chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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's relevant medical history included: "HBP" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "TAA (heart)" (unspecified if ongoing). The patient's concomitant medications were not reported. No other medication received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 01Feb2023 to 06Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 06-Feb-2021, the patient experienced HEADACHE (Very bad headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Very bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 06-Feb-2021, the patient experienced HEADACHE (Very bad headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Very bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Drastic changes in behavior. When set down previously, patient would crawl around and happily explore the house for most of the day. Now when set down he would just sit in one place and scream and cry incessantly. He stopped crawling and exploring. Even when he was being held he would arch his back and thrash about instead of cuddling or just sitting calmly like he would previously. Instead of making eye contact and holding our gaze like he would previously, he seemed disconnected from us. He started slamming his head back into his highchair over and over again which he had never done before. At night he used to cuddle, calm down, and nurse to sleep.  Now he was nursing for like 10 seconds then pulling away and screaming. He seemed hyper agitated and couldn't stay still. Instead of putting him in his crib each night already asleep from nursing, we were putting him down with him still crying. As the symptoms wore on throughout the week we really became aware of how much his behavior had changed. We went from having a very calm, chill, easy baby to one that was crying and intensely screaming almost all day long. He was not the same person he had been just days ago. This lasted for a week and by the end of the week we got lucky and shared what was happening with a friend and only after various homeopathic therapies, ozone treatments, and a variety of detox techniques did the severity of the symptoms ease. We continued for about two weeks after with ozone treatments and other holistic supplements and saw improvement, but patient has never regained his ability to calm down and nurse to sleep in the evenings and is always put into his crib awake. He also seems to have more of a propensity for high pitched screaming now.
Patient diagnosed with COVID on 1/12/2021, was given vaccine at a clinic on 1/11/2021
I received the Johnson and Johnson vaccine. Within 1 hour my calf tingled. Within 48 hours I had muscle twitching 300 times per day, blinding headaches, blurry vision, insomnia, and Paresthesia. Additionally I suffered terrible nerve pain in my shins and 5 months later I still have symptoms.
p/ recv vax in 7/96 pt in 6/98 devel scattered lesions of varicella @ different stages over trunk & extremities.
This spontaneous report as received from a registered nurse referring unspecified number of patients of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dosage regimen were not reported) lot # M004116, expiry date 12-OCT-2017 and lot # M009378, expiry date 23-APR-2018 for prophylaxis (incorrect product storage). Temperature excursion: 47.3F, Cumulative time frame: 50.5 hours data logger was used. No adverse effects (no adverse event) reported. The outcome of incorrect product storage and no adverse event were unknown. This is one of two reports MARRS # 1612USA012828. Additional information has been requested.
Wrong immunization was ordered and given to patient. The correct immunization should have been PCV 13, Prevnar. Patient did not have any signs or symptoms of an adverse reaction.
Received first dose of vaccine on Jan 25th at 0940. Immediately noted itching, soreness at injection site. It continued to be itchy. On Feb 1st noted injection site to be swollen, itchy, red and hot to touch. This continued until I noticed on Feb 6th that the site was hot red and raised the size of a tennis ball shaped like a heart. This continued until Feb 8th Employee health was notified on Feb 8th. It seemed to dissipate on or about Feb 10th.      Ice was used at the injection site
Pain at a "7" in right thigh where shot administered. No swelling or redness. Mild fever-didn't take, but my skin was abnormally warm. Very tired. Fever gone by 7/10/15 @ 5pm. Pain & tiredness starting to go away now 7/10/15 @ 8:30pm. I am a RN. The nurse did administer the shot correctly.
