chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm up to her neck and jaw hurt; Had body aches; Vomiting; Had nausea; She had a headache; Fatigue; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Her arm up to her neck and jaw hurt), PAIN (Had body aches), VOMITING (Vomiting) and NAUSEA (Had nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was tested for COVID positive on Nov 2020.) in November 2020. Concurrent medical conditions included Drug allergy (The patient was allergic to certain blood pressure medication but was unsure of name.), Borderline diabetes and Blood pressure high. Concomitant products included AMLODIPINE, CHLORTHALIDONE, ATORVASTATIN and METFORMIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Had nausea), HEADACHE (She had a headache) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm up to her neck and jaw hurt) and PAIN (Had body aches). On 20-Feb-2021, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Her arm up to her neck and jaw hurt), PAIN (Had body aches), VOMITING (Vomiting), NAUSEA (Had nausea), HEADACHE (She had a headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report has been received from the 17 years old female patient's father. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. The reporter mentioned that the patient also received on 22-MAY-2018 (reported as 2 days prior) a "non-merck" hepatitis A virus vaccine (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported) and a meningococcal vaccine (unspecified) (dose, strength, frequency, lot#, expiration date, indication and route of administration were not reported). On 24-MAY-2018, the patient was vaccinated with M-M-R II lot# N025895 and 19-SEP-2019 expiration date for routine vaccinations (dose, strength, frequency and route of administration were not reported). Also the patient on the same date was vaccinated with GARDASIL 9 lot#/batch reported as N028092 and 28-MAY-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration were not reported) and a poliovirus vaccine inactivated (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported). The reporter stated that on 27-MAY-2018 (reported as 3 or 4 days after receiving M-M-R II and GARDASIL 9, the patient experienced swelling in her lymph nodes, puffy eyes, abdominal discomfort, back pain, difficulty with normal movement and a slight fever of 100°F. Additionally on an unknown date in 2018, the patient was seen by the physician and thought it could be mononucleosis. The reporter stated that his daughter had improved but was still feeling very fatigued. An unspecified blood work on an unspecified date was made with an unknown result. The causal relationship between the events and M-M-R II and GARDASIL 9 was not reported. No Product Quality Complaint was present.
Experienced nausea, dizziness, felt hot and face flushed, and felt like he was going to pass out 15 minutes after receiving vaccine. Patient assessed in the emergency department and found to be stable but has complaints of nausea and dizziness with headache. Received IV fluids, meclizine, and prochlorperazine. Discharged from emergency department at 1454 after tolerating fluids and foods by mouth without difficulty, no recurrence of symptoms, vital signs remaining stable, and stating he feels like he is back to his baseline status.
ZOSTAVAX administered at 4:30 PM. Pt went home and called to report throat closure at 5:45 PM. No NEOMYCIN allergies. Advised pt to call 911.
Patient c/o dizziness, and a buzzing sound in ears for a few minutes. Vital Signs 2:25pm--99% pox 80hr 160/110bp 97.1temp 2:30pm--99%pox 70hr 140/95bp 14rr 2:40pm--98%pox 74hr 140/100bp 97.2temp  Took patient into the private cot area to lay down for a few minutes, where we took vitals and he drank some water.  Pt stated he is dehydrated from working outside 5 days in a row.  He said he was not dizzy prior to receiving the injection.  The buzzing sound resolved after a couple minutes. The dizziness resolved after laying down for approximately 15 minutes. Patient walked to his car without any s/s of distress.
