chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Swelling & severe pain in right ear, all around the ear, the right side of my neck & back of head.  Rash in front of my right ear on 3rd day after vaccine
Fever of 102, glassy eyes, redness around the eyes, lethargic at breakfast table.
3 days after vaccines rash started, mildly itchy. 10/11/07 skin started peeling on lower abdomen and arm pit. Abx started. Strep test was performed negative results.
Menstrual cycle came 2 weeks early.  I am not on birth control and am very regular. The period was lighter than normal. I am approaching the normal time of my cycle and just received the my second dose yesterday.
Slept for three days; Lethergic; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for Antidepressant therapy, LOSARTAN for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache). On 27-Apr-2021, BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-095733 (Patient Link).
spike in temperature to 100 F; chills; fatigue; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (spike in temperature to 100 F), VACCINATION SITE PAIN (soreness at site of injection), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at site of injection). On 02-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (spike in temperature to 100 F), CHILLS (chills) and FATIGUE (fatigue). On 02-Mar-2021, BODY TEMPERATURE INCREASED (spike in temperature to 100 F) and VACCINATION SITE PAIN (soreness at site of injection) had resolved. On 03-Mar-2021, CHILLS (chills) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (Inconclusive) Body temperature increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.     This case was linked to MOD21-043648 (Patient Link).
Injection site pain started within 15 minutes. When the patient got home later that evening she noticed redness and a lump at injection site. Soon, a large red rash that was painful and warm to the touch appeared, with a hard lump at injection site.  Patient advised to take Tylenol. Patient consulted Dr who advised this is an allergic reaction.
This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers to herself. The patient had no medical history and no known drug reactions or allergies. On an unknown date, the patient performed a home pregnancy test (the result was not reported). The patient became pregnant with last menstrual period (LMP) on 06-NOV-2017. On 25-JAN-2018, while being in first trimester of pregnancy, the patient was vaccinated with GARDASIL 9 (dose, route, site, batch number, lot number and expiration date were not provided) for prevention of HPV. On the same date, she received a dose of unspecified tetanus vaccine (indication, dose, route, site, batch number, lot number and expiration date were not provided). The patient was not receiving any concomitant medications. At the time of this report, the outcome of pregnancy was pending. Estimated date of delivery was: 13-AUG-2018. No fetus demographics were provided. The patient reported that she had an upcoming appointment on 26-FEB-2018 for her first prenatal visit with a healthcare provider.
PNEUMOVAX 23 was mistakenly administered intravenously rather than intramuscular route. No adverse effects were noted.
COVID VACCINE WAS INAPPROPRIATELY ADMINISTERED TO PT OF INCORRECT AGE GROUP [LESS THAN 18 YEARS OLD] BY PHARMACIST. NO ADVERSE REACTION TO REPORT AT THIS TIME; PT STATES THAT MINIMAL TO NO SIDES EFFECTS OTHER THAN EXPECTED SITE REACTIONS
Fever (104 deg), swollen lymph nodes ( (L) axillary), swelling of upper (L) arm. Treatment: Ice, Aleve, cefuroxime 250mg x 10 days twice daily
Fever, otitis media (pseudomonas), neutropenia.  Nurse follow up on 09/29/04 states: "Extreme irritability and extreme listlessness."
left upper posterior arm swelling, cool, no erythema, no hives or blistering.  At the time patient reports the reaction (approximately 4 hrs post vaccination) the area of swelling was the size of my palm (4inches in diameter). Pt was advised to apply cold compress, elevate left arm above heart as often as possible, and take oral benadryl every 4 hrs for 24hrs, report reaction to PCP, notify clinic if condition worsens.  Pt arm evaluated at private doctor's office 10/5/07
Pt had large knot at injection site. Arm is bruised from shoulder to elbow. Pt was seen by his family physician. Pt was told by MD that "vaccination just needed to dissolve."
Left arm at injection site 3 inch round red area, occasional itching. Slightly hard, painful and warm to the touch.
