chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry Mouth; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Allergy. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED CO).    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing). At the time of the report, DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included albuterol inhaler.
pt recvd vax; 2-3 days later,exp neck pain,neck stiffness,ha; events have not subsided;
I had been on an antibiotic for pneumonia that was not getting better. It started causing problems with my heart and caused me to go into A-fib. My doctor had me admitted to the hospital so that we could get this under control. The doctors ran test to try and determine what caused the A-fib. It was determined I had community acquired bacterial pneumonia. I was put on stronger antibiotics than have cleared up the pneumonia. I am scheduled to see a heart specialist to see what may have been causing the A-fib.
Following night after shot a rash started on upper right shoulder going down to middle of back; also on upper left hip and midway down left leg. Itching stopped 5/17/21, but rash is still visible. Did not see a doctor.
Severe nausea, sluggishness, body aches, headaches, cold and hot flashes, swollen injection site
Pt developed a rash on his chest and his abdomen approximately two weeks post vaccination to COVID Vaccination(Moderna).  Rash started with multiple small papules that then subsided after three days.  After papules subsided it turned into a pruritic red rash.  Location was primarily on his chest and his abdomen.  No treatments needed to manage symptoms.  Since onset the rash has subsided.  Pt did not do any extensive yard work, change his body wash or laundry detergent.  Pt does not have a past history of rashes on his chest or abdomen.
Information has been received from a physician, via a company representative, concerning a female patient, who on approximately 07-MAY-2007 ("about 2 weeks ago"), was vaccinated IM with a dose, 0.5ml, of Gardasil.  The physician reported that on 07-MAY-2007, "the patient fainted right after receiving Gardasil," and confirmed that the patient had recovered (date unspecified).  The patient sought unspecified medical attention.  No further information is available.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/21/2021. Presented to ED on 8/17/2021 with complaints of fever and shortness of breath for 2 days with increased oxygen requirements. Medications administered: dexamethasone, methylprednisolone, ceftriaxone, cefepime, azithromycin, remdesivir, epoprostenol, and vancomycin. Patient continued to decompensate requiring more oxygen. On 8/29/2021 patient's mental status declined while on BiPAP. Patient expired at 13:44 on 8/29/2021.
Unbearable left upper arm and shoulder muscle pain and shoulder joint pain. Inability to get comfortable, especially at night. Some tingling in thumb.  Have tried heat, ice packs, massage, alternating ibuprofen 800 and acetaminophen. Pain is going on 6th day and no signs of improvement.  Contacted administering pharmacist & primary physician on Day 4 who advised the above treatment and to 'wait'.  Will contact again on Day 8.
Goes to prove the vaccine is not 100% [...] still get/Suspected vaccination failure; Some people still get (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that this gone to prove the vaccine was not 100 percent some people still get Shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2022AMR139418 reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR139418:Same reporter
Site: Pain at Injection Site-Medium, Additional Details: Pt is complaining of a sore arm, racing heart, chest tightness and some shortness of breath.  Was vaccinated 3 days ago; I didn't ask when the symptoms started.  I did advise her to call her MD.  I will call her on my next day to work to see if she was seen.  I assume they will want to and that is the option I selected.
Pt had almost immediate itching and redness at site and has increased in size. Left upper outer arm has redness and mildly indurated with small mass palpated. Non tender and non warm.
3rd COVID Vaccine: Pfizer Monovalent-10/26/2021- C-FH8020- Dose 3. Patient is a 57 y.o. female who was admitted to the hospital with foot pain after recent TMA procedure. She was seen by vascular surgery and subsequently underwent left below knee amputation for gangrene. Patient was unable to wean off the ventilator. We were consulted for ventilator management and weaning. The patient was hospitalized on 09/18/2022 for LLE infection post great toe amputation. The patient had a trans-metatarsal amputation that was then infected and dehisced. She went for L BKA on 10/19/2022.  She was extubated, and eventually transferred out of ICU but was later transferred back to ICU after she became hypotensive (septic). ID broadened Abx. She subsequently required reintubation on 11/4/22. She was managed aggressively with vasopressor, ventilator and CRRT support, but continued to decline and developed multiorgan failure with shock liver, coagulopathy secondary to this. She grew VRE and Stenotrophomonas on various cultures and was treated appropriately with antibiotics by ID. Despite all this she continued to require multiple vasopressors and developed GI bleed from coagulopathy which was corrected aggressively. Goals of care discussions were initiated as outlook was very poor and on 11/10, family decided to pursue palliative extubation and hospice. She was discharged to hospice for comfort care after palliative extubation on 11/10/22.
My menstrual cycle has been abnormal since being vaccinated. I may be developing PCOS which affects fertility as stated by my OBGYN. My period was heavier then usual, and the date of menses has not been regular.
