chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially after vaccination I felt fine, typical arm soreness maybe mild immune response. I was able to go to the gym for 2 days straight the following monday and tuesday. But on Tuesday, despite feeling completely fine after the gym (heavy weight lifting) and eating lunch, about an hour of elapsed time, I drank some coffee and noticed my heart beating faster and faster like I was having a panic attack (also shortness of breath). I also took a multivitamin that morning (single dose) and ate another 2-dose multivitamin after lunch since I figured that I might've been vitamin deficient that my body would just dispose of the excess vitamins if it couldn't absorb them. My hands, feet, neck, shoulder, and lower part of my face were buzzing, my vision was felt like it was fuzzy. Since then I've had symptoms of a pounding heart that have gotten better through the past 2 weeks but have plateaued somewhat. It only happens when I'm trying to exercise (have since paused), when I eat food past a certain limit, add salt to my meal, or am in a hot room for too long (81-82 degrees), so I think anything that can stimulate the heart.   Other than that, as long as I'm conscious of those things I can feel pretty normal, though sometimes I get shortness of breath.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (lot # reported as 0615AA, exp date 02-JUL-2012) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of the report, no adverse event was reported. Additional information has been requested.
pt recv vax & 1wk later started feeling lightheaded, dizzy, nauseated & seeing white spot Tuesday AM/PM, Wednesday AM/PM saw MD 9NOV97 placed on muscle relaxant for neck stiffness-tingling arms & fingers 1 days;feeling shaky/hot;
gets very sick after shots; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via agency through social media.  This case involves a patient of an unknown demographics who got very sick (after shots) (illness), after administration of INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, it was reported that the patient got very sick (after shots) (illness).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
#2 - given shingrix 9/12/19, 11/14/19 and 3/3/22; This case was reported by a other health professional and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2019) and Shingrix (2nd dose received on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd 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 Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received three doses of Shingrix vaccine. The reporter asked could GlaxoSmithKline tell him/her if there were any ramification of three doses of Shingrix was given to a patient. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR062283:same reporter
Shingles, rash & blisters, valacyclovir,tramadol,ice packs
103.7°F Fever on the 30th, still having mild fevers. Been treating with Tylenol. Still having pain and redness at injection site. Muscles underneath right arm hurt all the time until 11/3. On 11/01 started getting fever blisters all over mouth, and they are still there. Now dealing with swollen lymp nodes on neck.
Left arm swelled, face swelled, rash on right breast. They said to take Benadryl and keep an eye on it and make sure it doesn?t effect my breathing.
Migraine; nausea; vomiting; low grade fever; tired; chills.
After first dose, about 9 weeks ago, I had no problems other than a sore arm. that lasted about 24 hours.  After the second dose some time that early afternoon, I woke up 3:30 in morning with twitching of my legs and other parts of body.  I tried to relax, but and could not get comfortable.  Had a bad feeling like something was thumping, cannot really described it, although it did not feel like my heart.  Had a very bad headache, warm feeling, and stuffy nose.   After about a half hour of not being able to relax, took a mild sleeping pill (generic Lunesta) and was then able to fall asleep.  Woke up around 8 AM, feeling warm, with bad headache, and didn't want to get out of bed.  Got a little water, took 2 Tylenol, and went back to bed.  I lay in bed for a few hours, then went downstairs to get some food and water.  I was only able to spend a few minutes standing up before I felt the need o sit down.  I tried to eat a little a few hours later but felt a little nauseous so only had a little orange juice and part of a sandwich my husband brought me.  I stayed  pretty much in bed with little activity until about 5 PM, when I felt good enough to go downstairs and eat more of the sandwich.  I took one Tylenol and Excedrin because my headache, while better, was still present.  Now (10 PM) I feel almost completely back to normal.
