chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling little tired; Some diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling little tired) and DIARRHOEA (Some diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02532OA) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling little tired) and DIARRHOEA (Some diarrhea). At the time of the report, FATIGUE (Feeling little tired) and DIARRHOEA (Some diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received shot 10/3/15 next day pain (L)arm continued to get worse went back to MD. then Ortho. then Chirop. then and still doing PT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Anti-viral Paxlovid for Covid-19 treatment from 24Jul2022 to 25Jul2022, (Lot number: Gc0529). When taking Paxlovid the medication created a horrible taste in his mouth starting about 1-2 hours after taking the dose. This was also happening to his partner and matter if we eat or not. Adverse events start date: 24Jul2022, Adverse event start time 02:30 PM. Patient was recovering. Received no treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection:  fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration)  emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
sore arm; Fatigue; Kind of delirious; dizzy; Temperature 102. 9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in morning on 28Jan2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis, start date 05Sep and stop date 06Sep. Vaccination history included: BNT162b2 (Dose: 3rd, Date/time:, Date: 31Aug2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 31Aug2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 2nd, Date/time:, Date: 15Apr2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 15Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 1st, Date/time:, Date: 05Mar2021, Time: Morning , Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EN6207), administration date: 05Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue". The following information was reported: DELIRIUM (medically significant) with onset 28Sep2022, outcome "unknown", described as "Kind of delirious"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Sep2022, outcome "unknown", described as "Temperature 102. 9"; DIZZINESS (non-serious) with onset 28Sep2022, outcome "unknown", described as "dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (28Sep2022) 102. 9 Fahrenheit, notes: Norm Low: 98.6, Norm High: 98.6, Kind of delirious, dizzy; COVID-19: (08Sep2022) positive, notes: I continue to test positive. Clinical course: The patient stated she had no adverse events associated with any of my vaccine, just sore arm plus fatigue for one day.
Patient complains of left shoulder pain and difficulty moving shoulder continuing 4 days post vaccine.  Patient is taking anti inflammatories, icing shoulder, and performing gentle range of motion stretches.
Intensified depression, anxiety, and suicidal ideation starting the day after the booster shot was administered. These symptoms fluctuate but are strongest the week of my period and the week after. I have not experienced this intensity of emotional distress around my period until after I received my booster shot.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years 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: "Lupus SLE" (unspecified if ongoing); "Lupus Nephritis" (unspecified if ongoing); "Known allergies shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; HYDROXYCHLOROQUINE. Past drug history included: Rituximab, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as COVID-19 treatment 08Dec2022 to 12Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash around front side of neck. Inflamed/sensitive. Benadryl 50mg, cortisone cream.
2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve
This spontaneous report as received from a licensed practical nurse refers to a 2 months old male patient with no pertinent medical history and no drug reactions/allergies who on 30-APR-2013 was vaccinated with dose 1 of ROTATEQ (batch and Lot No. H016249, exp. 27-MAR-2014) 2 ml,, oral. There were no concomitant medications. In approximately May 2013 (reported as "a little more than 48 hours after receiving ROTATEQ") the patient developed diarrhea. The patient did not received any treatment for the event and no lab diagnostics studies were performed. At the time of the report the patient was currently having 4 episodes of diarrhea per day. The patient's outcome was reported as not recovered. Relationship between diarrhea and therapy with ROTATEQ was not reported. Additional information is not expected.
Face swollen around cheeks areas; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 02Mar2021 10:30 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure, kidney disease stage 2, mild gastroesophageal reflux disease (GERD), and penicillin allergy. Concomitant medications included hydrochlorothiazide, losartan, and tamsulosin. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. Prior to vaccination, the patient had no COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID vaccination. On 02Mar2021 18:30, the patient experienced face swollen around cheeks areas. Therapeutic measures were not taken as result of the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up on the 19th and felt like I had a really bad cold all of a sudden. I had a headache, congestion and coughing but I just assumed it was a cold. I took a shower and some medication but was still feeling badly so I tested for COVID-19 with an at home test which came back positive. I spoke with my doctor over the phone who prescribed Paxlovid. I had to wait 72 hours to begin that treatment since I had already taken the migraine medication. So I began that treatment on 4/29. I still have a bit of a cough but am otherwise feeling better.
