chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it was 1 day he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days; he is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy; This is a spontaneous report from a contactable consumer or other non hcp (patient wife).   A 78-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9262, expiration date unspecified), via an unspecified route of administration on 30Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL1283, expiration date unspecified), via an unspecified route of administration on 09Jan2021 as 1ST DOSE. SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date it was reported that the patient took pfizer first it was fine the second, he took, patient had, it was 1 day patient was tired, and it lasted a day and half, and he was fine so, he was fine for 3 days, now it seems like he have another repeat of what happened the first time, on the second dose, the patient is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy. The outcome of the event he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days was reported as recovered, while for the other event it was reported as unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Chronic severe Tinnitus.  Non-stop ringing in the ears. Driving me crazy, Causing insomnia.  This ringing in my ears is 24/7.  Seems to be getting worse.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient (health care professional) via other manufacturer (Pfizer) concerned an adult male. The patient's height and weight were not reported. The patient was a health care professional. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was treated with Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 20-JUN-2022 to 25-JUN-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 28-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 29-JUN-2022, the patient was rebounded with covid-19 which was coded as confirmed covid-19 infection which led to confirmed clinical vaccination failure (dose number in series 2). On 30-JUN-2022, Laboratory data included: COVID-19 virus test Positive with return of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0: 20220729874-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . 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. Therefore, this event(s) is considered not related.
Upper arm swelling, warm, 2 1/2 x 2 1/2 red blotch.
@04:27 pm patient reported having tightness in chest, used albuterol per NP X2. Patients vitals were BP 131/82 HR 99 O2 100%. Patient continued to report sharp pain in chest and heaviness with tingle in throat, denied difficulty swallowing, no swelling noted. Pt was picked up by EMS at 4:45pm.
Leg swelling. Went to local ED area marked and instructed to observe. Swelling increased outside of marked area came into clinic following day antibiotics given.
patient reported feeling hot and dizzy 5 minutes after injection and collapsed to the floor next to his mother. Denies loss of conscience or injury. Patient was transported via gurney to EMS room for observation by physician, patient reports he had not ate anything this morning, apple juice and granola bar given to patient with no issues. Mother reports that this has happened in the past. Patient denies chest pain shortness of breath nausea, discharged into mothers care in no distress @ 9:55am.
Approx 1 wk after vax, PT began experiencing fatigue, racing pulse (130-140); chest pain that radiated down arm and up neck on right side. Felt as if she couldn't catch her breath. This occurred every day for 4 days w/Sx's onsetting in late afternoon to early evening. Still experiencing evening fatigue and racing pulse but no chest pain.
Two Seizure Events one at 8pm and another at 8:15. Temperature was taken immediately after second event and was normal at 98.7. Childs arms and legs flexed out and entire body including limbs became very stiff and rigid. Child started turning red and his eyes where wide with a stare. Same reaction both times. First event child was laying inclined getting his diaper changed and second time child was sitting in his walker playing with toys. Called dr right away was told if child was breathing and not lethargic to watch closely through the evening and call 911 if another event occured. Nothing happened again until the following Monday Aug 2 in which child was immediatly taken to the Dr.
Growing temperature, severe chills and shaking, difficulty breathing, weakness for first 3 hours. after chill subsided, I had 101 degree fever for 5 hours. Finally subsided at 4:30PM.
Chills, joint and body aches, mild nausea, photophobia 24 hrs after administration of Tdap.
This spontaneous report as received from a pharmacist via company representative refers to a 73 year old female patient. Information regarding the patient's pertinent medical history and drug reaction/allergies was not reported. Concomitant therapies included CLARITIN. On 09-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration was not reported). On an unspecified day in March 2016, the patient developed an extreme rash that was a strawberry sunburn color on her lower abdomen and both forearms following the administration of ZOSTAVAX. The patient also developed a fever of 100 to 101 F, vomiting and sharp pain when she touched her abdomen. The patient stated that when she touched her abdomen, her finger left an indentation in her skin. She sought medical attention by contact with pharmacist. There was no product quality complaint. No treatment was given for the events. The patient was recovering the events, at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
sore on her left arm at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore on her left arm at site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore on her left arm at site of injection). At the time of the report, VACCINATION SITE PAIN (sore on her left arm at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI: Fax number of HCP updated.