NO ADVERSE EFFECTS. IT HAS BEEN A MISTAKE THAT WE GAVE THE PATIENT THIS VACCINE AND HE IS NOT 12 YEAR OLD YET. PATIENT IS DOING FINE AFTER THE VACCINE BUT WE NEED TO DOCUMENT THE MISTAKE AND MONITOR THE CASE
pt recv vax & exp dizziness & insomnia for 5 days p/vax; sx persisted @ time of report; No further details were provided;
Onset of about 50 vesicles, 3 weeks after Varicella vaccine. Lesions were culture positive for varicella.
increased ALT, Creatinine/BUN; increased ALT, Creatinine/BUN; increased ALT, Creatinine/BUN; joint pain; her joints in her fingers are really bad, they are blown up and she can't move them; her joints in her fingers are really bad, they are blown up and she can't move them; her knee is blown up; liver function test/blood test were high; liver function test/blood test were high; This is a spontaneous report from two contactable consumers (including patient's husband) via a Pfizer-sponsored program. A 79-years-old female patient (reporter's wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), via an unknown route of administration on 28Feb2021 as single for COVID-19 immunisation and scheduled for second dose on 21Mar2021. The patient's medical history included Covid-19 infection from Oct2020 to an unknown date. The patient tested positive of Covid-19 way back October last year and mentioned they still have the antibody. The patient should get the 2nd dose of the vaccine with their history of elevated liver enzymes. Concomitant medications were not reported. On unspecified date in Mar2021, it was reported that the patient was scheduled for the 2nd dose on 21Mar2021. However, less than a week ago she had an increased ALT, Creatinine/BUN. The physician stated yes to taking the 2nd dose, another physician said no. She has complaints about joint pain she associates with receiving the first dose. She also reported that her joints in her fingers were really bad, they were blown up and she can't move them, also, her knee was blown up. She had some liver function tests and blood tests after the 1st dose. Took a blood test (ALP & AST) and the results of those both liver function test/blood test were high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Event occurred after 2nd dose. Patient was diagnosed with COVID 19 Tylenol In-patient
Received Hep B vaccine IM @ 08:30 7/28/09 - Presented to ED @ noon with rash, SOB, pressure to chest and diaphoresis. TX: BENADRYL and SOLUMEDROL Cardiac monitoring. P.O BENADRYL Q6 x 2 days. Follow up with PCP. Advised to take BENADRYL before next Hep B vaccine. Went to PCP- A BENADRYL to Prednisone.
Less than 18 years old received Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergies or medical history reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer (Dose number 1 and lot number and dose was unknown) on 01-Jul-2021 and Pfizer (Three weeks after first dose. Dose number 2 and lot number and dose was unknown). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 22-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received booster dose of Moderna COVID-19 Vaccine.  Treatments were not provided.
Shoulder and arm slightly sore; one day; vaccine area still slightly tender legs muscles extremely tight; warm soak in epsom salt and overnight rest seem to dissolve the situation
I noticed the day after the injection that the site was covered by a large red circle, the area was very hard, like a large knot and sore. The soreness wore off by the second day but the area is still covered in a large red circle, hard and hot to the touch. I have not received any treatment.
16 year old patient received Moderna vaccine for 1st dose.  He did not experience any adverse effects.
Hive reaction to middle arm below deltoid above elbow towards back of arm. No reaction to injection site. Red, raised, warm, hives. Mild itching. Took 1 dose of Benadryl on 1/4/21 with hydrocortisone topically. Rash lasted approximately 8 days, gone by 1/6/21.
c/o itching; splotchy, red "rash" mostly on legs and his back;
Patient was administered PPSV23 instead of PCV13, spoke to provider verified that PPSV is not beneficial nor harmful for patient. Notified of incident.
Covid arm.  Red and sore at injection site.  Started to go away on day 6, came back worse on day 8.
Patient complained of pain and paralysis in arm.  She sought medical attention that night or next morning.  At first they though it could be SIRVA, however 3 days after event, patient is still in pain but mobility has returned and pain is getting better.
