chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose which was not given; Numbness; Scab on injection site; Hives on arm; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness), SCAB (Scab on injection site), URTICARIA (Hives on arm) and PRODUCT DOSE OMISSION ISSUE (2nd dose which was not given) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness), SCAB (Scab on injection site) and URTICARIA (Hives on arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose which was not given). At the time of the report, HYPOAESTHESIA (Numbness), SCAB (Scab on injection site) and URTICARIA (Hives on arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose which was not given) 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 was reported. No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and it was reported that the patient didn't take the second dose.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Gluten" (unspecified if ongoing). Concomitant medication(s) included: AROMASIN. Vaccination history included: Bnt162b2 (Dose 1, Single, (Lot # not provided)), administration date: 2021, for COVID-19 immunization, reaction(s): "discomfort at site of injection", "fever", "pain in the injection area". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "discomfort at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She received the first and second doses in 2021. The ones (doses) received, she was aware about side effects like fever, discomfort at site of injection. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201053803 Same patient, same drug/different dose, different AEs; PFIZER INC-202201053843 Same patient, same drug, similar events, different dose;
Patient noticed arm soreness later in the day, got progressively worse throughout the evening. next morning notice swelling and hives local to the injection site. Hives then spread across the body and patient noticed lip swelling as well. Patient proceeded to local quick care office to be evaluated, given scripts for prednisone, famotidine, and cetirizine to combat reaction
Severe dizziness; Blurred vision in right eye; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) in the left arm on 09Mar2021 at 10:30 AM (at the age of 67years) as a single dose for COVID-19 immunisation. The patient had no past medical history. Patient's concomitant medications included thyroid medication (MANUFACTURER UNKNOWN) which were taken within two weeks of vaccination. Patient had no history of allergy to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 10Mar2021, patient experienced severe dizziness for 10 days with no improvement and two days after vaccine on 11Mar2021, patient experienced blurred vision of in right eye only for one day. Therapeutic measures taken as a result of dizziness and blurred vision included prednisone and meclizine. The clinical outcome of the event severe dizziness was not resolved, and the clinical outcome of the event blurred vision in right eye was reported as resolved on 11Mar2021.  No follow-up attempts are needed. No further information is expected.
Chest pain, dizziness, heart palpitations, abnormally higher blood pressure and heart rate than my historical norm. Much heavier menstrual cycle than ever experienced.
Constant itching at injection site, started 03/28/2021 per patient's wife, benadryl tablet used without relief
This case was forwarded by Crucell, No: CVAE-005-2012. An initial report was received from a nurse on 13.Feb.2012 and concerns a 57-year-old male patient who, on 14.Jan.2012, received his fourth administration of VIVOTIF (batch no: 3002119). It was noted that the patient received a Hep A vaccination on the day of his first VIVOTIF dose. The patient's medical history and concomitant medications were not reported. On 20.Jan.2012, 6 days following VIVOTIF administration, he experienced muscle soreness, especially his arms. Laboratory investigations have been undertaken and the results are awaited. No further information was available. At the time of reporting, the patient had not yet recovered and he was still feeling some discomfort. The event was considered non-serious. Follow-up information received from the nurse on 03.Apr.2012: Upon internal review, the case was upgraded to serious (other medically important condition) due to the duration of the events. The patient had a concurrent medical history of diabetes, treated with metformin, hypertension, treated with metoprolol, gastro-oesophageal reflux and depression, treated with PROZAC. The patient's symptoms were defined as fibromyalgia. He received treatment with prednisone, with no subsequent improvement of his condition. At the time of this report, the patient had not yet recovered.
I started developing bilateral breast pain about 3 days after my 2nd Pfizer vaccine. A few days later both breasts were very hard and have grown over a cup size. The pain is not improving,  in fact, it seems to be getting worse. Both breasts are  much larger, more dense, and very painful. It?s not like a swollen lymph node in my axils, it my entire breast. I?m currently unable to sleep on my side or stomach. Ibuprofen or Tylenol doesn?t help. Warm packs don?t help. I have never had any issues like this in the past.