Onset soreness at 18 hrs l arm induration 27x29mm, erythema 40x55mm.
Left arm swollen, red and warm to touch from shoulder to elbow. Mother also stated that patient's left leg was stiff after waking up on 7/26/02. No treatment required. Patient and mother instructed to return as needed.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Redness and swelling of both arms starting at wrists and itching on left arm. Subsided after about 45 minutes. Advised Benadryl, but wanted to wait until she got home as she had a bit of a drive and didn't want to drive drowsy.
3 days after vaccine, I developed pins and needles/numbing in my arms, hands, legs and feet. I still have it today. I am continuing to go to different doctors and practitioners. Sometimes it gets a little better and then gets worse again.
Pt should have received adult pfizer dose 0.3ml but received pediatric dose 0.2
EDEMA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: male breast cancer (Patient was breast cancer survivor). 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 edema. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of edema was not reported. This report was non-serious.
Pt's right arm around injection site is red, swollen, and painful. Pt said the reaction started about an hour after the injection, but didn't notify the pharmacy until 3 days later. The redness and swelling is starting to wrap around her arm. Pharmacist told her to use ice and apap/ibu and called the dr.
period type cramps & fatigue for 2 days starting about 2 days after the injection. i do not typically have these symptoms.
THIS LOCATION WAS INSTRUCTED TO PICK UP PFIZER VACCINE FROM HUB STORE FOR USE 3/24/21/ AND 3/25/21. THERE WAS NO EXPIRATION DATE OR SIMILAR INFO ON THE PACKAGING IN WHICH WE RECEIVED THE VACCINE AND DILUENT. SINCE WE WERE TOLD TO USE THE VACCINE ON THESE DAYS ONLY (WE NORMALLY USE MODERNA). THE ASSUMPTION WAS THAT THE VACCINE WOULD BE WITHIN ITS BUD/TIME. OUR STORE MANAGER WAS INFORMED AT END-OF DAY ON 3/25/21 THAT VACCINE HAD EXPIRED AT 11:00 AM THAT DAY. CONSULTATION WITH PFIZER INDICATED THAT THE DOSE DID NOT HAVE TO BE REPEATED FGOR PATIENT.
After receiving the johnson johnson vaccine I began to feel a bit of chest palpitation on my drive back home. Early  the next morning I felt extremely winded I checked my vitals. My B/P was significantly lower than normal and my heart was racing averaging 119 to 128. I felt dizziness and as if I'd faint if I bent down. Massive craking headache and chills ensued. I decided to go the urgent care where they did and ekg and found abnormal reading that doesn't correlate with my normal ekg when I go to my provider. They insisted that I betaken to the ER via ambulance. The ER also reproduced the same abnormal readings. I was advised to see my primary. And my primary advised for me to see a cardiologist. Soon after my hearing in my left ear became diminished with ringing and a blood shot developed in my right eye.
Pt states she got the vaccine and felt some discomfort that day but did not think anything about it, she states then that the pain was dull and in her left arm. She felt her arm heavy and just sore, then she felt some pain...but still thought nothing of it but simply a flu shot. She says the dull pain is still there and has not gone away since oct 3, and that at time she feels like it radiates down her arm. But patient never went to see a MD regarding her pain.
Swelling and rash at injection site 4 hrs after shot lasting 7 days.    no word recognition 6 hours after shot. Migraine headache 4 to 6 hours after shot.  Fever of 101.2 at the same time.
Pt developed swollen and itchy hands, 2 days, post vax. She was treated with Benadryl and prednisone with a full recovery.
DTaP: IM right deltoid 08/18.  Seen 08/20 5PM to read PPD.  Nurse noticed bruise at left deltoid and red area below injection site.  Given Benadryl.