On the 11th of August 2020 I received the shingrix vaccine at my pharmacy. By 8pm that evening I began to have fever >100 deg F along with Chills , significant myalgia and arthralgia. I took ibuprofen 400mg q 6-8 hours and supplemented with tylenol 100mg  every 6 hours or as needed.  After a very uncomfortable evening ( chills fever and joint pain ) the next morning the fever had subsided however the fatigue, weakness and arthralgia persisted. By 5 pm of day 2 the fever had returned and the arthralgia persisted through to day three. by the end of day three there was residual joint and muscle pain and persistent albeit improvement is fatugue.
injection site reaction - redness at injection site, width about size of blood pressure cuff, almost all around the arm, warm to touch, sore
Sitter found pt not breathing, turning blue, unable to get breath, called EMS, got infant to breathe; pt taken to hosp & hospitalized 12MAR92 to 14MAR92; d/c home w/infant monitor;
Chief Complaint diagnosed with coivd 5 days ago.  having malaise, fatigue, shortness of breath at times.  vomitted this morning and near syncopal episode today; History of Present Illness - Patient is a 70yo man with PMHx of HTN, HLD, central retinal vein occlusion of L eye 10/2013 (on ASA 325mg), GERD, vertigo, who was admitted to internal medicine on 8/25 for further management of hypoxemia and COVID-19 pneumonia. He reports that on Wednesday 8/18 he started to have a sore throat, body aches, chills, and subjective fevers which were worse by Thursday. He was seen by his PCP on Thursday and tested positive for COVID-19 pneumonia, and started on prednisone 20mg, levofloxacin 500mg, and prescribed an albuterol inhaler. He also notes that he was prescribed apixaban 2.5mg bid for DVT ppx. He states that he was doing ok until Saturday when he developed a cough and dyspnea which has gotten significantly worse since that time. He also has been experiencing nausea, vomiting, and diarrhea, but feels like he's been tolerating po intake well. He presented today because he had a presyncopal episode today and felt extremely fatigued. He states that his highest fever at home was 100.1 which was on Thursday. He states that he has been vaccinated with his last dose of Pfizer being in 3/21. He has not had any recent travel or known sick exposures. He states that currently his primary symptoms are a severe headache as well as a cough and dyspnea.
pt recv vax;subsequently became pregnant;noted that conception date was 27jan96;at 4.5 wk gestation,pt had miscarriage;
(None noted - adverse reaction). MMR vaccine expired 6/18/2011 but administered on 06/20/2011.
ADACEL vaccine given on 6/13/06 to right arm. By 6/16/06 had pain erythema itching right arm within 1 day had cough. Was not seen in ER was seen today in outpatient clinic
Pt was fussy after giving vaccination, and L thigh was red. Pt's mother was given ice pack for effected area.
hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hard time getting around) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (hard time getting around). At the time of the report, VACCINATION COMPLICATION (hard time getting around) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment medication reported by reporter.
Information has been received from a physician concerning her 15 year old daughter who was vaccinated with HPV. Subsequently, the patient experienced red dots/rashes on her ankles, elbows, and buttocks. Subsequently, the patient recovered from red dots/rashes on ankles, elbows, and buttocks. Therapy with HPV was not re-introduced. Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a physician concerning her approximately 18 year old student daughter (previously reported as her 15 year old daughter) who was vaccinated with a first dose of GARDASIL. Subsequently, 48-72 hours after the first dose, the patient experienced red dots/rashes on her ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen. The patient was treated successfully with BENADRYL and recovered from red dots/rashes on ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen within 24 hours. Before the second dose of GARDASIL, the patient was pre-medicated with CLARITIN. No rash or other adverse experience was noted. Additional information is not expected.
Patient developed burning sensation and rash on her scalp, neck, arm, legs, in between thighs near groin, and in between her breast area; as well as welts on her stomach on 10/19/18, she then took BENADRYL and the reaction subsided some. On 10/20/18, her reaction was still present and she stated her skin was tight feeling.
medical assistant diluted vaccine with 0.2 cc diluent and adminsistered 0.3 cc pt is doing ok
REALLY COLD; SWEATY; VERY VERY THIRSTY; FEVERISH; DEEP MUSCLE ACHES IN THE BACK AND SHOULDERS AND NECK; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 73 kilograms, and height was 72 inches. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage. the patient have no history of hospitalizations within the last month; no medical conditions; takes no medications regularly.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced really cold. On 05-JUN-2021, the subject experienced sweaty. On 05-JUN-2021, the subject experienced very very thirsty. On 05-JUN-2021, the subject experienced feverish. On 05-JUN-2021, the subject experienced deep muscle aches in the back and shoulders and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really cold, sweaty, very very thirsty, and feverish on 06-JUN-2021, and had not recovered from deep muscle aches in the back and shoulders and neck. This report was non-serious.
