chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 1.5 hours after the shot I noticed that I was scratching the site through my clothing. I then looked at the site and found a firm (hard), itchy, mildly red tender lump, about 3 inches wide by 4 inches long by 3 inches tall. I took ibuprofen and diphenhydramine before bed. Today the lump is more diffuse, about halfway around the arm, firm, a little darker than my other arm. Circumference of my non-dominant arm, which was injected, is 1 inch greater than my dominant arm at the biceps level. I have a temperature of 99.9 degrees F and flu-like aches and pains. I previously had Prevnar 13 and wonder if there is crossreactivity between Pneumovaxx and Prevnar.  If this is a known and expected adverse event related to the Pneumovaxx 23 after having previously had the Prevnar 13 (more than a year ago), this should be in the warnings, if it isnt already, and pharmacists should be instructed to warn their patients.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
TOOK THIRD DOSE ON DAY 9; This spontaneous case report was received from a pharmacist (PVX2019-002) on 02-Jan-2019. The report describes a 27-year-old adult male consumer who "took third dose on day 9". The consumer was receiving oral Vivotif capsule (every other day) for typhoid prevention.  It was reported that the consumer took two doses of Vivotif and then forgot to take it for 5 days and then took the remaining two doses. The doses were taken on 20-Dec-2018, 22-Dec-2018, 28-Dec-2018, and 30-Dec-2018, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 9" was not applicable.  The clinical outcome of the event "took third dose on day 9" was unknown.  Company's Comment: The causality of the event "took third dose on day 9" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 9" was considered as not applicable.
Soreness and difficulty moving arm where vaccine was administered starting 9/20/15 and continuing through office visit 10/30/15. Pain in shoulder and upper arm with raising arm. Potentially SIRVA.
Alright so in late afternoon/evening on April 16th 2021, I went on a long walk which is normal for me. I noticed my yoga pants feeling tight and I felt bloated. When I got back, I had a lighter dinner. The next day I wasn't feeling well still and it was my Mother's birthday. I was feeling really weird and I just kind of ignored it. By the end of the day, after dinner, I started feeling really not great. I felt sick to my stomach, I wasn't getting sick/vomiting but then the next day I tried to go out to see my friends at brunch and just talked - I did not eat because it hurts to eat anything. I went to the store and got yogurt because it is all I could stomach. The following day I finally went to the ER because I was just really in pain, I said to my mom can you just cut out my stomach it hurts so bad. The pain was on my left side though, I'm not even sure if that's stomach pain. The DRS at the ER they did exams and they gave me medications for my pain  but they weren't really sure what to diagnose it as. I got a stool softener, a nausea tablet and pain medicine. Most of that week I was still eating just yogurt. Also, mind you, I had started my period around this time and that made it confusing as well. I drove out to Iowa and saw my GI DR on May 11th 2021 in CA and he said well if it is all gone, that's great. So when my period came back, I began having the pains again. I was in pain so much that it hurt to even turn my body. That pain has continued to be repeated every time after the second dose of the vaccine. I saw my OBGYN on Friday July 2nd 2021.
5 hours after the injection my left arm started to swell, and over the next 2 days a knot formed where I received the injection. It?s been a week and it?s gotten bigger. It?s currently the size of a coin.
This case was reported by a consumer, via Mylan Pharmaceuticals Inc, and described the occurrence of abdominal cramp in a 60-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included Buspirone hydrochloride tablet for an unknown drug indication. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). On an unknown date, the subject started Buspirone hydrochloride (unknown) at 15 mg, unknown dosing. At an unspecified time after vaccination with Influenza vaccine and taking Buspirone hydrochloride, the subject experienced abdominal cramp and decreased appetite. At the time of reporting the outcome of the abdominal cramp and decreased appetite were unspecified.
This spontaneous report was received from a pharmacist via a company representative concerning a male patient of unknown age. No concurrent conditions or medical history were reported. On an unknown date, reported as "July 2nd" (unspecified year), the patient was vaccinated with a dose of ZOSTAVAX (Lot # L002422 Expiration date: 20-APR-2016) subcutaneous (dose, strength and anatomical location of administration were not reported). No concomitant therapy was reported. On an unknown date, reported as "July 2nd" after receiving vaccination, the patient became lightheaded and "lost control of his bowels". The reporter stated that the patient was taken to an unspecified hospital, on an unspecified date, due to unspecified accident (it is not known if the patient was in a car accident or if the "loss of control of bowels" was the accident). It was not known whether the patient was admitted to unspecified hospital. No treatment was given for the adverse event. No Product Quality Complaint (PQC) was involved. The outcome of accident, faecal incontinence and dizziness was unknown. Additional information has been requested.
