chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; DAMAGED THE LUNGS; This spontaneous report received from a consumer concerned a 77-year-old male. 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, and batch number was not reported, expiry date: unknown) dose was not reported, 1 total administered at  left arm on 15-APR-2021 for COVID-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 76 years old. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient got COVID (suspected covid-19 infection), and was hospitalized for 10 days on an unspecified date in 2022 for which patient was in physical therapy and had to retire from his job. He also stated that when he got COVID, it knocked his oxygen level down and damaged his lungs. He stayed on oxygen all the way until OCT-2022. Patient stated that it had nothing to do with the Janssen shot. Laboratory data included: Oxygen saturation low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and damaged the lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230320386. Sender's Comments: V0-20230320475-Suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  V0-20230320475- Damaged the lungs. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
The patient was sick with a fever (over 105) and chills, body aches, night sweats, loss of appetite, headache, and painful eyes, followed by what feels like a kidney stone, bladder infection, and diverticulitis.  Worsening of ADHD and OCD.  Phone call with provider office & received no assistance. The person on phone hung up on her.
Left thigh red, swollen and firm. Area 5" long and 9" wide across left upper thigh. Nontender. No lymph node enlarged. Slight limp with ambulatory.
Information has been received from a physician and her office manager concerning a 19 years old female with no drug reactions and a history of anemia and ulcerative colitis which began at age 17 years who in July 2007, was vaccinated with the first dose of GARDASIL. In July 2008, the patient had a Total Colectomy and was hospitalized. In October 2008, the patient had J-Pouch surgery and on 05-JAN-2009, had "reversal" surgery. On 25-JUN-2009 (also reported as April 2008), the patient was seen in physician's office and received the second dose of GARDASIL (lot # 660616/0570X). At the time of reporting, the patient had recovered. Total Colectomy, J-Pouch surgery and "reversal" surgery were considered to be other important medical events, disabling and life-threatening. Follow up telephone call was made to the physician, and was transferred to the Office Manager. The Office Manager was not able to confirm that the patient's surgeries (Total Colectomy, J-Pouch surgery and reversal surgery) were related to a worsening of ulcerative colitis. Additional information has been requested.  7/7/09 Spoke with mother-emphatically denied that symptoms were related to HPV4, patient has a long history of colitis and does not want any follow-up on this report.
Diagnosed with prostate cancer in 2020 prior to vaccinations.  Error in reporting adverse event as preexisting condition.
my hot flashes disappeared/from the time the reactions began/ did not reappear for 1-3 days after symptoms disappeared; This case was reported by a consumer via other manufacturer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for covid-19 prophylaxis.   Concurrent medical conditions included hot flashes.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.  Additional details were provided as follows: The patient reported case for him/herself The age at vaccination was not reported. The patient reported that, a few days after receiving both the Shingrix and the Pfizer Covid vaccinations, the hot flashes disappeared. The patient had moderate reactions to both vaccinations that lasted 12 and 36 hours respectively. The patient reported hot flashes disappeared from the time the reactions began and they did not reappear for 1 to 3 days after symptoms disappeared, which led to unexpected therapeutic effect for Shingrix and Pfizer Covid vaccinations . The patient requested if GlaxoSmithKline could find the correlation and eventually provide a permanent treatment for hot flashes. The patient consented to follow up.
This case was reported by a nurse via sales rep and described the occurrence of injection site redness in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness and injection site warmth. On an unknown date, the outcome of the injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the injection site redness and injection site warmth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The nurse sent out an email stating that she had at least 8 staff member that had local adverse reactions (redness and hot to the touch at the injection site) to FLUARIX QUADRIVALENT. The reporter did not have any additional details.