Patient states she has had numbness from right jaw down to right arm since vaccine was given. Bruising at injection site warmth at site since given. Referred to MD.
On the 8th day after I had the Moderna vaccine, my left arm deltoid area (where I had the shot) developed a very red, defined area about 3 inches by 5 inches. It didn't really hurt but was somewhat swollen and felt itchy/achy. After 2 days it started to fade and now after 8 days, it is almost gone. I did not have fever or other symptoms.
This patient received a 3rd dose of Moderna. 1st dose on 2/18/21, 2nd dose on 3/5/21, 3rd dose on 4/8/21.
sore injection site arm after each vaccine; greater than 36 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after each vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) 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 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm after each vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after each vaccine) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-402774 (Patient Link).
Pt presented to the ED 1/17/22 for woresening confusion and near syncope.  No fever, n/v/d or cough.  Fully vaccinated and boosted - Moderna - 3/24/21, 4/26/21, 11/30/21.  Pt found to have a left MCA stroke, failure to thrive with reduced oral intake, dementia.  Patient remained asymptomatic during hospitalization.  She was ultimately discharged to Hospice services on 1/28/22.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 12Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 30 years, in right arm for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Covid was tested post vaccination. Facility type vaccine was workplace clinic. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Sep2022 at 02:00, outcome "unknown", COVID-19 (medically significant) with onset 11Sep2022 at 02:00, outcome "unknown" and all described as "Tested positive for COVID after having vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive, notes: At 02:00 AM, Tested positive for COVID after having vaccine. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 19 week old male, with no medical history and no allergies, who on 30-MAY-2007 was vaccinated with a dose of Rotateq (Lot# 656385/0030U). On 04-AUG-2007 the patient had surgery for intussusception and was hospitalized. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experience was considered to be immediately life-threatening, disabling, and an other important medical event by the reporter. Additional information has been requested.  9/28/07 Received hospital medical records which reveal patient experienced vomiting, irritability, restlessness, abdominal distention & bloody stools x 2 days.  Seen in outlying ER & transferred to higher level of care.  Admitted 8/4-8/7/2007.  IS was nonreducible by air contrast enema & taken to OR for exp lap w/reduction of IS & open appendectomy.  Progressed well but continued to have bloody stools throughout hospitalization but lessened w/more formed stools.  D/C to home w/pcp & surgical f/u. FINAL DX: Intussusception, surgically reduced.
Unconsolable high pitch cry with onset about 2 hours after receipt of vaccine.  Lasted for 6-7 hours even after administering acetamenophen.  No fever or selling of extremities noted.
Patient tested positive on their covid test, tested positive the same day as receiving the vaccine.; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 1st of 2 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive the same day as receiving the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283276 Same reporter/events/ drug/diff patient
Client ambulated on her own to clinic check-in and stated that she wanted her vaccine but was also anxious about receiving it. During the pre-screening she stated she had history of anaphylaxis to the following: cinnamon, lilacs, lilies and colognes but no other substances. She filled out the rest of her paperwork without assistance; there were no documented reasons to refuse vaccine administration. She ambulated normally to vaccination station and received vaccine without complications and then ambulates self to observation area for normal 15 minute observation period. After normal 15 minute observation period was over she was noticed by clinic staff to not look well: she was pale and looked "sick". Clinic staff questioned her about how she felt and stated that she, "felt woozy". Staff brought cot to her side and she sat down and stated she felt like her throat was closing so staff immediately called emergency number for EMS assistance. Client started to list to her left side and staff aided her in laying down, she did not lose consciousness. Staff retrieved cool packs for her and helped her to remain still until EMS arrived. Prior to EMS arrival staff see red blotchy patches appear on her neck and chest and she again stated that she felt "foggy". Epinephrine was prepared for administration but was never given.  Fire EMS arrives at 1747 hrs who assess until ambulance arrives shortly later. No difficulty breathing was found and she developed no signs of wheezing or rales. She is overheard by clinic staff to admit to Fire personnel that she has anaphylaxis to penicillin, this is not declared on her written paperwork or to clinic staff at time of check-in.   V/S: 1738 hrs  BP 159/62  P 110 bounding 1740 hrs BP 155/81  P 118 bounding
Shaking Irritability Fever Feeling unwell A non-serious report of shaking, fussiness, fever of 102, and not feeling right has been received from a pharmacist in the USA concerning his son, a three-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. On 15-Oct-2008, the patient received a dose of FLUMIST. Two days after the dose of FLUMIST, the patient developed a fever of 102 degrees and had symptoms of being fussy. The patient received ibuprofen and acetaminophen and the fever went away. The patient also experienced "shaking" and "not feeling right". The patient has not seen a physician for medical evaluation. The event of fever of 102 resolved on 20-Oct-2008; the events of shaking and not feeling right were still ongoing and the outcome for the event of fussiness was not provided by the reporter.