chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; he could not speak; diarrhea; vomiting; This is a spontaneous report from a contactable physician. A 63-years-old male patient received bnt162b2 (BNT162B2), intramuscular on 12Mar2021 as single dose for COVID-19 immunization at a workplace clinic. Medical history was reported as none. There was no known allergies. There was no vaccine administered in four weeks. There were no concomitant medications.  On 13Mar2021, the patient experienced diarrhea and vomiting for 8 hours and 2 days later on 15Mar2021, he could not speak so patient went to the hospital and was told he had a stroke. The patient underwent lab tests and procedures which included SARS-COV-2 test, pcr swab test: negative on 14Mar2021. Therapeutic measures were taken as a result of the events which included aspirin, clopidogrel (PLAVIX), atorvastatin calcium (LIPITOR), evolocumab (RAPATHA). The events caused hospitalization. The patient recovered from the events on an unknown date.  Information on batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the reported events of diarrhea, vomiting, could not speak and stroke cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a physician refers to a 48 years old female patient. The patient was vaccinated with PNEUMOVAX 23 on 20-NOV-2012. Dose and route of administration were not reported. The physician reported that an unspecified physician who administered the vaccine reports that he was unsure if the patient was immunocompromised. No other co-suspects were reported. No concomitant medications were reported. The patient experienced headache, nausea, muscle aches and fatigue ever since (from 20-NOV-2012). No treatment information was reported. The outcome of headache, nausea, muscle aches and fatigue was reported as not recovered/not resolved. The relatedness for headache, nausea, muscle aches and fatigue was not reported for PNEUMOVAX 23. Additional information is not expected.
Four days after pt vaccinated with TD developed Bell's Palsy dx by MD rt sided - now slightly resolving.
Hot flushing and strong medicinal taste. Few days later nausea and diarrhea.
The shot was probably the most painful shot that I ever had. The point of injection became quite itchy.  I had a large red mark - almost like a welt but not quite - which lasted several days.  It remained slightly discolored until yesterday.   The itchiness was most irritating for 4 days, but in reality the most itchiness lasted for a week.  It even now still itches occasionally - after almost 2 weeks.
Fever, light headedness, chills, headache, sore injection site, bodily aches
Moderna COVID-19 Vaccine EUA Under left arm/lymph nodes swollen and tender
Pain, swelling, redness at site. Given Benadryl 50mg-some help. 10/26/02 Axd 150mg bid x 7 days. Allegra 180mg x 7 days. 10/26/02 site indurated tender warm.
5:30 pm Red - quarter size. Gave BENADRYL and ice. 10:00 am Lg fist size or softball size more BENADRYL and ice/heat. Less red same size more same then gone.
Loss of voice; major swelling under left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:3, Expiration date: 31Mar2022, Lot no.: FF2589), for Covid-19 Immunization, reaction(s): "Dizzy", "Change of voice", "Dose received: 3", "lymphadenopathy", "Swelling under right armpit"; Bnt162b2 (Dose:2, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "loss of voice", "lymphadenopathy", "fever", "swelling under her right armpit"; Bnt162b2 (Dose:1, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "right clavicle pain", "right clavicle was swollen", "soreness of her right arm".  The following information was reported: SWELLING (non-serious) with onset 09Apr2022, outcome "recovered" (11Apr2022), described as "major swelling under left arm"; APHONIA (non-serious) with onset 11Apr2022, outcome "not recovered", described as "Loss of voice". Therapeutic measures were not taken as a result of aphonia, swelling.  Additional information: Stated that this was after her fourth dose. that there was a loss of voice. Previously reported that her right clavicle was swollen, right clavicle pain and soreness of her right arm for the first dose. Stated that she reported previously that she had swelling under her right armpit with the second dose. Stated that she reported previously that she had swelling under right armpit and loss of voice and referenced that she thought she reported it also with the second dose. For your forth dose, event major swelling under left arm" reported with start ate was 09Apr2022. But this report L7VU8YZ5 was submitted on 12Apr2022. The awareness date for the swelling was April 9 and submitted along with the Voice issue.  No follow-up attempts are possible. No further information is expected.
