chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy Rash on both arms that changes in location day to day. Today I have a 4 inch by 6 inch rash in left antecubital that appears will be spreading down my entire arm and 2 by 2 in right antecubital. Have applying hydrating cream to arms. This morning applied steroid cream.
She had sudden onset of fatigue, stiffness, joint pains in her shoulders and hips bilaterally, and depression. The pain was worst in the mornings and across the shoulder girdle. These were the most severe symptoms she had ever had and they reduced her to about 50% of her usual capacity. These symptoms started much more suddenly than past joint aches and were persistent without any improvement for two weeks, leading her to seek care on 3/2/2021. This provider checked labs and referred her to specialist. I saw her on 3/17/2021, ordered a few more labs, and prescribed prednisone on 3/22/2021 for suspected polymyalgia rheumatica. She is starting to have less pain, fatigue, and depression as of 3/26/2021.
8 days after immunization, patient noticed red, swollen and itchy area around immunization area, later that night she felt that her tongue and throat were swelling and she had a very strange feeling.  She went to the ER and they gave her Benadryl and Prednisone and her symptoms resolved
pain on her arm for over a year; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 02Dec2019 via an unspecified route of administration in the arm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a pneumonia shot (unspecified trade name) on 02Dec2019 then she had been suffering with pain on her arm for over a year. The patient was seeing an orthopedic, she has had been on steroid pills, shots, done physical therapy, everything, and she didn't know the problem, why she was still hurting. The patient was concern that when that COVID vaccine, that Pfizer or Moderna, she doesn't know which she will get, but she was afraid to get the vaccine, so she was trying to find out, if there is any place else she can get it, like the butt or someplace else, she is afraid to get the shot in the arm. The vaccine was still bothering her. The outcome of the event was not recovered.  Information regarding lot/batch number has been requested.
This case involves a 20 years old female patient who was administered with wrong diluent was used for the yellow fever vaccine/used sterile water rather than sodium chloride  with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - US [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of 0.5 ml once of suspect YELLOW FEVER VACCINE - US (of unknown formulation, strength) lot UJ397AA, expiration date: 22-Oct-2022), in unknown administration site. On an unknown date the patient developed a non-serious event "wrong diluent was used for the yellow fever vaccine/used sterile water rather than sodium chloride and administered to a patient with no reported adverse event" (product reconstitution quality issue) same day following the administration of YELLOW FEVER VACCINE - US. It was reported" Caller reported the wrong diluent was used for the YELLOW FEVER VACCINE. Caller reported they used sterile water rather than sodium chloride and administered to a patient. Caller wanted to know if there are any repercussions or if they need to re-vaccinate the patient." Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable. It was not reported if the patient received a corrective treatment for the event (wrong diluent was used for the Yellow Fever Vaccine/used sterile water rather than sodium chloride and administered to a patient with no reported adverse event). At time of reporting, the outcome was Unknown for the event wrong diluent was used for the yellow fever vaccine/used sterile water rather than sodium chloride and administered to a patient with no reported adverse event.
Reaction was to Pneumo vaccine: Severe LUE pain, erythema and edema to much larger area than injection site, warm to touch. Patient was seen by MD and given Amoxicillin and Bactrim.
Significant swelling, redness, induration, tenderness- getting larger in circumference 8 days after receiving vaccine despite taking Tylenol, NSAID and applying topical steroid and anitihistamine.
States received flu vaccine around 10 AM and approx 3 hours later (1:00 pm) developed flushing, hot feeling to neck. Went to ED for evaluation: noted flushing to upper chest and under neck. (L) upper arm erythema approx 4-5 cm diameter. No wheals or other rash. Denies prior h/o allergy or reaction to flu shot or eggs.
BREAKTHROUGH COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via news report concerned a 70 year old male. The patient's height, and weight were not reported. On an unspecified date in the year 2020 the patient had covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date in SEP-2021, the patient experienced breakthrough covid-19 infection (suspected clinical vaccination failure), was hospitalized (date unspecified) and eventually intubated. At the time of reporting the patient was on ventilation. The family members are seeking for the option of extracorporeal membrane oxygenation treatment for the patient. The number of hospitalization days was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0- 20211014827-covid-19 vaccine ad26.cov2 s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211014827-covid-19 vaccine ad26.cov2. s Breakthrough covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Mom reported 2 episodes of vomiting that started this morning. No other S/S "Pt has no appetite" per mom. DOH recommended to call pediatrician for treatment if needed.