Mother of patient reports that patient experienced joint pain all over her body immediately following the administration of MCV 4 vaccine. Mother states that patient also reported a bowel movement od diarrhea on 3/18/14. Mother states that patient did not use anything to treat joint pain. Per mom joint pain resolved on Wednesday 3/19/2014 in the afternoon.
nausea; chills; her lips became really chapped; This is a spontaneous report from a non-contactable consumer. This female consumer (patient) with unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization at hospital. The patient medical history and concomitant medications were not reported. Patient did not experience any problems there after waiting 15 minutes. When she got home, she started to have chills and her lips became really chapped on 21Jan2021. This morning 22Jan2021, she's having some chills and nausea. She was taking diphenhydramine (BENADRYL). Outcome of events was unknown.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Pain increased significantly, stopped having periods, hot flashes, increased fatigue, decrease in concentration, shocks of pain irradiating to head and all over body.
Amyotrophic lateral sclerosis; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2K-163-4277320-00 (AbbVie).  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 62 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "not recovered", described as "Amyotrophic lateral sclerosis"; HEADACHE (medically significant), outcome "recovered", described as "Headache". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of amyotrophic lateral sclerosis.  The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on the company causality assessment.   Causality for Humira (Adalimumab): AbbVie's opinion is that the event of amyotrophic lateral sclerosis is not assessable. AbbVie's opinion is that there is no reasonable possibility that the event of bad headache is related to humira (adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: retested and received a faint positive result; (24May2022) Negative, notes: I tested negative on 24May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2weeks: Yes. Other medication in 2weeks product=Losartan 100mg. Adverse event: Rebound of covid. I tested negative on 24May and really had no symptoms since then for the most part other than tiredness. Symptoms of shortness of breath, sore throat and headache returned today so retested and received a faint positive result. Adverse event start date: 31May2022. Adverse event start time: 08:00 AM. If patient recovered: Unknown. If treatment ae: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had headache, sore throat, cough, I was prescribed PAXLOVID  for my symptoms.
Involuntary jerking motions in my arms and sometimes my legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs). On 25-Jan-2021, DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included hospitalization. Very limited information regarding this event/s has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: DOB and patient initials corrected by the reporter; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Swelling arm; very sore arm; large red circle; itching; hard lump; soreness; discolored itching circle; This non-serious case was reported by a consumer and described the occurrence of swelling arm in a 82-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included diabetes, blood pressure and copd.   On 19-OCT-2023, the patient received RSV vaccine. In OCT-2023, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: large red circle), pruritus (Verbatim: itching), mass (Verbatim: hard lump), pain (Verbatim: soreness) and skin discoloration (Verbatim: discolored itching circle). On 19-OCT-2023, the patient experienced swelling arm (Verbatim: Swelling arm) and pain in arm (Verbatim: very sore arm). The outcome of the swelling arm, pain in arm, pruritus, pain and skin discoloration were not resolved and the outcome of the erythema and mass were not reported.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.     It was unknown if the company considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-OCT-2023 The patient used too many to list other products which were ongoing Since the rsv vaccine the arm had a large red circle and kept itching constantly.  First came hard lump and soreness now (at the time of reporting) discolored itching circle about 1-2inch diameter.  The reporter asked if it was normal. The reporter consented to follow up.
administration beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
I got the shot and still have them /Suspected vaccination failure; Still have them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023  Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that the he/she got the shot and still had them (Shingles). Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.  Follow-up would not possible as no contact details were available.
severe muscle and joint pain - felt like I fell down the stairs.  Nausea.  I couldn't lift my left arm without assistance because it hurt so much and the muscles locked up.  After 26 hours, I finally took an ibuprophen and felt better.  I felt like myself 48 hours later.
throbbing in upper arm couldn't remember which side immed p/vax;sharp pain in lt shoulder, progressive, weakness of mouth, tongue, lips over next several wk;adm to hosp 7DEC98 w/suspected GBS;
Headache, chills, fatigue, light cough, general malaise. Symptoms lasted for about 36 hours
NAUSEA, VOMITING, AND DIZZINESS. SYMPTOMS SUBSIDED 07/10/2012 @ 8:00 AM.