chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a male patient who in approximately April 2007 was vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and lot number were not reported). On an unspecified date soon after vaccination, the patient developed a mild shingles-like rash. The physician reported that the patient did not experience post herpetic neuralgia. Subsequently, the patient recovered from the shingles like rash. Further information was requested.
She had redness and soreness in first week then lump appeared in second week, went for ultrasound and still has smooth lump on right arm. Vascular Dr asked her to use hot therapy but didn't help.
I tested positive for COVID-19 on 12/18/22. I had a sore throat, headache, fatigue, and body aches. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I took the 5-day supply of PAXLOVID and was still not feeling well, so I contacted my doctor again and was prescribed prednisone and azithromycin. I still have some fatigue, but other than that I am fine now.
A report has been received from a Health Professional concerning a 13 year old male patient. No medical history, concurrent diseases and concomitant medications were reported. On 11-Jan-2013, the patient received FLUMIST. Dosing and frequency were not reported. This patient was tested positive for influenza A on 14-Jan-2013. The patient also had fever and cough. The outcome of the events of tested positive for flu A, cough and fever were unknown. The event of tested positive for flu A was considered to be non-serious by the reporter. The events of fever and cough was considered to be non-serious by the company physician.
I started coughing & had a fever over 100 & it lasted for over 3 days. I decided to take a home test for COVID-19 and it was positive.
Erythematous maculopapular rash head, torso, neck, upper arms on day 10 after vaccine. No treatment.
Pt presented to pharmacy 1 day after receiving vaccination with extreme pain and massive swelling from injection site down to elbow. Pt was immediately referred to ER where it was later confirmed to be an infection at the site of immunization. Antibiotics were started.
Pt was admitted on 12/31/2021 because of complaints of cough and chest discomfort.  Patient reported being exposed to her granddaughter who tested positive for COVID-19.  Patient reported dry cough and discomfort over retrosternal area during cough.  Associated with fatigue and decreased appetite.  She tested positive for COVID-19.   Vitals stable, patient was not hypoxic in the ED.  Creatinine was 1.3.  Troponin was negative.  CRP was 2.14.  Chest x-ray was negative for any acute process.  Patient had Persantine stress test a year ago which was negative for any ischemia.  She was placed on cardiac monitor, admitted to Hospital for observation.  Patient started complaining of abdominal pain after that.  She stated that she takes enema for bowel movements. She was on bowel regimen.  Review of past records shows that patient had complained of abdominal pain and received CT scans which did not show any acute abnormalities.  Abdominal x-ray showed gas throughout GI tract.  Maalox was added.  Abdominal pain improved.  She was moving her bowels.  She did not have any respiratory symptoms and was on room air.  Patient was able to eat and reported improved pain. She was subsequently discharged
Arm was very sore after the second shot; headache; Nausea; Dry, burning eyes; burning eyes; Stuffy head; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry, burning eyes), EYE IRRITATION (burning eyes), HEAD DISCOMFORT (Stuffy head), PAIN IN EXTREMITY (Arm was very sore after the second shot) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI from 19-Feb-2020 to 02-Dec-2020, Arthritis (more widespread since begining) in 1990, Raynauds in 1993, Peripheral neuropathy (started in one foot, now includes both feet and both legs) in 1998 and Blood pressure since 2015. Concomitant products included NITROFURANTOIN (NITROFURANTOIN "DAK") from 02-Dec-2020 to an unknown date, NAPROXEN, NIFEDIPINE, LEVOTHYROXINE and AMLODIPINE BESYLATE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DRY EYE (Dry, burning eyes), EYE IRRITATION (burning eyes), HEAD DISCOMFORT (Stuffy head), HEADACHE (headache) and NAUSEA (Nausea). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore after the second shot). On 26-Jan-2021, DRY EYE (Dry, burning eyes) and EYE IRRITATION (burning eyes) had resolved. On 22-Feb-2021, PAIN IN EXTREMITY (Arm was very sore after the second shot) had resolved. At the time of the report, HEAD DISCOMFORT (Stuffy head), HEADACHE (headache) and NAUSEA (Nausea) had not resolved.      Treatments included Pseudoephedrine, acetaminophen and antihistamine   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Additional information received; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Slight Dizziness, severe Brain fog, eye socket and nasal inflammation.  Symptom worsening over the first two weeks, slowly resolving over past two weeks.
