chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immune reaction diary: Vaccinated at 2:58 PM, 3/19/21 Started feeling sleepy after I got home around 5 PM, T+2 hours, as I expect with a flu shot. I took a melatonin to boost this effect, and was cozily asleep by 6 PM, T+3. 5:00 AM, T+14: woke up chilly and overall mildly sore. Normal temperature. Very mild headache behind the eyes. No Tylenol yet for anything. Chills compounded by the fact I was  wearing the same T-shirt from the day. I changed into a long-sleeve pajama turtleneck, pull-over sweater, and put on socks, and went back to sleep.  7 AM, T+16: Soreness and chills fading. Arm still a bit sore but less than shot #1. 8 AM, T+17: Headache and soreness comparable to a rough hangover. Moving slow today. No Tylenol needed yet. 11:30 AM: Mild fever of 100.7. Headache and soreness have remained mild. 2:30 PM (T+23.5): Fever of 101.0 (peak) 6:30 PM (T+27.5): Fever reduced to 99.5. 8:00 PM (T+29): Finally took some Tylenol with dinner for bedtime. 8:30 PM: temperature back to my normal baseline. 11:00 PM (T+32): Feeling back to normal, though worn out from the day.
PERIPHERAL NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA 1/3/2023 &  03/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
extreme stomach pain and extreme chills. Unable to stop trembling and extreme exhaustion. headache that lasted for at least 4 days.  stayed in bed for 3 days after first vaccination.  It's been more than 2 weeks and I'm still tired.
Patient fainted.  No injury.  Patient was assisted to supine position with legs elevated.  Responded quickly.
My smell and taster are gone. I can only smell cooked foods and they all smell like trash or garbage compost mixture. My taste is starting to taste the same too like the trash smell. It?s going on two-three weeks now. The day of the vaccine I had every symptom. Body aches, headache, chills, fever, nausea, dizziness, and fatigue for 4 days the fifth day I was fatigued and disoriented at times. 6th day just fatigued  and still to this day. But now with no smell and taste now and it?s still very much gone.
A warm, red, raised rash 4" x 4" on left thigh. Pt to take 2 tsp Zyrtec daily until rash gone. Also cold rags to rash.
My niece testes positive for Covid.; My niece testes positive for Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "My niece testes positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: type: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229381 same reporter/drug/ae, different patient.;US-PFIZER INC-202300229421 same reporter/drug/ae, different patient.;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma; "Allergies" (unspecified if ongoing), notes: other medical history: allergies; "high cholesterol" (unspecified if ongoing), notes: other medical history: high cholesterol; "chronic pain (degenerative disc)" (unspecified if ongoing), notes: other medical history: chronic pain (degenerative disc); "chronic pain (degenerative disc)" (unspecified if ongoing), notes: other medical history: chronic pain (degenerative disc); "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex; "known allergies: avocado" (unspecified if ongoing), notes: known allergies: avocado. Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL], start date: 01Jul2022, stop date: 18Jul2022. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin; Ibuprofen (nsaids), reaction(s): "known allergies: ibuprofen (nsaids)", notes: known allergies: ibuprofen (nsaids). The following information was reported: VACCINATION FAILURE (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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received vaccine and had other medication in 2 weeks. Anti viral details: product: paxlovid, treatment start date: 06Jul2022, treatment stop date: 11Jul2022, indication: Treatment of COVID-19. Had sore throat, headache, stuffy nose, (reinfection of covid, or rebound) on 15Jul2022, and was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This child had complained of itching, redness, and swelling in a 3-4" diameter, last PM. Noticed at 7 PM. Has resolved 01/29/01.
Fever of 100.2, body aches, headache, nausea, injection site pain, chills and sweating
The reason I'm reporting is that how I felt was similar to my sensitivity to Claritin: increased level of alertness, difficulty falling asleep; minor anxious feeling with diastolic BP in low 90's/ high 80's( usually in 70's) on home electronic BP cuff, and increased feeling of feeling my heart beat in my chest. It's now 6 days later and I feel about 50% better, but with continued elevated diastolic BP at similar levels.
