chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (Strength, dose, frequency and anatomical location were not reported) (Route defaulted to oral) of lot # R015607 with an expiry date of 21-APR-2020 for prophylaxis. There was no adverse effect reported. The ROTATEQ was exposed to a temperature below 32 Fahrenheit (29 Fahrenheit) for a timeframe of 1 hour 15 minutes. There were no previous temperature excursions. A digital data logger was involved. There was no product quality complaint associated with this report. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1812USA012134; US-009507513-1812USA012132.
I started off with a sore throat on Jan 28st. Then, got worst on the next few days. On Jan 31st, I went to my doctor and got tested for the Flu and Covid-19. I was negative for the flu. On Feb 2nd, I got my results back and I was tested positive for Covid-19. I then had a slight cough, headache, and congestive. These symptoms lasted for about a week.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) over six months after the third dose (extra dose). No adverse effects were reported. The physician confirmed that this event is a result of a human error and an issue with electronic records.
The following day developed hematoma, swelling, erythema and pain to R  upper arm At 48 hrs tenderness, erythema and swelling or area worse and spread to R shoulder /neck
This spontaneous report received from a patient concerned a 70 year old female. 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: unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced soreness while lifting arm. On 30-MAR-2021, the subject experienced minor nausea. On 30-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness while lifting arm on APR-2021, and was recovering from minor nausea, chills, and fever, body aches. This report was non-serious. This case, from the same reporter is linked to 20210410251.
Patient had a vasovagal episode. VS were performed: 0830 - 129/79, 59, 97.2, no pain; 0850- 126/74,60, no pain. Elevated legs. Patient given water, and juice. Pt recovered without difficulties. ER precautions given. Pt acknowledges and understands. Pt left facility without difficulties.
got a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vacination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient got a rash, exactly what Shingrix was supposed to avoid.
Lip swelling inside mouth - lower lip within 20 minutes after injection resolved within 24 hrs. No treatment needed.
Chills: Onset 19 March 2021 Fatigue: Onset 19 March 2021 Sore Throat: Onset 21 March 2021 Diarrhea w/Fecal Incontinence: Onset 20 March 2021
Tingling on left side of the body; Elevated blood pressure; Tongue began to swell; Facial tingling; Facial numbness; A spontaneous report was received from a physician concerning a 54-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and numbness on the left side of the body, elevated blood pressure, swelling of tongue, facial tingling, and facial numbness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Feb 2021, immediately prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (batch# unknown) for prophylaxis of COVID-19 infection.   The patient had an immediate reaction that resulted in tingling/numbness on the left side of her body as well as an elevated blood pressure. The numbness continued to her face/mouth and her tongue began to swell. After a short period of time, the tingling in the body subsided, but the numbness/tingling in the face persists. The health department where the patient received the vaccine attempted to call an ambulance, but the patient refused medical treatment.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of tingling on the left side of the body was recovered. The outcome of the events, elevated blood pressure, and swelling of the tongue were unknown. The events, facial tingling, and facial numbness were not recovered.; Reporter's Comments: Based on the current  available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax;  fever 103 9may95; 11may95 sz; seen at hosp; 13may95 fever of 104;
Patient brought to the ED by EMS on 11/26/22 for confusion; he has a history of glioblastoma. Additionally, patient has not been feeling well over the last couple of days and had a positive COVID test at home. Symptoms included fever and mild cough. Repeat COVID test done in the ED on 11/27 also positive. Ultimately, patient admitted on 11/26/22 - 12/1/22 for acute hypoxic respiratory failure due to COVID-19 pneumonia. O2 sats initially 88% on room air, during admission his max O2 need was 8L O2 via high flow nasal cannula. He was weaned off O2 for 24 hours prior to discharge.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with doses of an unidentified Merck HPV vaccine (name, lot number, dose, route, anatomical site of injection and frequency were not reported). It was reported that, on unknown dates, the patients experienced injection site pain. No product quality complain (PQC) was involved. At the reporting time, the outcome of the event was unknown. The reporter did not provide a causality assessment between the event and the unidentified Merck HPV vaccine. Additional information has been requested.