Got shot, arm started hurting, severe pain, all day, I was fatigued, next day I ended up with chills, body aches, I developed a fever that went to 103.0, dizzy, generally did not feel good, body sweats, weakness, loss of appetite, nauseous. This all lasted about 7 days
Approx. 1 hr. after vaccines were administered in Pt.'s (L) delt. pain & redness started per Pt. mom. Pt. returned (on 5/19/11) to office with redness, warm to touch & slightly swollen (L) delt. area measuring 110mm x 100mm. Tx: cool compresses, TYLENOL & monitor area.
5.5 x 5 in red patch. 7 x 7.5 in induration and redness.
Right after the shot I had a weird taste in my mouth which laster for the entire day and would come back and forth over the next 10 days.  2 nights after the shot I woke up around 5am having pain around the kidney area on the left side. Slept on the other side and went ok. Next night same pain around 5am, this time I couldn?t sleep after.  Then 3/4 days after the shot, pain in my groins and intestines. It feels really irritated and pain varies from 1 to 4.5 on a scale of 10 throughout the days. It?s been now 10 days since the shot and this pain is not getting away or improving. Sometimes I also experience pain in the left side of my  stomach as well but it?s much less frequent than groins and intestines.
4-5 cm area erythema and induration, left anterior thigh.  Temperature 98.9F.
ADMINISTERED THE ENTIRE VIAL OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned an 84 year old male. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies, no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: 21/JUN/2021) .5 ml, administered on 02-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administered the entire vial of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the entire vial of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421803 and 20210408236.
pinpoint rash which started on chest & abdo & spread all over; It started w/in 24 hrs of immun; pt had a fever of up to 101; pt was taken to family MD who told them to come back;
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine.  On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
This is a spontaneous report received from a contactable consumer via a Pfizer sales representative. A roughly 18-month-old (infant) female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. 12 hours after vaccination the patient experienced seizures which lasted for an hour (recovered) with no corresponding fever or additional symptoms, and tremors with outcome of unknown.
Menstrual cycle was supposed to start and didn?t.   No chance of being pregnant. It is always regular (never late) for last 15+ years. Only other time it was late was my last covid shot.
This spontaneous report was received from a medical assistant regarding to a patient of unknown demographics. The patients medical history, drug reactions/allergies and concomitant medications were not reported. On 18-MAR-2019, the patient was inadvertently vaccinated with expired dose of ROTATEQ (lot # N021308/expiration date: 05-MAR-2019) for prophylaxis (expired product administered). No adverse events were reported.
Febrile seizure, low grade temp, papulovesicular rash 11 days after vaccines.  T max 100.3. Seen in ER - MD office following day.
pt complained of redness and heat at the injection site. i advised them to use ice and bennadryl after driving and to monitor their condition and to seek medical attention if it worsens
72yo female hx GERD, CKD stage 3, alpha thalassemia trait, COPD, NIDDM2 presents with acute renal failure, hyperkalemia, AGAP metabolic acidosis, uncontrolled diabetes and hyperglycemia, and sepsis of unclear etiology.   Acute kidney injury on chronic kidney disease stage 4: 72-year-old female with history of chronic kidney disease, anemia, GERD, COPD diabetes who presented with elevated creatinine not feeling well and was found to have acute kidney injury.  During hospitalization patient required 2 sessions of hemodialysis.  Patient's temporary hemodialysis catheter has been removed as per recommendation of Nephrology.  Patient's creatinine is stable.  Patient is to follow-up with nephrologist as an outpatient.   Hypertension: It was uncontrolled, patient medication has been adjusted.  Patient is currently on amlodipine, Coreg, losartan as per recommendation of nephrologist.   Diabetes: Mostly uncontrolled, patient is currently on home medication, that will be resumed on discharge   Physical exam: Constitutional:  Patient is lying in bed, no distress Head/eyes: atraumatic, normocephalic ENT: moist mucous membranes Neck: non-tender Cardiovascular:  regular rate and rhythm, no murmur, no rub Respiratory: decreased breath sounds, clear to auscultation, mild crackles Abdomen: non-tender, normal bowel sounds, soft, no rebound Extremities:  No clubbing, no cyanosis, edema mild Skin: intact, normal turgor 1   Discharge condition: stable
Redness; Itching ocassionally; Faith rash; Swollen, mushy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen, mushy), ERYTHEMA (Redness), PRURITUS (Itching ocassionally) and RASH (Faith rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (Swollen, mushy). On 14-Mar-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching ocassionally) and RASH (Faith rash). At the time of the report, SWELLING (Swollen, mushy), ERYTHEMA (Redness), PRURITUS (Itching ocassionally) and RASH (Faith rash) outcome was unknown.            No treatment information was provided.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L000425, expiration date 21-JUN-2016, oral (dose and dose number were unspecified). No adverse effects reported. This is one of two cases received from the same reporter (US-009507513-1606USA003775). Additional information has been requested.
