chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medication were reported.  Vial size was 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. Dates of administration of vaccine were 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.  This case is of patient 30 out of 42 patients, as described by the reporer.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
Patient received vaccine tolerated well after 15 min of wait time. vaccine was expired05/15/2022 but with in she same month of administration. Patient was notified of incident at the time of visit by providers she will also see her specialist.
The night of the vaccine, the patient developed fever, chills emesis and lethargy. He improved in about 2 days but by 3 days later developed sudden onset left sided chest pressure which improved somewhat that day with ice to chest but by next day (now 4 days after vaccine) developed sharp chest pain, with radiation to left shoulder and shortness of breath. In ER, he showed EKG changes, elevated troponin and was diagnosed with myopericarditis; no other cause yet found.
Significant heart palpitations approx. 16-18 hours post-injection lasting throughout the day
No symptoms after first vaccine besides soreness to the injection site. After second vaccine, only symptom was soreness in the injection site for approximately the first 20 hours. Shortly after that I started experiencing chills and fatigue. Afebrile at 98.2F. Took an OTC Ibuprofen tablet and symptoms subsided. That same night fatigue and chills returned as well as I started experiencing a headache. By the morning headache subsided after a OTC Tylenol tablet but fatigue remained.
Narrative: Patient presented to ER on 9/15 with reports 4 days of progressively worsening non-productive cough, fatigue, malaise, and feeling lightheaded/dizzy when he stands up, and loss of appetite. Past medical history of HTN, HL, CKD, GERD, OA, anxiety, schizophrenia, depression, bipolar disorder, and chronic pain. Diagnosed with acute hypoxic respiratory failure 2/2 COVID pneumonia. Two dose vaccination series completed in February. Admitted due to elderly age and fatigue and patient report of living alone and unable to care for himself with symptoms. AKI on labs secondary to dehydration. Treated with remdesivir per protocol 09/15 - 09/20, dexamethasone, 09/15 - 09/21, and supportive treatment with supplemental oxygen, ascorbic acid, zinc oxide and benzonatate, acetaminophen for fever. Discharged on 9/21 with methylprednisolone dosepak, guaifenesin, benzonatate, and albuterol inhaler. Received COVID vaccine booster dose on 9/29.
This spontaneous report as received from a mother's consumer refers to approximately 4 months old male patient. On 1997, the patient was vaccinated with dose first, 0.5 ml MMR II. On 2001, the patient was vaccinated with dose second, 0.5 ml MMR II. On 2012, the patient was vaccinated with dose third, 0.5 ml MMR II. The patient's mother said that her son had received th MMR II vaccination three time since 1997. The patient received the vaccination in 1907, 2001 and 2012. No more information provided. At the time of the report the patient outcome was unknown. Action taken with MMR II was reported as discontinued. Additional information has been requested.
pt recv vax 3OCT97 & 5OCT97 numbness rt foot;13OCT97 saw MD tested for diabetes negative;14NOV97 rt ankle stopped working;7JAN98 myelogram & CAT dx peripheral neuropathy, perineal palsy;12FEB98 ?dx vasculitis;
Not certain if related but suddenly developed splotchy rash over face and neck. Intensely itchy with sporadic bumps/hives.  Started 8 days post injection. Began taking Benadryl shortly after I set and continue to take as this is day 2 of reaction.