This spontaneous report as received from a physician refers to a female patient of unknown age. In approximately May and July 2012, reported as about 2 years ago the patient was vaccinated with the first and the second dose (respectively) of GARDASIL at the proper time interval (0 and 2 months)(dose, route, lot number and expiration date were not reported), but did not received the 3rd dose. On 30-MAY-2014 the patient was presented in the physician's office to receive the 3rd dose of GARDASIL (route, lot# and expiry date were not reported). No adverse effect was reported. No PQC was involved. Additional information has been requested.
Acute inflammatory demyelinating polyneuropathy, treating with IVIG, is showing some improvement so far
spit out blood and blood clots; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (spit out blood and blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATEMESIS (spit out blood and blood clots) (seriousness criterion medically significant). At the time of the report, HAEMATEMESIS (spit out blood and blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not provided, no treatment information were provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Swelling of about 5 inch diameter around injection site, discoloration (black & blue, off-white areas) continuously appearing over time, warm/hot areas in this circular patch, itchy, sore to touch.
requested pt's medical records, but never received them; pt had a positive COVID test on 9/7/21; per death certificate, pt died in the hospital with the cause of death being COVID 19
extremely sick; Initial information received on 11-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Social Media.  This case involves a patient of unknown age and gender who got extremely sick after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 1985, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, route, frequency, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. It gets people extremely sick many times including me , never again since 1985.   On an unknown date in 1985. the patient got extremely sick (illness) (unknown latency) following the administration of influenza vaccine.  Reportedly, Haven't had a flu shot since 1985 when it got me extremely sick. Really Haven't been sick since. It gets people extremely sick many times including me , never again since 1985.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Patient returned to class at 11:25 am and at 11:35 am got up and told the teacher that she was feeling woozy hot, and things were blurry. She also claimed to have difficulty breathing. Ambulance came at 11:55 am and patient received IV BENADRYL and a nebulizer. In the hospital she was admitted and given IV BENADRYL.
I got very dizzy since then; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I got very dizzy since then) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Feb-2021, the patient experienced DIZZINESS (I got very dizzy since then). At the time of the report, DIZZINESS (I got very dizzy since then) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
was up all night with leg pain; like I had flu; growing pain that kept me up all night; pain at the vaccination site; pain goes from my shoulder to all the way down behind my back; top of my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site) and BACK PAIN (pain goes from my shoulder to all the way down behind my back) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 013A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder). At the time of the report, PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder) outcome was unknown.            Reporter did not allow further contact
Second night after the vaccination, I woke up to use the restroom. I passed out and found myself laying on the floor, not sure how long has passed. Something like this never happened before.
Unusual taste in mouth, throat tightening within 30 mins of vaccination. SX resolved with Benadryl 25mg PO x 1
This spontaneous report as received from a pharmacist via Company Representative refers to a 54 year old female patient with no drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (injection, dose not reported). On 28-APR-2014, the patient experienced injection site reactions, described as following: injection site was warm to the touch, injection site was red, with swelling and it had a lump. The patient had no fever (date unspecified) and had not previously had reactions to other injections. The patient's outcome was unknown. Causality assessment was not provided. Additional information has been requested.
I went to my primary care physician for a check up and I had not had an EKG in over a year. My primary care physician performed an EKG and noticed irregularities. I was referred to my cardiologist. My cardiologist stated it was nothing to worry about at this time.
In a few minutes are going to be 72 hours after the shoot. I had been experiencing severe headache many times during this days. I had take advil and acetaminophen for this condition.  Also, I had experienced articular pain in arms and legs. Pressure in my chest yesterday in the afternoon. Muscular pain, pain in my left arm. And I had felt an unusual sweep in my hands and body. And I had felt a non normal condition of my nose, I feel like if I smell diferent, medicine or something like that. For that reason, I schedule an appointment for Covid test Tomorrow at 4 pm, to discard I don´t have the COVID. If somebody contact me please in language. Thank you.