Trouble urinating; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Trouble urinating) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSURIA (Trouble urinating). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSURIA (Trouble urinating) outcome was unknown. Not Provided          Concomitant product information was not provided. Action taken with mRNA-1273 in response to the events was not applicable
Flut shot to left thigh. 11/23 - Developed significant erythema spreading down from groin area to knee and never involving any specific joints. Not wanting to walk on that leg. Over next few days saw redness improve but new rash developed on her body ( raised and itchy). 11/28 - Macular rash on chest, abdomen, and back. Lesions only about 2mm in diameter and easily blanchable. A few areas of excoriated erythema more consistent with eczema. 11/29 - Rash worse over the last 24 hours. Mom states she feels her face is slightly swollen. No breathing concerns. Very itchy.    Topical triamcinolone gave no relief for itching. Prednisolone for 3 days then prescribed. Topical management recommended after. Referral made to allergy specialist.
severe reaction; This case was reported by a contact via call center representative and described the occurrence of hospitalization in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patients had severe reactions and had to be hospitalized The reporter did not consent to follow up
she may have had some fluttering of the heart as well.; her arm still hurts/Caller states the soreness is whole area where the vaccine was injected; felt some muscular twitching in a few places including her arm as well; high fever; chills; muscle aches for two days; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: 30135BA; Expiration Date: 30Nov2021) via an unspecified route of administration on 04Oct2021 as dose 3 (booster), single for COVID-19 immunisation (age at vaccination: 69-years-old), (She clarified her age at the time of event was 69. she just turned 70). The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2, on an unknown date as dose 1 and dose 2 for COVID-19 immunisation. The patient experienced she may have had some fluttering of the heart as well., her arm still hurts/caller states the soreness is whole area where the vaccine was injected, felt some muscular twitching in a few places including her arm as well, high fever, chills and muscle aches for two days on Oct2021. She states that her arm still hurts and she wants to know if this was unusual. Caller states she felt some muscular twitching in a few places including her arm as well. Caller states the soreness is whole area where the vaccine was injected. Caller states she did not have a reaction with the first two doses of the vaccine. Caller states but with the booster dose she had a reaction that also included a high fever, chills, muscle aches for two days but her arm is still sore and that is what is calling to get information about. Caller also mentions that it be part of her imagination, but she may have had some fluttering of the heart as well. Caller states she heard on the internet that its unusual for older people to have more side effects than younger people because they have a weaker immune response. The outcome of the events high fever, chills and muscle aches for two days was recovered on an unknown date in Oct2021, she may have had some fluttering of the heart as well and felt some muscular twitching in a few places including her arm as well was Unknown, her arm still hurts/caller states the soreness is whole area where the vaccine was injected was not recovered.
1FEB97 afeb (nasal congestion, loose cough); 3FEB97 given med x 21 days;
Employee was provided with 1st VZV after stating no history of chicken pox.  Employee received vaccine and 9 days later came down with body aches, fever and rash.  Went to physician on day 12th and was diagnosed with chicken pox virus.
Patient fainted while in the pediatrician office approximately 15 minutes after receiving vaccines.  Patient did not hit her head, her mother caught her fall.  Vital signs were performed on patient with normal results.  Patient c/o slight headache and nausea.  At approximately 2:30pm a call was made from pediatrician's office to the parent to obtain an update on child.  Per Mom, child was resting and was no longer c/o of headache or nausea.
Psoriasis flare-up/Chronic plaque psoriasis flare up; Stress; Vaccination site lump/Lump at injection site; Vaccination site swelling/Swollen over a week; Pain; Discomfort; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up), STRESS (Stress), PAIN (Pain), DISCOMFORT (Discomfort) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE MASS (Vaccination site lump/Lump at injection site). In 2021, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress). At the time of the report, PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress) had not resolved and PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue), VACCINATION SITE MASS (Vaccination site lump/Lump at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week) outcome was unknown.            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.  No concomitant medication was provided. No treatment medication was provided. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient had plaques on legs, stomach and back of scalp. His left ankle affected the most of legs. His stress and cold weather caused chronic plaque psoriasis flare ups. He had scaling on scalp close to left ear and left ankle. He had Moderna vaccine and first dose caused fatigue, swelling in arm with hot feeling and inflammation. His second dose caused a lump at injection site, the size of large egg that was swollen over a week. The second and booster dose caused pain and discomfort with fatigue.   This case was linked to MOD-2022-630475, MOD-2022-619152 (Patient Link).
patient noticed neck/back/shoulder/ear pain starting thursday evening. By friday she had rashes all over her body hip level and higher. On saturday her mouth and lips were swollen. She went to the ER and they gave her a prednisone shot. Since the steroid shot her symptoms have been getting better. Pt picked up rx for prednisone, benadryl but has not taken them yet.
