chrisvoncsefalvay/vaers-outcomes huggingface dataset:
moderate diarrhea; This is a spontaneous report received from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 01Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included COVID-19 before vaccination. The patient's concomitant medications were not reported. No other vaccine was received by the patient in four weeks. The patient not tested for COVID after vaccination. The patient has no known allergies. On 03Jul2021 03:00 PM, roughly 48 hours after receiving the vaccine, the patient experienced moderate diarrhea. It has not gone away yet, but it was only been a day. The patient was hoping it won't last much longer. No treatment was taken for the event. 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.
Initial- Left knee soreness with mild swelling and some heat noted on swelling areas. Taking aspirin due to risk of clotting and drinking water. Sharp pain noted with walking on and off. Some relief noted by evening 12/12. By next day, 12/13, swelling coming and going, still mild heat with swelling. Walking now showing major weakness at knee with knee "giving out" suddenly while walking, needing a cane. Pain not present with knee "giving out"12/13- 12/20 but minor swelling and heat still present.  Continuied with aspirin and ice as recommedation by primary via portal initially and now going in for appt. as soon as possible to assess further.
Awoke at 1 am and felt like I was freezing. My teeth were chattering, and I was shivering. The temperature in the room was normal, 68-70F and I had a blanket on the bed. I got up, put sweats on, and another heavy blanket and laid shivering until 5:00 am when I dozed off again. I had to get up at 6am so that didn't last long. This was the worst reaction I have ever had to a vaccine. The aching muscles and joints lasted another 48 hours. Even today, over a week later, the injection site is still sore.
I was almost dead; Stomach pains; Left eye was painful; Headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Decreased napping after the vaccinations.  Poor oral ingestion of fluids.  Fussiness since 6 a.m. on the day of the visit to see pediatrician on 10/31/2014.
Home apron 15-30 min felt chocking lying down  sat up hard to breathe  began wheezing  continuing to get worse rapidly. Had received flowers i thought oh no allergic to flowers too them outside  still difficult breathing wheezing chocking. Took breathing treatment. Brovana then Budesamide  not relieving, take Prednisone 10mg.   Seem to calm little but still wheezing  Took Incruse inhaler.   Repeat few hours later all above wheezing and SOB return.  Continued next day doing treatments and prednisone more frequently than suppose but I know I have a DR Apt Friday an she will give me shot get me over hump.  Fri very bad almost call 911  repeated all treatments above drove to DR  given More Breathing treatment and Steroid injection but not getting relief  To hospital for admit most likely from vaccine not flowers  yikes  Hospital 6 days IV Steroids Pepcid ataraxic  breathing treatments.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included/other medication in 2 weeks: ASPIRIN (E.C.); ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: On 27Jul patient had recurrence of sore throat, headache and congestion and tested positive again for COVID19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with anti-viral and details included: brand: Paxlovid, treatment start date: 18Jul2022, treatment stop date: 22Jul2022, indication: Treatment of COVID-19, administrator route: Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Symptoms: myalgia and headache and then chills and fever. Treatment: used acetaminophen and helped symptoms. Outcome: fever broke and myalgia has subsided, still headache. Over the course of 8 hours (since 2:30A).
After receiving 3rd dose booster I experienced light headedness and had one fainting spell that caused me to fall. I called my doctor and he put me on a heart monitor for 2 weeks. The heart monitor results did not show any abnormalities. The also completed a Cat Scan and MRI which also came back ok. I am still experiencing the lightheadedness. I recently had surgery on my hip so I am recovering however I do intend to contact the doctor to see if I can see an ENT.
Pt recvd 2nd dose of Hep B vax on 5JUL91 & 24AUG91 lab eval revealed SGOT 37 & SGPT 75; On 6SEP91 SGOT was 33 & SGPT 40; No further details were provided;
pt recv vax 4AUG97 915AM & 9:45 pt arm was checked & found to be red w/quarter size swelling;DPH given per MD ice applied to site & pt observed in ofc for another 20min @ which time swelling & redness was better;
Information has been received from a nurse concerning a 23 year old female patient with an unspecified food allergy who on 19-JAN-2007 was vaccinated IM with a first dose of Gardasil lot #654702/0011U. Concomitant therapy included Yasmin and Advair. On 19-JAN-2007 the patient experienced some irritation around the injection site after the first injection. She reported soreness, burning, erythema at injection site. On 05-APR-2007 patient's father (a physician) administered the second dose of Gardasil lot #656372/0243U to the patient. Within 24 hours of receiving the second injection she developed hives which covered her entire body. The injection site was red, swollen, and burned. She was prescribed Benadryl. The patient was recovering. Additional information has been requested.
