chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash around injection site. Next day - awoke throat tight and itching. Later morning face hot, flushed and prickling more difficulty swallowing.
On 9/27/22, three days after receiving the vaccinations, I began to get a headache that did not go away. The headache became increasingly worse over the next several days and by 10/1/22 the pain was so severe that I was not able to function and spent most of the day in bed. My neck also became very sore, I was very fatigued, and was taking frequent naps. The headache did not respond to treatments I tried including Tylenol, caffeine, Maxalt, Tizandine, and chiropractic adjustments. On 10/3/22 I went to the ER and was given by IV, Toradol, magnesium, Ativan, Benadryl, and fluids, but the headache did not improve. I was then given IV morphine which helped a little. - Continued-
On 12/29/21 I had a syncopal episode.   On 12/31/22 I noticed a lump on my leg which was diagnosed as a blood clot.   I was treated in the ER on 12/29/21 for the syncopal episode.  ER referred me to PCP (seen on 1/4/22 to get referred to Cardiology and for blood clot symptoms.  I  have seen by Cardiology and Vascular.  I had a second syncopal episode  the week of 3/12/22.  I am scheduled to have a LinQ loop recorder inserted on 4/18/22 to monitor my heart due to 2 different syncopal episodes.  I am still being seen by Cardiology and Vascular to try to treat blood clot and syncopal episodes.
Sleeping 12-14 hours at a time; Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue). At the time of the report, SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue) outcome was unknown.        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 got the Maderna booster and a week later got Covidr; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the Maderna booster and a week later got Covidr) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got the Maderna booster and a week later got Covidr). At the time of the report, COVID-19 (I got the Maderna booster and a week later got Covidr) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient got the Moderna booster and a week later got Covid. No Concomitant medication was reported. No treatment information was provided.
Late in the day on 8/31/22, the rescinded order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Government to staff and then to the staff administering vaccine. Because of this delay, some monovalent vaccine throughout was inadvertently given after 8/31/22. They stated that any monovalent vaccine administered as a booster dose after was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the requirements.
Redness and mild swelling surrounding injection site (R) thigh x 2 days (diluent J015691 06/2016 - for both MMR/VZV).
injection site soreness; tiredness; nausea; headache; fever; myalgia; general malaise; blisters on her abdomen, upper arm, legs, thighs; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the tiredness, nausea, headache, fever, myalgia, general malaise and blister were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister to be related to Shingrix.  Additional details were provided as follows: The patient received dose of the Shingrix vaccine and had injection site soreness tiredness, nausea, headache, fever,myalgia, general malaise, which resolved in a few days. About 3 weeks after the first injection patient had blisters on her abdomen, upper arm, legs, thighs, which took about a month to subside. The follow up consent was granted.
Chest Pain  (786.59) 5-000009  6/10/09 Medical records received DOS 1/21/09 to 2/3/09. CLINICAL IMPRESSION: Palpitations resolved. Post vaccination patient c/o substernal chest pain and palpitations at rest. "Chest lightness', jaw pain, "I feel anxious". ICD-9 Code: Chest Pain  (786.59) 5-000009
Red, hot swollen arm was reported. Patient was advised to put a cold compress on it and take ibuprofen is required. Seek medical help if symptoms of severe allergic reaction appear.
Vaccine was kept in refrigerator on 08 Nov 2021 and administered on 08 Nov 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 08 Nov 2021 and administered on 08 Nov 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 08 Nov 2021 and administered on 08 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 08 Nov 2021 and administered on 08 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  On 08-Nov-2021, the vial was stored in the refrigerator. The vial did not undergo any temperature excursions and had no adverse event.
