chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US006171 is an initial spontaneous report received from a health care professional on 26 Mar 2014. This report refers to an unspecified age and gender patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date, which was stored at a temperature of -1 C for approximately 35 minutes. The reporter thought the vaccine did not freeze. No adverse events were reported following this medication error. No additional information was available.
The patients entire post right forearm red, warm, and swollen; status post Anthrax vaccine 3 days prior.
Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; Painful, difficult arm; Rash and blister on the site of injection and itchiness; Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness) and RASH (Rash on the neck and other side of neck, very red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lidocaine).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE for Adverse event, at a dose of UNK dosage form. On 01-Aug-2021, PAIN IN EXTREMITY (Painful, difficult arm) had resolved. On 02-Aug-2021, ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness) had resolved.        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.   No concomitant medication information was provided   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: TCR Received on 17-AUG-2021 and It included reporter contact details
Pt was seen in clinic as walk in for redness, swelling and warmth to L deltoid at injection site. Was given Prescription of BENADRYL and instructions to continue with TYLENOL and MOTRIN as needed and to ice area, reddened area on Deltoid was marked for progression father of patient was advised to return to clinic if symptoms worsen.
Headache; flushed cheeks and nose; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced Headache flushed cheeks and nose after vaccination.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
EXPOSURE TO COVID-19; COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic. The patient previously received covid-19 vaccine ad26. cov2. s vaccine (suspension for injection, route of administration, batch number were not reported and expiry: unknown) dose was not reported, (dose number in series was 1), 01 in total was administered in APR-2021 for prophylactic vaccination.  The reporter had not reported any adverse events following vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported (dose number in series was 2), 01 in total was administered on 20-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included semaglutide (Ozempic) for indication diabetic. On an unspecified date, following the vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced exposure to coronavirus disease-19 (COVID-19) from his daughter who tested positive for COVID-19. He reported symptoms such as fatigue, nausea and headache (symptoms subsumed under event "covid-19 symptoms", dose number in series was 2). He stated that the symptoms were mild and very similar to previous side effects from taking semaglutide (Ozempic). He was not sure if symptoms were from COVID-19 or semaglutide (Ozempic) side effects. It was reported that, patient had not done any test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure to covid-19 and covid-19 symptoms was unknown. This report was non-serious.
Pt in office today to receive Covid booster. Pt was given >12 Bivalent booster instead of 5-11.
Erythema and swelling in right thigh x2, one measuring 15.5 x 11.5cm, 2nd  9.5 x 10.5cm without bullae in center cellulitis suspected and cephalexin prescribed, CBC and blood culture also done.
I went to a Digestive Services for a colonoscopy. I had prepared for it by taking the prescribed Suprep.  I didn't sleep well the night before, I was dehydrated from the Suprep, and I hadn't eaten in about 30 hours.  Dr. said she couldn't do the colonoscopy because I was in Afib and had a very high heart rate (150+).  She also said she couldn't send me home like that.  I was sent to the local Hospital ER for 24 hours of observation.  About 4pm that day, I was finally given fluids and a liquid potassium drink.  My heartrate immediately fell. I was cared for and my heart rate observed.  A Dr. changed my basic blood pressure medicine to Metoprolol plus Losartan Potassium.
Patient was provided vaccine on 9/2/22 that was past it's beyond use date of 8/31/22.
Vomiting, fever of 102, elevated liver enzymes, abnormal blood proteins indicative of Major inflammatory event.
Breakthrough case admission after 2 vaccines Pfizer 4/20/21 Lot# Ew0162;  Pfizer 5/11/21 Lot# EW0172
Chest pressure, Fatigue. Treatment: No anti-Covid treatment needed at this time. Maintain COVID isolation.
