chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after vaccine I developed a nodule and soft swelling in my neck on the same side as the vaccine. It is not red but is sore to touch. This has not changed much in 4 days. I did go to a clinic and was told it could last 2 weeks and was very common.
Patient turned age 12 on 11/10/2021 and should have received a full dose but was administered a Pedi dose. In 21 days a full dose will be administered
This spontaneous report as received from a registered nurse refers to three patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on an unknown date, the patients were administered PROQUAD (Merck) that had been improperly stored (dose, route and lot number not provided). No adverse effects were reported). This case is linked to case MARRS # 1504USA022234 (same reporter link). Additional information is not expected because the reporter did not provide consent to follow up.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 19-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020).This is one  of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
The day after the second dose, I had a high fever and felt very ill. I stayed in bed that day.  My arthritis in my right hip got very bad.  My right leg is measurably weaker than my left leg.  I had not used a cane much until that day, and have needed one almost all the time since that day.  I am undergoing physical therapy to deal with the problem.
Patient liver enzymes were consistently within normal limits during her hospitalization until March 30th her admission lab work for the nursing home showed severely elevated liver enzymes and alk phos. Patient is also less responsive
Visit of 6/11/15->pt c/o itchy/rash. Area warm to touch, bigger in size than on vaccination date of 8 x 10 c,. ? Cellulitis vs local rx.
The adverse event was the accidental administration of the Hepatitis A vaccine to a newborn infant instead of the Hepatitis B vaccine. The Infant has not suffered any symptoms or signs following the administration.
Pt complained shivering, aches around 11 PM. The next morning she experiences light headache and mild fever.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of 7 years old child patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Still Covid positive - rebound.  Covid like symptoms after treatment; Still Covid positive - rebound.  Covid like symptoms after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Still Covid positive - rebound. Covid like symptoms after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Still Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral drug. Treatment start date was 29Sep2022 and treatment stop date was 03Oct2022.   Clinical course: The patient reported that he was Still Covid positive - rebound. Covid like symptoms after treatment. The patient had some known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable other healthcare provider.  A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 21Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient said that she received the Pfizer-BioNTech Covid-19 Vaccine last Tuesday, 21Dec2020, then tested positive for Covid on 26Dec2020. She said the symptoms started on 24Dec2020. Now, she wants to know if it is still okay to get the 2nd dose of the vaccine on the scheduled date. The outcome of events was unknown.    Information about Lot/Batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event "tested positive for COVID" and vaccination with BNT162B2 cannot be excluded.
ACHY; ARM SORENESS; MINIMAL CALF PAIN; SPLIT SECOND FEELINGS OF NAUSEA; TIRED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood transfusion, and concurrent conditions included toxic shock syndrome, and neutropenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced arm soreness. On 09-APR-2021, the subject experienced minimal calf pain. On 09-APR-2021, the subject experienced split second feelings of nausea. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and the outcome of arm soreness, split second feelings of nausea, achy and minimal calf pain was not reported. This report was non-serious.
Patient admitted on 8/19/2021 for COVID19 pneumonia after being fully vaccinated. Patient presents with SOB. Patient diagnosed with COVID last week, since diagnosis patient with worsening shortness of breath.  Patient with fevers and chills, patient with diffuse myalgias and arthralgias, patient with poor appetite, no nausea and vomiting, no diarrhea. Following admission pt was started on and completed 5/5d of Remdesivir he had not received any MAB infusions in the outpt setting PTA as he was requiring O2, Pulmonology was consulted for further recommendations they recommended continuation with Dex and Remdesivir and to hold off on Baricitinib as he - at the time - was oxygenating well and was felt to overall have a poor COVID Prognosis, pt was also concerned that his cancer Tx (CRC) was stopped on admission, HEM-ONC was consulted and informed pt he needs complete resolution of his COVID before CHEMO will be re-initiated. He was re-evaluated by Pulmonology and felt that pt had developed COP, IVMP was started along with a 7d course of Levaquin of which he will complete the remaining 4d of this in the out pt setting.
Patient was given the Hep B vaccine the day she was born and shortly after her vaccination she broke out with a rash over her entire body.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL, 0.5ml (unspecified route).  The physician reported that the patient experienced syncope or seizures after receiving the GARDASIL vaccine and on the same day, the patient recovered.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information is not expected.
Got the Covid arm but can't remember which dose it was something going on covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic pain and Sleep disorder. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Chronic pain, TIZANIDINE for Muscle relaxant, HYDROXYZINE for Sleep disorder, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], SEROTONIN, DOCUSATE SODIUM (STOOL SOFTENER), ASPIRIN [ACETYLSALICYLIC ACID] and SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm). At the time of the report, VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm) outcome was unknown.            The patient broke ankle 2 weeks ago, had a surgery and was put on aspirin. The patient had COVID over Christmas break 2021.  Treatment medications were not reported.   This case was linked to MOD-2022-510774 (Patient Link).