Rash on right side of mouth, typical of her food allergies Per Dr. administer 5mL of Cetirizine Hydrochloride, administe5red at 1620 Rash resolved by 1635 Advised to administer another dose at bedtime if rash returns
48 hrs later, fever, chills, shaking, pain in joints.  lasted about 8 hours.   Fatigue lasted about 24 hours after that.   72 hrs later: enlarged and swollen lymph node underarm.  Painful for about 4 days and lasted about 2 weeks until the swelling was entirely gone.
strong, whole body heat, and flushing; strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported for similar events for 6 patients. This is 2nd of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend was a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardia and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. It was unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The reported transient events of whole body heat, flushing, tachycardia and palpitations were likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinic course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patients.
Information has been received from a physician concerning a 62-year-old female who on 31-JAN-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX. The lot number was not provided. Concomitant therapy included an "antibiotic". On 01-FEB-2008 the patient experienced local irritation at the injection site. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Pt with recurrent, severe muscle spasms starting after 2nd shot. Worse since 3rd shot (2-3 months ago). Persistent, daily, lasting 5 minutes and worse with physical activity. Will check CPK/muscle enzymes, sed rate, kidney, etc. Doc 20416, 60 day follow up, states that patient never came back for follow up, suspect that his symptoms have been resolved. The annual follow-up states "symptoms resolved spontaneously."
Fever - swollen lymph nodes under arms and neck - lethargic - over 1 week. Headache - body ache.
Fever, chills, muscle pain, fatigue, headache, reduced appetite, injection site pain and swelling, sleepiness
Intermittent numbness and tingling left hand and fingers preventing/restrict (L) hand use.
Developed itchy hives all over my body 9 days after getting my Moderna Booster shot. They were constantly appearing and very uncomfortable. After a few days I had a virtual doctors visit and was prescribed prednisone and antihistamines. The prednisone helped while taking it, but after I was finished the hives came back. This time it wasn?t as random, but when something rubs, brushes, or scratches my skin. This has continued for the past month now.
Fever >100.4,  Subjective fever (felt feverish),  Muscle or body aches,  New loss of taste or smell,  Cough (new onset or worsening of chronic cough),  Fatigue or tiredness,  Headache, ER visit, Hospitalization
headache on 8/19/08 8/20/08 given 2 childrens tylenol each time, complaint of chest pain on 8/21/08 was given pepto bismol thinking was heartburn, hives 8/21/08 was given benedryl, complaint of upset stomach 8/22/08 not given medication, severe hive breakout could not administer benedryl due to throwing up, taken to hospital on 8/22/08 due to severity of throwing up out of control and hives so bad,as of 8/25/08 still hospitalized and waiting to be transferred to another hospital for further treatment 9/24/08-records received for DOS 8/23-8/25/08-DC DX: Acute febrile illness with rash, most likely viral in nature versus related to recent immunizations. Abdominal pain with right ovarian cyst. Dehydration with hyperkalemia, resolved. Day after receiving vaccines had headache, low grade fever and urticarial rash. Symptoms persisted developed nausea with vomiting and abdominal pain. Transferred to another facility. 10/8/08-records received for DOS 8/25-8/26/08-Fever, rash, abdominal pain.