Pt had body aches, sore arm, sniffles, general malaise for about 36 hrs.
allergic reaction; Diarrhea; vomiting; Fever; Fatigue; Pain at the injection site; Sore arm; Difficulty sleeping; arm was swollen; arm was swollen and was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction) and PERIPHERAL SWELLING (arm was swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine (Allergic to pneumonia shots).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PAIN (Pain at the injection site), VOMITING (vomiting), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown and PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient reported that her physician told her she had an allergic reaction and recommended not to take the second planned dose.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Added events ( allergic reaction, swollen arm, erythema) was added  and medical history was added  action taken updated to withdrawn
20 minutes after infection, stiff neck and headache began 14:00.  Throat "felt like it was starting to swell up." with aching feeling.  Took Tylenol 16:00 and slept.  Headache continued until 11/12.  Face became itchy and 11/12 accompanied by chest pain.  Went to quick care 11/12 AM.  Diagnosed with probably allergic reaction to vaccine and GI irritation from Tylenol.
Chickenpox, onset 9/6/99 with less than 50 lesions, lasting 4 days and a fever for 1 day.
Arm was a little sore just where the shot was / Caller confirms if was after both vaccines; This is a spontaneous report received from a contactable female consumer (patient). A 66-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6207 and Expiration date not reported), via an unspecified route of administration in left arm on 16Mar2021 (at the age of 66-year-old) at a single dose for COVID-19 immunisation in clinic. Medical history included ongoing Tumor Induced Osteomalacia from Jul2019 and surgery in Feb2021 (but they told her to hold off on the vaccine until 3 weeks after the surgery, so she did). The patient was been working on a diagnosis for 6 years, about 2.5 years ago she went to NIH and they diagnosed her, so maybe 2019, Jul 2019, and she's been going for labs every 3 months and that's why she noticed such a difference in the labs. Concomitant medication included calcitrol (CALCITROL) 0.5mcg every morning and every night by mouth and then when that blood work came back because her calcium level was elevated, they had reduced it to 0.25mcg every morning and every night taking it for 2.5 years. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse event prior vaccination. Blood work was performed in Jan2021, results were unknown. On 16Mar2021, after vaccination the patient experienced arm was just a little sore. Patient stated she didn't do nothing that she noticed, her arm was a little sore just where the shot was, it was just like a normal shot. Patient stated only if she touched it, it felt like a shot. It was the day of the shot, maybe even the day after, she didn't pay attention to it. Patient confirmed if was after both vaccines. She stated it wasn't a whole sore arm, just the spot they gave it to her, if she didn't touch it, it didn't hurt. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Red area about 4 inches in diameter near injection site; warm, tender, hardened to touch; some swelling/raised Some itching or discomfort.  No systemic symptoms or fever. Lasted 4 days.   ( retired RN)
Had an allergic reaction with hives all over her body and in mouth/ she has a lot of allergies; Had an allergic reaction with hives all over her body and in mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Had an allergic reaction with hives all over her body and in mouth/ she has a lot of allergies) and URTICARIA (Had an allergic reaction with hives all over her body and in mouth) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple allergies.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Had an allergic reaction with hives all over her body and in mouth/ she has a lot of allergies) and URTICARIA (Had an allergic reaction with hives all over her body and in mouth). At the time of the report, HYPERSENSITIVITY (Had an allergic reaction with hives all over her body and in mouth/ she has a lot of allergies) and URTICARIA (Had an allergic reaction with hives all over her body and in mouth) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.  The patient asked which version of the vaccine doesn't have the TRIS in it and how does the person administering the vaccine know when to give the formulation with the TRIS or not. Patient states she received the Moderna vaccine and had an allergic reaction with hives all over her body and in her mouth. Also states she thinks its the TRIS that made her react and she hopes it is not the MRNA.  Patient reports to the manufacture of Corminaty for medical information potential AE.  No treatment information were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-039158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-039158:Other People case
Contracted covid (Positive test); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid (Positive test)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced COVID-19 (Contracted covid (Positive test)). At the time of the report, COVID-19 (Contracted covid (Positive test)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: (Positive) Contracted covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. treatment medication reported was Tylenol.
unknown if adverse effect, parents found baby unresponsive and blue and called 911 and CPR started and baby expired unknown cause
Patient jerked away during administration, half dose came dribbling down patiets arm. We called Pfizer and spoke with vaccine department, they said to immediatley give a half dose to equal the full dose. So we vaccinated patient again with a 0.1 ml half dose.