I was having shortness of breath and felt my throat closing  I took Zyrtec every 12 hours it did help me . I?m afraid to take my second dose of the vaccine  Please I will really appreciate it if someone contacts me and advices me on what I should do pls my next dose it?s due on 02//08/2021
CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
COVID-19 infection (confirmed); COVID-19 infection (confirmed); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease", start date: 1995 (ongoing); "Perianal fistula", start date: 2000 (unspecified if ongoing), notes: Stop date: unspecified; "IR drainage", start date: 2003 (unspecified if ongoing), notes: Illness: IR drainage, Stop date: unspecified; "IR drainage", start date: 2019 (unspecified if ongoing), notes: Illness: IR drainage, Stop date: unspecified; "Hypertension", start date: 2010 (ongoing); "Hyperlipidemia", start date: 2011 (unspecified if ongoing); "Depression", start date: 2007 (unspecified if ongoing); "Osteopenia", start date: 2007 (unspecified if ongoing); "Herpes zoster", start date: 2008 (unspecified if ongoing); "Lyme disease", start date: 2012 (unspecified if ongoing); "Nephrolithiasis", start date: 2005 (unspecified if ongoing); "End stage renal disease requiring kidney transplant", start date: 2009 (unspecified if ongoing), notes: Additional medical history: End stage renal disease requiring kidney transplant (2009); "COVID-19 infection (suspected)", start date: 2020 (unspecified if ongoing), notes: Additional medical history: COVID-19 infection (suspected)(2020); "Non-smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2023, outcome "recovered" (06Feb2023) and all described as "COVID-19 infection (confirmed)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Pathogen was identified as SARS-CoV-2. Clinical course: This subject is a participant in the registry. It has been reported the subject was diagnosed with a confirmed COVID- 19 infection on 25Jan2023. Pathogen was identified as SARS- CoV-2.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) , covid-19 cannot be ruled out.
Having symptoms of sinus and cold, but no fever; Having symptoms of sinus and cold, but no fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 16Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had the first vaccine on 16Mar2021. She was supposed to go get second dose tomorrow (on 13Apr2021). She was having symptoms of sinus and cold, but no fever. She asked if she can go ahead and get the second dose. Events outcome was unknown.  Information on the lot/ batch number has been requested.
DID NOT USE NEBULIZER AS OFTEN; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, prostate cancer, penicillin's allergy, alcohol user, and non smoker. The patient was previously treated with salbutamol for asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included budesonide/formoterol fumarate.  On an unspecified date, the patient experienced did not use nebulizer as often. Laboratory data (dates unspecified) included: Lab test (NR: not provided) 0.02. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of did not use nebulizer as often was not reported. This report was non-serious.
swelling at the site and pain; swelling at the site and pain; a lot of swelling in her left arm at the site there is a 2 inch circle-ish reddish purple rash raised area; a large red blotch and swelling the form of a 2 inch circle, raised and discolored; inflammation; a large red blotch and swelling the form of a 2 inch circle, raised and discolored.; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 15:00 (at the age of 44-year-old) (Batch/Lot Number: FC3181) as dose 1, single for covid-19 immunization. The patient medical history included gastric bypass, mitochondrial DNA mutation of CYTB gene and MBD5 gene deletion. The patient concomitant medications was not reported. There was no prior vaccination (within 4 weeks). On 07Aug2021 20:00, the patient noticed a large red blotch and swelling the form of a 2 inch circle, raised and discolored. She read online that this was side effect of the vaccine called covid arm and would last a week. Caller would like to know how long this side effect will last since it had been more than a week. She stated that it did not show any sign of going away. She also added that she takes her body measurements (biceps) and her left arm was swelled up an inch and a half more than the right arm, there was swelling and inflammation. Her right arm was smaller because of her weight loss. She got the shot about 3pm and was getting ready for bed about 8pm taking off her clothes for a shower and noticed a large, red blotch with tenderness and pain. Stated that as she loses weight her left arm was getting to an inch and a half larger, but her right arm was getting smaller with the weight loss, not that her left arm was getting bigger. Caller stated no treatment aside from monitoring she really can not say nothing, she did take Tylenol sometimes for it but nothing major for sure. Patient did not visited for Emergency room and Physician Office. The clinical outcome of the events were not recovered.