extreme fatigue; chills; sweats; Diarrhea; Nausea; loss of appetite; mild temperature/ temperature spiked to 103.4/temperature hovered around 100.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FK5618) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Vaccine Name: Pfizer Covid Vaccine, Lot Number: FK5127, Expiry Date: 31Jan2022, Anatomical Location:  Left arm, Time the Vaccination Was Given: Both first and second dose appointments were at 1445.), administration date: 12Nov2021, when the patient was 7 years old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: no". The following information was reported: PYREXIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "mild temperature/ temperature spiked to 103.4/temperature hovered around 100."; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (11Dec2021), described as "extreme fatigue"; CHILLS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "sweats"; DIARRHOEA (non-serious) with onset 05Dec2021, outcome "recovered with sequelae" (10Dec2021), described as "Diarrhea"; NAUSEA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "Nausea"; DECREASED APPETITE (non-serious) with onset 05Dec2021, outcome "recovered" (12Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was reporting her daughter received the second dose Pfizer Covid Vaccine and had a pretty severe reaction. The next day, 04Dec2021, had just a mild temperature, the temperature went down on 06Dec2021 and the temperature hovered around 100. Caller states the physician strongly encouraged the caller to report the patient's event. The caller wanted to be a good citizen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
9/14/2020: Mother noticed onset of dermatologic after school aroudn 2 pm, reports hives on left ear, neck, back, and elbow. Associated itching and clear fluid filled lesions "large pimples" at left ear and left face; puffiness under left eye. Treated with oral Benadryl and calamine which helped. Advised by after hours clinic provider to go to urgent care. Mother brought patient to urgent care, decided to leave due to long wait so was not evaluated or treated. Denies any fever, respiratory, behavioral, mental status, or musculoskeletal changes. Symptoms nearly resolved at time of report per parent.
No known adverse event. No known bad outcomes as of the date of this report. Vaccine administration error.  Patient was intended to receive Moderna "bivalent" 0.5 mL booster dose; received Moderna "monovalent" 0.5 mL dose in error.  Vaccinating nurse did not readily distinguish between the similarly colored Moderna monovalent vial and the bivalent vial.  Did not notice the lack of "bivalent" labeling/grey colored strip on front of monovalent vial/purple strip on front of vial.  Both vials have same blue cap.
Pain, crying for hours. Redness on arm. Lost more language. Ceased developing communication and social skills. Doctor would not see her, was requested.12/14/07-records received for DOS 5/20/02-6/20/05-include well and sick visits.Fever times 2 days, cold symptoms with frequent stools on 9/29/02-Congested, fever vomited on 1/12/03-. Vomiting and increased fatigue on 2/13/03. Achieving milestones 6/20/03. Fever vomiting and shaking 6/26/03. Drooling, fever runny nose congested 10/14/03-upper respiratory infection.
Patient came in for Bivalent and we gave her the Monovolent dose on accident.
On April 19, 2021, I noticed complete numbness on right side of my face, above my lip and up through my nose, right eye and head. After several days, I contacted my primary care physician.  She was concerned I may have suffered a stroke so on Friday, April 23, she sent me for a CT Scan at Imaging.  The results of the scan were negative for a stroke.  However, my PCP asked that I see my neurologist as soon as possible which was Thursday, April 29th at 10:15 am. A Neurologist sent me back to Imaging for an MRI.  The MRI also proved negative for stroke and confirmed my brain tumor was staying the same size.    I still have numbness in the right side of my face, eye and head.
Itchy rash over whole body, swollen nodes,  submandib and left occipital. Erythema to site of injection left tricep and elevated hot to touch. SS onset 05/06/2005 then worse over weekend. Pt denies SOB. TX Zyrtec 1 PO QD, Benadryl 1 QHS and FU with PCP if worse.
Mother called health dept. about child having elevated temp of 102 and uncontrollable shaking for 3-4 hours after receiving the flu shot on 10-22-08 . Took the child to the Dr. on 10-23-08 and Dr . instructed mom to not get the child the second flu shot this season since this was probably a reaction to the flu vaccine .
pt recvd vax & 10OCT95 pt again exp pain @ inj site & 4cm red, hot area @ inj site;pt recovered
Narrative:  77 year old MALE with PMH of metastatic adenocarcinoma of the rectum (stage IV) on chemotherapy, peripheral neuropathy, and COPD. Pt presented to ED on 06/09/22 w/ 2 days worsening hemoptysis in setting of persistent right-sided pleural effusion and pneumothorax. Pt reports shortness of breath has been going on for several months, however progressively worsened approximately 2 days ago. Pt w/ increasing fatigue, dyspnea on minimal exertion and increasing productive cough with noted blood-tinged sputum. Pt admitted to hospital on 06/09. Pt tested negative for COVID 19 on 06/09. Pt tested positive for COVID 19 on 06/10 and transferred to ICU due to Afib RVR. Pt received remdesivir (06/13-06/16). Pt converted back to SR on 06/13. Pt stable and discharged to home w/ hospice on 06/16.