At 48 hours felt front tip of tongue and 1/2 back numb. Metallic taste with liquids and solids. Dizziness at times
took the shots,  have them now/Suspected vaccination failure; have them now; hurting so bad; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, took shots and had shingles now and hurting so bad. The patient went to emergency room for 5 hours. The reporter stated that, the physician took blood, x ray and CT scan. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Arm pain; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular in the upper arm on 05Feb2021 12:30 (Batch/Lot number was not reported) and dose 2 intramuscular in the upper arm on 05Mar2021 12:30 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history included coagulation disorder and heart problem, both ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) as blood thinner;  metoprolol (unknown manufacturer) as hearth medicine, Aspirin (acetylsalicylic acid) low dose as hearth medicine and ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) all oral and ongoing. The patient experienced arm pain on 05Feb2021 12:30, after the first dose and on 05Mar2021 12:30, after the second dose both with outcome of recovered in 2021 without treatment.  Follow up (12Mar2021): New information from the same contactable Consumer included: administration details (day and hour, route and site), medical history, concomitant medications, adverse event updated, second dose information.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fever to 102 within 12 hours of vaccination, and firm red rash with central vesicles. Rash became quite large at 48 hours, measured 16x12.5cm. Rash corresponded to Proquad vaccination site.
Information has been received from a male consumer who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number not provided). When the patient got home he experienced dizziness and fainted. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention.
This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. In APR-2021, the patient became bedridden. On an unspecified date, the patient experienced taking iron puts me in the hospital with gastrointestinal bleeding, and was unable to maintain a normal hemoglobin level. On an unspecified date, patient was hospitalized. Laboratory data (dates unspecified) included: Hemoglobin level (NR: not provided) abnormal. Patient reported that "I have been bedridden since the jnj vaccine in April. I am unable to maintain a normal hemoglobin level and taking iron puts me in the hospital with bleeding in my GI." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bedridden, unable to maintain a normal hemoglobin level and taking iron puts me in the hospital with gastrointestinal bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220118407-COVID-19 VACCINE AD26.COV2.S-bedridden, unable to maintain a normal hemoglobin level and taking iron led to gastrointestinal bleeding . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt nose started to bleed shortly after H1N1 injection and would not stop. 14:49 pt transported to hospital by EMS for treatment by ER arrived at 14:58
12/27/2022 I had a scratchy throat and a stuffy head. I have sinus issues on the right side of my head often. I used a Netti pot, a hot compression and extra pain reliever. I had a telehealth with my doctor on 12/30/2022 and he prescribed a Z Pak and Flonase. He also told me to continue the sinus rinses. I started both on that day.  I am not having a scratchy throat. I have a lot of discharge out of the nose and spitting up dark thick green mucous which smells and taste really bad. I had canker sores.  I have not had any fever. I have an occasional headache. The hinge of my jaw really hurt for a few days but is not as bad now.
Swollen groin lymph area.  Possible hernia with no history or contributing cause.
My arm was sore immediately after, and as the days have passed it has gotten progressively worse. I have limited mobility in my arm, weakness, and shoulder pain. I can't lift my arm laterally.
approximately around 11:40  am patient had a vasovagal episode a few moments after recieving the vaccine.  She stated she felt very dizzy, then fell to the floor
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with one dose of PROQUAD, which was improperly stored (lot number M007961 with expiration date of 15-AUG-2017) (strength, dosage schedule, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not reported. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of -14.4 Celsius (C) for 2 hours and 54 minutes and it was reported that there was not previous temperature excursion. Furthermore, no product quality complaint was involved. Additional information has been requested.
patient got hives and rash on face about five minutes after giving vaccines. pt's vitals were checked and stable, pt was watched for increasing rash and resp distress. rash stayed localized to face and after patient was calm he left.