Sore arm; Fever 99.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Someone such as me with cardiovascular, lung disease" (unspecified if ongoing), notes: Someone such as me with cardiovascular, lung disease; "Someone such as me with cardiovascular, lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Fever 99.9". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:  It was reported that consumer asking a statement on the need for a booster dose (3rd dose) that was Pfizer investigating the need for a booster dose or not. Received first and second dose of vaccine. Second dose being received on the 03Mar2021. The consumer stated "I have the opportunity to receive third dose. A second dose of the second dose.  I am scheduled for this opportunity Wednesday. Variants outpacing variants at the moment.  Spoke to a pharmacist.  Amount to even less than the Moderna vaccine. Less of a serum of the dosing.  A colleague, Escape the antibodies that vaccine.  My provider. Casual conversation with pharmacist. Even though they were about the same in efficacy. Critically at high risk,  Comorbities. They may say that 90 percentile in terms of percentile.  No guarantee and open to interpretation.  Someone such as me with cardiovascular, lung disease. If I get the flu it could lay me out for weeks, with Prednisone.  My wife crossed over from Cancer. Trying to get as much protection.  Disinfecting gloves with Clorox wipes.  Exquisitely at high risk. Was there going to be unforeseen side effects.  First the starter dose then the hammer dose.  Had very little side effects.  I personally did not have any issues. Periodontal. Fever 99.9 and sore arm. I had an appointment awaiting a decision. At this point its everyone and their dog trying to get an appointment. Endocrinologist. If it ends up killing me."    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Almost died taking the flu shot; Took the flu shot while pregnant; This prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Flu vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Flu vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and vaccine exposure during pregnancy. The patient was treated with herbals nos (Herbs). On an unknown date, the outcome of the near death experience and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.   The reporter considered the near death experience to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was almost died taking the flu shot while pregnant 18 years ago. The reporter stated that, If it were not herbs it were not right. This pregnancy case was considered as lost to follow up. The reporter thought that the event might had been related to the product/device.  Additional Supportive Information: The follow up would not possible as no contact details were available.
24 hours after booster I started having a real high fever and chills. After 3 days it didn't go away and my temperature was 104 so I went to the hospital and discovered that I had the flu. I'm not sure if this was coming on at the time of the booster shot.
flu like symptoms; achy; feverish; headache; chills; decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  The reporter was patients wife. The patient experienced flu like symptoms, achy, feverish, headache , chills and just decreased mobility after receiving Shingrix in high up on the deltoid muscle. The stayed in chair most of the day. The reporter reported that about 36 to 72 hours later the issues resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection  Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping
Breathing issues; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Breathing issues) 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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced DYSPNOEA (Breathing issues) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Breathing issues) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cardiac Catherization was performed on 16 november 2021.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (hospitalization) unexpected event of DYSPNOEA. The event occurred approximately 4 days after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was provided. The rechallenge is not applicable considering missing information on other vaccination doses. It is reported that patient went to cardiac catherization on the same date of occurrence of the event. No diagnosis or information about hospitalization course has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (hospitalization) unexpected event of DYSPNOEA. The event occurred approximately 4 days after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was provided. The rechallenge is not applicable considering missing information on other vaccination doses. It is reported that patient went to cardiac catherization on the same date of occurrence of the event. No diagnosis or information about hospitalization course has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The usual effects at first, like everyone else's; felt better after two days; about 11 days later, began to have fatigue, headache, night-time chills, palpitations, premature beats -- as of today, none of this has resolved.
Pt recv vax on 2/3/99; 2 hr post vax pt exp staring x 20 min, fever (100.5), shaky & clingy
Large red circle around injection site which appeared 7 days after shot. The area is probably 4 inches in diameter and there is a large lump accompanying it.  Some itchiness is also accompanying.
About 12 hours after the shot, I started running a fever and was very achy.  It got progressively worse.  Around 4:15 am I got up to use the restroom and I passed out.  My husband was able to get me to regain consciousness.  I then passed out again after about 10 minutes.  We then went to the ER because I had a laceration on my eye,and head pain from hitting my night stand, wall, and floor.
pt recvd vax 430PM father stated pt slept til almost 10PM, woke up crying, white as a piece of cotton & had difficulty breathing; stated eyes appear unfocused & wouldn't react to parents; stated they thought pt was dying; went to ER;
Mucus stools; Discomfort; Particularly urgency going and often diarrhea/Bowels move almost immediately after ate; Weight Loss; This spontaneous case was reported by a consumer and describes the occurrence of MUCOUS STOOLS (Mucus stools), DISCOMFORT (Discomfort), WEIGHT DECREASED (Weight Loss) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Blood pressure high and Weight loss.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced WEIGHT DECREASED (Weight Loss). On 06-Jul-2021, the patient experienced MUCOUS STOOLS (Mucus stools), DISCOMFORT (Discomfort) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, MUCOUS STOOLS (Mucus stools), WEIGHT DECREASED (Weight Loss) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate) had not resolved and DISCOMFORT (Discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: Weight loss.   No concomitant medication details were provided.  The reporter's causality for the events with HUMIRA 40MG/0.4ML(ADALIMUMAB) was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623426 (Patient Link).