entire body hurt stopped after two days; all bones hurt stopped after two days; all joints hurt stopped after two days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (entire body hurt stopped after two days), BONE PAIN (all bones hurt stopped after two days) and ARTHRALGIA (all joints hurt stopped after two days) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Current medical history includes prediabetic, overweight , Knee hip and back problems  and Hypertension ,as provided by the patient.  Concurrent medical conditions included Pre-diabetic, Overweight, Back disorder NOS (Knee hip and back problems) and Hypertension. Concomitant products included CELECOXIB (CELEBREX), Metformin HCL ER, AMLODIPINE BESYLATE, LOSARTAN POTASSIUM, OMEPRAZOLE MAGNESIUM, FENOFIBRATE, ATENOLOL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (entire body hurt stopped after two days), BONE PAIN (all bones hurt stopped after two days) and ARTHRALGIA (all joints hurt stopped after two days). At the time of the report, MYALGIA (entire body hurt stopped after two days), BONE PAIN (all bones hurt stopped after two days) and ARTHRALGIA (all joints hurt stopped after two days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil. Subsequently, after vaccination, the patient developed Guillain-Barre syndrome and was hospitalized. It was reported that the patient "recently had plastic surgery and is now in rehab." The patient's outcome was unknown. Additional information has been requested.  4/1/08 Received only partial medical records of 5/23-6/04/2007. FINAL DX: Guillain Barre syndrome. No d/c summary available.  Records indicate patient experienced 2-3 days of neck & back pain & tingling in his legs followed by weakness which became profound until patient fell & was unable to move either leg, also had weakness of both arms along w/facial numbness.  Had HA, cough, runny nose & sore throat & recent dx of URI tx w/antibiotics.  Had nausea x 1 wk & difficulty voiding & swallowing.  Had brief episode of diarrhea 1 week prior.   Was on business trip from out of state.  Admitted to ICU.  Neuro & pulmonary consults done.  Exam revealed hyporeflexia.  Tx w/plasmapheresis.  Developed N/V.  Feeding tube placed.  Transferred to inpatient rehab w/foley cath.  5/6/08 Received hospital medical records of 6/4-7/11/2007. FINAL DX: Guillain-Barre syndrome; neuropathic pain; debility; asthma; dysphonia.  Also developed URI; UTI; hypersensitivity vasculitis, all resolved. Records reveal patient experienced improvement during this rehab hospitlization.  Improved to be able to ambulate w/walker.  Continued to awaken at night w/leg spasms & have erectile dysfunction.  Transferred to another rehab hospital.  This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up Information has been received from two physicians concerning a 56 year old sexually active male homosexual (previously reported as female) with a "questionable" history of illicit substance abuse. At the time of this report, the patient was recovering. Additional information has been requested.
Pt devel t102ax 13JAN92 1130PM; p/tepid bath & APAP, pt went to sleep; 14JAN92 @ 1100AM pt started shaking, screaming & lips turned blue; Mom noted red rash on chest & arms; to ER t104.4 R; ER MD gave APAP; ears sl red; Rx Ceclor; Left ER;
The day after i got my 2nd dose of the vaccine, my whole body ached my head was pounding i didn't eat anything really but i did keep hydrated, and i slept most of the day and i had cold chills. but it only lasted 24 hours, i feel better now.
Woke up a little stiff in neck and shoulders. Went to spin class @9:30 by 10:10 felt lightheaded, about to pass out, lightheaded until 10:30 end of class.  10:50 on my way home heart monitor was up to 240 for about 10 min on ride home.
Patient called the pharmacy on 10/14/23 and said she was experiencing eye pain that began shortly after her two immunizations on 10/12/23 and continued until today. She did not describe them as very painful, but said she could feel pressure in her eyes. I instructed her to go to an urgent care/er immediately to have a doctor examine her.
Administration Error:  Pt reported never receiving a COVID vaccine. He was given a dose of Pfizer and an incentive. When his data was entered it was discovered that he received a dose of Janssen on 3/9 at another location.