Patient noticed a small red rash around the injection site and her arm felt warm to her. Denies itching, shortness of breath, throat or face swelling. Redness observed around the injection site, no swelling, warm to the touch, localized rash. Blood pressure elevated at 172/108, pulse 73, oxygen saturation 100%. Doctor on site called and 10mg Zyrtec administered sublingual. Patient's blood pressure decreased over time and patient's symptoms resolved.
The patient came in to receive a moderna covid bivalent booster vaccine. This was the first day of the newly approved booster for pediatric patients.  The patient was inadvertently given the pediatric monovalent vaccine at 0.25 ml instead of the bivalent moderna booster. He had already received 3 pfizer doses previously. On calling patient's family, the patient was not currently experiencing symptoms or side effects.  We called Moderna to ask for next steps for getting bivalent and we were told to call CDC. On calling CDC, they said they would get back to us in 7 to  10 days.
Information has been received from a physician concerning a male who was vaccinated PO with the first and second 2mL doses of Rotavirus. Subsequently, after each dose, the patient was constipated for about 3 days. At the time of the report, the patient was "about 4-6 months old and didn't receive his third dose yet". No medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested. This is one of several reports received from the same source.
Blanching rash starting on face to chest, back over 2-3 days, no treatment.
Patient had adverse reaction with selling of the tongue, lips tingling, and hives. After taking Benadryl, patient's symptoms resided within an hour.
2 hours later developed tightness in my chest which caused to begin coughing; 2 hours later developed tightness in my chest which caused to begin coughing; developed a lump feeling in the left side of throat; developed a lump feeling in the left side of throat. As it progressed felt the gland in neck located near ear had swelled and was pushing and making the ear hurt.; developed a lump feeling in the left side of throat. As it progressed felt the gland in neck located near ear had swelled and was pushing and making the ear hurt.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, underactive thyroid, penicillin allergy and sulfonamide allergy. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:35, 20 minutes after vaccination, the patient developed a lump feeling in the left side of her throat, as it progressed she felt the gland in her neck located near her ear had swelled and was pushing and making her ear hurt. On 15Apr2021 at 14:15, 2 hours later, the patient developed tightness in chest which caused her to begin coughing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported event and included treatment herself with Benadryl and albuterol inhaler. The clinical outcome of the events lump feeling in the left side of her throat, as it progressed she felt the gland in her neck located near her ear had swelled and was pushing and making her ear hurt and tightness in chest which caused her to begin coughing was resolved on 15Apr2021.  No follow-up attempts are needed. No further information is expected..
By the end of the month patient went from speaking 50-75 words to becoming completely silent for half a year and has yet to regain any words a year and a half later.  he was since been diagnosed with autism.  He was an happy intelligent normal little boy before this vaccine and that was quickly changed after the vaccine.
Immunization hurt upon receiving vaccine pain persisted; 2 days later unable to lift left arm; pain is persisting 2 weeks and 2 days later. No previous adverse events to vaccinations.
Prolonged crying at time of administration of the shot.  More sleepy than normal for next sveral days.  Warm, cranky and generally uncomfortable on 7th day post-shot.  Squealing sounds on 8th day post-shot.  Non-stop screaming, fever on the 9th day post-shot.  Whining/crying, fever 10th & 11th day post-shot.  17 days post-shot - high fever, non-stop screaming.  18, 19, 20 days post-shot - fever, alternate screaming.  22 days post-shot - screaming, rash, diaherria.  Follow up:  Diagnosed with autism at 2 years of age.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot # and exp date unspecified) injection, dose 2 (dosage unspecified). The registered nurse stated that the patient received 2 doses of GARDASIL in one day. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Fever up to 103.8 ax started > 24 hours after pt received DTAP, HIB.
Received my Covid booster on Saturday. On Sunday and Monday my armpit was extremely sore and throbbing. By Tuesday the throbbing has mostly subsided. However, I developed a large red rash on my left arm along with swelling.  The swelling got worse throughout the day. This is three almost four days - post vaccine. If not better in a few days I will call my primary care doctor.