Pt. never had a flu shot before. Only listed Novocaine as an allergy. Took PARLODEL > 17 yr. ago. Was temporarily on TEGRETOL for seizures from PARLODEL reaction. No longer having seizures or on TEGRETOL. 10 minutes after the shot she felt shaky hands, heavy feet. No breathing problems, but rapid heart beat. Called 911 - paramedics said she is OK. She left on her own.
2 days after vaccine the patient developed a rash which was itchy and then painful.  On evaluation in clinic the rash was consistent with varicella zoster.  Notably she has had both of her shingrix vaccines.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
A spontaneous report was received from a consumer concerning an 81 years old, female patient who experienced headache, heart flutter and skip a beat/extra systoles.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 02 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Mar 2021, the patient experienced headache, heart flutter and skip a beat. Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events headache, heart flutter and skip a beat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client stated that her arm (the injected) became extremely painful to the touch. It became hot, red, swollen, and itchy. Client reported that arm reminded this way for 7 days, and is still itchy.
patient is a pediatric patient administered adult dose 30mcg 0.3 ml; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 11-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2022, outcome "unknown", described as "swollen lymph nodes"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "patient is a pediatric patient administered adult dose 30mcg 0.3 ml".  Additional information: patient is a paediatric patient administered adult dose 30mcg 0.3 ml Pfizer or Comirnaty should've received a paediatric dose now experiencing swollen lymph nodes and other side effects.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax&7-10 days later pt exp purpura&low platelet count of 11,000;p/being treated w/IV immunoglobulin platelet count went up to 50,000;2wk later pt devel purpura a 2nd time&exp low platelet count of 38,000;pt hosp unspecified;
Hospitalization for COVID-19 infection on dates 7/22/2023- 8/1/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
09/14/21 @ 1240 - Pt arrived to Health Center after she called from her room stating her watch was alerting her that herHR was 170. Pt had a syncopal episode this morning while she was in class. Witnesses reported that shewas only lost consciousness for a few seconds and when she "came to" her entire body was pale as aghost. Denies hitting her head. Syncopal episode occurred at 0955 this morning. Pt did not have postictalphase. Other Health Center staff rushed to her. At that time her VS were stable and pt had a follow up appointment this afternoon scheduled for 1530. She states she went back to her dorm room after her syncopal episode and was laying down when a few minutes ago her Apple watch alerted her that her HR was dangerously high (170 BPM). She admits to having some SOB since she went to class around 0930 this morning, as well as feeling lightheaded, and a pressure-feeling in her ears when she regained consciousness. She denies any hx of seizures, syncope, or elevated HR. She denies any recent illness, stating "well I have been having allergy-like symptoms lately but I didn't think anything of it." She received her 1st dose of Pfizer vaccine yesterday around 1500. She denies any other medication usage other than her regular medications. Shestates her Ritilan has actually been decreased lately.
The first night after vaccine was fine, but the next morning I felt flu-like symptoms but didn't have a fever. My skin was sensitive and I was tired and that lasted for a few days. I did feel very tired which was unusual for me because I am very active. I had no issues before and I stayed clear from Covid all the way through the holidays and I was super safe but on 01/19/2022 I went and got tested and was positive. I got the antibodies on the 22nd and then by Monday I was getting worse with the throat pain and the mild cold feeling went away and right now I have bronchitis. I went to the urgent care on the 24th and told them my symptoms and what happened and they did a chest x ray and seen that my lungs were clear but I did have inflammation so they gave me an inhaler and antibiotic and something for the cough. I took that and then saw my PCP on February 9th or 10th and by this time I had tested again for Covid and it was negative. At the PCP, he said everything was clear and good and he told me he didn't think it was long term Covid and that the bronchitis was triggered by Covid and that I'm fine and he couldn't hear anything in my lungs and that my vital signs were good. He changed my inhaler from one that urgent care gave me and every now and again I get a little congestion and so I take a little bit of the inhaler just in case because I'm afraid the bronchitis will come back.
heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional hour
Moderate body aches and headache beginning about  20 hrs after the vaccine, then progressed to severe headache, nausea, photophobia, phonophobia at about 27 hours after the vaccine and lasting  about 4-5 hours, then reducing to moderate headache and fatigue until about 40 hrs after the vaccine, then gradually resolved over the following  6 hours.
