chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red spot at the injection site; Soreness and pain (at injection site); Itched a little bit (Injection site); Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included LISINOPRIL for Rise in blood pressure.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HEADACHE (Headache). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)). The patient was treated with HYDROCORTISONE for Itch, at an unspecified dose and frequency. On 31-Aug-2021, HEADACHE (Headache) had resolved. On 10-Sep-2021, VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE PAIN (Soreness and pain (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also had concomitants for cholesterol (NOS).
3 days after Td booster given, pt's right jaw (upper and lower) felt "tight" and painful. Still not normal, but better.
I have a little bit of fever; My arms hurt; I am feeling pretty weak; My joint hurts; My muscle hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 29Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "I am feeling pretty weak"; PYREXIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "I have a little bit of fever"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2023, outcome "unknown", described as "My arms hurt"; ARTHRALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "My joint hurts"; MYALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "My muscle hurts". Additional information: Patient was wondering if patient could take some Tylenol or some Ibuprofen or something along that one.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
patient reports history of anxiety, shaking and passing out with shots.  Patient reports shaking, weak and is pale and sweaty.  After lying down, patient reports symptoms resolved at 3:12pm
Nausea; Severe body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL 12HOUR) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache) outcome was unknown.     Action taken with mRNA-1273 in response to the events was not applicable   No concomitant medications provided
Local reaction to COVID-19 vaccine-Cellulitis of left upper arm  Prescribed Doxycycline hyclate 100mg and PredniSONE 10mg
Tongue and lip swelling on one side (left) and throat closure, admitted to ER then ICU 2/17/2021.  Discharged from ICU on 2/19/2021.
8 days post vax lasting for 4 days rash-dx as measles-t103;ear infect rt ear x 4 days;runny nose;
Mother reports that he spent Sat. night 7/25/09 (afebrile) with gmo. No rash noted Sat. night but Sun. AM (9:00AM) child woke up with red "bumps" on face. As day progressed, the "rash" continued to arms (partic. underarms and inside arms), diaper area. None on back or legs. Mom took him to ER - they Rx'd CLARINEX. Today R/o staph. Today he saw regular Dr.- Rxd's SINGULAR instead of CLARITIN.
laying in bed with 103.6 temperature; feels like she's dying; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional.  This case involved a female patient of unknown age who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal), while she received vaccines INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) patient who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Breakthrough case admission after two vaccines Pfizer 7/4/21 Lot# Ew0191;  Pfizer 7/27/21 Lot# FA7485
pt said he felt bad.  could not touch his skin with out it hurting him.  could not get out of the bed if the house was on fire
4/15 Woke up with sore arm, to be expected, had full body aches, chills, brain fog, trouble concentration, extremely tired.  Had a fever of 100 degrees.  Felt like really bad flu symptoms.  Slight headache.  Just mostly extremely tired and hurt all over. Woke up on 2nd morning after the shot, 4/16 with no more pains or discomfort.
Systemic: Flushed/Sweating-Medium, Systemic: Nausea-Medium.
Nosebleed; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patient. This is one of 2 reports.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unknown date for Covid-19 immunisation. The patient experienced nosebleed on an unspecified date. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101236195 Same reporter/drug/event for different patients
Developed a red rash 5 min after administering vaccines. Rash located on forehead upper thorax, shoulders, cheeks and upper back. Administered 12.5mg/5mL Benadryl po. Hives.
Hives, facial swelling and chest tightness occurred within 24 hours.  Treated with Benadryl OTC at home and Benadryl 50mg IM at clinic.
After administration of all 4 vaccines, upon departure and standing, client reported feeling dizzy.  Assisted client back to chair.  Client fainted.  Incoherent or unconscious for approximately 30 seconds.  Client then nauseated and vomited clear fluid (mucus); pale.  BP assessed and cool rag applied to forehead.  Given water to drink.  Remained in clinic 20-25 minutes. BP assessed and monitored.  Stable at departure.  Voiced no complaints at departure.