From initial information received on 8/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 57 year old female patient received a third dose of TD ADS ADULT, lot number U1025AA, administered IM in the left deltoid on 7/29/04. Later that same day, the patient's left arm was sore. Two days alter, she experienced redness of the site of injection. The patient's left arm continued to be sore and on approximately 8/4/04 the patient started to experience a burning and tingling sensation from the left shoulder to her finger tips and the arm felt hot at the injection site. The injection site was red with a 4cmx3cm area of induration. The patient's recovery status was reported as unknown. From additional information received on 9/24/04 from a health care professional, it was reported that the patient's physician stated that the adverse event appeared to be cellulitis at the injection site. He also reported that the patient works at a nursing home and that possibly the site was not cleaned well at the time of vaccination. The physician stated that he thought the reaction was vaccine related. The patient's recovery status was not reported. From additional information received on 10/13/04 from the patient's physician, it was reported, "No new information. Patient never followed up. Uncertain whether the infection was vaccine related, but rather I expressed that infection may have been introduced at time of the injection. There definitely was cellulitis developing around the site that resolved (apparently) on Biaxin XL 500mg daily for seven days." No further information is anticipated, this case is considered closed.
Patient broke out in welts all over the body, patient took Epsom salt bath and did not help they are getting bigger, size range from pin point to eraser
Patient presented to pharmacy with husband for a BOOSTRIX shot and was given a FLUZONE HD vaccine in error. No treatment necessary or adverse effects noted by patient.
Hospitalization: 12/28/2022 - 12/31/2022 (3 days) Presentation to the ED: generalized weakness COVID + date: 12/28/2022 Treatment: Remdesivir & oxygen therapy.  Discharge to: home.   006B21A 3/26/2021 039B21A 4/23/2021 037F21A 11/29/2021
On 6/19/00, the pt awoke with painful knees and quadracepts; Feldene did not seem to alleviate the pain. His leg muscles got very weak and he awoke on 8/9/00 with left hip joint aching. By 8/30/00, the pt's leg muscles were withering and Celebrex was not helping. Starting on 10/3/00, the pt developed pulsing pain in right hip and knee. He started using a cane and now his left leg below knee hurts and the left side of his jaw is hurting.
Rash all over her body; For 3 days her period stopped but then it started again, she is having her period almost everyday; severe cramping; Headache; severe cramping; period every other day; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MUSCLE SPASMS (severe cramping), MENSTRUATION IRREGULAR (period every other day), RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday) and the second episode of MUSCLE SPASMS (severe cramping) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced the first episode of MUSCLE SPASMS (severe cramping) and MENSTRUATION IRREGULAR (period every other day). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday), the second episode of MUSCLE SPASMS (severe cramping) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Cramps, at a dose of 1 dosage form. At the time of the report, MENSTRUATION IRREGULAR (period every other day), RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday), the last episode of MUSCLE SPASMS (severe cramping) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable No concomitant Medication was reported by reporter.   This case was linked to MOD21-088826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received included second dose information and patient have more event after second dose like headache and rash all over her body
I had a fever on the same day as vaccination. Then on Sunday night my right foot felt weird. Then the next day it felt weird when I would wear shoes. On Tuesday I was limping by the end of day and by that night my ankle was swollen and then I went to the ER on Wednesday. I was prescribed an antibiotic, Cephalexin. It helped the swelling to go down. During that time I have also had rashes under both breasts and some along the spine and off to the left. I have been putting hot towels to soothe.
I had leg pain and hallucinations as well as flu-like symptoms for 24 hours. A month later, developed severe fatigue. In late June, I developed Optic Neuritis and continued fatigue. Muscle weakness. After my booster, I had low appetite for 2 months, severe fatigue and optic neuritis again. MRI showed a lesion formed and I was diagnosed with MS officially.
Patient's wife called today to state at about 1pm on Sunday after her husband received his second dose of Moderna (given about 10:45am), that the "side of his face dropped" and his "eye locked open" because he "couldn't blink". His face then went numb. The only medicine she gave him after was Tylenol. She said that on Monday morning he was a little better but by the evening he was worse with a swollen jaw in addition to the other issues. Tuesday they went to the doctor. The doctor gave a steroid shot and oral Prednisone 20mg bid for 7 days and also referred patient to a neurologist. Wife states that doctor's diagnosis was a facial stroke. Wife reports that he is still not much better today.