Noticed itchy skin in morning. Took Benadryl. Slept for 5 hours. Fine that night. Fine next day. 12/05/10 11:00 PM started itching again and noticed lots of hives. Took Benadryl. Some hives 12/06/10 and still some 12/07/10.
Tingling sensation on her right arm, lower back pain that she states "is either from the lung or kidney", and neuro symptoms such as "feeling something is wrong".    Around this time she was having difficulty urinating. She then contacted her Primary Care Team , who advised her to go to the EC. Pt refused to go to EC at the time, and started hydrating further, with water and coffee. Eventually she was able to start a flow of urine, but it was foamy and white.    The next day, she states that she continued to hydrate, and that she was eventually able to maintain a stream of urine. Her other symptoms did persist, as well as a new bout of diarrhea. Pt denied any fever or chills, and denied any anaphylactic symptoms, such as difficulty breathing, rash or swelling. When asked about any wheezing, pt stated she did not really have what she believes is wheezing, but did experience some cough and a slight pain on her back, which she could not differentiate if it radiated from her lung or from her kidney.  Pt did state that 2 weeks prior to her first covid vaccine shot, she did have a UTI, that was treated with a 5 day course of Cipro, and 1 dose of Diflucan.
the flu shot didn't work; got the flu a month later; Initial information received on 12-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu a month later and the flu shot didn't work after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event of the flu shot didn't work (vaccination failure) (latency: 1 month) following the administration of INFLUENZA VACCINE.   On an unknown date, the patient developed a non-serious event of got the flu a month later (influenza) (latency: 1 month) following the administration of INFLUENZA VACCINE.  It was reported, I got my flu shot and got the flu a month later, the flu shot didn't work, first time I've had the flu in over 20 years.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got the flu a month later).  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: The event of vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 20-Nov-2022: This case involves an unknown age and unknown gender patient who got the flu a month later and the flu shot didn't work after receiving vaccine INFLUENZA VACCINE. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based on the data provided, the role of vaccine(s) cannot be assessed.
2/16/21 - 7:30pm:  Chills, fever, nausea, body pain and weakness, dizziness began.  One episode of dry heaves; one episode of diarrhea.  I could not eat, but could drink small sips of water.  Symptoms continued until 5:00AM on 2/19/21.  I was able to drink a cup of hot tea at approximately 9:00AM on the 19th.   Body weakness and regular sensations of nausea continued until approximately 12PM on 2/20/21.  Loss of appetite and sensation of familiar food tasting "different."  As of 2/22/21 (6PM), I am continuing to feel overall weakness.  Other symptoms have subsided.
soreness at the injection site; small, round, red mark on opposite elbow; This spontaneous pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (soreness at the injection site) and ERYTHEMA (small, round, red mark on opposite elbow) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at the injection site) and ERYTHEMA (small, round, red mark on opposite elbow). At the time of the report, INJECTION SITE PAIN (soreness at the injection site) and ERYTHEMA (small, round, red mark on opposite elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment drugs were provided.
Mother state school called her to get child from school 12/10/08 not feeling well slight temperature,  blister, red and hot at site of shot "RTR" "area looks like it was burned". Mon called in the reported issues. Cold compress helped with discomfort use of Tylenol for fever.12/11/08 @2:32PM called mother state temp 102.4 last night Tylenol help the large blister broke there are still some small once, will take picture of them, but child in school today
Her arm was a little warm up there; the next morning she found big welts; hives and it was 4-5 inches; Redness was warm to the touch; itchy; does not know if the right arm the needle hit something in there like tissues; sore at the same time/nowshe has two sore arms; red around the injection site/It is still a little red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch) and PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot (left deltoid arm) on 25-Nov-2021. Past adverse reactions to the above products included No adverse reaction with flu shot. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), BIFIDOBACTERIUM LACTIS (DIGESTIVE PROBIOTICS ADVANCED), LANSOPRAZOLE (PREVACID), SIMVASTATIN and TROSPIUM for an unknown indication.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site). At the time of the report, VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site) outcome was unknown.            Patient put Ice on it and it cooled it down and took Acetaminophen.   This case was linked to MOD-2021-403759 (Patient Link).
red and itchy; an area that has gradually grown from her site of injection and from her shoulder down; red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy) in a female 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy). At the time of the report, VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
24 Hours after receiving my second dose of the Pfizer Covid-19 vaccine, I fainted. I was only unconscious for s few seconds, and seemed OK upon regaining consciousness. So far, it has not recurred.
Fever; chills; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller got her first shot last Saturday, then she woke up today with fever and chills (2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Tested positive Oct. 7 with mild cold symptoms; Tested positive Oct. 7 with mild cold symptoms; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 012L20A), on 09Feb2021 as dose 2, single (Lot number: 024M20A) and on 22Sep2021 as dose 3 (booster), single (Lot number: 045B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 14:00, outcome "recovered" (12Oct2022); DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, outcome "recovered" (12Oct2022) and all described as "Tested positive Oct. 7 with mild cold symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: Tested positive with mild cold symptoms and started Paxlovid; (12Oct2022) Negative, notes: negative and no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: There was no other medication in 2 weeks. Patient received Paxlovid for COVID 19 Treatment started from 07Oct2022 to 12Oct2022. Patient was tested positive on 07Oct2022 with mild cold symptoms and started Paxlovid; negative on 12Oct2022 and no symptoms.    No follow-up attempts are possible. No further information is expected.
received both doses and received another dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received previous 2 doses on an unknown date).   On 4th March 2022, the patient received the 3rd dose of Shingrix. On 4th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient self reported the case.  The age at vaccination was not reported. The patient received both of the required doses of Shingrix, however, no one could find record of those immunizations. The patient received another dose of Shingrix on the reporting day, which led extra dose administered. The reporter asked could this cause harm. No other information was reported.
Basically last Tuesday, I just started having a headache. It's hard to function. Wake up with a massive head rush. Also have mild nausea.
Blood in urine for 5 says since receiving shot . Rash on left side on torso in 3 patches. Left pain internally under ribs.
Baby was asleep in crib and started high pitch cry. I wen to tend to her but when I picked her up she wouldn't open her eyes and her body was limp. She couldn't hold her head up and the white of her eyes was visibly rolling back almost as if she was paralyzed. She was extremely pale. This happened for about 10 minutes. I stopped vaccinating and this has not occurred again. I spoke with the doctors office the next day and they advised it was a " night terror" and not vaccine related and would see my baby for a check up, they had a nurse call me back to explain this.
Dizzy; feel hot like crazy; chills; Bad headache; Nausea; Fever 100F; Felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING HOT (feel hot like crazy), CHILLS (chills), HEADACHE (Bad headache) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizzy), FEELING HOT (feel hot like crazy), CHILLS (chills), HEADACHE (Bad headache), NAUSEA (Nausea), PYREXIA (Fever 100F) and VOMITING (Felt like throwing up). At the time of the report, DIZZINESS (Dizzy), FEELING HOT (feel hot like crazy), CHILLS (chills), HEADACHE (Bad headache), NAUSEA (Nausea), PYREXIA (Fever 100F) and VOMITING (Felt like throwing up) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Rash mid chest, itchiness all over, headache, large swelling at injection site, onset in 10 minutes- rash was not urticaria- >15cm of erythema and swelling in deltoid site of injection also- relief with Benadryl, pts vital signs did not change
First Vaccine Dose on 12/26/2020 felt extremely fatigued. After 2nd vaccine dose on 01/16/2021 developed fever, chills, weakness, fatigue, body aches approximately 10 hours after received the 2nd dose. This all lasted about 24 hours. Then on 01/19/2021 which was the 2nd day of mine menstrual cycle, I had a very abnormal menstruation. I was passing "fist" size blood clots  which made me very weak. this lasted again about 24 hours then it stopped. I had some labs drawn on 02/27/2021 which came back with very low Iron, Hematocrit and Hemoglobin levels.  I usually do show signs of anemia in previous blood work but this time the levels dropped lower so i was referred to see a Hematologist.