Information has been received from a registered nurse concerning an "18 to 19 year old" female consumer who on an unspecified date in April 2008, was vaccinated intramuscularly with a "second dose" of GARDASIL (lot # not reported).  There was no concomitant medication.  The nurse reported that the patient "fainted ten minutes after vaccination".  The nurse noted that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting".  It was also reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day".  The patient sought unspecified medical attention during an office visit.  The patient recovered from fainting "on the same day".  This is one of several reports from the same source.  Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while running/exercising. Went to emergency room within an hour had CT scan verifying acute subatachnoid hemorrhage.  MRI, Angiogram and Ultrasounds of the head and neck were also performed.
1520 Moderna Dose 1 in the left deltoid from RN #1, then a few minutes later, received the Twinrix (Hepatitis A and B) and Flu vaccines in the right deltoid from RN #2, at a separate station. The records show that he had previously received one dose of Havrix (Hepatits A) in 2021, but no prior influenza or COVID-19 vaccines.  Patient consumed snacks during post-vaccination period: Per patient, he ate two snack-sized bags of Cheetos and two snack-sized bags of Doritos. He also drank water, quantity unknown.  1545  He developed sudden onset of nausea, then vomiting. The small to moderate amount of vomitus appeared to be orange colored food. It was not bloody or bilious.  1547 Vitals #1 His heart rate was 94 beats per minute, blood pressure was 137/91, oxygen saturation was 99%, and temperature was 98.2 degrees F. His skin was dry, no diaphoresis noted. He was vomiting during this vital sign check. He stated that he felt a little lightheaded or ?foggy.? No difficulty breathing noted or stated by the patient.   1549 Vitals #2 We repeated vital signs after he was no longer vomiting. His heart rate was 68 beats per minute, oxygen saturation was 99%, and his blood pressure was 131/87. He stated that his nausea had decreased, but the ?foggy? feeling in his head was still present. He stated there was no difficulty breathing, no tightening, swelling, numbness, or odd sensations near his mouth, throat, or chest.  Based on these observations, he did not appear to be having an allergic or anaphylactic reaction to the vaccines. The medical staff was notified of his condition, and they were planning to come take him to the medical ward for further observation. They arrived and the patient was able to ambulate to the medical ward with the medical staff.   1700  RN reported that the patient was no longer nauseated, his appetite returned, and he had consumed and held down Gatorade. They stated he appeared to have recovered, but would be held under observation for some time longer to be certain.
Muscle spasms around the pelvic area, Fatigue, On and off muscle pain around the joints ( different muscle or extremity every time)
This spontaneous case was reported by a physician and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021), PRODUCT LABEL ISSUE (labeling error) and EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry). On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and PRODUCT LABEL ISSUE (labeling error). On 30-May-2021, EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry) had resolved. At the time of the report, PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and PRODUCT LABEL ISSUE (labeling error) 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. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up report received included information that all patients did fine with no problems.
pt states p/recvd vax started running temp 103 even w/APAP; also states had episodes of eyes rolling back into head & turned pale; did not go to ER or call MD; today arm red & extremely warm all the way to forearm;
reported on 9/1. said once she got back to work from recieving the vaccine she felt tingling in lip and left cheek. Head felt hot but she never ran a fever. that night she reports burning in her kidneys and lips  and had face swelling in left cheek. each day since then, the burning has moved down her legs. Today she reports it is below her knees. reports burning was so intense she thought she would have blister on her lips but none have showed up.
Excessive hives and inflammation all over body. On face, neck, chest, shoulders, arms, hands, back, groin, buttocks, thighs (front and back), knees, behind knees, shins, calves. Red rash bumps everywhere.
The day after my vaccine, on 02/09/2021 at 2:00 AM, I was woken up because I was having trouble breathing and I was very hot. I couldn't get up. I tried to tell myself to breath in and out because there was a lot of pressure and pain from trying to breathe, and this episode lasted about 2 minutes. I broke out in a sweat and the whole episode lasted about 10 to 15 minutes. I had a low-grade fever, but it wasn't an event. I'm not able to exercise anymore like I was prior to my vaccination, but I do not know if it from the adverse events or some other condition.