BRIEF OVERVIEW: Admission Date: 8/20/2022 Discharge Date: 8/23/2022   PRESENTING PROBLEM: COVID-19 affecting pregnancy, antepartum [O98.519, U07.1] Asthma during pregnancy [O99.519, J45.909] INTRAPARTUM COMPLICATIONS: Medical Problems (from 08/20/22 to present)      No problems associated with this episode.         PROCEDURES PERFORMED:   none   HOSPITAL COURSE: Patient presented at 23 weeks and 1 day gestation with an acute asthma exacerbation and COVID 19 infection. CTA showed patch ground glass opacities, no central PE. She required 6L O2 NC to maintian SpO2>95%. She was given 2 days total of betamethasone for treatment of her asthma and for fetal lung maturity and then transitioned to solumedrol.  She was started on Paxlovid and Aspirin for her covid infection as well as lovenox for anticoagulation while inpatient. Pulmonology was consulted and patient was started on Symbicort BID and Albuterol nebulizers PRN q 4 hours. Patient's symptoms improved significantly over the course of 3 days and her O2 requirements dropped completely until she was satting appropriately on room air.  It seems that the most significant factor contributing to her clinical picture was her uncontrolled asthma and not her acute COVID infection.    She had a detailed MFM US done on 8/22 to assess cervical length given her history of a cervical laceration.  The US found her cervical length appropriate at 36.4mm with a left cervical fibroid measuring 3 x 3 x 4 cm. She had reassuring fetal heart tones daily throughout her stay.    She was able to be discharged home on 8/23/22 with the following medications per pulmonolgy recommendation.s Symbicort 2 puffs BID, Albuterol as needed, Prednisone taper (20mg daily x3 days, 10mg daily x 3 days).  She is to followup with her established pulmonologist this week.  If her symptoms return during the steroid taper, the dose may need to be increased and tapered more slowly. She is to continue aspirin, but not lovenox.    She is to continue her scheduled prenatal care with her established OB.
1st dose on 01Mar2022, 2nd dose vaccine hadn't been administered at the moment of the call; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 1st March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: From what the health care professional told the patient that the vaccine had not been administered at the moment of the call.  The reporter wanted information on how to proceed since second dose was not administered on time. The health care professional wanted to remain anonymous and wanted to remain anonymous, did not have consent to follow-up and dropped the call before it could be transferred.  The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Rec'd immunization 6/18/08 around 10AM.  6/19/08 in AM noticed a knot in her arm & marked tenderness.  Appears today (6/21) approx quarter sized reddened area with visible nodule.  Also has been very tired with sl headache & 1 episode of dizziness.
Received dose 1 of Moderna vaccine 1/13/2021. No reaction until 1/22/2021. Large red, swollen, itchy rash @ injection site. Advice nurse recommended Claritin. Symptoms diminished.
SOB started on 6/5 per family and ER report. presented to ED on 6/7/23.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 59-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 25 August 2013, the subject received unspecified dose of BOOSTRIX (unknown route and arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site. She continues to have swelling in that arm since the vaccine was administered. At the time of reporting, the event was unresolved.
STIFF JOINTS; IE HANDS, NECK, HEAD PAIN, loose stomach and some pain in intestinal area, CHEST/BREAST MUSCLES, FELT LIKE A PTSD RELAPSE; Contacted nurse and was to report to emergency room at Hospital. Released to rest/fluids? Didn't work rest of week; this is Saturday still have muscle burn across chest no energy!!!
1st dose on 24Mar2021 and 2nd dose on 14Apr2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Motor vehicle accident (Car accident.), Fibrillation atrial (He had ablation in 2014, which took away the a fib.) and Cardiac ablation.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2022-573333 (Patient Link).
Pain in the stomach; Vomiting; Chills after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was under no concomitant medication
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 01FH22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pulmonary function test: Fine.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient was not feeling well since getting over COVID first week in November 2022. She had runny nose, headache, shortness of breath. She had receive 2 primary series vaccines and 2 boosters. Doctor sent her to pulmonologist test were ran and results were fine. Still experiencing shortness of breath and nausea. Doctor thought she may have issues with gallbladder scheduled to see gallbladder surgeon. Concomitant medication not reported. Treatment medication not reported.   This case was linked to MOD-2021-022860 (Patient Link).
Severe puffy eyes; No itching; No swelling at point of injection; Small rashes behind left ear; treatment - administered Benadryl and Cortisone orally; No asthma symptoms observed;  awaiting eyelid puffiness to abate.
Breakthrough case admission after 3 vaccines PFizer 3/10/21 Lot# En6207;  Pfizer 3/31/21 Lot# ER8734;  Pfizer 9/23/21 Lot# FE3592;
Patient complained of fever small lesions on arm and thigh about 14+ days post vaccination.  Lesions not pensular nor pustular not erythema affusion, more like insect bit which had been scratched.  Not resolving refer to Dermatologist for evaluation and assist in diagnosis and treatment (05/15/2003).