Patient received the RSV vaccine (Abrysvo) in her right deltoid (IM) About a half hour after she got home (vaccine was administered at 12:30pm)  patient noticed diffuse red blotches on her right arm, right cheek, and her right ear was warm and red. Pt called me at 2:50pm to report her symptoms and stated she did not have any breathing issues or any swelling of face/tongue/lips etc. Pt is a nurse so she is very aware of what to do in case of anaphylactic shock. Pt has not had this type of reaction to a vaccine in the past. Pt applied topical Benadryl to any red blotchy areas and is planning to take Benadryl after she returns home from going out to dinner.
Itchy skin below the injection site closer to bicep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep). At the time of the report, VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
This spontaneous report as received from a 67 years old female consumer refers to herself with breast cancer, drug allergy to unspecified amnesia drug and drug allergy to pain pills. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX on 13-OCT-2012. No other co-suspects were reported. Concomitant medication included unspecified thyroid medication. On 14-OCT-2012 "a day after receiving ZOSTAVAX", the patient experienced itching and redness on her injection arm. It was varying degrees of red, swollen, and with a lump. As of today, the redness has reduced from an original grapefruit-sized circle to a quarter-sized circle. She mentioned that there was some minor pain, and she treated herself with over-the-counter antihistamines. The patient had not sought medical attention and no laboratory diagnostics studies were performed. The outcome of itching on her injection arm, some minor pain, her injection arm with a lump, her injection arm swollen and redness on her injection arm, varying degrees of red was reported as recovering/resolving. Additional information has been requested.
Patients states felt lump in throat, able to swallow, denied shortness of breath or difficulty in breathing. Able to manage secretions. , Respirations 24, heat rate 102, skin warn and dry. Diphenhydramine 50 mg IM left gluteus maximums. Monitored for 30 min. Husband arrived to escort home. Refused transport or advice to seek medical attention. States "I am a ER nurse, and I am OK now".  Respirations 18 heart rate 84. Patient left with husband following.
Within 5 minutes of the injection, I was weak and lightheaded, my BP dropped to around60/40, began sweating profusely, wasn't able to function.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 19:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, Vaccine location: Left arm), administration date: Oct2022, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive; (21Oct2023) Negative; (23Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Nausea vomiting diarrhea headache and chest pain that began 15 minutes after vaccination and persisted over the next 7 days.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Fever-Severe, Systemic: rash at injection site-Medium
pt recv vax 20JUL95 & 30MAR96 pt presented to MD w/1 chickenpox lesion on ear & a low grade fever;the lesion never scabbed over & gradually faded away;pt recovered;MD also reported pt 2 siblings;
Resident travels frequently, complained of coughing/sneezing, went to an Urgent Care and tested positive for Covid
Fever of 103.7 F started at 1:00 a.m. of 5/8/2021  (had second vaccine at 9:33 am 5/7/2021).  Fever continued until 5:00 p.m. of 05/09/2021 .  Took Tylenol 500mg every 4 hours, and 400 mg of Ibuprofen  every 6 hours.  Temperature would drop to 102's and spike back up to 103.7 within 2 hours of taking either tylenol or ibuprofen.  Severe body aches. Chills.  Temperature was at around 101 on 5/10/2021 without any medication, and low grade on 5/11/2021.  Took 400mg of ibuprofen once on the 11th when temperature reached 100.F  No fever or temperature today 5/12/2021.  No body aches or chills.   After 1st vaccine I had a temperature of 101 for a couple of days, body aches, headaches and arm soreness but was resolved by taking either tylenol or ibuprofen.  After 2nd vaccine I would take both tylenol and ibuprofen at the same time or within a couple of hours of each other and neither the fever would reduce or the body aches.