On evening of Jan 25th.  She asked me if it was weird that her eyes weren't blinking at the same speeds.  Her right eye was blinking slower than her left eye.  The next day at school she began experiencing loss of muscle control on the right-side of her face.  She lost taste in the right side of her tongue.  We went to the walk-in clinic where she was diagnosed w/ Bell's Palsy.  They provided prednisone and Valaciclovir
Patient stated after flu shot that his arm became tight and eventually had pain up his neck. Patient stated he visited E.R. and was later treated with medications listed in block 9. TX 4 Robaxin 500 mg Administered at 1430
Two years after receiving Anthrax vaccine was diagnosed with multiple sclerosis. 12/16/08-records received for DOS 9/25/07-PMH: developed hypothyroidism in January 2004, in 2005-2006 marked weight gain, fatigue and weakness. Hypogonadism and pseudo Cushings's syndrome (hypercortisolism). Presently stable, with some generalized fatigue, lack of energy and intermittent paresthesias in left side of face, trunk and back and noted left foot inversion.
Claims to have HA's after being notified vaccine was stored in freezer for 33 days.
Patient called pharmacy about 2 hours after receiving vaccination. She complained of SOB, chest tightness, and stuffy nose. Patient instructed to immediately contact physician. Patient is pregnant.
The day of the vaccine, Mom said the patient had a knot, swelling and pain. Mom reported she was treated in April for cellulitis of that area. She came to our office 05/17/22 complaining of fever, cold symptoms and a blister of the left thigh. Mom was advised to bring the child back if it drained for culture. No treatment at that time, but Dr. called hospital. On 06/30/22 patient returned to our office complaining of fever, cold symptoms and a blister. Cephalexin was prescribed by Dr. Patient was referred at ER and Allergy/Immunology at hospital. An Ultrasound showed an area of inflammation or infection. Dr. at hospital recommended treating with Ibuprofen and said antibiotics were not needed.  She said it sounded like a sensitivity reaction to the aluminum in the Kinrix. She recommended calling the CDC and the CDC recommended reporting to VAERS. The patient will see specialist on 07/25/22. The patient will see but that appointment is not set up yet.
This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010451: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010526: US-009507513-1707USA010528:
Patient got his first dose of covid vaccine and while sitting for 15 min for us to monitor him, patient fainted but regain consciousness after after few second and fully aware of situation. 911 was called but patient decline service
woke up today shaky; and felt like he was going to pass out.; This case was reported by a consumer via call center representative and described the occurrence of tremor in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received Shingrix. On 30th June 2021, 2 days after receiving Shingrix, the patient experienced tremor and felt faint. On an unknown date, the outcome of the tremor and felt faint were unknown.   It was unknown if the reporter considered the tremor and felt faint to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that, the patient received Shingrix vaccine and on a day of reporting, woke up shaky and felt like he was going to pass out. Initially reporter consented to follow up, however on 5th July 2021, reporter denied to provide further contact details.
Pt recvd vax 23OCT92 & the next day devel red sore & swollen area around the inject site which was 4cm in diameter;
Redness/swelling to leg (thigh). Tx: Cephalexin 250/5 10 ml q 12 hours x 10 days. Follow up 3 days.
Narrative :  Symptoms: Headache, Fever & NauseaVomiting  Treatment:
06/12- had DTaP, cried alot, developed fever up to 105 degrees. Gave Motrin, Tylenol alternating. Later that evening went to ER.
14 x 10 cm local reaction - red, hot to touch, painful. Taking Motrin every 6 hours. By that evening, pt was better.
2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral calf, left lower leg in the medial aspect, right tibial tubercle area, left medial knee, right distal forearm, left wrist underneath her watch, posterior olecranon processes, posterior proximal humerus bilaterally.  No bruises in the trunk, back, face or neck.  She started Plavix treatment with Cardiologist 12/28/20.  Cardiologist, Hospital physician.approved her to get the COVID vaccine.  She will call her Cardiologist and let us know what course of action resulted.  She could just be bruising from mild trauma that she is unaware of since Plavix is a new med for her.  States she does cross her legs when she sits and leans on her elbows.  Shoulder bruising seems to be where she lays when in bed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Negative; (08Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid from 26May2022 to 30May2022. Tested negative 02Jun2022 but started testing positive again today 08Jun2022. Some mild nasal congestion, but no fever. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 hrs after shot severe tendonitis & bursitis. Etodolac 2+ months til could not tolerate; then ibuprofen. 3 Dr. appts, 2 mos. PT repeated muscle strains. Considerable loss range of motion, chronic pain, weakness.
Patient got Janssen 3/10/2021; Moderna 8/17/2021; then Pfizer 11/08/2021.
