chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given KINRIX and PROQUAD, about 20 minutes later returned to office with facial swelling, lip swelling and chest tightness. He was given PO BENADRYL and IM epinephrine after evaluation by MD. He was referred immediately to ER for observation and was discharged to home/self care.
Overnight, following the afternoon of the booster, I noticed my left ear itching, some slight liquid coming from it, a popping feeling when pressing the ear, and my tinnitus got worse.  I have had this issue before, but my ENT doctor recently cleaned out my left ear and it went away.  But now (as of the next day following the booster), these symptoms have come back.  I previously reported that I got tinnitus for the first time 3 weeks after my 2nd dose of Moderna.    (I've also had slight body aches, 99F fever, tiredness).
mom reports a 10 sec shaking spell on 18OCT94 remained conscious, eyes open; no temp same type of episode again 19OCT94; none since;
Woke up the next day my eyes were extremely sensitive to light , headache (all day), body aches low grade fever and no energy.
Right arm: Soreness, warmth, swelling, redness, fever (felt warm) 1-2 days.  Symptoms progressed for 4 days then receded slowly after 1 week.  As of 10/22/2003, mother describes right upper arm as having hollow puffiness; squishy; flabby muscle, but arm function ok.
Patient received a Covid vaccine and instructed to wait 30 minutes before leaving facility.  A few minutes later patient started c/o swelling in throat, difficulty breathing and being hot and flushed.1600: Pt was moved to a quiet space, BP was 146/83 HR 93 RR 20.  911 was called. 1604: Epinephrine injection given in right thigh. 1606: BP 175/74, HR 94 RR 20. EMS arrived at 1610. 1611 2nd dose of Epinephrine given in left thigh, per direction from EMS.  Client continued to  c/o shortness of breath and "throat closing off". EMS took over care at 1612, transferred to Hospital.
Expired vaccine administered to 2 of the patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) 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.  Based on their knowledge, vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. The vial that was moved from the freezer to the refrigerator was already expired last 20Jan2022 but they were still able to give it to 2 of their patients
Mom reports cried inconsolably for 2 days; temp to 100.5; exaggerated swelling on rt thigh; pt recvd DT 3DEC91 w/no problems;
pediatric patients that were administered Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist The Agency (Reference number-00326369) and transmitted to Sanofi on 21-Oct-2020.  This case was linked to case 2020SA299919 (12 year old patient).  This case involved a 13 year old patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number Uj497aa and expiry date: not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 21-Oct-2020, (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication included sodium (NA).   No other vaccines administered to the patient.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Vertigo & nausea for last 3 days. Meds tried: TYLENOL & SUDAFED. Referred to physical therapy for eval.
Started feeling achy, feverish, and had a sore throat; Took home COVID-19 test and it was positive; doctor prescribed PAXLOVID; Felt better 5 days later; Took a home COVID-19 test and it was negative; Then 2 weeks later on 11/25/2022 I tested positive for COVID-19 again; Just took MUCINEX and rested; Took another COVID-19 test two days later and I tested negative again.
Joint pain and stiffness; soreness at injection site; fatigue; fever for 6 weeks; skin rash on back and buttocks; eye swollen shut; headache; backache which started in April 1999 until present. Received e-mail stating an address change; change made on 10/24/01.
positive for rubella PCR which was later confirmed to be the vaccine strain; historical condition: hematopoietic cell transplant (HCT); Literature Report:   Information has been received from the authors in a published literature article entitled as stated above concerning a 37-year-old female, who had a history of acute lymphoblastic leukemia and had undergone a matched unrelated donor myeloablative allogeneic (HCT) 542 days before vaccination.    On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot numbers and expiration date were not reported) for prophylaxis. (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine is a live-attenuated vaccine usually contraindicated within the first 2 ears of hematopoietic cell transplant (HCT) (Product use issue).   On the day of vaccination, she was on maintenance ponatinib (tyrosine kinase inhibitor, BCR-ABL pathway), her total lymphocyte count was 1.7 K/mcL, and she reported feeling well. Twelve days after, she presented with a maculopapular rash that initially appeared on the face and progressed to the shoulders, arm, and chest. She denied any associated symptoms such as fever, conjunctivitis, cough, coryza, or arthralgia. She was briefly hospitalized out of an abundance of caution because of an initial suspicion that the rash could be measles. IgM serology for measles and rubella was negative. Extensive workup for other infectious diseases, including parvovirus B19, adenovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV), herpes simplex virus (HSV), and varicella-zoster virus (VZV), was negative.   A nasopharyngeal swab returned negative for measles polymerase chain reaction (PCR) but positive for rubella PCR, which was later confirmed to be the vaccine strain (genotype 1a). The patient fully recovered without complications.  The authors considered the causal relationship between rubella event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was related.  This is one of two reports received from the same source.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2112USA010068:
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-DEC-2015 the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX 0.5 ml, subcutaneous, lot # L029472, expiration date in: 06-AUG-2017 (dose was not provided). Concomitant therapies were not provided. The register nurse reported a temperature excursion with the following vaccine: (Oka/Merck) VARIVAX, (Lot #, L02942 Expiration date on 06-AUG-2017), Temperature: 7 C, Time frame: 1 month, Outcome of excursion (Oka/Merck) VARIVAX must be used with in 1 month. No adverse events were reported. No product quality complaint was involved. This is one of two cases from the same reporter (MARRS # 1601USA005965). Additional information has been requested.
