chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for himself. A 61-year-old male patient received PREVNAR 13 , on 30Dec2016 at single dose for immunization. Medical history included hepatitis C, two cataract surgeries and panic attacks. Patient was 100% disabled veteran. In 3 months he lost 30 pounds and he had 3 lumps on his left testicle ("one soft and spongy, the middle one was hard like a rock, and the third one was kind of soft"). The patient's concomitant medications were not reported.  Patient had a pneumonia shot about a year before (in 2016, no other details reported). Approximately 2-3 days after vaccination (in Jan2017) patient started feeling sick and it got worse and worse. It was also reported that since an unknown date, for 3 weeks, patient couldn't even eat and at the time of the report  he still wasn't eating well. He had no balance and has been falling down. He also stated that he was bouncing off the walls; he hit his head on the door jam and was bleeding.The final outcome of the events was unknown.
4 hrs after vaccine sudden onset of intense crying (inconsolable) arching back rigid could not put in carseat both legs swollen temp began with irritability T max 103 similar event at 2mos when received no series at 4 mos had HIB only- fussy, temp 99 but much less than when he had all 3 shots at 2mos + 6 mos
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection  for a few days
overwhelming fatigue; pain in my legs; I continue to feel extremely tired; unable to do things throughout the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I continue to feel extremely tired"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "overwhelming fatigue"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in my legs"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "unable to do things throughout the day".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature. Vials were not stored in approved freezer with a digital data logger.  No treatment medication was reported by reporter.
I had the first Pfizer shot in my left arm on 3/11/21.  Shortly after, I had a patch on my lower forearm that was itchy and would not heal.  I had surgery on my right arm at the end of March and had my second shot on 4/2/2021 in my right arm.  Around May 6, 2021, I began to have weeping around the surgical scar on my right arm from a partial elbow replacement surgery in March.  It was yellow fluid.  Initially I was treated for a bacterial infection and put on steroids.  The weeping spread and I had a rash on my lower right arm.  There was concern I might be allergic to the metal implant.  It then spread fully to my left arm with the initial patch never healing.  I was taken off of Lamictal to ensure that was not the cause.  I went to dermatology and was put on oral and topical antibiotics and steroids.  The rash continued to spread and I went for patch testing June 21-25, 2021 and was found to be allergic to linalool, bacitracin, neomycin and tobramycin (none of which I had previously been allergic to.)  I was not found to be allergic to anything in the implant, as the doctors contacted Johnson and Johnson to ensure none of the above allergens were in in the implant that was used and after reviewing their notes, none of the known allergens were used deeply during my surgery.  I continued to have weeping, itchy patches on my body which the dermatologist treated with topical and oral steroids.  To try to control the skin outbreaks, I have been prescribed Dupixent, of which I took my first does on 8/16/2021 along with topical steroids.  As of 8/24/2021 the outbreaks are continuing.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 168 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
High fever of 100.1, body aches with chills, slight headache and sore left arm.
On April 1, 2023, I felt my first symptoms like a scratchy throat. The next day I had body aches and joint pain. I was fatigued and had to take a nap. I had a head cold. Monday, I felt much better. I tested positive for COVID-19 on 4/2/2023. I had consult with nurse practitioner and doctor on Monday. I took PAXLOVID beginning the next day. I tested negative the following Sunday. My symptoms were gone by late Friday. However, at an event a few weeks later, I had some side effects after drinking beer. I was sleep-walking and went outside.
Injection site warm and hot to touch; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.            No concomitant medications were provided. No treatment medications were provided. It was more pronounced when patient woke up on (09Nov2021).  This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Site Warmth and expected event of Vaccination Site Erythema. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine. The event Vaccination Site Erythema is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380108 (Patient Link).; Sender's Comments: This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Site Warmth and expected event of Vaccination Site Erythema. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine. The event Vaccination Site Erythema is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Initial sting, then swollen, painful, area around shot sites; bruise evident at shots site (had both flu and pneumonia shots); applied Arnica salve; unable to sleep on left side that night; on morning of 12/16, still swollen, painful and bruised at shots site; applied Arnica salve; achy all over, but especially lower back; took 3 aspirin at 8 AM; spent most of the day in bed with hot pack on lower back; better as day progressed; on morning of 12/17, woke up with lower back an shots site still hurting; applied Arnica and took 3 more aspirin; better as day progressed; on 12/18, still achy but better; did not take aspirin.