After getting home, pt lost all control of his arms/legs and body, then blacked out.  Neighbor found him passed out in hallway and called ambulance to take to ER. Kept in hospital for 3 days. Patient still has problems with legs as of today not wanting to function
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX. The patient's past medical history included fibromyalgia (since 2006), arthritis (since 2012), shingles (in 8th grade), chickenpox and herpes zoster. Concurrent medical conditions included diabetes. Concomitant products included amlodipine, Furosemide, lamotrigine, Levothyroxine, Losartan, pantoprazole, Pravastatin, calcium, VOLTAREN, sertraline, etodolac, HUMALOG, TOUJEO and zafirlukast. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 14th April 2018, the patient experienced tiredness, shivers, sweating and swelling arm. On 15th April 2018, the patient experienced erythema of extremities. In April 2018, the patient experienced headache and skin warm. On an unknown date, the outcome of the pain in arm, skin warm and swelling arm were not recovered/not resolved and the outcome of the erythema of extremities was unchanged and the outcome of the headache was unknown and the outcome of the tiredness was recovering/resolving and the outcome of the shivers and sweating were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, tiredness, shivers, sweating, skin warm and swelling arm to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX at 1:15 PM on left arm. The patient reported that after receiving SHINGRIX, she experienced a hurt arm which was red, warm and swollen. She was tired after the injection and slept for 12 hours. The patient quickly mentioned headache at the beginning of the call but there was a bad connection and the physician forgot to inquire about her headache statement.
Couldn't move right arm/shoulder.  Went to primary care doctor ASAP.  She did not do any tests, was told it's possible it could be from the Covid 2nd vaccine, suggested I had shoulder impingement.  Two more weeks after that visit, I scheduled with my Pain Doctor and he examined, did an onsite ultra sound.  Determined fluid was in the shoulders and did steroid injections.  That gave me some relief for about a week and the pain returned.  Went through 18 weeks of physical therapy including dry needling to relief pain and bring some mobility back to my arms.  Nothing worked.  Ended up in the ER room in early July.  Was told by the Hospital ER doctor that everyone missed a step and that he believed I had Sirva or a frozen shoulder.  We tried to get Doctor to schedule and MRI and no one would return our messages.  We went back to Doctor and he requested xray's as well as an MRI to be done.  Completed MRI and per findings on MRI with Doctor, he suggested we go see Doctor to review/plan course of treatment.  I still could not use my arms and have become dependent on my daughter to care for me.  Today, I went to the Hospital per my visit with Doctor and have xray cortisone injections performed in both shoulders.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine and hepatitis B vaccine for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine on 11/3/97, 1/9/98, 3/30/98, and 4/21/98. He also received hepatitis B vaccine, haemophilus influenzae type B conjugate vaccine, oral poliomyelitis virus vaccine, and MMR. He received an unspecified tuberculin test on 9/28/98. The subject's attorney alleged that, as a result of mercury in thimerosal-adulterated infant injections that the subject received as an infant, he now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. The attorney also alleged that the subject will be hindered and prevented from pursuing a normal course of employment.
9:20 patient complains of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. 9:44 blood pressure elevated, patient was sent home with daughter. 10:02 patient was given Benadryl 25mg x 1 dose. Patient ate food and at 10:18 reports lip swelling and burning. 10:20 patient was given dexamethasone 4mg x 1 dose and Pepcid 20mg x 1 dose. 11:28 patient verbalized improvement of symptoms, patient was advised to continue with Benadryl 25mg every 8 hours x 1-2 days and to follow up with her primary care provider the next day.
she almost called 911, problems:fever, diarrhea, nausea, pain arm, flu like symptoms , dry heaves
The patient received a vaccine that was drawn up 18 hours prior which would have made it expire.
Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications were not reported.  Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were Administered.  Treatment information was not reported.  This case contains information of 4th out of 6th patient reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:(Patient no-1 out of 6 )
Body aches and fever for 2 days. Then shortness of breath and coughing for 5 days.
Swelling, redness & tenderness to (L) shoulder about 12 cm x 12 cm. No fever - decreased use in arm. Mostly resolved after 2 days of ice & MOTRIN.
jaw pain; ear pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever). At the time of the report, PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medicines were reported
Red, warmth, swelling, discomfort, hot flashes, sweating, nausea, decreased appetite, headache and muscle aches. Acetaminophen.
pharmacist would not give her the second dose; left hip joint pain (last 4 to 5 days); left hip joint pain is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing). On 02-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) outcome was unknown.        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.   Concomitant medications was not provided by the reporter Treatment information was not provided