ANGINA, UNSPECIFIED ACUTE RESPIRATORY FAILURE  10/28/2022 -- RECURRENCE OF SAME SYMPTOMS
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcohol user, and non-smoker. The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient underwent COV 19 IGG AB test (SARS-COV-2 IGG antibody test) which showed IgG antibody 0.1 non-reactive and COV 19 IGM AB test (SARS-COV-2 IGM antibody test) which showed IgM antibody0.2 non-reactive (confirmed immunological vaccine failure was not reported). On 14-SEP-2021, the patient underwent COVID 19 AB test (COVID-19 antibody test) and result was not reported. The patient described tests as blood tests. The patient reported that, according to the doctor test results showed that he did not have antibodies against COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210929231-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
round, Red, swollen, hot to the touch on my arm where I received the injection. When I got home it was about the size of a quarter. When I got up the next day (1/21/21) it was much larger. My arm is throbbing and hurts when it rubs against my clothing.  Was seen by my PCP and he said to monitor it for a few days. A circle was drawn on my arm to see if the red site grows over the next few days.  PCP could not tell me if I should get the 2nd shot.
felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contactable consumer. A consumer (patient) reported for herself that the 55-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid-19), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:40-10:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tired on 26Mar2021 13:00 with outcome of recovered, felt tenderness on an unspecified date with outcome of unknown, felt a nodule on an unspecified date with outcome of unknown, swollen lymph node on an unspecified date with outcome of unknown.  Therapeutic measures were taken as a result of tired. The clinical course was reported as follows: She received her second dose at 1040 yesterday. Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. Caller asking will it go away in 48hours. Caller doesn't have a physician at this time. She got tired today at 1230. That was the primary symptom the first day after the first dose also. It was not so much that she couldn't function, she was just tired. Caller works remotely. She went and sat on the couch hoping to take a 15 minute cat nap. She laid down and thought why is her neck sore? She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot. It's not worse or better. She was tired after the first vaccination on 25Mar2021 at 1040 or 1045. It started on 26Mar2021 about 24-28 hours after around 1300. It stopped on 27Mar2021, she awoke feeling fine, and recovered completely. Second dose LOT EW0158, left arm injection She is on no medications, she takes vitamin C and vitamin D in the mornings. She has no medical conditions. Caller tried here first and figured she would start here and if it was recommended to her to see a physician, she has one she has been referred to. No AE require a visit to Emergency Room or Physician Office. No relevant tests.   No follow-up attempts are needed. No further information is expected.
Spotting that turned to heavy bleeding and clotting for 3 days.  Very sore, to the point of being uncomfortable, lower back kidney area.
Patient received Moderna for 2nd dose versus Pfizer which was given at first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose). On 15-Mar-2021, WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of wrong technique in product usage process for mRNA-1273, lot # 002a21a with no associated AEs.
Initial case was received on 04 October 2010 from a health care professional. An 18 month old female patient received on an unspecified date, an injection of FLUZONE "0.5mL Pre-filled Syringes" (lot number not reported). She also received within 4 weeks prior to FLUZONE, on 13 September 2010, a dose 2 intramuscular injection of DAPTACEL (lot number C3473AA) and a dose 2 subcutaneous injection of IPOL (lot number E0123). The patient became "ill after receiving a flu shot". The patient experienced a fever of 102 degrees. However, a fever of 102 degrees is also reported as an illness at the time of the vaccination. No other pre-existing medical conditions, no allergies and no concomitant medications were reported. The patient recovered on an unspecified date. Follow-up information received from a nurse in on 02 December 2010. The patient was male. The FLUZONE (lot number U3579AA) was administered intramuscular in the left deltoid on 13 September 2010. Per the reporter, the patient had no concurrent illnesses at time of vaccination on 13 September 2010. No further information is expected. The reporter for this case is the same as for cases 2010-05048, 2010-05746, and 2010-05747 and is part of a cluster of four patients. Documents held by sender: None.
This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M015931 with expiration date of 30-MAR-2018; lot # M035935 with expiration date of 09-AUG-2018 and lot # M002419 with expiration date 12-JAN-2018) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the dose of the vaccine (lot # M002419) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 hours 25 minutes and the dose of the vaccine (lot # M015931) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 hours 25 minutes and between 0 degrees Celsius to 2 degrees Celsiusfor 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000364: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000928.
