chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(Consumer). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 47 years, in right 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's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAFUSION MULTIVITES, start date: 01Sep2018, stop date: 10Jul2022; PROBIOTICS, start date: 01Sep2018, stop date: 10Jul2022. The following information was reported: COVID-19 (medically significant) with onset 25Jun2022, outcome "not recovered", described as "COVID-19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 25Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Unknown results; (08Jul2022) Positive, notes: I tested positive on day 13 with mild cold symptoms; (10Jul2022) Positive, notes: Still testing positive on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a 12 month old female patient. On 23-APR-1997, the patient was vaccinated with the first dose of MMR II for prophylaxis (lot#, expiration date, strength, dose and route not reported) and then the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX (lot#, expiration date, strength, dose and route not reported) on 30-APR-1997. The patient received her second dose of MMR II (lot#, expiration date, strength, dose and route not reported) on 21-DEC-2000, and she received her second dose of (Oka/Merck) VARIVAX on 07-JUL-2011. The patient had not experienced any adverse effects. It was unspecified if the patient sought medical attention. Additional information has been requested.
Patient states that she felt pain immediately upon administration of vaccine. This pain has persisted since, making it difficult to raise and lower her arm. Upon evaluation by PCP, it was concluded that her diagnosis is tendonitis of anterior shoulder due to improper placement of vaccine. Doctor did not state whether he believes this to be permanent. Patient was seen by doctor on 11/20/20, medication prescribed was a medrol dosepak. Patient picked up medication on 11/24/20. She would like someone from Risk Management to contact her.
Red rash and itchiness on the injection site 7 days after the initial injection. The size of the rash is about 3 1/8 inches x 3 3/4". Upon filling out this application I am only one day out of the reaction. It has not yet resolved. I am assuming this localized reaction will resolve in a few days.  Also had some body aches the same day the rash started, but they seemed to have resolved. I am not sure if those were related to the vaccine since it occurred a week after the first dose.
And within 8 months I came to know that my right kidney has no use; I came to know my right kidney is significantly atrophic; suddenly due to my right side abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 09Apr2021, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 19Mar2021, for Covid-19 Immunization. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "And within 8 months I came to know that my right kidney has no use"; RENAL ATROPHY (medically significant), outcome "unknown", described as "I came to know my right kidney is significantly atrophic"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "suddenly due to my right side abdominal pain". The events "and within 8 months i came to know that my right kidney has no use", "i came to know my right kidney is significantly atrophic" and "suddenly due to my right side abdominal pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (02Nov2022) right kidney was significantly atrophic. Compensation for organ loss due to Pfizer Covid19 Vaccine Like everyone, the patient had given covid-19 vaccine of pfizer (1st dose 19Mar2021, 2nd dose 09Apr2021, booster 10Dec2021, 4th dose 22Dec2022). And suddenly due to the patient's right side abdominal pain, doctor did an ultrasound on 02Nov2022 where for the 1st time the patient came to know his/her right kidney was significantly atrophic. And within 8 months, the patient came to know that his/her right kidney had no use. The patient didn't have any previous history of kidney disease or injury.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough Covid case. Took Paxlovid.  Resolved in 5 days.
At 12:10 PM th patient reported back to the area where the flu clinic was being held compalaining of throat being scratchy and eyes "sandy".  Her eyes were totally injected and her BP was 180/102.  She was given Benedryl 25 mg po and monitored for 1 hour.  Her BP went down to 146/70.  She was sent to her primary care physician who put her on a medrol dose pack.
I didn't feel good; nauseous that whole day; vomit; my arm hurts really bad all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 (Lot number: FC3181) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid Reflux" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease. The following information was reported: MALAISE (non-serious) with onset 10Aug2021, outcome "recovered" (2021), described as "I didn't feel good"; NAUSEA (non-serious) with onset 10Aug2021, outcome "recovered" (2021), described as "nauseous that whole day"; VOMITING (non-serious) with onset 10Aug2021, outcome "recovered" (2021), described as "vomit"; PAIN IN EXTREMITY (non-serious) with onset 10Aug2021, outcome "recovered" (2021), described as "my arm hurts really bad all day". Therapeutic measures were not taken as a result of malaise, nausea, vomiting, pain in extremity.  Additional information: patient report adverse effects to the COVID-19. Patient had the side effects and just wondering If patient should just report this patient first vaccine was on 09Aug2021 patient had the first dose. Patient did not feel good, and patient was nauseous that whole day and in fact patient did vomit. Well patient saw as the side effect you know no big deal arm hurts really bad all day. Prior vaccination: patient never take flu vaccine, ever.   Follow-up attempts are completed. No further information is expected.
Mom calls office morning of 6/10/2017 and states that last night (6/9/2017), child was sending her "bizarre texts." She states that child had complaints of a headache, was lethargic, had difficulty walking, and was having "lucid dreams" from midnight to 0700. Mom also states, per child's father, child felt "feverish."
May: tingly/pins-and-needles in hands June: loss of feeling/numbness in left lower leg; quickly followed by acute weakness and loss of feeling/mobility in right leg and both hands and forearms
On 4/14/2021, I received my first vaccine at about 8:40 AM. Within about 5 minutes, I had a rash on my neck and chest. My blood pressure and heart rate were checked. They gave me an injection to counteract the allergic reaction in the left arm. I had a fever for 2-3 days, headaches, and dizziness. Both of my shoulders hurt, so I was confined to my bed. I was advised to take Tylenol, drink plenty of fluids, and stay in bed. After 3 days, I felt a little bit better, though I still had some dizziness, headache, and pain, but they were less severe. I received my second vaccination on 5/5/2021. I had red, itchy, painful eyes that came and intermittently for about a week. Sometimes I couldn't breathe well. I developed a rapid heart rate, and I called my doctor; he advised me to go to the hospital. I went to the ER on 5/28/2021. They gave me an IV and three medicines to counteract the allergic reaction. The red, itchy, painful eyes on 6/8, and I went to the ER again. They checked my heart rate and examined my eyes. The doctor prescribed eye cream to treat the itchiness. I went to the PCP, and he prescribed me 25 mg of Banotaen. I have recovered from most of my symptoms, but I still sometimes feel a little dizzy and lethargic.
Information was received from a certified nurse assistant regarding a 13 year old male patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 21MAR2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Faint; Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over; headache; swelling on her arm; redness; itchiness; cold; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over). In October 2023, the patient experienced PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint), PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold), DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over) and HEADACHE (headache) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Halfway through the night after receiving the most recent dose of the vaccine she felt dizzy, lightheaded like a balloon, and faint. She went to work, where she felt she got worse. Feeling like she was going to fall over, was dizzy, cold, and had a headache. She also had some swelling on her arm, itchiness, and redness. She called her doctor who recommended ice on her arm, Tylenol, rest, and drinking lots of fluids. She had attempted these treatments. Company comment: This spontaneous case concerns a 57-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of SYNCOPE, halfway through the night after receiving an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, among other non-serious events. Vaccination with influenza vaccine on the same day remains as a confounder for the event. She took paracetamol, rest, and drank fluids as treatment. No further clinical information was available for medical review. She reported having received previous doses of the COVID-19 vaccines without any specifications. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745400:Spikevax NOS case (Same patient)
Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer.  A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020  for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products.  On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills  that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis.  Information on the lot/batch number has been requested.
Pt was seen in the ER 3/15/03, C/O redness and pain and itching in R rib area. Dx: shingles, had past history of shingles. Rec'd smallpox vaccine 6 wks ago. No fever or chills. Erythema over lower lateral rib cage in dermatomal  distribution with small vesicles present.
She had been seeing a chiropractor for her joint pain and was feeling better but her hip and leg pain returned starting the day after the vaccine.
Tested positive for Covid19 after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid19 after being vaccinated) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included DICLOFENAC, ATORVASTATIN, VALSARTAN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced COVID-19 (Tested positive for Covid19 after being vaccinated). The patient was treated with AZITHROMYCIN ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form and BENZONATATE ongoing since an unknown date for Sinusitis, at a dose of 100 milligram. At the time of the report, COVID-19 (Tested positive for Covid19 after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-114418 (Patient Link).
Patient c/o injection site being very swollen, red, painful, and hot to the touch. Patient presented on 7-28-10 with above symptoms. Upon exam, patients (L) arm has blisters around injection area. Also had clear yellow drainage from both injection sites on (L) arm. Patient was given KEFLEX, Prednisone, Hydrocortisone cream.