Patient had the small rash that occurs with the vaccine the first two days, but it had gotten better.  Then yesterday exactly 1 week and one day after administration her site started to itch really badly.  She tried benadryl cream and that didn't work.  She then called me on Saturday 02/27 and said that the site was red and itchy this morning.  There was no soreness, pain, or heat coming from the site.    I recommended OTC steroid cream for the itching.  Also to try and put a cold compress on it for the redness.  It it did turn to hot or painful to go see the urgent care.  I am going to follow up on Monday 03/01 to see if she needs to be seen or if it is better.
Felt a full body flush seconds after administration. Rapid HR and tingling of left hand. About one 30-45 min later SOB and light headedness. Seen in Emergency room, labs/EKG normal.  Most symptoms resolved after 3hours. Continued with intermittent SOB, as if I can't take in a deep breath.  Went home took a Claritin with little improvement. The following day, continued with intermittent SOB.
Initial unsolicited report received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (same lot number). This case involves a 60 patients (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UI669AA, expiry date: 30 Jun 2017, dose and site was not reported) via intramuscular route on 04 Oct 2016 (also reported as over the past month). Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination was unknown. Concomitant medications were not reported. On an unspecified date (reported as over the past month), following the vaccination, the patients had experienced gastrointestinal symptoms. It was reported that, patient do not require ER/ doctor visit. Lab data was not reported. Corrective treatment was reported as no (none). The patient's event outcome was reported as unknown. List of documents held by sender: none.
sore arm; slight Headache; fatigue; slight nausea; Woke up the next morning (Saturday); the tingling appeared to be gone. When I began talking with Four hours later (approximately 12:00 noon), the tingling remained, again, no better, but no worse. I decided to visit the E.R.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Woke up the next morning (Saturday); the tingling appeared to be gone. When I began talking with Four hours later (approximately 12:00 noon), the tingling remained, again, no better, but no worse. I decided to visit the E.R.), PAIN IN EXTREMITY (sore arm), HEADACHE (slight Headache), FATIGUE (fatigue) and NAUSEA (slight nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (Nasal passages completed blocked and swollen with full-blown flu symptoms for 36 hours 13 years ago) and flu vaccine (Tingling in back of tongue 23 years ago). Past adverse reactions to the above products included Adverse reaction with FLU and flu vaccine. Concurrent medical conditions included Osteoarthritis since 06-Jan-2012, Hypertension since 07-Jan-1994, Drug allergy (Linopril), Drug allergy (Diflucan), Latex allergy and Allergy to nuts (Walnuts). Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ), GABAPENTIN from 02-Jan-2021 to an unknown date, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PARAESTHESIA ORAL (Woke up the next morning (Saturday); the tingling appeared to be gone. When I began talking with Four hours later (approximately 12:00 noon), the tingling remained, again, no better, but no worse. I decided to visit the E.R.). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (slight Headache), FATIGUE (fatigue) and NAUSEA (slight nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 28-Mar-2021, PARAESTHESIA ORAL (Woke up the next morning (Saturday); the tingling appeared to be gone. When I began talking with Four hours later (approximately 12:00 noon), the tingling remained, again, no better, but no worse. I decided to visit the E.R.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (slight Headache), FATIGUE (fatigue) and NAUSEA (slight nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Relevant history was added, Concomitant and treatment medications were added, Outcome of events was updated , new events added.
Patient appeared with parent for flu vaccine appointment. Patient was checked in for appointment and was given vaccine. Afterwards, the father came forward and said they believed the child had already gotten a flu vaccine for this year. Upon review this indeed was the case and the patient has received 2 flu vaccines for the 2022-2023 season. No adverse events of harm was reported.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient/ Temperature: -11.8 degree Celsius; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U039726, expiration date: 15-DEC-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.8 degree Celsius for 1 hour 45 minutes, no previous temperature excursion. There was no additional adverse event reported.
Pt vaccinated with Flu Tirvalent experienced inflammation and itchyness at vaccine site.
Got COVID Disease 2 weeks after receiving a booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID Disease 2 weeks after receiving a booster) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 2 weeks after receiving a booster). At the time of the report, COVID-19 (Got COVID Disease 2 weeks after receiving a booster) outcome was unknown.            No concomitant and treatment medications were reported.  Company comment: This spontaneous case concerns a 76-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-465533 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 76-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed.  Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Injection site pain, tiredness,, headache, muscle pain, chills, joint pain, fever, feeling unwell