Pt received immunizations on 4/21/2010. Returned to office on 4/28/10 with 10cc red area on ( L ) shoulder/deltoid with tenderness & swelling.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with MMR II (lot # was unknown) a couple of years ago when she experienced joint swelling. It did not report whether the patient sought medical attention. The outcome of the adverse events was unknown. The relatedness for joint swelling and patient had a bad reaction was unknown for MMR II. Additional information has been requested.
Dizziness. Low blood pressure, diarrhea, and stomach ache, not feeling his usual self.
On 4/27, patient began to experience tingling/numbness in feet and hands.  This progressed to weakness of the extremities, affecting patient's ability to walk.  He presented to the hospital on 4/30 and was admitted with a diagnosis of Guillain Barre syndrome.  He was treated with plasmapheresis, and has been clinically improving with this.  Patient was discharged to inpatient rehabilitation on 5/5, and remains there as of this report.  Certainly unclear if the vaccine had any role in the onset of GBS, but given the concern with other vaccines, am reporting this in case other similar reports can create a measurable trend.
Initial case received from a healthcare professional on 31 May 2011. A 15-year-old female patient, with no reported illness at the time of vaccination, received a right deltoid first injection of MENACTRA (lot number U3841AA) and a left deltoid injection of HEP A (manufacturer and lot not reported) on 18 May 2011. The patient subsequently experienced distal swelling of the right arm, described as "swollen under elbow toward hand". She presented to the emergency room, and was diagnosed with "brachial plexy autoimmune response". She was treated with Medrol pack, and symptoms resolved as of 31 May 2011. Documents held by sender: None.
3/2022 developed blood clots in leg  4/15/2022 admitted to Hospital and found clots in lungs, respiratory distress, tracheostomy, on ventilator, endometrial uterine cancer, g-tube insertion within a month of admission. Discharged early July 2022 to rehab facility for 2 weeks then readmitted due to more blood clots with respiratory difficulty and low hemoglobin and has been admitted since Early October 2022 transferred to hospice facility
sore arm (left arm)/At the injection site; This is a spontaneous report from a Pfizer sponsored program,  from a contactable consumer. This consumer reported similar events for two patients (himself and for his wife). This report is for his wife. A 78 (unit unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Feb2021, she was scheduled for the next vaccine which was more than the 21 days. (County name) was only administering the (vaccine name), but she received the Pfizer vaccine, which was fine, but we have the appointment scheduled for the second dose according to the (vaccine name) time frame. She asked if she need to have that appointment changed. The patient experienced a sore arm (left arm) an hour after after vaccination we felt the soreness, it lasted maybe less than a day. At the injection site, but it was no biggie. She was asking what was the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine and if she can receive it earlier or later than 3 weeks. The outcome of event was resolved in Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same reporter/drug/event, different patients
The morning after the second dose of the vaccine he woke up and felt hot and my head hurt. He had woken up feeling similar a few times during the night. When he got up he felt really queasy and threw up.  He felt really warm and continued to throw up. With Tylenol the fever was 104 degrees and it continued for several hours even after two doses of Tylenol. I was told to give Benadryl and Ibuprofen. The fever returned to 102 degrees and four later the fever broke. It was almost 10 hours where he was throwing up and the fever fluctuated between 102-104. It is very unusual for him to have any fever.  We continued the Benadryl and Ibuprofen the following day because he still had a low grade fever and some dizziness followed by diarrhea. The dizziness and Diarrhea occurred again the next day three after the vaccine.  It has been five days and he feels better but his stomach is still a little sensitive.  It is possible that he had Covid-19 last year.
