chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have a rash on my throat, just on the front part of my throat; It itches; Have a rash on my throat, just on the front part of my throat; It itches; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9261), via an unspecified route of administration on 21Jan2021 (at 85-year-old) as single dose for COVID-19 immunization. Medical history included rashes. The patient's concomitant medications were not reported. The patient got vaccinated on 21Jan2021 and last, within a week, about a week, still she was having some rash on her throat (Jan2021). She had the vaccine on 21Jan2021, she thought and from last few days she was having rash on her throat. She just wanted to report that, she don't know, it has been better sometimes but she have been having it from three or four days now and she just wondered if they might want to know or Pfizer might want to know that she does have a rash on her throat, just on the front part of her throat. The patient got some topical itch medicine as it itches (treatment). Weight was reported as about 112 or 114 pounds. The outcome of the events was unknown. When probed if there is a relationship between consumer experiencing rash and Covid vaccine, consumer stated that she was not sure because she have had some rashes on other places and that was before this. So, she was not sure.
Patient got out of car 15 minutes after vaccination when patient was being released and she sat on the floor & laid down. It was reported that patient did this after her first vaccine. Caregiver stated patient has been in and out of the hospital 3 times in 2 weeks, lives in an adult foster care facility. Has history of faking seizures per caregiver. Onsite EMS was called vitals BP 92/55 HR 106 BG 87. Patient was transported to ED by EMS.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
First series had only a sore shoulder the next day. 2nd dose tender at site of injection the next morning, in evening had periods of hot flashes, upset stomach, headache, and no energy. Third day had no symptoms.
eyes watering / eye tearing; can't keep my head up / head stops working; sleeping a minimum of 12 hours at night; extreme back ache; head fog / foggy thinking; fatigue / so tired / too tired to make my bed; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache) and FEELING ABNORMAL (head fog / foggy thinking) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, 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 LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed) had not resolved.            No concomitant medications were provided. No treatment medications were provided.
we accidentally give someone a half dose of Moderna instead of full dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose) 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 ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.
7 days after the vaccination she developed pain, redness and itching around the vaccination site and extending down
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 53 of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
No adverse event; Patient received a 0.25ml booster dose instead of 0.5ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose).    No concomitant medication was provided.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided by the reporter.
medicine taste in back of throat; 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 TASTE DISORDER (medicine taste in back of throat) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (medicine taste in back of throat). At the time of the report, TASTE DISORDER (medicine taste in back of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
This is a 70y.o. female with a history of liver cirrhosis, PHG, esophageal varices, GERD, and former EtOH abuse (quit approx. 5 years ago per patient) who presents with complaint of nausea and generalized weakness. She states that her symptoms started on Friday 11/12/21. She reports a decrease in appetite, epigastric pain and loss of taste. Denies vomiting, diarrhea or constipation. Admits to one episode of hematuria on 11/16/21, mild shortness of breath and a non-productive cough that started around the same time. Her daughter at bedside states that the patient has been more fatigued and weak lately. Patient had difficulty walking ambulating today, so her daughter brought her to the ED for further evaluation. Patient received one dose of the COVID vaccine approximately 3 weeks ago. Denies fevers, chills, chest pain, headache, lightheadedness, dizziness, lower extremity edema.
red blotches and sores on fingers and toes; very painful and has lasted more than a month
A non-serious spontaneous report of we gave an expired dose of FLUMIST was received from a health professional concerning a seven-year old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 24-Jan-2012. On 17-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the considered resolved.
Right arm swelling approx 45 minutes after vaccination of influenza and menveo. Ice applied to right deltoid area.
This case was reported by a pharmacist and described the occurrence of therapy non-responder in a 63-year-old male patient who received TWINRIX. Co-suspect product included Hepatitis B vaccine. Previously administered products included TWINRIX (dose 1). On 28th February 2011, the patient received TWINRIX 1 ml. In October 2010, the patient received Hepatitis B vaccine. In October 2010, an unknown time after receiving TWINRIX and Hepatitis B vaccine, the patient experienced underdose. On 28th February 2011, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and underdose were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX and Hepatitis B vaccine. It was unknown if the reporter considered the drug dose administration interval too long underdose to be related to Hepatitis B vaccine. Additional information: Patient received TWINRIX on 28 August 2010 and 28 February 2011 with a dose of Hepatitis B in October 2010. Patient is now saying that he does not have Hepatitis A antibodies. Pharmacist has not seen the labs. Also the patient's 2nd dose of TWINRIX was delayed longer than one month. Also the patient had interchange of monovalent hepatitis B with TWINRIX.