Symptoms hit suddenly around 2pm on 2/112021( approx. 25 hours after vaccination) Soreness in right arm, Stomach cramping, Severe Chills, Low grade temp 99.8, Nausea. Pt was given Tylenol at 530pm and again at 2 a.m. on 2/12/2021.  Symptoms subsided by the morning  of 2/12/2021 but patient remained fatigued and "drained."  She did not seek medical attention for this
Migraine started 2 days after first dose, came back worse 3 days after dose
Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday; Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy to sulfites" (unspecified if ongoing), notes: Allergy to sulfites. Concomitant medication(s) included: DOXYCYCLINE taken for skin reaction, start date: 2020. Past drug history included: Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "Her throat swells", notes: 2 years ago, in 2020; Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "feeling like fire on the inside of her body", notes: 2 years ago, in 2020; Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "then felt tingly all over/ was like that tingly feeling you get when you hit your elbow/ Felt that tingly feeling all over her body", notes: 2 years ago, in 2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive. Clinical information: It was reported that reaction to her doctor and it happened about 2 years ago, in 2020. Believes it was before Covid. Tested positive for Covid yesterday, Tuesday. Called the doctor immediately and she wanted to make sure the medication didn't have sulfites in it. So she called today. Clarified that she didn't take the Doxycycline after that second dose. When she talked to the pharmacist about her reaction, she told him she was not taking it anymore and pharmacist said that was fine. NDC, LOT, EXP to Sulfites caller had reactions to in past: Unknown When she eats different things, like when going to a restaurant, she tells them she can't have anything with sulfites. Sometimes, they put thing in it, then she has a reaction and takes Benadryl. Once she stopped taking the medication, and it got out of her system she thinks it was fine, at that point. Tried to flush it out of her system with water and it was fine. Has taken Pfizer, all the shots, vaccinations and the boosters and it was just fine.  Description of complaint: had reaction to Doxycycline, which had sulfites in it. Has allergic reactions to sulfites. Product strength and count size dispensed: unknown   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
soreness at site, chills, headache, tiredness, swollen node in armpit, swollen vein/node in left breast. swollen vein/node in breast active currently 8.30.21
Patient presented with redness and swelling below the vaccination site on her right arm only and swelling extended downward towards her elbow. It originally caused her pain due to the swelling, but at the time of the report, no longer was hurting. She was concerned about the swelling only at the time of the report. Patient consulted her doctor after the presentation at the pharmacy. Patient reported back that her doctor believed the swelling to be possibly due to a spider bite instead of a side effect of the vaccination. Patient was prescribed Bactrim DS with directions of 1 tablet twice daily for a 10 day treatment.
ONE OF FOUR PATIENTS DEVELOPED FEVER, CHILLS AND ARTHRALGIAS WITHIN 24 HRS AFTER IMMUNIZATION. NO RESIDUAL EFFECTS.
Patient stated that she was feeling dizzy 15 minutes after vaccination. Her heart rate was 129 and blood pressure was 180/120. Patient stated that she felt pain in both her arms and legs and that they were rigid. Her hands were contorted. Patient had difficulty talking and was hyperventilating. She was conscious with labored breathing. Benadryl 25mg IM was administered. Observation nurses advised that EMS should be called, patient consented. EMS arrived and took patient to the hospital.
Not noticable early on, then 2 weeks after 2nd dose, the 1st time I sat in the sunlight, my allergies began. Rash, hives, redness, sensitivity to light, my elbows and arms burned when raised while styling my hair, severe itching after showers and my arms burned from heat of hot water whenever I do the dishes. Severe itching with exercise or sweating like hot flashes. I didn't report sooner because I thought it was more likely from Accutane I took approximately 7 years ago, which made my skin sensitive back then but nothing like this. I became aware it's from the vaccine when symptoms started getting really bad after the Pfizer booster. Allergy eased-up quite a bit before then.
On 04/27/21, exactly one week after my second injection, I experienced a fleeting headache, REALLY  bad chills and SEVERE fatigue, for 24-30 hours.
I had a macular hole and a detached retina after receiving the 4th dose. I had surgery on 09/22/2022. I am still in recovery.