chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sudden pain in my chest that quickly intensified; painful sinus infection feeling; migraine for 3 days with a lingering headache for 2 more days; migraine for 3 days with a lingering headache for 2 more days; I was then in panic mode; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Right on 17Feb2021 14:15 (at the age of 58-years old) as dose 1, single for Covid-19 immunization. Medical history included none. Concomitant medications received within 2 weeks of vaccination included topiramate (TOPIRAMATE), ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took motrin [IBUPROFEN] and experienced allergies. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 17Feb2021 14:15, the patient stated 24 hours after first dose she was teaching online and got a sudden pain in her chest that quickly intensified. She was in severe pain and had her husband take him to the EMT station a few doors down from her home. The pain began to radiate down her sides and into her stomach. The EMT did an EKG and determined it was not a heart attack and helped her calm down. She was then in panic mode. The chest pains lasted the rest of the night off and on but less intense. She also had a painful sinus infection feeling/migraine for 3 days with a lingering headache for 2 more days. Treatment received with Imetrix, lots of fluids and lots of sleep. Since the vaccination, patient has not been tested for Covid-19. The patient underwent lab tests and procedures which included electrocardiogram: not a heart attack on 17Feb2021- The EMT did an EKG and determined it was not a heart attack and helped me calm down. Outcome of events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 21-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 456 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient (gender not reported) who was vaccinated with 0.5 ml first dose of FLUZONE QUADRIVALENT (batch number UT6290KA and Exp. Date not reported) via intramuscular route in unknown administration site on 05-Sep-2018. The patient's medical history was not reported. Concomitant medications included HEPATITIS A VACCINE for Immunization; HIB VACCINE for Immunization; and PREVNAR for Immunization. It was an actual medication error due to overdose as the patient was given 0.5ml instead of the recommended 0.25ml. No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023; No adverse event; 5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-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 (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023).    No concomitant medications were reported.  It was unknown if patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 mL.The vial was initially stored in the refrigerator on 16-Mar-2023. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for the patient 1 of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-720518, US-MODERNATX, INC.-MOD-2023-720544, US-MODERNATX, INC.-MOD-2023-720545, US-MODERNATX, INC.-MOD-2023-720546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720545:4th patient case US-MODERNATX, INC.-MOD-2023-720544:3rd patient case US-MODERNATX, INC.-MOD-2023-720546:5th patient case US-MODERNATX, INC.-MOD-2023-720518:2nd patient case
Significant ringing in ears (Tinnitus) which occurred originally after shot #2 on March 2, 2021 and lasted approximately 6-7 months.  Upon receiving shot #3 February 1, 2022 Tinnitus returned and is currently mostly moderate in intensity but bothersome sometimes affecting sleep.
She got her vaccine, her temperature went up, her normal is 97.3 when she came home as she always takes her temp as she had a reaction to Shingrix in the past.  It went up by Saturday morning sometime ? as she was out of it, and it was 103.1.  It was still 103.1 later in the day.  Her pulse was very high and erratic so she did not know what it was, normally 55 and it was in the 70s and 80s, and was all over the place.  She had a really severe headache and moderately light headed and why she had difficulty taking her pulse and temp due to that.  She did not have strength to get up until Saturday around 3:00 PM.  She remember opening her eyes and looking at the clock several times in the morning and afternoon but she could not even communicate and was out of it.  She felt really bad.  She had severe headache when she finally was able to get up, moderately light headed, had a moderate sore throat, moderate cramps in extremities and body aches.  She sat in her chair for a little while was watching TV and was sort of out of it (drunk type reaction but not a drinker), did not eat much, loss of appetite and then went back to bed.  She got on Sunday and was definitely better, the temperature was down in the 101 range when she got up.  Her body aches were worse, possibly due to the fact that she was more awake on Sunday.  The light headedness was bothering her yesterday and still a little bit today.  The sore throat seems to be gone but a little scratchy.  She was able to eat something last night but does not remember what, and then did eat breakfast this morning.  She is still not feeling her best, kind of wondering if she is fighting off a bit of a migraine, which she had after the 2nd Pfizer vaccine, which she had a few spells in which she was talking to somebody and knew who they were and her memory would drop for a second, and maybe she wasn't getting enough oxygen.  Somebody gave her a ride to her car, wearing a mask and some fresh air and forgot what she was talking about.  She then got the J&J for her booster.  She doesn't get migraines often just seems when she gets a vaccine, takes a new medicine or has to switch medicines (calcium).  She still as a headache today but not like she had Saturday.  She did take a children's Tylenol, which she felt helped her temp a bit.  Her temp today is normal at 97.3.  Her pulse is still a little bit higher than her normal pulse and not real steady, which is sort of her normal.   She is still a little bit achy.