Lengthy congestion, cough, sore throat, sinus issues. Never tested positive on at-home test for Covid. Started Jan. 4 Sought treatment March 7.  Prescribed Z-pack, followed by Amoxicillin.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetic, allergies, asthma and allergies to mold, pollen and iodine. Concomitant medications included metformin, glimepiride, simvastatin, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and amitriptyline. The patient previously took cefaclor (CECLOR) and experienced allergies. On 15Jan2021 at 15:15, the patient's face, chin and chest turned bright red. The patient also experienced hot sensation all over and tightness when breathing. No treatment was received. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Fatigue, weakness, light fever 99.9, aches, lack of appetite, sore arm
parents reported that approx 4 hrs p/vax pt exp 1 episode of projectile vomiting, pale coloring, & limpness; parents had pt examined by MD;
patient started with back pain the next day and it progressed to nodules in the muscles of the back, starting with left lower back, left upper back, then appearing in the right lower and upper back. Patient had to take time off work and file for short term disability
Day 6, developed large local reaction w/ erythema, swelling, tenderness. Splotchy, 10cm x 5cm
Pt received J&J vaccine on 5/12/21. Diagnosed with COVID 6/23/21 and admitted to the hospital to receive COVID treatment on 6/29/21
Around 2 weeks after receiving the first vaccine dose, I woke in the middle of the night gasping for air. My heart was racing and I was so weak that I could barely sit up. The following day I could not get out of bed. I also had an intense headache, which is unusual for me since I never get headaches. On the 3rd day I developed dizziness/vertigo. Since those events occurred, I've been dizzy 24/7 and had about 25-50% of my normal energy. I cannot drive, I cannot work, I cannot many of my normal daily activities. This has been devastating. It has been over 3 weeks now with these symptoms, and I will probably lose my job this week. I don't know where to turn. There should have been a safety net for these things.
Headache, myalgia, severe fatigue, limb pain 12-18 hours after injection.
1/7/14-Started with rash (right leg with bump and redness in area of shots given) now with rash too. 1/15/14-Fever (102.8), brusing to injection site area, warm to touch, area firm/indurated.
no adverse event; office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022).    No concomitant medications were provided. No treatment medications were provided. It was reported that the office was aware of 3 patients that had received mention vaccine vials.
allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 15Oct2023 as dose 1, 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: HYPERSENSITIVITY (hospitalization) with onset 2023, outcome "unknown", described as "allergic reaction". Additional information: patient had Pfizer Covid 19 Booster last 15Oct2023 from a pharmacy then she had an allergic reaction which got her hospitalized. She also would like to ask for help with her hospital bills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme fatigue for 24 hours- Could not get out of bed.  Brain fog.  Diarrhea, metal taste in mouth.  Injection site is swollen/ hard.
Respiratory. Labored breathing, felt strange, little tingling in hands, tongue felt thick a little layet
21 y/o male report with rash across chest/ stomach/ neck. Received small pox vaccine 19OCT2004. Disseminated vaccinia.
Completely lost my sense of taste and smell; Completely lost my sense of taste and smell; Cant have eggs anymore since the vaccine/Egg allergy; Off label use; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001084 (RA).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE), administration date: 25Jan2021, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 22Dec2021, outcome "unknown"; OFF LABEL USE (non-serious) with onset 22Dec2021, outcome "unknown"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Completely lost my sense of taste and smell"; FOOD ALLERGY (non-serious), outcome "unknown", described as "Cant have eggs anymore since the vaccine/Egg allergy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE; Inbound call from HCP requesting evaluation of temperature excursion. Caller stated that 1 of their patient's received the VARIVAX after the excursion.  No symptoms reported.  Vaccine was administered by a RN who is a repeat user. No additional AE/P; This spontaneous report was received from administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis lot#X011424, expiration date: 19-APR-2025(strength and route of administration were not provided). This vaccine underwent temperature excursion for 1 hour 21 minutes in 11.37 Farenheit (Product storage error). No additional adverse event was reported.