GAVE SHINGRIX TO PATIENT WITHOUT A PRESCRIPTION FOR TRAVEL 5/2023.  PATIENT NOT ELIGIBLE DUE TO AGE.  NO TREATMENT NEEDED DUE TO NO ADVERSE REACTION REPORTED BY PATIENT.
sore; his bones were sore; felt warm; temperature of almost 101°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt warm), PYREXIA (temperature of almost 101°F), PAIN (sore) and BONE PAIN (his bones were sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included PANTOPRAZOLE SODIUM for Blood pressure, SIMVASTATIN, MULTIVITAMINS & MINERALS PLUS LUTEIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FEELING HOT (felt warm) and PYREXIA (temperature of almost 101°F). On 28-Feb-2021, the patient experienced PAIN (sore) and BONE PAIN (his bones were sore). On 28-Feb-2021, FEELING HOT (felt warm), PYREXIA (temperature of almost 101°F), PAIN (sore) and BONE PAIN (his bones were sore) had resolved.        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.
pt states that after getting the vaccine she had some stomach cramps and loose bowels.  Then on 10/2/22 after getting the flu vaccine she started vomiting non stop.  This lasted all day.  The next day she was really weak, dizzy and nauseated.  The entire next week she remained weak and dizzy and felt like she was going to pass out.
Elevated blood pressure reach dangerously high levels  at 199/154. Patient complains of debilitating migraines which last for days
This spontaneous report was received from a pharmacist refers to an approximately 73 year old female patient. Approximately on 19-AUG-2013 (over the past 48 hours), the patient was vaccinated with PNEUMOVAX 23 lot # 1418AA, exp date on 25-MAY-2013, 0.5 ml. The patient received an expired dose of PNEUMOVAX 23. The reporter did not know who administered the dose to the patient: the dose of PNEUMOVAX 23 was ordered by her oncologist, but he did not know if she took the dose she purchased from the pharmacy to her oncologist or to her primary care physician. The reporter was not aware if the patient was experiencing any adverse effects at this time. Additional information has been requested.
Severe headache, fever, severe body aches, increased arthritic pain and mild asthmatic reaction
Night after Menactra, complained of fever, chills.  AM complained of headache, achiness; temperature 09/21 14:30 100.9 degrees, pulse 78, blood pressure 140/68, strep screen negative, fluids, REST, Tylenol as needed.   Patient saw doctor on 09/21/2005, no follow up.
From about mid October or a few weeks later, I began having extreme fatigue and weakness in my legs.  I am a very active person and walk several miles a day with three dogs, and we do not walk slow.  Out of nowhere I realized I was not able to walk as fast or as many steps.  I also felt like I have the flu off and on and that has happened at least six times since October.  I have a history of not tolerating statin drugs but I was doing fine with Crestor and Zetia until October and then I decided that once again the muscle fatigue and weakness and pain wherever I have arthritis was horrible.  I do not know if it is the medications for my very high cholesterol or if it is from the Covid booster.  I have been advised by my cardiologist to discontinue the statins and we will try the injectable drug such as Repatha.  I have a follow up appointment next week.