On 8/24/12 - pt. came in for Hep B #3. C/O of having pain, redness and prolonged swelling of (L) arm after PNEUMOVAX injection on 6/7/12.
several pt devel exaggerated inj site rxn p/vax;reporter unable to specify the number of people who exp this event;
they are going crazy and want peace of mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunization. The patient's relevant medical history included: "Splenectomy", start date: 1998 (unspecified if ongoing), notes: spleen removed; "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization; Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "they are going crazy and want peace of mind". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's wife stated that her 68 year old husband have already gotten 4 vaccine shots, but when they had an antibody test back in Oct2021 the husband tested negative. Caller now thinks that maybe the vaccine is not working for her husband who also doesn't have a spleen. Caller wanted to know if there is a test that will accurately tell if the vaccine is working for them. She says she doesn't know if the test is reliable, and she has read that there have been a lot of false negatives, so she wanted to know if there was a way to know if the vaccine is working. Antibody test that you get at facility, not one that the doctor orders, one where you make your own appointment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The day after the vaccination, she developed shaking chills and soreness at the injection site + fever to 100, two days after vaccination (today), has H/A, fever to 102.8 + fatigue.  There is an approx 7x15 cm area of erythema, warmth, tenderness + induration at inj site.  Rx'ed with KEFLEX to cover possibility of cellulitis.
Syncopal episode while getting off exam table after Gardasil injection.  Hit forehead (on left side) presumably on floor or wall.  Ice pack to forehead.  Evaluation at Oakwood Healthcare Center.
Extreme pain in shoulder, interrupted sleep, chest heavy, left side.  pain spreading spreading left to right
I conceived and became pregnant between Dec 25-December 29th, the days following getting the first dose of the covid vaccine. I found out I was miscarrying January 15th via lab results from my primary care doctor. I became pregnant again in late February 2021 after having my second covid shot on January 26th 2021 where I had 2 weeks of a low fever, nausea and dizziness.  I had a confirmed pregnancy test and a week later miscarried at 5 weeks.   Prior to this I have had a successful pregnancy with no complications and no hx or miscarriage.
10NOV92 c/o feeling unwell, loose BM x 15, vomited x 1, nausea; resolved over next few day-MD consulted by pt suggested illness was viral; 12NOV92 sl soreness of neck;
RECEIVED COVID VACCINE(MODERNA) 5-6 MINUTES AFTER VACCINE WAS ADMINISTERED I HAD RUNNY NOSE, WATERY EYES, FLUSHED, BLANK STARE, THROAT TIGHTENING, SOME DIFFICULTY BREATHING, UNABLE TO SPEAK. BECAUSE I WAS UNABLE TO SPEAK I TAP MY DAUGHER TO GET MY HELP. SHE GOT EMT ON SITE, RECEIVE EPI, 50 MG BENADRYL-IV. I WAS TRANSPORTED TO BRIDGEPORT HOSPITAL ER VIA AMBULANCE
I had the shingles vaccine - zoster -administered by a pharmacist on Tuesday, 11/14/2011 and have had a significant reaction which includes: site soreness; swelling; edema; radiating heat in the upper arm and a developing rash. I have been instructed to take BENADRYL but have had no relief.
This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral, lot # reported as L008054, expiration date: 30-NOV-2016, (dosage was not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
THREE DAYS AFTER VACCINE EXPERIENCED REDNESS AT THE INJECTION SITE.  THE REDNESS CLEARS THEN MOVES DOWN HER ARM. TODAY 6/7/2019 THE REDNESS WAS PRESENT AND THE SITE BEGAN TO ITCH.  I SUGGESTED EXAMINATION BY MD.
This spontaneous report was received from a nurse referring to 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 15-SEP-2017, both patients were vaccinated with expired doses of GARDASIL 9 Lot # L014198 expired since 05-SEP-2017 for prophylaxis (dose, strength and route were not reported). No adverse effects were reported.
Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.; No adverse event; HCP stated they accidentally administered 2 doses beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.    On 06-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 06-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.).    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023. Vial size was reported as 2.5 ml. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736290:Patient 2
4 days after the 2nd dose of the Pfzer vaccine had chest Pain for 2 hours.  Patient seen by PMD and sent for Troponin which was mildly elevated, and sent for an ECG at urgent care.  Had a normal ECG at urgent care but told to go to the ER.  In the ER was well appearing with no chest pain.  Had a repeat ECG which was normal.  Troponin  repeated and very mildly elevated. She was discharged from the ER on Motrin 600mg PO TID, and had cardiology outpatient follow-up set-up within 48 hours with me.