Mom to clinic with 5 yo with concerns about swelling/redness to R thigh.  Received vacc 3d in bil thighs and mom states R thigh had lump next d. with fever but told possible rx monitor.  Following d. child complaining of worsening pain and redness and swelling.  Today redness is bigger with swelling and hardness and hot to touch.  No fever today.  Assessment: R thigh cellulitis post vaccination administratioN.  Rocephin 1000 mg given today advised return in 24 hrs for re-eval.
Local reaction Lever body aches, muscle pain right neck and shoulder pain.  Cellulitis at + around injection site.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th June 2018, the patient experienced skin eruption and erythema. In June 2018, the patient experienced burning sensation, swelling, dry skin and skin wrinkling. The patient was treated with prednisone and Prednisone Cream. On an unknown date, the outcome of the pain in arm, burning sensation, swelling and skin eruption were recovered/resolved and the outcome of the erythema was recovering/resolving and the outcome of the dry skin and skin wrinkling were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, burning sensation, swelling, skin eruption, erythema, dry skin and skin wrinkling to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her arm was really sore on the night of the vaccination. The next morning, the patient started breaking out on the inside of both arms, chest including above and below the breasts, and across the stomach and she went to the physician the same day, and he ordered 5 days of Prednisone. A day or 2 after completing the Prednisone, the patient stated that the redness came back in her both armpits, and she also had a big oval circle that was swollen (maybe 4 inches long). She stated that the redness went past her elbows and also included her upper chest (below breasts) and across the stomach, and upper legs. The patient also reported burning under her arms. The patient went back to her physician who then prescribed her a stronger dose of Prednisone and also referred her to a dermatologist. The dermatologist prescribed her a Prednisone cream that she took for 14 days and stopped (per order). At the time of this report, the patient had light, red marks under her arms and on her stomach, and the skin above her breasts was dry and wrinkly. The patient had asked her physician if she should receive the 2nd vaccine, and physician referred her to the safety department. The patient had been informed that the safety department could not make any recommendations and referred her back to her physician. The contact details of the physician was provided. This case has also been linked with US2018122090, reported by the same reporter.
Patient is a 69 y.o. female with a history of HTN, HLD, DM2, colon cancer s/p resection 2020, recent admit 10/8-10/10/22 for transient neuro symptoms and UTI, who presented to HCF 10/27/2022 with blurry vision, high BP reading, cough, congestion, sore throat. She was found to be febrile and SARS-CoV-2 positive and BP 218/68.    1. Sepsis secondary to COVID-19: Sepsis present on admit with fever, tachypnea. Symptoms present 10/26/22. Tested positive on admit. CXR on admit with bilateral coarsened lower lung bronchial markings, basilar interstitial vascular congestion. Required oxygen on admit, no hypoxia at time of discharge even with ambulating. Continue dexamethasone x 10 days at discharge  2. Acute hypoxic respiratory insufficiency: Required 2L NC on admit due to COVID-19. Resolved 10/28/2022  3. Uncontrolled HTN: blood pressure 200/60s on admit, noted history of elevated blood pressure causing transient neurologic symptoms. Changed metoprolol to carvedilol and added lisinopril  (pt not taking enalapril) at discharge.  4. Chest pain: reproducible on palpation. Suspect MSK due to COVID / cough. Steroids as above. 5. Elevated BNP: Admit NT-Pro BNP 2740. CXR on admit noted vascular congestion. Consider echocardiogram outpatient  6. Hypokalemia: K 3.1 on admit, potassium 3.5 at time of discharge, replaced magnesium, added lisinopril   7. Hypomagnesemia: magnesium 1.2 10/28/2022, replaced IV 8. DM2: Controlled. A1c 6.8% 10/9/22.  9. Left ICA stenosis: 60% stenosis on recent CT angio head/neck. Continued ASA and statin. 10. Colon cancer: Patient reports resection in 2020 at HCF. Denies metastatic issues and did not require radiation or chemotherapy. Reports recent scans have been negative
Eye swelled, skin around eyes (lids and undereye) red and extreme dryness.  The skin around the mouth and chin is swollen, very red, and very dry.
the patient received her vaccine on 6/15/21 and stated that she woke up itching on 6/17. She said she had a rash on her chest and on her arms. She took Benadryl and I told her she should continue with the Benadryl and if she had a more severe reaction ( swelling in the mouth/throat ) that she should seek immediate medical attention. She did reach out to her doctor and they told her to continue with the Benadryl also and to monitor for any severe reaction. I spoke with her this morning on 6/18 and by the afternoon of 6/18 she stated it seemed a little better
L/deltoid painful, indurated, edematous, erythematous with scattered red macules approx 1 1/2 c.m. diameter to deltoid down to mid humerus.
Very terrible symptoms; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) showed she had antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact