chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the first COVID vaccine, about a week later My neck started to get really rashy and itchy. With some time and cream it did heal. After receiving the second shot, and being in the hot sun for several days the rash returned but was a lot worse, and looked more like a bright red sun burn. I went to urgent care because it was unbearably itchy, and my face, ears, eyes started to swell. My blood pressure at urgent care was in a dangerous spot 188 over 55 I believe. Luckily they checked it again before I left and it has gone down to 155 over 55. They prescribed me a Epi pen, Pepcid and antihistamine. A week later after being in the hot sun again, The rash came back. More like a rash this time and less like a sun burn. It wipes me out for an entire day because of how puffy, itchy, and uncomfortable I am. It brings on this extreme fatigue that I am not used to. What helps the most is sitting with an ice pack on my neck for the entire day, getting rest, and staying on anti histamine. Even in less severe sun It can easily gets triggered. I am doing everything I can to stay out of the sun, because of course everyday life makes that impossible. I am concerned because I have never experienced a reaction to the sun, or vaccine, or anything on my neck like this before. All three reactions have been different  on my neck, but what remains the same is that itchiness, and hot ears, and puffy eyes. It all started after getting the COVID vaccine, and the doctor in Urgent care told me that when I am due for a booster shot to get competitor instead. Please advise on what I should do, or if there is any insight on this. Thank you!
he had diabetes; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on unspecified date at unknown DOSE 1, SINGLE for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date at unknown DOSE 2, SINGLE for COVID-19 immunization. No medical history reported. No concomitant medications. He stated that he was confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they could get it because they were informed that after 12 months getting the 2nd dose they will be receiving the 3rd dose but up to now they didn't receive it. (Withheld) is aggravated already in regards to what happened and he stated that he wants to go to the media to inform people about Pfizers general plan because he had diabetes and his wife had a polycystic condition. While talking to the representative she stated that she thinks she can not help it since he was in the original trial and we were in the clinical trial. The outcome of Event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
They were all itching; I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (They were all itching) and URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.) in a 62-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history information was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.). On an unknown date, the patient experienced PRURITUS (They were all itching). At the time of the report, PRURITUS (They were all itching) and URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported.
Patient developed COVID 13 days after vaccine administration presenting with shortness of breath and generalized weakness.
I feel like I have a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (I feel like I have a cold) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (I feel like I have a cold). At the time of the report, NASOPHARYNGITIS (I feel like I have a cold) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Patient was given Daptacel vs Adacel left deltoid in PM on 6/28/07. At 12:30p on 6/29/07 c/o 101 temp, arm pain, dizziness, frontal HA, slight edema at injection site.
blacked out, profuse sweating, weak Narrative:  Reports that on 2/19 at 0030 - she blacked out, had profuse sweating and required an ER visit  Other Relevant History:
patient felt dizzy and passed out at pharmacy counter, his glasses caused a 1/2cm scrape to his left eyebrow
On her right inner wrist area she developed a hive; This is a spontaneous report from a contactable consumer (patient's husband). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 (batch/lot number: EL8982) at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The first experience was with the first dose. On her right inner wrist area, she developed a hive, just one. The hive appeared a couple hours after the first vaccine. The hive stayed there for 3 to 4 hours and then dissipated. Outcome of the event was recovered on 14Jan2021.
itching and bruising all over her legs; itching and bruising all over her legs; This is a spontaneous report from a contactable consumer or other non-HCP. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 24May2021 as DOSE 1, SINGLE (at the age of: 21-year-old) for covid-19 immunization. Medical history and Family Medical History Relevant to AE(s) reported as none. There were no concomitant medications. Vaccine was not Administered at Military Facility. No Additional Vaccines Administered on Same Date of Suspect. On an unspecified date of May2021, the patient experienced itching and bruising all over her legs. The patient underwent lab tests and procedures which included blood test: normal on 14Jun2021, platelet count increased: 14Jun2021 on 14Jun2021 she later clarified and mentioned the PTT was a little elevated, but nothing concerning. Patient had her blood test done a week ago from Monday, clarified as last Monday. She further explained, a bunch of test were done and there was nothing concerning. The blood test came back normal. The platelets and all that was checked. However, she later clarified and mentioned the PTT was a little elevated, but nothing concerning. The outcome of all event was recovering.  Follow-up (20Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (After 7-8 days, he started getting random rash all over his body) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), ATORVASTATIN, CLONAZEPAM, FLUOXETINE and BUMETANIDE for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Apr-2021, the patient experienced RASH (After 7-8 days, he started getting random rash all over his body). At the time of the report, RASH (After 7-8 days, he started getting random rash all over his body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Follow up on 5 May 2021: Treatment: Hydroxyzine 25mg three times a day, Benadryl, Claritin.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated patient information(patient initials and gender). Added product information,added concomitant drugs. Added event Rash all over body outcome Not recovered. On 11-May-2021: NNI On 11-May-2021: Patient confirms visiting doctor for treatment.
The patient called 11/29/2022 complaining of vertigo, nausea, vomiting. Patient stated she's had a migraine since she received the vaccine. The patient did not seek treatment for these symptoms. Patient stated she's lost 20 pounds.
12 hours after receiving vaccine pt developed hives, on back and arms (both) treated with BENADRYL. Have resolved but pt began with generalized pruritus. No respiratory symptoms. Left arm site of administration is red and indurated.
Vomiting, shaky, hyperventilation, resp 42, checked at ER and returned. Slept well, no ill effects next day.
7 days following 2nd Covid 19 vaccination, I had hives on the upper arm receiving the injection and spreading across the shoulders to the right upper arm.  Hives were itchy for about a week, then went away after about 2 weeks.  Only treatment was body lotion.  6 weeks and 1 day after 2nd vaccination experience near syncope.  This occurred again 10 days later.  Went to E.R.  after 2nd occasssion. No clear reason found.  Heart halter monitoring to follow, although vasovagal reflex a possibility.
started having chills,sweats approx 12-14 hrs p/vax;arm felt very hard c/o flu-like sx-body aches;red,itchy rash started 17SEP95 lt arm;
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml subcutaneously. Subsequently the patient developed shingles. This is one of several reports received from the same source. Additional information has been requested.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing); "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022, outcome "not recovered" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive; (13Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received 2 Pfizer vaccinations as well as a booster. Patient was tested positive for Covid on 03Aug2022 after returning from a trip. Because had congestive heart failure and Crohn's Disease the Dr put him/her on Paxlovid. Symptoms abated until today when began sneezing, sinus pressure and slight chills so purchased and took a drug store Covid test which showed positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
injection site pain; left arm began to become sore; This is a spontaneous report from a contactable other hcp. A 50-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 intramuscular, administered in Arm Left on 06Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, hypersensitivity, food, or other products:Yes, illness from Nov2020 to an unknown date I was sick with covid-19 in November, covid-19 from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed, musculoskeletal stiffness from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain and left arm began to become sore. I received my 1 st vaccine in my left arm and my second in my right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. I started to injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon I noted that my neck was stiff 2 days after receiving my second dose. The only reason I mention that was when I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered and left arm began to become sore with outcome unknown.  Follow-up attempts have been completed and no further information is expected.
This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 19-MAR-2018 the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. Estimated last menstrual period was 15-MAR-2018 (also reported as 4 weeks) and estimated delivery date was 20-DEC-2018. Estimated conception date was 29-MAR-2018. On 12-APR-2018, the patient's mother informed to the reporter that the patient was pregnant. Pregnancy was confirmed by a home pregnancy test, on an unknown date. No product quality complaint was involved.
THird party administered Flublok to the patient that was only supposed to get Pfizer covid vaccine. No signs and symptoms for now. Patient's mother was informed to call us if there are any side effects.
This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 hr after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a patient's wife. The age at vaccination was not reported. One or Two hours after receiving SHINGRIX, the patient developed hives mainly on his back, some around on his abdomen and upper arms. The reporter had pictures of reaction and would send if needed.
New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating with pred/valtrex
had two shots since then very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times in 25 years).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient. The age group was not reported but was captured as adult as per vaccine indication.  The age at vaccination was not reported. The patient had receive 2nd dose of Shingles vaccine and since then it was very painful. The follow-up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095145:same reporter, same patient
Gland in throat swelling. Pt came to clinic 2 days later and had golf ball size left cervial lymphnode. Tender. No lab work done. Pt had sore throat, chills, joint pain.
Mother states that child developed hives after receiving the vaccine.  notes dates this as 10 days prior to 29JUN2012 when it was first documented. Provider stated in record "4yo M patient presents with rash starting on his hairline and moving down to his face, neck, chest, and abdomen x 10 days. MOP thought it might just be a heat rash. MOP states that he also has a different rash under his armpits that has been there for a couple months. MOP has not put any creams on him. MOP states that he does not itch very much but he is itchy.  MOP denies associated sx of congestion or fever.  Child has no hx of allergy issues but FOP does.  Reports due to recent TDY child has been exposed to many new things, including a new pet dog.  She reports no one else if the family is having similar issue. She has not tried to treat the issue with anything." Pt was prescribed Benadryl.
Got shot and still got them/suspected vaccination failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via  interactive digital media. The patient got the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
1/22 day of vaccination pt started experiencing extreme tiredness, pain in right arm/tender, low grade fever, headache, sluggish, trouble sleeping, runny nose, sneezing, fever 100 after a couple days. PT is still experiencing tired, headache, extreme sluggish.
received his first Shingrix  vaccine about 8 months ago/has not received the second dose yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) 8 months ago from reporting date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. No HCP (healthcare professional) information was provided. The reporter did not consent to follow up.