain/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; redness at site/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; Low grade fever/low grade temps like 100-101; fatigue; myalgias/generalized myalgia; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is 3rd of 3 reports.  A 16-year-old patient of unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. The patient had no medical history. There were no concomitant medications.  The patient had significant systemic reactions to his/her first dose of meningococcal group b rlp2086. The patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The patient was tested at the time of the reaction and was COVID negative. These reactions all occurred in the last week (Aug2020). The physician considered the events to be serious (medically significant). The patient had recovered completely in Aug2020. The physician considered the events to be related to meningococcal group b rlp2086. The information on the batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the 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.,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020314784 same reporter,suspect drug and adverse events in different patient
Patient received RSV vaccine and during her 15 minute post vaccine waiting period she felt dizzy. Patient was asked to stay seated and when I checked back in within 5 min she stated she felt fine. She stated she could have been dizzy because she didn't eat or drink anything this morning before the vaccine. She refused any further assistance or treatment.
Heavy debilitating painful period came earlier than usual 8 days after shot.; Heavy debilitating painful period came earlier than usual 8 days after shot.; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 14-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 16:00 (at the age of 14-years-old), (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was not tested positive for covid 19 prior and post vaccination. On 03Jun2021 the patient experienced heavy debilitating painful period came earlier than usual 8 days after shot. Patient did not receive other vaccine in four weeks. Patient did not received treatment. prior vaccination and post vaccination patient did not test for covid. The outcome of the events was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 5/1/2023 RECTAL CANCER
The pt received PNEUMOVAX in L-should and flu shot in the morning (10/3) and experienced headache that evening. He woke the following day with chills, nasal congestion and that evening was febrile to 101.5 and noticed swelling, pain and redness of his left shoulder where he'd received the PNEUMOVAX. Vancomycin 1 gm once.
This spontaneous report has been received from a registered nurse via company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with GARDASIL (route of administration, lot#, and expiration date were not reported) for prophylaxis. The reporter stated that on an unknown date, the patient could had experienced neurological side effects. At the time of reporting, the outcome of neurological side effects was unknown. The relatedness between the neurological side effects and GARDASIL, was not provided. Additional information is not expected no reporter details were provided.
red area to Rt thigh, hot to touch ?oozing-to ER-Dx-Cellulitis, started on Keflex and topical
Body aches/muscle aches starting about 12 hours after injection. Resolved by 100mg Tylenol. Woke up achy again, took another 100mg Tylenol at 9AM.
Sore arm all the way to wrist, constant pain on left side of neck up to bottom of my ear, constant pain in left shoulder blade,  constant pain at injection site
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a medical center (considered a hospital) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at the same medical center (not specified whether admitted; considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe 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. Causality assessment was related. Additional information has been requested.
Day of vaccine 4/6  2:45 PM Fuzzy feeling in head causing feeling of off balance, light headache. Injection site pain. 5:00 PM Tiredness Next day, 4/7  12:00 AM woke up with extreme back pain and chills.  8:00 AM nausea, no vomiting. Nausea subsided by 11 AM. Chills went away by 4 PM. Back pain and other aches continued through the day. Shot sight pain made it hard to raise arm. Extreme fatigue but body aches made it hard to sleep. 7:00 PM Severe headache with sensitivity to light. Went to bed at 8:00 PM, woke up several times in the night sweating and with pain in back (spine). 2 days after, 4/8 6:00 AM woke with extreme pain in left arm pit area. Injection sight still very sore. Moderate headache and back ache continues, though both significantly better than day before. Fatigue continues.
Severe to moderate headache, fever (unknown first night and feverish feeling since), large joint and abdominal pain, very fatigued, thirsty, increasingly redness and tenderness at 8njection site and surrounding area over the past 2 days.
sore throat; stomach is bothering him; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a male Patient (Reporter son)  A 13-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced sore throat and stomach is bothering him on an unspecified date. The reporter considered the events as non-serious. The clinical course reported as follows Consumer said her 13-year-old son already received the 1st dose and was supposed to get the 2nd dose today. However, he was feeling a little bit under the weather. He has sore throat, and his stomach was bothering him. Consumer would like to know if he can push with getting the 2nd dose next week, which would be 4 weeks after his 1st dose, and if it would still work. Consumer said she is not sure if her son was exposed to someone who has Covid. For this, she will have him tested. She wants to know if she should postpone his 2nd dose until he is feeling well and has tested negative for Covid. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Patient states medic gave him 2 shots. Medic state that when patient informed him he already received vaccine, she withdrew the needle without administering the vaccine. Patient observed for 30 minutes without reaction.