A lot of swelling and redness at injection site & all lymph nodes very swollen in upper left region of body.  Injection site and nodes painful.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
got 2nd vaccine and still feeling crappy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (got 2nd vaccine and still feeling crappy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (got 2nd vaccine and still feeling crappy). At the time of the report, FEELING ABNORMAL (got 2nd vaccine and still feeling crappy) outcome was unknown.            Concomitant medication and treatment drug were not reported.
pt had less than 50 pox, fever of 103 max, no complications, no rx med given
Child received routine vaccinations. Approx 15 minutes later, she fainted. This was during the time her brother had fainted earlier and we were waiting for the ambulance. She recovered immediately, was transported by ambulance to ER. Dr on call reported no ill effects;suspected fear. Released to home. Mom called next day; child ok.
c/o feeling warm, light-headed & not feeling well w/in 1hr of vax;pt returned to amb care in AM hr vital signs monitored-pulse remained @ 70 PMB @ least 10 & BP initially 145/95-136/100 & 149/86;no c/o airway problems;
headache; Queasy stomach; vomiting; diarrhea (loose, then changed to runny); severe chills; slight fever at 99.6 degrees F; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 11:00 as dose 1, single (Lot number: GK1337) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac sprue" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Gluten (celiac sprue)" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; GLUCOSAMINE; TYLENOL; VIT D [VITAMIN D NOS]; OMEGA 3 [FISH OIL]. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: NAUSEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "Queasy stomach"; DIARRHOEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "diarrhea (loose, then changed to runny)"; CHILLS (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "slight fever at 99.6 degrees F"; VOMITING (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered"; HEADACHE (non-serious) with onset 21Jun2023 at 01:30, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, chills, pyrexia, headache.  Additional information: No other vaccine administered in four weeks. Other medications in two weeks: Levothyroxine/glucosamine/Tylenol/Vit D/omega 3. No Covid prior to vaccination and Not tested for Covid post vaccination. At 7 pm: Queasy stomach, then vomiting and diarrhea (loose, then changed to runny) for approx 30-40 minutes; went to bed with severe chills & slight fever at 99.6 degrees F. Woke up at 1:30 am w/headache.
Inappropriate reconstitution technique; Incorrect dose administered; leaked out of the needle puncture; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 95TA2, expiry date 10-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate reconstitution technique (Verbatim: Inappropriate reconstitution technique), inappropriate dose of vaccine administered (Verbatim: Incorrect dose administered) and needle leak (Verbatim: leaked out of the needle puncture). The outcome of the inappropriate reconstitution technique, inappropriate dose of vaccine administered and needle leak were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The pharmacist reported that he was preparing a dose of Arexvy vaccine. He took an antigen vial from Lot number LM7J7 and adjuvant vial Lot number 9G793 and from the middle 2nd row of a multi dose carton / box. Pharmacist stated that he injected 0.2ml into the adjuvant vile and withdrew liquid. He then cleared the syringe of any air and started to inject the adjuvant into the antigen. The reporter stated half the liquid went into the vial containing the antigen and half leaked out of the needle puncture which led to needle leak. The reporter stated that the liquid came out of the stopper at the puncture point like a little explosion. The reporter then proceeded to get another adjuvant vial from the multi dose pack and withdrew 0.3ml into the syringe then he added the 0.3ml adjuvant to the antigen vial, withdrew 0.5ml total reconstituted liquid and administered to a customer which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter consented to follow up.
Injection site stays hot; Injection site swells; This is a spontaneous case, reported by consumer to Communications (reference number: SEQ19-04825) and initially retrieved on 16-Oct-2019, concerning 8-year-old, female patient.  Patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was administered INN Flu Vaccine [influenza vaccine, dose, route of administration, anatomical location, batch number, expiration date: not reported] for unknown indication.   On unspecified date, the patient developed vert bad injection site warmth and swelling. Reporter stated that it lasts for several weeks and looks like she was hit by a baseball. It was also reported that patient has been getting her dose from a multi-dose vile at the paediatrician and that these events have been happening for last couple of years.  The outcome of the events was not reported, at the time of the initial reporting.  The reported did not provide seriousness and causality.  Company comment: The patient developed vaccination site warmth and vaccination site swelling, associated with unspecified Influenza vaccine. The patient developed mentioned events on an unspecified day after vaccination. Chronology needs more clarification. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.