Fever of 101.9F from March 29, 2021 @ 1:00 AM through March 30, 2021 12 Noon.
reporter states 26MAR97 pt c/o warmth, swelling & discomfort in lt deltoid which began 25MAR97 in late afternoon;advised pt to use cold compress & APAP & contact MD if problems persists;28MAR & 7APR pt called MD w/cont problem;dx cellulitis
Initially:   only sore arm  08/09/2021 - presented with left arm, back and chest pain.  stable vitals.  Upon arrival at Medical Center, found to be having MI.  Found to have acute inferior ST-Segment elevation mycardial infarction.  Given antithrombolitics and transported via ambulance to ED.  At Cath Lab found multiple dissections in coronary arteries.  Stents placed and arteries dissected again.  Brought to Cath lab a second time and found other arterial dissections.    Additional workup for abdominal and back pain identified another dissection involving proximal celiac axis.  Multiple dissections and aneurysms suspect some type of underlying vasculitis.    08/10/2021 - subsequently developed headache and had CT scan.  showed intracerebral hematoma with very small cerebellar hematoma right superior (10mm x 6mm x 5mm).   Hematoma monitored for 4 days and increased in size a neg
A non-serious spontaneous report of fever of 105 F, ear infection, and pinkeye has been received from a consumer concerning a five-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST on 14-Oct-2009. On 16-Oct-2009, the patient had a fever of 105 F. She had an ear infection the following day, and on 22-Oct-2009 had pinkeye. The outcome of the events was not reported.
fever dec range of motion rt arm, pain, redness, swelling, 10cm nodule;poss cellulitis;
Pain upon injection, feeling of illness for the next 24 hours, swelling and redness at application site, patient applied heat and vinegar.
Patient said to have experienced soreness all over his body, rash developed about 2 days later on arms, trunk, neck. Weakness lasted 2 to 3 days. Patient spouse said Primary physician was contacted. Steroid pack was taking for rashes.
Pt stated arm (L) was sore to where unable to sleep at noc on 11/24/14. Noticed today-11/25/14-that arm was red and swollen, and came straight to doctor office. Left arm 18x14cm induration and tenderness w/erythema 18x18xm. Denied n/v/d, fever, or any other symptoms. Rx'd-sml-tmp DS tablet x 10 day, abx cream daily.
Developed severe headache and dizziness approx 8 hours after vaccine received. Relief with TYLENOL. Also in context of sinusitis.
bleed a lot; saw that a lot of liquid came out/ worried he didn't get the full dose; This is a spontaneous report received from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said he got the Pfizer vaccine 2nd dose, the pharmacist from there didn't help him. Patient stated, "he bleed a lot and saw that a lot of liquid came out. He was worried he didn't get the full dose." Pharmacist asked if there was any guidance. Outcome of events was unknown.; Sender's Comments: Based solely on chronological connection to the vaccine causality between event bleeding and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated 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, as appropriate.
SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was para 0, gravida 1.The patient was pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered 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 miscarriage(spontaneous abortion) and vaccine exposure during pregnancy. The pregnancy resulted in a spontaneous abortion. Reporter stated, "I tried to warned as many people that would listen to me, not to take those dangerous shots Very few people would listen to me, and some are dead now for not doing so. One lady (Not in my School Class, but is a church member), had two miscarriages after taking them. Everyone (53 members) in my School class took the shots, even though I warned them good not to take the shots Almost everyone in my class has had COVID since taking the shots They are now mighty quite about it all, when they announce that a member of our class now has COVID Some have had COVID the second time around, and they are filled up with those dangerous chemicals and man made viruses, that they allowed stupid doctors to give to them. When I was warning them, some of them said stupid things to me for not being protected, and risking other people's lives by catching it, and spreading it I don't hear a peep out of any of them now I did my research and I listened to "Real Doctors" Less " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221260842. This case, from the same reporter is linked to 20221257674 and 20221257582.; Sender's Comments: V0: 20221258686- miscarriage. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.   20221258686-vaccine exposure during pregnancy . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
This spontaneous case, initially received on 31-Oct-2017, reported by other health professional and concerns a 23-year-old female patient. Patient's medical history and concomitant medications was not reported. On 31-Oct-2017, while administering FLUCELVAX QIV (dose: not sure of the quantity (as reported), route of administration, batch number: 195233, expiry date: 31-May-2018), the vaccine squirted out of the syringe, syringe malfunctioned and vaccine squirted into another student's and nurse eyes and mouth. The patient washed her eyes after the incident. As per the PTC report, the damage occurred when one of the student was about to prepare for administering. It was reported that, the vaccine was not administered. It was reported that, there was no signs of damage, the syringe tray received sealed, rest of the syringes have been inspected, product stored in its original carton after receipt. The PTC number was reported 1025703 and the QA investigation conducted that FLUCELVAX Batch 195233 was manufactured in compliance with the approved internal procedures and in accordance with quality requirements. No internal root cause was identified in the manufacturing process, and no trends were identified for the batch for leaking syringes. The most likely root cause can be attributed to Supplier/Material/Defective. On 31-Oct-2017, while administering the vaccine. The reporter assessed the case as non-serious. Follow-up received from the QA (quality assurance) department on 13-Dec-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195233 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, and no trends were identified for the batch for leaking syringes. The most likely root cause can be attributed to Supplier/Material/Defective.
Felt dizzy; Wakes up sweating; Fever of 101.2, little low grade fevers; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating), PYREXIA (Fever of 101.2, little low grade fevers) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating), PYREXIA (Fever of 101.2, little low grade fevers) and CHILLS (Chills). At the time of the report, DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever of 101.2, little low grade fevers) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 101.2 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included unknown heart medication. Treatment information were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient administered 2nd dose hence action taken was changed to "No change".