Rec'd pneumonia vaccine in (L) deltoid & FLUZONE in (R) deltoid on 10/26/11. Returned to clinic 10/28/11 AM c/o pain & redness at injection site in (L) deltoid. Redness & swelling present at injection site. Advised client to ice & alternate heat.
Information has been received from a published article, concerning "a patient who was vaccinated with one dose of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA02000). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
HIVES ON TORSO, INNER THIGH, AND BEHIND EARS THAT STARTED 4-5 HOURS AFTER SHOT GIVEN.
reddening/soreness of injection site, followed by severe headache, wheezing for about an hour, dizziness, diarrhea. Benadryl, tylenol,imodium.
Full body faint hives and itching  since 24 hours following 3rd dose of Moderna vaccination
Blinking on rt side w/mouth going to one side, sl. fever; Tylenol tabs were given & tic continued;
The patient received the second dose of pfizer 16 days after the first dose.  No adverse reactions reported.
Full dose was not administered, Dose sprayed out the sides of syringe when plunger was pushed down.  CDC recommended dose should be readministered. Dose given on 10/17/10.
Pain in lower back and hip; Pain in lower back and hip; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes and hip replacement a year prior to the report. Concomitant medication included insulin degludec (TRESIBA) at 16 units a day for diabetes. The patient experienced pain in lower back and hip on 22Jan2021. Patient stated, he had the shot, the virus shot yesterday (22Jan2021). He woke up this morning with severe pain in his lower back and his hip and he wanted to see that can be a side effect, but he was to report it so he was reporting it. Patient stated event start date was last night (22Jan2021). Doctor told him to take Tylenol 500 mg as treatment. He was due to get the second shot on 11Feb. Therapeutic measures taken as a result of the events included Tylenol 500 mg. The patient didn't have any lab tests. The outcome of the events was unknown.  Information about lot/batch number has been requested.
A large red welt formed on my upper left arm, around the injection site. It was very itchy for a couple of days. I treated it with Hydrocortisone and Benadryl Spray. After couple of days the itchy subsided to a mild itch and the welt shrank in size. After about a week the itch was gone and the welt became a discoloration. The discoloration eventually faded away.
spreading redness, ring around injection site, warm to touch, itchy, swollen lymph node under arm
Vaccine was given during a flu mission conducted by clinic within the Medical home. Per medical record patient reported to the ED c/o of trouble moving his lower extremities the evening of the vaccination. Patient was admitted and White to r/o Guile-Barre. Patient was release on 29 NOV 2018 with the following restrictions for 14 days: "no prolong standing over 10 minutes, no running, no lifting over 1O pounds" Patient f/u on 3 DEC 2018 and Per medical record states that he can walk but does get "sensation of not being able to walk and it just comes and goes". Patient is currently enrolled in Physical Therapy.
Information has been received from a physician concerning a female who was vaccinated with her second dose of GARDASIL (site and route of administration not reported). About two weeks post vaccination the patient experienced swelling at the injection site. The patient's swelling at the injection site persisted. No problem with the initial dose. Additional information has been requested.
Chills, headache, fatigue, muscle aches, hot flashes, profuse night sweats. Has lasted more than 24 hours.
HIVES; itching; redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: corrected email added
Employee received seasonal Flulaval quadrivalent on 10/17/22. On 10/19/22 employee went to the employee health nurse at her place of employment to report that the vaccine site had become red/swollen and there was a spot in the center of the red area where the superficial skin was sloughing off. Employee was advised to monitor, keep clean, and report back, and see her PCP, if the area worsened. As of 10/24/22 I had not heard back from said employee.
Left arm became extremely sore within an hour.  Next day severe bone and muscle pain in arms and legs.  Chills, sore throat.   Previous had covid 19 in 10/2020.
Patient presented to the Student Health Services at University at the Campus on 08-03-17. Patient states starting on 07-28-17 she developed an itchy rash on face, upper and lower extremities and abdomen; most significant is a cluster of lesions on the right abdomen. She is afebrile. The rash is not painful, but patient expressed discomfort. Pt reports new lesions have developed every day since then. Most are papular; however, the lesions on her right abdomen are pustular. A varicella culture was obtained and will be sent to a lab. She was sent home in quarantine and instructed to take Tylenol, Claritin and apply Caladryl lotion topically.
Black circle down to elbow for 1st 2 days- turned into red circles with white bump in center and then turned into lump.
