chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Of note, patient vaccination site (RD vs. LD) unknown  Patient presented to the ED for altered mental status, weakness and new onset dark tarry stools. Patient was more altered compared to her baseline and that she is disoriented, confused. Also, for the past 4-5 days she has had dark, tarry stools and has been progressively more weak, fatigued.  Additionally, patient does not normally have an oxygen requirement at home.   Patient with COVID-19 penumonia Completed Dexamethasone therapy - now on Chronic steroids  Of note, patient was COVID + on 11/22, initially treated at small hospital. No contact information on other hospital or provider who cared for her at other hospital is charted in the system electronic health record.   Discharge Disposition/Condition Disposition: Home against medical advise  Condition: Stable (s/sx potential problems absent or manageable)
0931 pt c/o vertigo and pain at injection site, became unresponsive. BLE elevated periods of apnea. Opened eyes after sternal rub. BP 70/30. EMS arrived. Disoriented to name, place, and time. Transported to ER.
Breakthrough case admission after three vaccines Moderna 2/24/21 Lot# 025A21A;  Moderna 3/24/21 Lot# 028A21A; Moderna 12/20/21 Lot# 068H21A
a little over 24 hours after vaccine - I started with a severe headache - by 2:00 I had to stop work and lay down.  By 6 I started with fever, chills, fatigue which persisted until 10:00 that next morning so about 18 hours
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On 29th January 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced shingles. The follow up consent was granted.
Patient received the COVID 19 vaccine on 4/2, he developed symptoms of COVID on 4/10, he tested positive for COVID on 4/13.  He was admitted to the hospital on 4/17 for acute respiratory failure.  On 4/20, he was diagnosed with a pulmonary embolus.
I was fine for a  few days then got really sick on 5 th day & have felt bad since then.
injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.
This spontaneous report as received from a pharmacy technician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medications. On 22-SEP-2016, the patient was vaccinated with ZOSTAVAX lot # L021609/expiration date-10-SEP-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Patients right thigh was swollen by the injection site and patient was complaining of itchy very much.
Approximately 12hrs following 2nd and booster injections; general malaise. Specific symptoms tired, chills, decreased appetite, sore arm around infection site. Symptoms lasting from the 12 hour following injection out to 72hrs in duration. Booster help to manage with over the counter NSAID?s.
Complaiing of cough, congestion, diarrhea, headache, shortness of breath, body aches
Injection site area became hot; Injection site area became swollen; Discoloration was 2.5-3 inches in size; Injection site area became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red). At the time of the report, VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 23-MAY-2018, the patient was inadvertently vaccinated with PROQUAD lot number: N025927, expiration date: 18-MAR-2019, for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
The day after the 2nd vaccine I had a slight headache and stiff neck. 1 week to the day I had severe breathing problems, felt totally run down, had recurring headaches. This has been going on now for a complete *month*. My PCP ran a battery of tests on me and found nothing wrong.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 30-year-old female patient who received Flu Seasonal QIV Dresden. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had received the flu vaccine only once and the next day patient experienced she ached from head to toe. The patient never got the flu vaccine again.
Individual received her second Moderna COVID vaccine at 1100 - 10 minutes after receiving the vaccine the employee complained of being lightheaded and nauseous. Brought over to a stretcher, manual B/P 160/98m 100% on room air, 56HR. Individual  reports that she hasn't "had anything to eat yet today" and that she is "pre-diabetic" and that sometimes her "sugar drops". Provided with a lot of orange juice, individual  only took a small sip. At 1135 the individual  blood pressure was 170/100 and now complains of a "metallic taste" in her mouth that she reports she has had since symptoms begun - but had only now just mentioned this complaint. At 1140 she began to feel as if she had to throw up and began attempting to induce vomiting by placing her fingers down her throat stating that if she didn't do it that way she "would aspirate" she was unable to induce vomiting but continued to dry heave and use her fingers. At this point she was transferred to the ER in a stretcher without incident and placed in an ER stretcher for registration and triage. Hand off provided to ER RN
Throat tightness began approximately 20 minutes following vaccination. 50 mg of diphenhydramine was administered orally at 11:04 am by RN. NP arrived at 11:22 at pt bedside and  EMS was contacted at 11:24 am. EMS  arrived at 11:36 am. Epinephrine was given at 11:31 am by NP. Pt was transported by EMS to hospital.
approximately 10 mins after vaccine administration patient was observed by accompanying person to be slumped over, unresponsive to stimulation, given 0.3mg epinephrine IM. Pt became coherent, vitals signs stable, transported to local hospital by ambulance. pt reports episodes of "spacing out" often, accompanying person confirms hx of unspecified seizure disorder.
had a horrible case of shingles for over 3 months now/ Suspected vaccination failure; Horrible case of Shingles; get him down; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and unwell. On an unknown date, the outcome of the vaccination failure and unwell were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and unwell to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient had the Shingles shot and booster shot in 2020.  The patient had horrible case of shingles for over 3 months now.  The reporter never seen anything got the patient down like this. Additional Supportive Information: This case was considered as vaccination failure since the detail regarding laboratory confirmation of shingles was unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pain, itching, redness.  Diffuse swelling around injection site - improving with use of Odal Medrol dose pack, rest, elevation and ice.
Right hand and right knee swelled less than 24 hours after vaccine.  Right ring finger had slight ?trigger finger?  issue when there has been no previous issues like this.  Swelling of both the right hand and right knee last about 3 days, and then went away.  Had no further problems with it until approximately 09/15/21 when hand swelled and had trigger finger issues with ring finger.  Will be having surgery got this in Oct. 2021.