I woke with three blisters on my left buttock. Impaired cognition, impaired word-finding ability, intermittent blurred vision, I have trouble focusing and short term memory loss, sometimes I will fall asleep in mid-sentence (somnolence) while my family is talking with me, marked sensitivity to light/sound/smell, insomnia/severe sleep deprivation, tremors, dizziness and disequilibrium, temperature instability, fever/night sweats/chills/shivering, flushing, nausea, loss of appetite, muscle/joint aches, extreme fatigue, heart palpitations, and blue dilated veins on back of hands and palms.
Immediate tingling of lips and tongue and light headedness.  I waited at the vaccination site for 45 minutes.  When there was no further progression of clinical signs, I left the vaccination site.  No treatment was given.  The symptoms lasted for approx. 2 hours.
After about 20 minutes of observation she started to dry heave/spit up white bubbles. She said her mouth felt "spicy" and her eyes felt "weird"  Checked blood pressure it was over 180/90 on the first read, 153/109 on the second and 176/98 on the third. Pulse was normal, strong and steady.  No classic symptoms of allergy.  Called 911 to be taken in, no treatment given in facility.
received his first dose on 4-November-2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th November 2020, 0.5 ml, intramuscularly).   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 provided as follows: 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. The reporter did not consent to follow up. The VAERS details were reported for 1st dose of Shingrix.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (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 Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261290 same patient, different drug/event;
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CLOPIDOGREL, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID] and POTASSIUM for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 11-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had 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.
I administered 2nd dose of Moderna vaccine to patient. Since patient has prior history of allergic reaction to medications and latex, I instructed the patient to wait 30 minutes post-vaccination for observation. Patient got up from the booth to sit in the waiting area. 6 minutes after, patient came back to the booth and complained of shortness of breath and dizziness. I instructed her to get on the floor. I, immediately, had my technician call a Code White and instructed them to start the Adverse Reaction protocol. In the meantime, I was in preparation to administer the Epipen. As I was just about break the seal (never quite got to opening it), the patient mentioned to me that she was was able to breathe a little bit better after taking her mask off. We provided her with a cold water bottle and 2 ice packs. She started to feel better within minutes. I am left to believe it was an almost syncope event.
Blood clotting in legs, livedo reticularis,  Antiphospholipid syndrome
Dizziness; Weakness; Chills; joint pain; muscle pain; Headache; overwhelming fatigue; brain fog; nonfunctional; debilitated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical History Information was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical History Information was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
This case was reported by a pharmacist and described the occurrence of tinnitus in a teenager female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced tinnitus and palpitations. At the time of reporting the outcome of the events was unspecified. The reporting pharmacist was questioning a possible bad batch of BOOSTRIX, product complaint. No other events noted. Follow-up information received via an investigational report from GlaxoSmithKline Biologicals on 18 August 2011 indicated that no sample was available for return. An investigational report received via GlaxoSmithKline Biologicals on 20 September 2011 indicated that based on the fact that no precise technical problem was reported, no technical investigational was performed accordingly. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
pt seen in office dx varicella 50 lesions 16MAY98;pt recv vax 26FEB98;
On  12-27-20 I was diagnosed with Covid. I saw a doctor the following day.
Took 1st dose of Typhoid at home 3/8/06. 2nd dose 3/10/06 at 9 am felt nauseous, vomiting and diarrhea by 6 pm. every 20 minutes until went to ER. Sat. am 3/11 2 liters intravenous fluids, phenergan, pain med. Vomiting stopped but continue diarrhea, fever 102 degrees F, headache, dizzy and red rash on arms. Symptoms diminishing today 3/13/06. Medical records state tachycardia. msv
Pt noticed decreased strength both hands, feet & right leg. Numbness & tingling in (R) leg. Improving but not resolved, weakness worse in am and unable to open jar. Pain after excessive use.