Began to have Chicken Pox lesions (6-8) on various body parts 4 days after vaccination. 2 weeks later he continued having new lesions appear. On 06/08/17 he was admitted for right hand cellulitis and varicella rash.
Patient presented to emergency department on 8/13/2021 after testing positive for COVID-19 at an outside facility. She had complained of dizziness and had one instance of nonbloody emesis. Reports no other symptoms related to COVID-19 infection. She was given monoclonal antibodies while in the emergency department. Patient was discharged on 8/13/2021 from ED to home. Patient presented to the emergency department on 8/14/2021 after a syncopal episode while showering at home. Patient was admitted due to quarantine restrictions at assisted living facility. She remained asymptomatic for COVID-19 during admission. Patient was discharged on 8/23/2021 back to facility.
Covid Arm. Warm itchy red rash appearing 8 days after first vaccine injection. About 2 inches in diameter.
Hot; Injection Site is Inflamed; Itching; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information included ice pack that helped her.
Admitted to Hospital 12/20/15 acute resp. distress, HTN crisis, facial/cervical numbness. Reported GBS. Intubated, trach and PEG placed, plasma exchanges.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Dec2022 to 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Generalized erythematous, macular eruption & tenderness with itching soon after #2 dose of 3-4 week duration.
Four days after my second Covid vaccine (4/13/2021) I developed a severe itchy whole body rash with little red bumps chicken pox like. I still have the skin rash after seven month have past.
12 hours post vaccine developed severe muscle and bone pain and a fever, took 1000 mg of Tylenol 17 hours post vaccine and the fever broke, but the pain persisted. Took Ibuprofen 20 hours post vaccine because I developed a severe headache in addition to nausea. Headache became less intense, but all other symptoms remained at the same intensity. I fell asleep and woke up with a 103F at 28 hours. Pain persisted as well. I went back to sleep and woke up at 7pm when the fever broke, I noticed all the other symptoms were gone except for some new neck pain. The neck pain could be related to how I slept though since it was new. I did not take any more medication and went back to bed later in the evening. I woke up at 4am, roughly 29 hours post vaccine, with a fever and didn't take my temperature, but did take 1000 mg Tylenol. It broke an hour later. I have had waves of symptoms of a low grade fever all day (slight chills), which then feels like it breaks on its own indicated by sweat and chills disappearing. I haven't had to medicate any further however and in comparison to yesterday I feel amazing!
On 12/25 after the vaccination I started feeling very fatigued and on the 26th and throughtout the next 3 days I had a low grade temp, body aches were mild that affected my knee joint but just a little, periodic taste loss, loose stool and the color change in the BM for 3 days.  I had a virtual visit on the 28th and got tested and got the results on the 12/29 and was positive for COVID-19.  I went to the ER on 1/3 because I just wasnt feeling well and was advised my bone marrow were throwing off immature white blood cells. And after about 8 or 9 days is when I finally began to get some relief an symptoms began to resolve.
I did a flu clinic and I thought his form said he was 69 but her was actually 64. He did not have a reaction
Chills for about 10 hours Facial numbness that included my cheeks, entire jaw, and chin. Numbness still present more than 24 hours later on chin.
pt says he had soreness in shoulders, neck and had a headache.  next day the soreness was throughout his body.  He had sweating, chills, headache and red blisters on his chest going towards his right arm.  pt says he has been taking ibuprofen, Tylenol, and Dayquil the symptoms are getting worse and will contact his PCP.
Extreme fatigue, sore at injection site, large knot and swelling at injection site, dizzy and disoriented
Got slightly nauseous and had pain in my left arm around 6pm. Then when that subsided shortly after I began to have chills, body aches, and a headache. Still had some body aches the next day.
