chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hrs after vaccination, sudden onset of violent vomiting , fever and diarrhea,.weakness..  was barely aware of self all night.  at 9Am these Sx stopped and I noticed: swelling/redness at injection site 5" diameter, burning skin left trapezius and below, on back of shoulder and down arm to wrist, walnut sized lump on left upper rib (5" down from "adams apple" 2" from center) similar on right side not as sore or big.  In bed all day Sat and Sun with slight nausea, weakness, fatigue, joint pain.
SWELLING IN BOTH LEGS AND FEET; FLUID RETENTION; This spontaneous report received from a consumer concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced swelling in both legs and feet. On 19-MAY-2021, the subject experienced fluid retention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in both legs and feet, and fluid retention. This report was non-serious.
Patient is a 86 y.o. female patient of a local MD with history of HTN, ESRD, chronic HFrEF who presented to Hospital with weakness. Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 11/30/2022 Symptoms present on admission: nausea, vomiting, weakness Date of covid positive test: 12/6/2022 Vaccination status: vaccinated Imaging: CXR Oxygen requirements on admission: 2L Current oxygen requirements: 2 Medical therapy: Finished course of steroids and remdesivir Consultants following: ID Anticipated special isolation end date: 12/17/2022   Wean oxygen as able. Out of isolation. She is status post remdesivir and steroids. Continue incentive spirometer.   Generalized Weakness with Fall PT/OT recommends 5 days a week therapy. Social services consulted for discharge planning     ESRD Continue HD per nephrology New tunneled cath placed 12/20   Chronic HFrEF Last TTE 12/11/2020: LV severely reduced with LVEF 24% Continue carvedilol Patient oliguric Management through hemodialysis   Intermittent difficulty swallowing Status post speech and swallow eval-placed on diet   Stable for discharge today to rehab
having problems with both my feet, both big toes are numb top and underneath my big toes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:30 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 05Mar2021 09:00 (Lot number: EN6198) as dose 1, single for COVID-19 immunization. Relevant medical history included: "high blood pressure" (ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; OLMESARTAN taken for hypertension. Past drug history included: Iodine, reaction(s): "known allergies: iodine". The following information was reported: HYPOAESTHESIA (non-serious) with onset Jun2021, outcome "not recovered", described as "having problems with both my feet, both big toes are numb top and underneath my big toes.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of hypoaesthesia.  Additional Information: Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no COVID prior vaccination. It was reported that patient had numbing on top right foot and around toes. Noticed numbing around Jun/ Jul2021. Especial big toe area. Numbing on left foot, mainly on top front around high toe area. Numbing was continued as of current date. Specific relevant test for thromboembolic events with thrombocytopenia was unknown.  Follow-up attempts are completed. No further information is expected.
First dose: Swelling at the injection site; The first dose was annoying and she slept for a day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection) via an unspecified route of administration, in arm right on 06May2021 (at the age of 57-year-old) (Lot Number: EW976) as 1st dose, single dose for covid-19 immunization. The patient medical history included ulcer (Diagnosed in 2020 and patient could not take Ibuprofen because of this). The patient concomitant medications were not reported. On 06May2021 (reported as after 6 hours of first dose of vaccine), the patient experienced swelling at the injection site. The patient reported that the first time she had a swelling the size of her hand at the injection site. The first dose was annoying, and she slept for a day on an unknown date in 2021. The patient was prone to swelling, she never progressed after the second round of allergies shots because of the swelling. The swelling happened after every allergy shot, she ever had this was 20 years ago. The swelling would start about a day later. The patient would get one allergy shot on a Monday (date unspecified) and then one shot on a Friday (date unspecified). The outcome of the event was swelling at the injection site was recovered on 10May2021and for hypersomnia was recovered on 2021.  No follow-up attempts possible. No further information expected.
received only the liquid component of Menveo vaccine; received only the liquid component of Menveo vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date unknown) for prophylaxis.   On 1st May 2021, the patient received Menveo. On 1st May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the liquid component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The batch number was reported as AMXA38OA and was updated to AMVA380A, as per sales data sheet. The reporter consented to follow up.