Fever ranging from 102.1 on the day after receiving the injection to current temp of 99.8 on day three. Severe headache, chest tightness; constant dry cough; severe body aches; severe pain in arm of injection site, unable to lift arm on day following injection and although the pain has lessened, the injection site is still extremely red, swollen, sore and hot to touch and itchy.
Narrative: Pt PMH includes afib, CKD, Anemia, hip replacement, cerebral infraction, asymptomatic carotid artery stenosis, HLD, BPH, ED, chronic back pain, osteoarthrosis, and DM. Pt 89y died July 25, 2021, at hospital. Vaccines not likely to be related to the event. Per outpatient death notification note the reason was not included.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            This case was linked to MOD-2021-100556 (Patient Link).
pt recvd vax;stomach cramps;apap given;;backache,n;v cont;cont to have stomach cramps but no v;slept all noc;pt denied fever but had cold chills; no problem in area of inject;
Information has been received from a consumer concerning her 18 year old daughter who on 22-OCT-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. The was no concomitant medication. In early February 2008, the patient developed mono. The patient had a high fever of 101 deg F and missed 2 weeks of school. The patient has not yet received the second dose. Unknown medical attention was sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Myalgia, Arthralgia, Fever, SkinRash, Rash, UrticariaPruritus, "Generalized vaccine symptoms such as body aches, tiredness, etc starting aroun 1400 that day. Slight chest tightness and low grade fever-100.3 that evening 2000. Rash/hives on hands/chest/arms 5/13/2022 1100 - came to Occupational health office: Narrative:
Pt passed out, quit breathing, and no pulse was found about 2 minutes after vaccinations were administered. Chest compressions were started, EMS was called, and AED was retrieved immediately.  1 shock via AED was administered. 1 Epipen was administered IM in Left outer thigh.  Patient then started breathing and verbalized that her leg hurt. EMS arrived right after patient started breathing. EMS loaded pt onto gurney and patient vomited once before being wheeled to ambulance. It was probably 11:45 that patient left facility to be taken to Hospital.  It was reported to clinic after about 1 hour that patient was doing fine, but she was in pain. As of 10/4/23 at 11:25am resident is still in hospital for observation only. She is showing signs of improvement, but still has aches and pains. She is not admitted to hospital, but in observation bed.
Pt complained of lower lip swelling and welts over trunk, arms, legs and face with itching. Pt had a similar reaction but only worse, post vax rabies vaccine.
PT presented at clinic for second covid vaccination; the appointment was made for pfizer second dose; when I met the patient in the room I asked him if he was ready to receive his second dose of pfizer vaccine; he responded with yes; I asked him which arm he would like the injection in and he requested left; injection was given in the left deltoid; I asked the patient for his vaccine card so I could fill it out and that's when I realized he had received moderna for his fist shot on 4/19/2021; I told the patient about the mistake; I advised the other practitioner working about the event; my direct manager was notified; an occurrence report was filed; the manager above my manager was notified via email because she was out of the office.
2 days after shingles vaccine developed itchy rash on neck - still has itchy rash. Advised to go to DP for evaluation of same.
fever,  fatigue, headache, malaise X 48 hours, medicated with antihistamines and ibuprofen and acetaminophen, resolved after 48 hours
Little soreness; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a patient (reporter's husband) that: A 45-years-old male patient second dose of received bnt162b2 (Solution injection; Batch/Lot number was unknown), via an unspecified route of administration on 11May2021 (at the age of 45-year-old) dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Solution injection; Batch/Lot number was unknown), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unknown date in May2021, the patient experienced little soreness after one or two days and was totally fine. Therapeutic measures were not taken due to the event. The clinical outcome of the event was recovered on an unknown date in May2021.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580004 same drug/reporter , different patient /event
Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Vomiting-Severe, Additional Details: Patient states that she had similar reactions lasting 4 days with the 2 Pfizer Covid injections in the past. Her symptoms with the Covid Moderna booster lasted 2 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Heavy sweating; Muscle aches; Chills; Fatigue; Rash; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications within two weeks prior to COVID-19 vaccine was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 21:30, the patient experienced heavy sweating, chills, fatigue, muscle aches, rash and headaches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events heavy sweating, chills, fatigue, muscle aches, rash and headaches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.