pericardial effusion tamponade; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN8208) at the age f 66 years old as 2nd dose, single for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Jan2021, (Lot Number: EL9264) in the right arm at the age of 66 for COVID-19 vaccination. The patient reported that she began having signs and symptoms on 29Mar2021; heavy weight in throat like there was a softball in her throat; pressure in that area when she bent over; chest tightness; difficulty breathing; a lot of chest pain; chest stiffness; sharp stabbing pain in upper left chest. The patient stated that it took 13 days and 2 trips to the ER and multiple Doctor calls before they could diagnose what was wrong. She had visited her general doctor who thought she had an embolism and sent her to the Emergency Room on her second visit. They did a D-Dimer test, which they hadn't done on her first Emergency Room visit. The patient was diagnosed with pericardial effusion tamponade on 08Apr2021 as confirmed with the echocardiogram performed on 09Apr2021. On 09Apr2021 they removed the fluid, 700cc of blood, surrounding her heart. The patient was in the ICU from 08Apr2021 to 16Apr2021. The patient stated that she was hoping she would be able to transfer to a hospital but she was in too bad of shape to be transferred. The patient reported that she has some mild symptoms, residual symptoms, some pain in chest and some tightness, but it was much better now. She had an echocardiogram a week after getting out of the hospital which showed no fluid now. The patient was placed on medication. The outcome of the event was recovering.  Follow-up attempts are needed. No further information is expected.
2 days after booster pt reported eye watering and crusting.  Next day eyes almost swollen shut.  now gradually improving but still complaining of redness crusting and mild eyelid swelling.
Stayed in bed for 24 hours; This case was reported by a consumer and described the occurrence of weakness generalized in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. In October 2020, less than a day after receiving Shingrix, the patient experienced weakness generalized. On an unknown date, the outcome of the weakness generalized was recovered/resolved.   It was unknown if the reporter considered the weakness generalized to be related to Shingrix.  Additional details were provided as follows: The patient had received Shingrix at the MD office and the Pneumonia vaccine on the same day. The batch number and expiry date of Shingrix was unknown. After the first Shingrix shot, the patient had to stay in bed for 24 hours and then he felt better. It was unknown if the reporter considered the weakness generalized to be related to pneumonia vaccine. The reporter did not consent to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2021002046.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002046:Same suspect, same reporter, same patient, different dose (2nd dose)
granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; This is a spontaneous report received from a contactable other HCP. This Other HCP reported for a 78-year-old female (patient) that: A 78-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular on 15Mar2021 (at the age of 78-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hx of total nephrectomy and Acid Reflux from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took MACROBID [clarithromycin] and experienced drug Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in Apr2021, the patient experienced granuloma annular (annular elastolysis granuloma-type) rash as a possible side effect from the vaccine. It was unknown that, since vaccination patient tested for COVID-19. Patient was not hospitalised for the events. Event resulted to visit Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with topical steroid and oral antibiotic. The outcome of the events was reported as unknown.  Information on the lot/ batch number has been requested.
Soreness in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter just wanted to know if he/she allowed to take ibuprofen after his/her Shingrix shot for the soreness in arm. The follow-up could not be possible as no contact details were available.
After receiving the 1st dose a pain presented in the arm and swelling. After weeks strong pains began in the bones that extended throughout the whole body. With cause to this I have been unable to exercise because the pain is too strong.
Pt had seizure 24 hours after receiving H1N1 nasal spray. Evaluated at ER. Pt developed flu type symptoms.11/20 and 11/23/09 Medical records receoved for DOS 10/29-11/13  FInal DX: Possible influnza with vasovagal syncopal episode, Leukocytosis of uncertain etiology. Emesis, LOC, tremulous. Arms twitching, clicking sound.  Fever. HA early in day, cough coryza. ABX IM.  D/C to home. EEG abn.
This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 12th September 2018, please refer the case US2018GSK227916.). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox and itchy legs. On 6th December 2018, the patient experienced burning sensation, vesicles, leg pain and buttock pain. On an unknown date, the patient experienced injection site pain, fever, chills, joint pain and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chickenpox, itchy legs, burning sensation, vesicles, leg pain and buttock pain were unknown and the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the chickenpox, injection site pain, fever, chills, joint pain, general body pain, itchy legs, burning sensation, vesicles, leg pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. The patient received 2nd dose of SHINGRIX vaccine in left arm. She experienced the exact same symptoms with the second dose of the vaccine and had recovered. On 5th December 2018, 5 days after receiving the vaccine, she started noticing itching on her thigh area. On 6th December 2018, 6 days after receiving the vaccine, while at work she experienced soreness and burning sensation around the buttock area, back of the legs and thighs. She also noticed small vesicles with white head. On 7th December 2018, she noticed vesicles with fluid on the waist area, on the back, side of her body, under arm, armpit area, under the breast and closer to belly button area. She sent pictures to her pediatrician and she thinks she might had chicken pox. She had an appointment with her physician later on the day of reporting. She wanted to know if she could develop chicken pox from SHINGRIX. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information.
Had blood in diarrhea 8 hrs. after getting vaccine. Sent to E.R.
Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain.  No asthma symptoms.
friend had the booster and they also had the same thing (Bell's Palsy).; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.  Company Comment - This regulatory authority case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious expected event of Bell's Palsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-456142 (Patient Link).; Sender's Comments: This regulatory authority case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious expected event of Bell's Palsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.