No olher adverse effects; lmproper spacing of GARDASIL-9 doses; This spontaneous report as received from a nurse refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Approximately in August 2019 (reported as 10 months ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 19-JUN-2020, 10 months after the initial dose, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
LEG CRAMPS; HEAVY LEGS; MUSCLE ACHES; DIARRHEA; CHILLS; INCREASED HEART RATE; NAUSEA; HEAVY ARM; INJECTION SITE PAIN; TIRED; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced heavy arm. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced tired. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced increased heart rate. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced diarrhea. On 04-APR-2021, the subject experienced muscle aches. On 05-APR-2021, the subject experienced heavy legs. On 06-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, chills, injection site pain, tired, headache, and nausea on 02-APR-2021, diarrhea on 03-APR-2021, heavy arm on 01-APR-2021, and muscle aches on 05-APR-2021, and had not recovered from heavy legs, and leg cramps. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
Information has been received from a physician concerning a 20 year old male who on 17-APR-1991 and 09-NOV-1998 was vaccinated with a first and second dose of MMR II respectively. On 26-DEC-2009 the patient experienced mumps. The patient had a fever of 103 F. Parotitis was on the right. The blood work was done on 28-DEC-2009 and the result was not reported. The mumps was diagnosed on 28-DEC-2009. At the time of the report, the outcome was not reported. Additional information has been requested.
Fully vaccinated patient admitted through the ED for increasing weakness.  No classic s/s of COVID.  Chief complaint was loss of balance (which has been ongoing since previous stroke).  Patient tested detected for COVID during routine admission testing.  No respiratory s/s.  Provider discharge note below:  "92 YO year old male with past medical history of pontine CVA, remote CAD s/p CABG, HTN, CKD 3b, GERD  presenting to Hospital with complaint of GLF due to imbalance and generalized weakness. Patient reported a GLF in the bathroom. Patient is using walker at his baseline, however, more dependent on the walker since the pontine stroke on 4/21 that he has more balance issue since then. The patient does not believe he passed out or hit his head, tongue bit or loss bowel or urinary control but much of the imbalance issue. Patient denies chest pain, dizziness, blurry vision, feel warm, nausea, shortness of breath, cough or palpitation at the moment.   In ED, Cr 1.6, BUN 28, UA: 14 RBC, Trop 35-- >32. All other labs are unremarkable, CXR shows Increased bibasilar opacities; CT cervical spine and CT head shows No acute intracranial disease. No acute cervical spine fracture. Multilevel cervical spinal stenosis. Patient was treated with 500 mL NS bolus.    Patient had a hard time hearing without hearing aids. However, answer question appropriately. Patient NAD without any complaints. Patient will be admitted for observation and further evaluation.    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Ground level fall - weakness, PT, OT eval.  History of stroke, pontine, 4/21 Uses walker at baseline CT cervical spine and brain shows foraminal stenosis, severe in places.  And chronic ischemic changes.  MRI negative for stroke, but does show hemosiderin deposits from chronic ischemic small-vessel disease verses cerebral amyloid angiopathy - Fall precaution, Strict I&Os - PT, OT recommending rehab,"
PNEUMOVAX given 5/14/10. Fever developed 5/15/10. By 5/16/10 pt. had hives surrounding injection site, tenderness of upper arm, continued fever. No sign of viral illness. On abx fro chronic sinus infection (CLINDAMYCIN). No sign of local infection around injection site. Continues with fever 5/17/10.
Patient felt a reaction on his tongue that presented as tingling and his throat was hurting.  He used liquid Benadryl and then felt completely fine.
got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; I have actual bone and bone pain which I haven't had before; booster in some way reduced the inflamation that protects me from having bone and bone pain; got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 28May2022 as dose number unknown, (second booster) single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Arthritis in my knees" (unspecified if ongoing), notes: I have Arthritis in my knees. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (First booster. , unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 28May2022, outcome "unknown", ARTHRALGIA (non-serious), GAIT DISTURBANCE (non-serious) all with onset 30May2022, outcome "unknown" and all described as "got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk"; BONE PAIN (non-serious) with onset 30May2022, outcome "unknown", described as "I have actual bone and bone pain which I haven't had before; booster in some way reduced the inflamation that protects me from having bone and bone pain". Therapeutic measures were taken as a result of arthralgia, gait disturbance, bone pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 101.5 degrees F, continuing through until morning of 5/6/2010.  Treated fever with infant Motrin every 6 hours.  Up and down crying the night of 5/4/2010.  Falling asleep during normal wake times.  Ate very little.
Erythema and edema approx. 4cm distal to injection site. Lesion is approx. 5-6cm x 8 cm, ovoid. It is pruritic and muscle tissue below is tender.  First noticed 4/10 first thing in morning. Not sure when it actually started, but pruritus not noticed prior to 4/10.  No treatment. Time course unknown, since today is first day.
TONGUE SWOLLEN; TONGUE WITH SPOTS; TONGUE WITH BURNS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On 2021, the subject experienced tongue swollen. On 2021, the subject experienced tongue with spots. On 2021, the subject experienced tongue with burns. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue swollen, tongue with spots and tongue with burns was not reported. This report was non-serious. This case, from the same reporter is linked to 20210516288.