Left side of face numbness and  tingling (mild). No assymetry. Worsened ove 4-6 hours. Gone the next day.
1 day post vax became irritable, constant crying & little sleep for 48 hrs; Called MD told to take to ER; Papular rash dx as URI;
Information has been received from a physician assistant concerning a 64 year old female with low immunoglobulin, diabetes, hypercholesterolaemia, niacin allergy and a history of recurrent infections who on 06-AUG-2008 was vaccinated with a 0.5 mL first dose of PNEUMOVAX (lot # 658673/0990U), intramuscularly into the right deltoid. Concomitant therapy included HUMALOG, GLUMETZA, glimepiride and CRESTOR . On the same date, 3 hours after administration of PNEUMOVAX, the patient experienced pain at the injection site, fever, chills and cough. The patient recovered by using TYLENOL and treating her arm with ice. On 07-NOV-2008 the patient received a 0.3 mL second dose, and on 21-NOV-2008 a 0.2 mL third dose of PNUEMOVAX. The reporter stated that "medicare guidelines require that patients receive two doses of PNEUMOVAX in order for the office to receive payment", according to the reporter this was why the patient was given subsequent doses. It was also reported that the physician thought that it would be better to split the subsequent dose instead of giving a full 0.5 mL dose to decrease chances of having another adverse event. The patient did not experience any symptoms with the 0.3 mL or the 0.2 mL doses.  The patient had an IGG and an autoimmune bloodwork. The patient sought medical attention through a phone call.  Additional information has been requested.
pt recvd vax 17NOV94 & 2 days later on routine blood screening, pt was noted to have an elevation in CPK, LDh & AST (SGOT); pt was afeb & all other vital signs were WNL; pt was completely asymptomatic; pt had no tremors, rigidity, burises;
aches and pain; fever; This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on 08Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history and concomitant medications. It was unknown if the patient had any allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On an unspecified date in 2021, the patient experienced aches and pain, and fever. Therapeutic measures were taken as a result of the events with ADVIL. The clinical outcome of the events aches and pain and fever were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dx with Varicella (Chicken Pox) 10/1/2019. Atarax 10mg/5ml TID prescribed for symptoms.  Pt also treated for ear infection today with Amoxicillin.
Pimples on her tongue; pimples on her tongue really hurt; cannot eat or drink; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Pimples on her tongue), GLOSSODYNIA (pimples on her tongue really hurt) and FEEDING DISORDER (cannot eat or drink) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Latex allergy, Seizures (since patient was little) and Disability (born with a disability and is wheelchair bound even before the 1st dose of moderna vaccine.).   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TONGUE DISORDER (Pimples on her tongue) and GLOSSODYNIA (pimples on her tongue really hurt). In May 2022, the patient experienced FEEDING DISORDER (cannot eat or drink). At the time of the report, TONGUE DISORDER (Pimples on her tongue), GLOSSODYNIA (pimples on her tongue really hurt) and FEEDING DISORDER (cannot eat or drink) outcome was unknown.            Concomitant medications includes seizure mediations and bunch of medications. No treatment medications was reported.
Tetnis shot- swollen lump on arm, swollen and bruised under arm (week after) (R arm pit) 2 cm red nodule at vaccine site.
Swelling, redness and itching above the injection site in the left arm.  Pain and swelling in the armpit closest to the injection site.  Side effects appeared 7 days after the 1st dose of the Moderna Vaccine.
myopericarditis (mild) managed as outpatient with colchicine, ibuprofen.  Patient ongoing symptoms with slight improvement at follow up doctor's visit 12/2/21
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included WHOOPING COUGH VACCINE for prophylaxis. On 6th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season and WHOOPING COUGH VACCINE. On 6th November 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was posted by patient on social media. The age at vaccination was not reported. On the day of reporting, the patient received a flu shot and whooping cough shot and experienced sore arm. The patient reported that these shots were very much worth it for the baby patients. It was unknown if the reporter considered the sore arm to be related to whooping cough shot as well.