Patient stated she is having severe pain in her right hip and leg, and it may be due to the vaccine. She received the vaccine in her left deltoid.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is the 1st of 2 reports (reporter's son). A male patient of an unspecified age and ethnicity received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swelling, extreme pain and limited arm movement, all on an unspecified date with unknown outcome. The events required a stay home from school on the next day. Follow-up (08JUL2016): Follow-up attempts are completed. No further information is expected.
Initially mild soreness at time of injection (9/25) then worsened x3 days. Eased, but then onset of pain with arm/shoulder movement/use on 10/4/20 (9 days after injection).  Patient states she believes that injection was given "too high" in her arm.
Information has been received from a pharmacist concerning a female patient in "late sixties" with no allergies or medical history who "last week" on approximately 11-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 663882/0133Y) SQ.  There was no concomitant medication.  Subsequently the patient developed a painful rash after administration of the vaccine.  The pharmacist suspected that it was zoster but had not seen the rash yet.  The pharmacist was not interested in VZV Analysis by polymerase chain reaction (PCR).  No diagnostic laboratory tests were performed.  The patient had sought medical attention via pharmacist.  The patient's painful rash persisted.  Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was very nervous/anxious upon arrival. Shortly after the vaccine was given he became unresponsive and unconcious. 911 was called. Patient became responsive minutes later. Patient became unconcious for a second time while EMT was present. Patient was taken to the hospital.
10-23-15 vaccine administered. 10/24-10/28 complains of occipital headache, neck pain, under arm and groin pain reported as "hot and painful" 11-28-15 reports severe confusion lasting approximately 2 mins.
Muscular pain x 3 weeks to bilateral shoulders/deltoids that began 1-2 days after the second dose of Moderna vaccine
Swollen lymph on side of vaccination that lasted for a week from 3/29-4/4, also vertigo occurring from 3/31 to present. Patient (self) has never experienced either of these conditions prior to the vaccination.
Pain in the arm pit of the arm  vaccinated, painful to sleep with tired feeling next morning.  Took Aleve which minimized the pain.
On February 28th her right ear felt like it is filled with water or something. She can barely hear on her right ear and it feels like it's popping a lot. Her ear has been in a lot of pain and aching. Feel like her ear is damaged.
Red itchy  "rash" on underside of right arm.  3 days after 2nd covid19 Moderna injection. Slightly elevated heart rate over normal?
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm, swelling at injection site0size of Palm. To ice it and take Tylenol. warm to touch.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-APR-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX subcutaneous injection, lot number M015731 with expiration date on 30-MAR-2018 (strength, dose and anatomical location were not reported) for prophylaxis with sterile diluent (lot number M041812 with expiration date on 17-MAY-2019. No adverse effects were reported.
11/09/2021: low grade fever and myalgias 11/12/2021: into Urgent Care as symptoms worsened; loss of voice, rhinorrhea, dry cough, sore throat, intermittent low grade fevers that would subside with antipyretic; given Augmentin BID X 10 days, flonase and received a steroid shot in office. 11/16/2021: fever and tachycardia remain, fatigue, shortness of breath.
Extremely swollen and sore arm 1 day. Lethargic, sniffly, major headaches, aches and chills lasting 5 days.
Information has been received from a pharmacy technician concerning her 18 month old son who was vaccinated SC with MMR II (lot # not reported). Subsequently the patient began experiencing swelling in his hip and joint pain. Also he could not walk for two months after receiving MMR II. The reporter thought the status of the patient improved but she was "not positive". The patient saw a rheumatologist. X-rays and ultrasounds were performed, results not provided. Swelling in hip, joint pain and can not walk for two months were considered to be disabling by the reporter ("sounds like it"). Additional information has been requested.
pt recv vax 16JAN96 & 4hr p/vax pt devel a fever & was treated w/APAP;pt recovered that evening;
Immediately after injection, I became light headed, clamy, increased heart rate, tingles over entire body and loss of hearing.  After a few minutes the symptoms decreased.  The tinkling feeling jn the fingers lasted longest. After 15 minutes the symptoms had ended.  The pharmacist kept me there for over 30 minutes for observation.
Patient was administered Havrix brand Hepatitis A vaccine, 1.0 ml in the right deltoid, at approximately noon on Tuesday, June 3, 2003.  At 5 PM, she called the office complaining of a red, blotchy rash on her chest, neck, and upper arms (bilateral) which first appeared around 3 PM.  She took Claritin and later reported to the ER due to the appearance of mild chest pain and shortness of breath.  She was administered Benadryl by injection with mild improvement of symptoms and discharged.  Her symptoms of blotchy, swollen, red, pruritic rash on her face, neck, arms back, and abdomen continued the next morning and she was advised to take oral Benadryl pending resolution.  She reports no rash below the level of the umbilicus.