Pt received her 1st Pfizer vaccine on 3/15/21 and was admitted to the hospital with sudden right hip pain on 3/20/21. she also tested positive for covid 19 during her admission.   she was discharged on 3/22 feeling better with resolution of her pain and was told to watch closely for worsening s/s of covid 19
Instant tingling down my arm, headache, dizzy, blurred vision. Went home, tingling spread to legs and jaw.  In the morning , my left side of body, arms and legs tingling and numb. Chest feels inflamed and hurts to take deep breaths. Indigestion, frequent urination, very thirsty nausea, intense dizziness. Sharp stabbing pains through the day in heart and stomach.  Went to ER Was only given steroid inhaler
Eczematous rash started about 2 days after vaccine in male - bilateral inner proximal arms, bilateral torso and inner thighs (sweating areas) consisting of large patches of dry bumpy skin, pruritic varying in intensity based on activity, burning sensation if touched by sweat, no scale noted on exam, normal skin pigmentation -> improving at time of visit on 9/29/21
Received influenza vaccine 1/29 at PCP clinic.  Received Moderna vaccine on 2/6 by pharmacist at her place of residence.  She was taken to the ER on 2/9, unresponsive.  Staff reported she wasn't acting normally since 2/7.  During her hospital course (2/9-2/13) she was only able to open her eyes.  Unable to follow any commands.  MRI showed large right MCA stroke.  She was discharged from the hospital on hospice.
Walking from bathroom to bed (three paces total), tunnel vision resulting in complete blackout visually.  No loss of consciousness.  No precipitating symptoms, other than existing body aches, chills, and sweating.  Severe nausea, body aches, and cold sweat drenching the bedsheets.  Tingling in both hands, similar to that accompanying oncoming numbness.  Vision returned once supine.  Conscious breathing and raising legs above heart reduced syncopal symptoms after 20 minutes.  Unable to rise from bed to alert family members due to risk of loss of consciousness and vomiting.  Fever of 99.5 F, chills, body aches, moderate nausea, sleeplessness continued for several hours.  Oral dose of promethazine 12.5mg at about 10am 17 Apr 2021 reduced nausea and ended sleeplessness.
Fever of 100-103 for ~15 hours. Joint pain. Mild arm pain at injection site.
This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 12-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K009482, expiration date and route were not reported) 0.5 ml. There were no concomitant medications. Few minutes afterwards the patient experienced dizziness, near syncopal episode and weakness. The reported stated that the patient lay down for 15-20 minutes and then the patient reported feeling better. Patient did not pass out. The outcome of dizziness, near syncopal episode and weakness was reported as recovered. On 12-NOV-2014, no treatment was given for the adverse events. No lab diagnostics studies were performed. Additional information has been requested.
dizziness / vertigo .... mild symptoms for about 3 weeks ... not incapacitating but enough to disrupt day and interfere with work .... symptoms resolved but have since returned in the form of more significant vertigo for the past 4 weeks
chronic diahrrea; This serious case was reported by a consumer and described the occurrence of chronic diarrhea in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 2 days after receiving Shingrix, the patient experienced chronic diarrhea (Verbatim: chronic diahrrea) (serious criteria clinically significant/intervention required). The outcome of the chronic diarrhea was not resolved.   It was unknown if the reporter considered the chronic diarrhea to be related to Shingrix.     It was unknown if the company considered the chronic diarrhea to be related to Shingrix.   Additional Information: GSK Receipt date: 29-MAY-2023 This case was submitted by consumer via the online direct entry reporting system. The caregiver reported that the patient received a dose of Shingrix and within 2 days of receiving vaccine had chronic diarrhea. The reporter consented to follow-up.
dizzy; This is a spontaneous report from a contactable consumer (patient's mother). A 28-year-old male patient (reporter's son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 28 years old, on 01Aug2021 (Sunday) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) at single dose for COVID-19 immunisation. After the second vaccination, the patient experienced dizzy all day long on 01Aug2021, yesterday (02Aug2021) too and today (03Aug2021). The reporter asked if this was normal. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Gave pt wrong Immz, pt was to receive a (1) DTAP and was administered Flu vaccine by mistake.
Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.
Severe hives on the face and the injection site day#8 after injection.  every 6-8hr Benadryl  helps. Follow up with an Allergist
Patient admitted to the hospital on 12/9/2021 for evaluation of body aches, fever, cough, and fatigue since getting the flu vaccine on November 29.  Progressively getting worse since then.  Also has associated shortness of breath when she coughs, as well as lower extremity swelling.
Patient received PNEUMOVAX 23 in rt. deltoid and ALFURIA flu in left deltoid at same time. Left arm had swelling and red welts. 1st day noticed and then swelling has gone down by 2nd day still warm to touch. Patient took BENADRYL in am and HS. AFLURIA Lot - WT52005.