Information has been received from a nurse referring to a 20 year old female patient. The patient's medical history included gallbladder removal and headache. Drug reactions/allergies was reported as none. Concomitant therapy included oral contraceptive. The patient was vaccinated with two doses of VARIVAX (dose, route, lot# and expiration date were unknown) one dose on 14-JAN-1999 and one dose on 28-JUN-2007. A varicella titer was drawn on 12-AUG-2017 and the results showed there was no immunity to varicella. One booster dose of VARIVAX (lot # N000682, expiration date 06-JAN-2019) was administered to patient on 18-AUG-2017. No treatment was given. The outcome of the event was reported as not recovered. The patient visited physician to seek medical attention. The causality assessment was not provided. This is one of two reports regarding to the same patient. Sender's Comments: US-009507513-1709USA000121.
Rash / hives on left leg, 3 inches about ankle and 3 inches up from  that one. Started in upper area first. Stinging first with two red marks. The ankle area was second on the back of leg.. Used Gold Bond to relieve the pain and burning. Two more marks showed up on the  right calf but did not change. Did show up on the back of left leg in the thigh area from bend and 3 inches up. Used Gold Bond from the 22nd  to today the 26th and have had a good improvement .
-Rapid heart rate: a few hours starting at 11pm -Labored breathing -Difficulty standing and moving due to extreme sudden fatigue, fast heartbeat and breathing  -Over the next few months experienced much more severe menstrual symptoms
Vaccinated: 18:05 Reaction: 18:08 Patient was taken to medical bay for vaccine booster injection for history of syncope after 1st vaccine. He was released from medical bay to observation. While sitting, patient reported he "zoned out, started to shake and flipped out of chair" onto floor. He denied pain anywhere.  Vitals: @18:09: 96/57, 89, O2 100% -> @18:14: 110/65 He was given water and within minutes was released to observation. Patient was stable and released from vaccination site @18:21 walking.
Pt recvd vax 11AM & became pale about 12noon; Approx 3-4PM became very quiet & still, unarousable w/cold extremities; Seen by MD & started to look better approx 5-6PM; pale/cool extremities approx 24 hrs later;
I am writing to report the most troubling event that occurred this morning.  Which is my left ear is very 'full' plugged feeling, my right ear also is plugged, but not nearly as bad as my left. I hear constant high pitched sound in my head and I have hearing loss in my left ear significantly more than my right. I also have numbness in my right side of my head and the itchy all over my head.  My breathing to breath in an out feels laboured.  The hearing loss is terrifying.
Delayed onset of intense swelling, redness, pain, at injection site, 6-8 days after injection (after initial swelling subsided). 7th-8th days very firm and swollen upper arm mass.
7hr p/vax pt developed swelling @ the inj site which extended past elbow;pt was seen by Md 1 days post vax;MD dx cellulitis & prescribed ATB;
Information has been received from a female consumer who on approximately 25-DEC-2007, "around Christmas 2007", was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot no., route and site of administration were not reported). The patient reported that she missed the other two doses of GARDASIL vaccine (yeast) because she could not afford it. No adverse event reported. Additional information has been requested.
On the second vaccine, it was about 2 1/2 days later (02/10/2021) during the night that I woke up very ill. I was sweating and vomiting and I had major diarrhea and felt very sick for about 8 hours. After the 8 hours I felt fine. I did feel weak but I did start doing better. Because of the symptoms of the  2nd vaccine and throwing up, I felt very dizzy. I could hardly stand up to make it to the bathroom that I wonder if I'm actually even vaccinated. No medication was taken and did not see a Doctor. I did have soup and started feeling better. I did have soreness in arm for about 3-4 days.
gen urticaria p/4th dose in series;tx w/antihistamines;due for 5th dose 15NOV95;will try to get RVA;
Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) (seriousness criterion medically significant) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out). At the time of the report, PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) outcome was unknown.            The action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My arthritis flared up after the 2nd dose.  Severe fatigue and weakness, increased joint pain and swelling
Between 7:30 and 9:30 symptoms progressed very rapidly. Extreme diarrhea, 1st temp, 104.5, gave TYLENOL and went down to 103 and then went back up to 1047. Went to emergency room and was admitted to intensive care. Temp went up to 105.7. Also, was shaking, very scared. Acting completely dehydrated.