Patient by 5/8/21 was experiencing fever to 103, lower back pain, palpitaitons, headache, nausea, left arm and neck pain and dizziness.  He was taking Advil and Tylenol to assist with symptom managment.  Left arm and neck pain persisted.  On the morning of 5/11/21 he awoke with central chest tightness, left arm/shoulder/neck achiness, nausea and headache. During ride to hospital, he had palpitations for 30 minutes.  He arrived at  Medical Center where he was found to have a positive troponin I of 4.2 (ULN of <0.045).  Echo done at that time showed EF of 59% with basal inferior, anterolateral hyokinesia, basal inferolateral hyokinesia, mid inferolateral hyokinesia, diastolic LV function normal function for age and trace mitral regurgitation.  ECG showed non diagnostic ST elevations in leads II, III, AVF.  The patient was transferred to another Medical Center  for urgent cardiac cath based on resting chest, arm and neck pain, positive troponin and wall motion abnormalities seen on echo.  Cardiac cath found normal coronary arteries that were free of disease.  Troponin I at this medical center was positive 0.31 and 0.39.  Further testing ordered is a cardiac MRI to assess for possible acute myocarditis.
Patient came in for second dose of Moderna vaccine. We at the time are out of Moderna and person checking patients in was told a couple of times. Inadvertently patient given Pfizer for second dose. Patient was told of the incident. Vaccine person told him that she had given wrong vaccine and that she had not double checked before giving vaccine. He was also told that was his second dose and did not need to come for another vaccine. Patient said he understood. Patient was monitored for about 20 minutes and no adverse reactions occurred. Patient left clinic feeling good.
Moderna pediatric dose administered to patient instead of Moderna bivalent booster; had sore arm after every mRNA shot; had headaches after every mRNA shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (had sore arm after every mRNA shot), HEADACHE (had headaches after every mRNA shot) and WRONG PRODUCT ADMINISTERED (Moderna pediatric dose administered to patient instead of Moderna bivalent booster) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (had sore arm after every mRNA shot) and HEADACHE (had headaches after every mRNA shot). On 25-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna pediatric dose administered to patient instead of Moderna bivalent booster). At the time of the report, PAIN IN EXTREMITY (had sore arm after every mRNA shot), HEADACHE (had headaches after every mRNA shot) and WRONG PRODUCT ADMINISTERED (Moderna pediatric dose administered to patient instead of Moderna bivalent booster) outcome was unknown.            No concomitant medication was reported.  Patient stated that she was scheduled to receive the Moderna COVID-19 bivalent vaccine on 25-Oct-2022, went to a local pharmacy, where she was assured that she would be receiving the Moderna bivalent vaccine. However, that night patient received a call from the pharmacy where it was stated that patient and her husband along with 200 other patients had received a dose from the pediatric vial instead of the bivalent vaccine. Doctor had told the patient to wait at least a month to get the next booster dose.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665518, US-MODERNATX, INC.-MOD-2022-665512 (Linked Report). This case was linked to MOD-2022-665445 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665518:Husband cases- Bivalent dose, same reporter US-MODERNATX, INC.-MOD-2022-665512:Husband cases- Primary doses, same reporter
This is a spontaneous report from a Pfizer-sponsored program via contactable consumer. This consumer reported for both himself and his wife. This is for the reporter.  A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in right arm on 11Feb2021 at 12:30 (at the age of 74-years) as dose 2, single for covid-19 immunization. The patient medical history included none. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in right arm on 21Jan2021 at 11:15 (at the age of 74-years) as dose 1, single for covid-19 immunization. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. After second vaccination, on an unspecified date in Feb2021, the patient had experienced a little bit soreness on their right arm where the vaccine was administered. Therapeutic measures were taken as a result of arm soreness and included treatment with Advil and Tylenol. The outcome of the event was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Constant tinnitus and periodically swimmy head. Treated with steroids. No difference by 7/29/2021.
over 42 days 1st dose 03/18/21, 2nd dose 08/5/21
Approximately 5 mins after administration of 1 st dose of Moderna Covid19 vaccine, patient began to report feeling flush, warm inside. flushed skinned noted by staff, medical staff administered epi-pen. Patient then began to feel worse, reporting pins and needles sensation in hands and feet and became more flushed. EMS called. She was transferred to 1st floor UC for better monitoring and await fire rescue transfer to nearest hospital.