she is going to be sicker than a dog; Hives; Hives were super itchy; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine, dose 1 via an unspecified route of administration, administered in Arm on 03Feb2021 (Batch/Lot Number: EL3302; Expiration Date: May2021) as SINGLE DOSE for COVID-19 immunisation. Medical history included mild to moderate asthma, thyroid disorder, rubber sensitivity, allergic to latex, bee stings, and tomatoes. On 03Feb2021, the patient had her first shot and two days later got hives near elbow on the injection arm. Then a day or two later got another hive. Couple days after that got one hive behind her knee. Hives were super itchy. She is an allergic type of person. As soon as she put Hydrocortisone cream on the hives, the hives went away. Hives weren't very big. First hive was the size of a dime. After that, hives were the size of pencil erasers. Hives were just on the arm and nowhere near the injection site. Doesn't know if it was the COVID-19 Vaccine or not. Second dose was on 03Mar2021. Everyone was petrifying her because she was told she was going to be sicker than a dog. Wanted to know if hives could occur two day, four days, and then a week after the COVID-19 Vaccine. Outcome of the event hives and pruritus was recovered and that of illness was unknown.
Pt immunized 3AUG89; evening of 4AUG developed fever & did not eat well; Taken to ER; Meningitis suspected; subsequently hospitalized & bacterial Meningitis dx;
This spontaneous report was received from a physician and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in May 2018 (reported as "within the past month"), the patient was vaccinated with a dose of GARDASIL 9 1 injection in the arm (lot number and expiration date were not reported) for prophylaxis (reported as "prevent HCP"). On an unknown date in 2018, 1 week after the vaccination, the patient experienced full body joint pain, stiffness in her knees and lethargy. She was treated with an unspecified non-steroidal anti-inflammatory medication. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
I had ablation completed and have been period free.   the next month after the shot my periods started back up and have not stopped.   I was also diagnosed with Sjogrens sydrome a month ago - not sure if it is related or not.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU. 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, the patient experienced MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
skin sensitivity / sensitive skin that felt like a large sunburn; skin sensitivity with pain on his scalp; Pain on his chest; Pain in his abdomen; Shakiness of his hands; Arthralgias in his fingers; Sore throat; Chills; MUscle aches; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included varicella vaccine (dose received in 2010).   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced headache. On 3rd November 2020, the patient experienced sore throat, chills, muscle pain and fatigue. On 12th November 2020, the patient experienced sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand. Shingrix was discontinued. On 4th November 2020, the outcome of the fatigue was recovered/resolved. In November 2020, the outcome of the headache was recovered/resolved. On 23rd November 2020, the outcome of the sore throat, chills, muscle pain, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand were recovered/resolved.   The reporter considered the headache, sore throat, chills, muscle pain, fatigue, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix from his pharmacy. After receiving Shingrix, he had a headache that resolved. The following day, he had a sore throat, chills, muscle aches and fatigue. The next day he felt well. However, on 10th November 2020 he developed a sore throat, chills, and muscle aches. He had a COVID test that was negative, collected 11th November 2020. On 12th November 2020, 10 days later the patient had skin sensitivity with pain on his scalp, chest and abdomen, but no rash. He also had myalgias, shakiness of his hands and arthralgias in his fingers. He did not have a fever. The patient's myalgias improved, but he continued to have painful, sensitive skin that felt like a large sunburn. The patient's symptoms resolved 23rd November 2020. The reporter had decided already not to give the patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020255814:Duplicate case
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 85-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
pt recvd vax 26JAN94 & on 29JAN94 became cranky, whiny; 30JAN04 pt cried, whiney & spit up, cranky all noc; dec appetite, no sleep, almost projectile vomiting; 31JAN94 t101, crying, went to MD blood tests results 10,000; 4FEB94 weak;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-SEP-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016866, MOD-2021-016843 (Patient Link).  This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016866, MOD-2021-016843 (Patient Link).
02/15/22 presents to ED for "epigastric abdominal pain and black stools ". PMHx of "esophagitis and COVID >2 weeks ago"