3 blisters- 2 on buttocks; 1 on back- 10 days after varicella vaccine administered. Scabbed over in 3 days- no treatment or doctor visit reported.
Narrative:  76 year old male, received first dose of COVID-19 vaccine on 2/11/2021. PMH HTN, CAD s/p NSTEMI and CABGX4, HFrEF and HLD. Spoke with pharmacy/anticoagulation on 2/16/2021. No further medical notes. Patient expired 2/28/2021.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756533A, A0756535A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Pt was given the vaccine around noon local time, and did not notice any reaction until later that night after he got off shift. His right shoulder had localized swelling around the injection point with a diameter of about 6 cm in diameter. There was some redness at the injection site with a diameter of 2 mm. Pt described it as slightly itchy, and denied any further symptoms. Pt was given anti-itch cream and told to follow up as needed.
Localized reaction red, swollen, warm to touch Rt arm from mid deltoid to shoulder - Lt arm red, warm, swollen area - size of baseball.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
A nurse reported that a 67 year old female pt received Pnu-Imune 23 on 12/7/99. That evening, she developed a "severe" injection site reaction characterized by swelling and redness "which wrapped clear around to axillary area" and low-grade fevers. She recovered. This is 1 of 4 pts, out of 6 vaccinees, from this facility who experienced this event following receipt of Pnu-Imune 23.
I fell ill for a couple of days and my arm was tender and sore but I expected that. I just felt generally unwell for the next week or so with fatigue and not feeling like myself. After a week I was feeling a little better but 2 weeks after having the vaccine my husband came down ill and I immediately came down ill a day later. I was testing initially negative but I was becoming more symptomatic with fatigue, sore throat, muscle and body aches, and chills. My sense of taste and smell changed but didn't go away. I testing again and it was positive. I had an antibody infusion and I started to feel better after 3 days and my symptoms started to go away a bit, but my asthma during this had flared up and I was still very congested in my chest and very shortness of breath on activity. As my other symptoms began to recede, my asthma continued to get worse and I was having difficulty doing minor things around the house. I did try to work but I was unable to because I couldn't tolerate having a mask over my face because it made me shortness of breath and light headed. I started to see pulmonology during this time and we tried different medications, nebulizers, and inhalers in addition to my own maintenance inhalers. He put me on antibiotics and steroids. I know that during that past year I've been on steroids and antibiotics 6-7 times. I'd go off of them for a couple of weeks to see how I was doing but it would go right back to the way it was. I talked to an ENT and he was looking at my sinuses to see if there was anything that would be causing asthma to get worse and it was inflamed so he put me on more antibiotics. I worked myself down to only needing 4 breathing treatments a day. We talked about how my weight might be a factor, so I seen a weight loss surgeon and with the amount of steroids I had been taking, my weight had climbed higher than it had ever been. Leading up to the surgery, I did everything I could to improve my asthma but I was still needing 2-3 treatments a day. I was able to start becoming a little more better. I had the surgery and I am still needing 2-3 treatments a day still. I got Covid again and I have a lot of congestion and drainage and I'm getting shortness of breath back again and needing breathing treatments again. The month of February-September is the time during which I was taking so my antibiotics and steroids and having such a difficult time. January 5th, 2022 I caught Covid again.
This spontaneous report as received from an unspecified reporter via online media refers to unspecified female patients of unknown age. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date, the patients experienced unspecified side effects. The side effects were not specified by the reporter. The outcome of the side effects was unknown. The causality assessment was not provided by the reporter. The reporter considered the event to be medically significant. This is one of the two reports received from same reporter.; Sender's Comments:  US-009507513-1711USA000459:
No adverse event; Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 04-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medication information was provided.  Patient received Moderna bivalent booster dose.  No treatment medication were provided.
Early in the shift on  January 31 resident was noticed to be more tired than usual and  was not eating well.  Lung sounds were crackly and resident was found to be hypotensive.  He was evaluated in emergency department.  He was diagnosed with pneumonia.  Received a loading dose of antibiotic and returned to facility.