Burning at site and some joint aches in shoulder of vac. site. Fever off and  on.
Pt received Tdap (ADACEL) 3/14/08 and was diagnosed with pertussis 6/15/10.
The day after receiving injection, the patient called to notify us of feeling pretty bad with flu like symptoms, cold and headache. Patient was counseled these are potential side effects and can be expected after receiving Prevnar 13. Patient was counseled to take OTC Tylenol or ibuprofen to help with the pain and fever.
REDNESS ON THE SITE OF THE VACCINATION WAS NOTED 2CM BY 3 CM, NO SWELLINGS, NO FEVER, AND NO INDENTATION NOTED. INSTRUCTED PATIENT'S PARENT TO APPLY ICE PACK AND ADMINISTER TYLENOL 320MG IN CASE OF ANY FEVER.
Patient was given vaccine and was told to wait in the monitoring area for 15 minutes post vaccination. Shortly after, the patient reported "feeling pale" and was told to remain seated. The patient then fell over from the chair and lost consciousness. We immediately called 911 and went to the patient's side with epinephrine. However, he recovered within seconds and was able to sit up and drink water.  He reported feeling "pale [...], weird [...]" and said he felt like his "ears are sweating." He did not want epinephine and remained seated and responsive. When asked, he said he had never received any adverse reactions to any vaccines in the past. A pharmacist then cleaned and disinfected his right temple that was bleeding, which he seemed to have hit when he fell. He later reported feeling chest pain and slight difficulty breathing but did not want epinephrine at that time. Emergency services arrived about 20 minutes after and assessed the patient and removed him in a gurney.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 07-JUN-2018, the patient was vaccinated with VAQTA 25/0.5 DF, lot # N002921, expiration date 08-APR-2018, for prophylaxis (dosage information, and route of vaccination were not informed). No adverse effects were reported in the patient.
Dizziness, Myalgia, Fever, NauseaVomiting, Lightheadedness, Lump at injection site,  Reported body aches x 2 days after the initial dose. Day after the 2nd shot (1/27/21) awoke with temperature of 101.2 and complaints of flu-like symptoms - myalgias, dizziness/lightheadedness, nausea (vomiting x 2). Noted lump and redness at the injection site - about 1 1/2 inches diameter with lump (ping pong ball size) under site. Missed 4 hours of work on 1/27/21 due to feeling poorly. Symptoms improved on 1/28/21. No known prior covid infection
This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. On unknown date the patient was vaccinated with M-M-R II which is considered an inappropriate age. Route of administration, lot number, expiry date and anatomical location of vaccination were not reported. No adverse effects were reported. Additional information has been requested.
headache; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced headache on an unspecified date.The outcome of the events was unknown.The patient wanted to know if she can take Tylenol because of a headache.  Information about the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Approx 21 hours after the shot was administered, patient became feverish, weak, dizzy, feeling chills. The shot was administered on Monday, Feb 8, 2021, at 1;05 pm, (EST). At approx 8 pm (EST) on Tuesday, Feb. 9, 2021, patient?s body temperature rose to 101.4 F. Patient continues to feel chilled. Patient has not taken any pain reliever or fever reducer do not to interfere with the action if the vaccine.
She was given Prevnar-13 on 3/25/16. She says that later that evening or the next day, her left upper arm became pink, mildly tender, and mildly itchy at the injection site. No fever. The pink color was faint but extended to her elbow. She initially had some swelling but that resolved by the time she was seen in office on Monday 3/28/16.
Sore Left Arm, Fatigue Day 1 and 2,   Day 3 Swelling and Redness of arms, face, and hives on chest ending in ER VISIT
Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el8982; expiry date: unknown) intramuscular in the right arm, on 22Jan2021 at 11:15, at a single dose, for COVID-19 immunisation. Medical history included ongoing trigeminal neuralgia and polycystic ovaries (PCOS). The patient had no known allergies. Concomitant medication included gabapentin. The previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ek9231) intramuscular in the left arm, on 31Dec2020 at 10:30 AM for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 23Jan2021 at 09:30, the patient experienced complex migraine and triggered trigeminal neuralgia event. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
Started spotting each day it has become heavier; it has become heavier until it was a real menstruation; Did not get periods anymore; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Did not get periods anymore), INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced AMENORRHOEA (Did not get periods anymore). On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation). At the time of the report, AMENORRHOEA (Did not get periods anymore), INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant and treatment drugs were not provided
Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored GARDASIL 9 lot # M028323 and expiration date of 26-SEP-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA001767: US-009507513-1706USA001765: US-009507513-1706USA001766.