Fully body itching and hives, started taking Benedryl every 4-6 hours and it seems to keep it under control.  Still taking Benedryl every ~6-8 hours, but less often at this point.  I've never experienced anything like this before in my life, and the only thing "different" that I can point to is the vaccine.
Pt received flu shot in Employee Health, within 15 minutes began having difficulty breathing and was taken to ED, later transferred to hospital for observation. Received epi x 2, solumedrol, Ativan, Zofran before transfer. Anaphylaxis
I had a sore arm during the first couple hours after the shot. Body aches and chills by midnight and I did not have a fever, my body temperature is really low so it just went up to 99, I basically was just really tired, aches for a few days and a little more congested than usual. I think it irritated RA because I had bone aches for a few days. It got better 2 and a half days later. I was fine within 4 days. I just sent my PCP a message through the portal and she told me it was a pretty normal reaction. I had an appointment already scheduled with the doctor, my Neurologist they wanted to keep a record of how patients were responding to the vaccine. I did see the Neuromuscular specialist Dr. was June 25th for a routine visit. I had a Neuromuscular test on May 20th. These tests were for preexisting conditions because I had a concussion in the past.
Local swelling/erythema/induration lasting x 2 days. No fever/rash at time of examination.  Decreased induration, still mild erythema - resolving.
My feet began to significantly swell roughly 4 hours after receiving the vaccine. While swollen, the skin on my toes, feet and ankles was very tight and the appearance was bloated and almost the color of red beets. Additionally, the edema was very apparent and frightening, and I could barely walk.  The symptoms had essentially disappeared completely by 07:30 the next morning.
DEATH; This spontaneous report received from a consumer via a company representative via social media ( JnJ Corporate social media) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  After vaccination, on an unspecified date, the patient died from unknown cause of death. As per the reporter, "Lost 2 friends to covid and 1 to the vaxxing." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220230301.; Sender's Comments: V0:20220230585-Covid-19 vaccine ad26.cov2.s-Death.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt received vaccine. About 5 min later, began to feel faint/diaphoretic.  States he always has this reaction to any shot.  Gave cool cloth/water.  Nurse alert call.  Pt declined further treatment.  Observed x 30 min.  Felt better and d/c to home from vaccine clinic.
administered Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Expired vaccine used) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered Expired vaccine used) had resolved.        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.  The vaccines was stored in freezer, and take out one to two vials and place in fridge each day as needed.
This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-FEB-2016, the patient was vaccinated with an improperly stored (temperature: 58 degrees Fahrenheit (F), time frame: 1 hour and 30 minutes; no previous temperature excursion was reported) dose of M-M-R II lot # L007217, expiration date 03-MAR-2017 (albumin status, dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; requested that her son receive Menveo. The HCP administered Bexsero; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Menveo (immunization received on an unknown date).   On 22nd September 2020, the patient received Bexsero. On 22nd September 2020, 1 hr after receiving Bexsero, the patient experienced pain burning, headache, neck pain, back pain and wrong vaccine administered. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain burning, headache, neck pain and back pain were not recovered/not resolved and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the pain burning, headache, neck pain and back pain to be related to Bexsero.  Additional details were reported as follows: Reporter was patient's mother. Reporter requested that the patient receive Menveo, but the healthcare professional administered Bexsero, which led to wrong vaccine administered. On 22nd September 2020, 1 hour after receiving Shingrix, pain symptoms started and became increasingly worse. The patient described his Pain as that he had never felt such fire in his head, neck, and back. The patient still had the symptoms and had taken ibuprofen. The reporter did not consented to follow-up.
productive cough, fatigue, headache, sore throat, fever-did not take temp, chills, body aches, sinus congestion, nasal congestion, post nasal drainage. starting 11/8/21
I left for the trip of the 22nd of March. I was on a trip, I tested when I came off the trip. I tested positive on the Thursday after the trip and then the following Sunday I tested Negative.  My niece got me medication to take and home remedies.  I had a cough and felt like I was going to choke.  36.6 degrees Celsius as a temperature.  I had an episode on the 27th on March and I was trying to get my steps in, and I felt that night a cramp in my left rib cage.  On the 23rd of March I started to sneeze.  I was coughing and wasn?t feeling well.