Noted mildly raised, erythematous skin lesion at area of injection site of approximately 2-3 cm.  + significant itching.  No fluctuance.  + improvement of itching with Benadryl. Recommend triamcinolone 0.1% lotion appy 2-3 times per day x 4-5 days.
a little soreness on the arm; swelling in the armpit area; swelling of the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), TRAZODONE and NORTRIPTYLINE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Allergy NOS, at an unspecified dose and frequency; FAMOTIDINE at a dose of 21 milligram and PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes) outcome was unknown.        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.   concomitant medication include Birth control pill. No medical history was provided by the reporter.   This case was linked to MOD-2022-445637, MOD-2022-445638 (Patient Link).
loss of appetite; loss of taste; diarrhea; vomiting; extreme fatigue; Felt cold; sore arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste) and DIARRHOEA (diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING COLD (Felt cold), PAIN IN EXTREMITY (sore arm) and FATIGUE (Very tired). On 12-Apr-2021, the patient experienced FATIGUE (extreme fatigue). On 17-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste), DIARRHOEA (diarrhea) and VOMITING (vomiting). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. On 16-Apr-2021, FATIGUE (extreme fatigue) had resolved. At the time of the report, FEELING COLD (Felt cold), PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste), DIARRHOEA (diarrhea), FATIGUE (Very tired) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
able to withdraw 0.47-0.48ml, patient received; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KZ455, expiry date 4th February 2023) for prophylaxis.   On 25th October 2021, the patient received Shingrix. On 25th October 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were provided as follows: The patient received 0.47 to 0.48ml of Shingrix vaccine , which led to incorrect dose administered. The pharmacist called to report that after reconstitution, he was unable to withdraw 0.5ml of the vaccine into the syringe. The pharmacist reported that this occurred with two Shingrix vaccine after reconstitution. The reporter stated that, this was the first time this has happened, and no cracks or leaks were observed in the vial. The patient did not experience any adverse event. The reprter did not consent to follow up.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: pt was advised to seek emergency medical assistance, pt took antihistamine that evening reported to use on 09/22/2021 10:27am
Syncope. BPs 96/60 (pulse 65), 98/62 (pulse 60). Dizziness.
Went outside to work in very cold temperatures the morning of March 2. Despite being appropriately dressed, my body temperature began plummeting. Because of my confusion I only huddled under a wool blanket instead of taking a hot shower, but I remember being afraid of having wet, cold hair.  The next day my hands became extremely itchy, and I developed chilblains on my left pinky and right big toe. Circulatory issues as well as temperature regulation were very big issues for me in March.
Mild itching and appearance of three 5-6 mm pink papules (nearly vesicular) in L antecubital fossa, ipsilateral side of injection; no pain
Covid Arm, large swollen lesion that is hot to the touch and raised and red. Large circle around injection site appeared after ?bruise? appeared 7 days after vaccine. Still present.
After shot, six hours later had  24 hours of general malaise which has occurred with each vaccine. Then 48 hours after shot, bucal mouth pain that eventually turned into mouth sore 4 days later. Off and on headache and loss taste. Upper left arm pain slowly decreasing, still sore 6 days later.
Red rash near injection site, not nearly as bad as last time.  Within about 8 hours, high fever, sweats, terrible headache, and chills until approx 6am.  Fever continued the entire next day on and off, with extreme body aches throughout the entire day.  Headache could not be remedied.  Fever throughout that evening  as well until approx 6 am and then, felt much better.  Ran a temperature in the morning but felt normal since.  Red rash appeared only late in the Day 2.
Case number PHEH2016US030018 is an initial spontaneous report received from pharmacist on 11 Nov 2016. This report refers to 63 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168805, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 04 Oct 2016. On the same day, the patient experienced pain in upper arm and deltoid arm which had been ongoing for weeks. The outcome of the event was reported as condition unchanged. The seriousness and causality of the events was not reported.
Patient was under the age of 18 years old.  Side effect: sore arm, better now.
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a patient (age and gender not reported), who was vaccinated with FLUZONE QIV (batch number: UI823AB ; expiry date, dose, dose in series not reported) in arm and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in arm (inch apart between two vaccines) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Student received dose 2 with this clinic within 21 days of receiving prior H1N1 vaccine per mother of student. Verbal decline form parent failed to be reinforced with paperwork: consent did not get removed. Per mom and school nurse student never showed signs or an adverse reaction to date of form being completed.