3 consumer experienced a medication error with the Flu zone Quadrivalent described as receiving an expired vaccine, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves three patients of unknown demographics who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UJ304AA and expiration date 30-Jun-2020) that was expired (PT: expired product administered), via unknown route in unknown administration site as prophylactic vaccination on an unknown date.it was also reported that while receiving a flu vaccine for the wrong flu season year and that the vaccine was for the flu season 2019-2020.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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 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.
Very mild symptoms like body pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very mild symptoms like body pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYALGIA (Very mild symptoms like body pain). At the time of the report, MYALGIA (Very mild symptoms like body pain) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided.
An hour and a half after the patient's second dose of Shingrix, he became severely exhausted and drained of energy. He also developed a headache and became very hot and sweaty. These symptoms lasted all day long, but subsided by the next day.
No adverse effect from vaccinations other than usual side effects. But, had two vaccinations, plus two boosters. The second booster was April 23rd, 2022.   Tested positive for COVID on July 10th, 2022.
burping gas; Can breath deeply now, but has to do it more often; muscles are sore like when you do exercise; sharp pain in the chest; kind of muscle spasm; could not breath; Could not get up without her husband lifting her; Fever; muscle pain; chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get up without her husband lifting her), CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm), DYSPNOEA (could not breath) and ERUCTATION (burping gas) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer, Hypertension and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue). On 09-Feb-2021, the patient experienced CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath). On 12-Feb-2021, the patient experienced ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise). On 04-Feb-2021, MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue) had resolved. On 12-Feb-2021, CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath) had resolved. At the time of the report, ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Kitruda Autoimmune medication for Cancer, Vitamins, High blood pressure pill, Stevia and beat root rice pills High cholesterol. Treatment details were not reported by the reporter.
Swollen joints Tired intermittent  Rare but out of breath sometimes. Worse after 2nd Treated with med pack of prednisone No help.
Including any of and all of its sequelae; Shingles; This spontaneous report as received from a lawyer concerning a case in litigation and refers to a 54 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On 01-MAY-2017, the patient suffered from shingles (herpes zoster), including any and all of its sequelae (Ill-defined disorder). The patient suffered from serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physical pain and mental anguish.   The outcome of herpes zoster and Ill-defined disorder were not recovered.     The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The lawyer considered the shingles and Ill-defined disorder as a disabling events due to its were permanent.
Wooziness; Stomach Pain; Vomiting; Pain; swelling; A spontaneous report was received from a consumer concerning a 87-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, swelling, wooziness, stomach pain, vomiting.  The patient's medical history was not provided. Concomitant medications reported were Loratadine, Thyroid Pill, Ocuvite, Lipitor, Vitamin D3, Calcium, Vitamin C for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) pain, swelling. On 10 Feb 2021, the patient experienced the event(s) wooziness, stomach pain, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain, swelling, wooziness, stomach pain, vomiting was unknown.
Tender, swollen, erythema (L) upper arm mildly firm, but no induration. Min splotchy erythema (12-16 cm width x 15 cm length) & itching.
got the flu; Initial information received on 13-Dec-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who got the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) last two times (Unknown latency) following the administration of INFLUENZA VACCINE.  Patient reported that he/she never took it again and had not had the flu since over 15 years.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
pt recvd measles vax 17SEP91 & approx 20 mins following vax devel stuffy nose, congested eyes & complete inability to breath through nose; pt improved w/in 5 to 36mins; MD sent pt to hosp but heard pt did not go; 18SEP91 pt was nl;
EVERYONE I KNEW THAT GOT IT HASN'T BEEN OK; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced everyone i knew that got it hasn't been ok. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everyone i knew that got it hasn't been ok was not reported. This report was non-serious.
infertility; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFERTILITY (infertility) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     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 INFERTILITY (infertility). At the time of the report, INFERTILITY (infertility) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   Reporter did not allow further contact
My menstrual cycle is typically 5 to 6 days long and extremely heavy. Once I was vaccinated my menstrual cycle shortened the next cycle to 3 to 4 days and extremely light. I also had less cramping and less pain from my menstrual cycle
Information has been received from a medical assistant concerning a female who was vaccinated with a dose of MMR II in the past, and now has low titer for rubella. The patient sought unspecified medical attention. The patient's outcome was unknown.  Additional information has been requested.
Noticed child suddenly had numerous nervous ticks of the head. Throwing head back over and over, turning head to the side to touch shoulder and raising shoulder slightly while doing this and general jerking and twitching  motions of the head. Later a new one started bringing the chin down to touch chest over and over.
pt recv vax & states that has aged/looks older/has devel more wrinkles since vax;also states had a low grade fever following vax;pt has not been seen by MD;
Patient calling with complaint of vertigo, feeling off balance, and headache that began 24 hours after receiving her first Moderna Covid vaccine. She had her first covid vaccine and says ever since she has been having balance issues. Last night she states she could hardly walk to the bathroom when she got up in the middle of the night, because she was so dizzy/room was spinning. She also says she has been experiencing heart palpitations.  Patient has not had any known recent exposure to Covid, but did return approximately 1 month ago. Patient has history of hypertension, but has not had her blood pressure checked in a very long time (does not currently take any medications for hypertension- no PCP at this time). Patient states that the vertigo is happening on and off, but mostly when she is laying down in bed. Reports that she feels off balance when she first stands up to walk after laying down. Also reports that she is noticing heart palpitations on and off for the past 2 days. Patient has not had difficulty breathing, difficulty swallowing, facial swelling, rash, or chest pain.