Facial swelling, arm burning, stomach upset, headache on 7/10/13. On 7/11 facial swelling subsided, arm burning worsened, felt flu-like symptoms, called the pharmacy late evening where administered for consultation was told oral Benadryl and call MD in AM to report to them. On 7/12 no change in symptoms, consulted with MD, was told Benadryl cream and cold compresses.
bad taste in mouth/ bad after taste that she described as a metal taste; dizzy; Tired; arm hurts; tingling in right hand; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via an unspecified route of administration, administered in right arm on 19Feb2021 (at the age at vaccination of 71-year-old) as dose 1, single for covid-19 immunization. The patients medical history included fibromyalgia diagnosed as a child. The patient's concomitant medications were not reported. On 19Feb2021 the patient mentioned she was dizzy, tired, arm hurts a little and tingling in right hand, they had her move it around and it went away. On 20Feb2021, the patient stated she had a bad taste in mouth/ bad after taste that she described as a metal taste. The patient stated when she brushes her teeth or uses mouthwash the taste goes away but if she drinks water, it comes back. The patient stated the people at the medical college told her to call Pfizer. The patient wanted to know if her symptoms were normal after receiving the vaccine. The outcome of event tingling in right hand was recovered on 19Feb2021 and for the rest of the event the outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Chills, painful left arm, extreme aching and pain throughout body, shaking, heavy chest.
a throbbing arm pain at the injection site.; throbbing arm pain at the injection site / preventing her from sleeping.; arm got pretty sore / extreme arm pain; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, sleep problem and pain in arm. On an unknown date, the outcome of the injection site pain, sleep problem and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sleep problem and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reacted like that with the Pfizer shot like did with Shingles shot. No further information was provided. For tolerance to the Flu shot, refer case US2021AMR087690 reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087690:Same reporter, same patient, different suspect
2nd dose administered on 2/20/21, on 2/23/21 the patient fell and sustained a facial  injury
I had two regular menstrual cycles following my vaccine, and my current cycle has thus far lasted 21 days with no signs of stopping. It is heavy enough that I need to use four tampons a day.
Administered above vaccine past 75 days of storage in the fridge to 25 days past BUD. I'm calling all 55 patients to let them know their options
Within 15 minutes of the vaccine my legs were contorted and I was unable to move them.  Within 30 minutes from the waist down and with in 60 it was from the neck down.  I also had hives and petechiae.  It is three weeks later and I can move everything, but have MARKED weakness, am having hot flashes, bowel and bladder problems, and high blood glucose levels.  I am still in the hospital with no clear end in sight. Discharge summary states tremor, constipation. Medical records state urinary incontinence, dysarthria.
No adverse effects. Covid 19 vaccine given > than 12 hours from drawing. Vaccine was drawn, stored in refrigerator overnight. given to patient the following afternoon. Manufacturer notified. Awaiting guidance re. patient.
Tongue Swelling 8/23/2021 and 10/6/2021 lasting approximately 6 hours - 50 mg Benadryl administered
2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This increased in severity I took nsaids topical steroids Saw rheumatologist who ordered prednisone snd multiple lab tests. Suspect autoimmune reaction triggered by vaccine in some way. Also have migraine
A non-serious spontaneous report of "staff person > 49 years of age received FLUMIST" was received from a nurse concerning a 53-year old female. On 13-Nov-2009, the patient inadvertently received FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient was seen in office 03/16/2014.  One week after receiving Zostavax vaccine at local pharmacy, patient began to complain of right hip pain, described as an ache and burn, radiating down right leg.  Also with pins and needles in right foot and toes. Pain is a 9 out of 10.  Difficulty urinating, pink tinged at times, with some noted constipation and nausea. On physical exam there was a nonblanching reticular rash right buttock, right posterior upper leg and right upper calf.  Patient was unaware of rash, but was located at site of pain.
Moderna COVID-19 Vaccine EUA Severe teeth chattering chills, body aches, muscle & bone pain, temperature 99-101. Diaphoresis, Dizziness, Nausea, Vomiting &  Diarrhea lasting 48 hours. Severe body aches, muscle & bone pain persisted.
Flushing/sweating. BPs 93/57 (pulse 62), 103/55 (pulse 56). Rest and hydration recommended.
Patient was 6 weeks out and was still in a wheelchair; Long term muscle weakness; Experienced pain going down to the front of legs; This spontaneous case was reported by a physician and describes the occurrence of WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair), MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair), MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs). At the time of the report, WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair) had not resolved and MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was not having funny sensations and the weakness in muscles was not just for 2-3 days but even after 6 weeks later patient had to go on a wheelchair because the legs were so weak. The patient was walking before, and it was not just muscle pain.  Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-624196, US-MODERNATX, INC.-MOD-2021-624209 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624196: US-MODERNATX, INC.-MOD-2021-624209:
The patient presents with 8 day hx of viral symptoms. Pt reports to have been experiencing fevers, chills, cough, shortness of breath, myalgia, headache, nasal congestion, rhinorrhea, and headache. Recent sick contacts and COVID-19 exposure. Has administered with over the counter cold medicine. Denies all other acute systemic symptoms.  The onset was 8  days ago. Associated symptoms: fevers, chills, cough, shortness of breath, myalgia, headache, nasal congestion, rhinorrhea, and headache, denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies dizziness and denies back pain.
received a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA392579(CLUSTER).  This case involves Elderly of an unknown gender patient who was given expired  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiration date: date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date, the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nothing reported at time of event. Patient called 7/6/21 and reported Sunday ? swollen at injection site and hot to the touch. Patient unable to lift arm or sleep on left side.
within an hour of getting the shot I experienced muscular dystrophy and and a flare up of an old back injury that causes me severe sciatic pain.