This spontaneous report as received from a consumer refers to a 60 year old female patient with hypersensitivity. On 08-AUG-2017 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous for prophylaxis. On 09-AUG-2017, 2 days after onset of therapy the patient experienced injection site erythema and injection site urticaria. On 11-AUG-2017 the patient experienced injection site pruritus. The outcome of injection site erythema, injection site pruritus and injection site urticaria was reported as not recovered/not resolved. Additional information is not expected because there is no consent to contact the reporter.
Patient states she received the Moderna COVID vaccination one month ago and has had persistent severe headache ever since.
Initial and follow up information has been received from a registered nurse concerning a 27 year old female with penicillin allergy and no pertinent medical history or concurrent conditions who on 09-Mar-2009 was vaccinated with the first dose of GARDASIL (lot# 661703/0651). 0.5ml, intramuscular administration. There was no concomitant medication and no other vaccines given with the GARDASIL that day. On 10-Mar-2009 the patient experienced facial cheek twitch. ("one of her cheeks had a little twitching for a week"). The patient did not report the adverse event until she came to the office for her second dose of GARDASIL. The doctor determined that the second dose of GARDASIL was discontinued. It was reported that the patient was recovered a week after it started. No further information is available.
Case previously recorded as MA2009-3695. Initial case report received from a nurse via Novartis Pharma, on 04 NOV 2009. A 1-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102041P1) i.m., on 04 NOV 2009. No adverse events was reported. MedCom reference no.: NA09-007553.
This spontaneous report was received from a registered nurse referred to three unspecified patients of unknown ages and genders. On an unknown dates the three patients were vaccinated with VARIVAX (Lot# unspecified), 0.5 ml, subcutaneous (frequency and indication unspecified). The registered nurse reported that three unspecified patients received improperly stored VARIVAX, exposed to -13 C for 10 minutes. No adverse effect was reported. Additional information has been requested.
stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266 and expiration date not reported) via an unspecified route of administration, administered in the left arm on 24Feb2021 16:15 as a single dose for COVID-19 immunisation. Medical history included LBBB, HTN, and high cholesterol. The patient is not pregnant and has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had the first dose of the vaccine on 24Feb2021 and had stroke on 09Mar2021 16:00 with no CVA history. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized on an unspecified date for the event for 1 day. Treatment was given in response to the event which included CT Scan and MRI. The patient underwent COVID test post vaccination via nasal swab on 09Mar2021 and was negative. The outcome of the event was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208) on 17Mar2021 for COVID-19 immunization.
The patient died of a hemorrhaging cerebral hemangioma 3 weeks after getting the vaccine.
Based on additional information received on 24 November 2014, this case became medically confirmed. Initial report received from a consumer, who is also the patient, on 10 October 2014. A 71-year-old female patient, with a history of allergies to cedar, ragweed, and poison ivy, received in intramuscular left deltoid injection of FLUZONE HD (lot number not reported) on 27 September 2014. She reported no illness at the time of vaccination. Two days post-vaccination, on 29 September 2014, the patient began experiencing chills, and complained of her left arm feeling "heavy". Six days post-vaccination, the patient developed a red, raised, itchy rash of varying size, widespread over her body. Her eyelids also became red and itchy. She stated it "feels like she is on fire inside". She also stated that she had been feeling a little bit of muscle weakness, and felt as if she had some swelling in her throat. She was seen by her primary care physician and was advised to use BENADRYL every six hours and use cortisone cream; a few days later she was given a shot of cortisone. She reported that she had not seen significant improvement, and an additional unspecified prescription treatment had been ordered by her physician. At the time of the report, the events had not yet recovered. Follow-up information was received on 24 November 2014 from a healthcare professional. The lot number was reported as U5022AA. The report was reviewed and the reporter had no additional information to provide. Documents held by sender: None.
Headaches on day 6,7,8   Swollen lymph node on neck ...same side as the injection  And still present
I didn't feel well Thursday, but thought it was normal. Thursday night, I knew it was not normal reaction. Had chills and sweats, my ribs started hurting, and also started to itch. By Friday night a rash appeared ribs felt like I cracked them (very painful). Couldn't sleep. Saturday, traveled as symptoms got worse. Pain was so bad (10/10) that I lost appetite.  Sunday morning went to urgent care. given Valacyclovir 1 G and a useless Ketorolac 10 MG.  Blood pressure very high Symptoms persisted. Changed my trip and returned home. Sought another urgent care. Gave Lidocane by injection around rib cage and prescribed Pregabalin 75 MG. Pain persisted. Added N-SAIDS like Alka-Seltzer,  Ibuprofen, and Tylenol for pain. Today is 8/25/22, still have pain but not 10/10. Discomfort 5/10. Rash is going away slowly.
3" x 3" area of red raised slightly in area where injection was given on upper left arm.