Information has been received from a medical assistant concerning a 41 year old female with hypothyroidism who on 12-MAY-2008 was vaccinated intramuscularly in the right arm with her first dose of pneumococcal 23v polysaccharide vaccine (lot # 659199/1541U). Concomitant therapy included vaccination with ADACEL (not further specified) and unspecified therapies for hypothyroidism. On 12-MAY-2008, the patient developed an injection site reaction. The patient's right arm was warm to the touch, with tingling down the arm, and sensitive to touch. The patient also had pain during administration. The patient sought unspecified medical attention in the office. The patient outcome was not reported. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2008. Initial and follow up information has been received from a certified medical assistant concerning a 41 year old female teacher with hypothyroidism, asthma and allergies who on 12-MAY-2008 was vaccinated intramuscularly in the right deltoid with her first dose of PNEUMOVAX (Lot # 659159/1541U). Concomitant therapy included vaccination with ADACEL (lot # C2927AA) and unspecified therapies for hypothyroidism. There was no illness at the time of vaccination. On 12-MAY-2008 the patient developed an injection site reaction. The patient's right arm was sore, warm to the touch, with tingling down the arm, and very sensitive to touch, and the right hand was cold. The patient also had pain during administration. The patient sought unspecified medical attention in the office. The patient was given a referral to neurology clinic for an EMG, but the patient did not make the appointment. On an unspecifed date the patient recovered from sore, warm tingling right arm, arm very sensitive to touch, and cold right hand. Additional information is not expected.
Severe nausea and throwing up 10-14 times over 24 hour period. Head ache, chills, disoriented, sore body, and extreme fatigue. Couldn?t keep water down.
Fever of 100, chills, fatigue, headaches, and body aches started 7 hours after vaccine.
Decrease range of motion, erythema left arm and elbow 3-4 hours after administration. No fever.
Widespread papules, macules, vesicles DX Varicella, vaccinated, TX Acyclovir and Atarax.
The day I got the first shot of Moderna Covid19 vaccine I was 4 weeks pregnant. Starting week 6 I start to have symptoms of miscarriage (January 14 2021). This continued until January 18 when I lost the baby. I was due in September 2, 2021.
vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11, achy, fever, tired 1/12-1/14, got covid test to double check, negative
Expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: The healthcare professional reported that the patient received an expired dose of Havrix.  There were no reactions reported.  The reporter consented to follow up via email or postal. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Dizziness, Myalgia, SORE ARM DAY 2 AND 3; DIZZY/ FATIGUE-DAY 5-7 UPTO DAY 14 SORE ARM DAY 2 AND 3; DIZZY/FATIGUE- DAY 5-7 UPTO DAY 14
Became very sick and whole body hurting, unable to get out of bed for 1 day
Pt. dev. severe stiffness starting w/ R hand esp. wrist then to elbow, shoulder, across L shoulder and down to L hand. ^ in stiffness 5-6 days post vaccination.  Few systemic symptoms.
Red "bump", 3.25" x 3", raised, warm, sore to touch, minimal nausea, minimal dizziness.
seizure - only one ever one month after shot. no cause found after all the tests and a hospital bill. neurologist  dosen' have a clue.
Received TD on 4/1/02 and broke out with hives rash from head to toe, that evening.
Patient claimed that she got in infection after getting a flu vaccine from pharmacy. She claimed that provider from Urgent Care confirmed that. Tried to get clarification from patient to no avail. She claimed that "Pharmacy screwed up" so she does not want to talk.
swell; Sore arm; hard like ball; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball) 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball). At the time of the report, SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: FU attempt made, NNI, reporter declined to give email and disconnected the call
01/05/2021 site of injection had a big, large dark reddish area and multiple raised red bumps along my arm and that continued to spread to my abdomen, legs, and neck. Spoke with Dr. on 01/06/2021 and he ordered Prednisone 60mg, I don't know if it was 5-day, HC blocker Pepcid & Benadryl. As far as the skin reaction, it was kind of developed and continued to spread, some areas would be darker red. Even with starting this high dose of Prednisone and other medications, it started to peel and looked like welts. Every time I start to fight anything, I start to break out in a similar reaction with my back, arms, legs, abdomen, neck. And that would happen anytime I start to get anything. I've had multiple respiratory panels throughout the year, and I was negative for all of them. I was also tested for antibodies the day of the vaccine and I had neither IGG, IGM. Following the vaccine, I was tested, and I have the antibodies, positive for IGG antibody 03/17/2021 (+), 08/09/2021 (+), 11/18/2021 (43.1). I have not received the 2nd vaccine, and I want to receive the 2nd vaccine, but I have not been able to discuss with someone regarding that. I still have spots that are still visible, almost as if they're scarred. And if my body is fighting something, they become raised and red again and almost looks like chicken pox or a combination of welts. As far as being sick, for that first week, there was no symptoms. Several respiratory panels and tests done in regard to the spots, everything comes back negative.
Unable to locate vaccine type - told it was tetanus booster with pertussis, a 'new' vaccine. Symptoms increasing from 8/24 to present (8/29) including intense pain radiating to fingertips of L arm, across L scapula, up L side of neck. Pain @ injection site, cannot lift arm voluntarily. Spasms of hand & fingers, involutary mvmt, delayed mvmt, tremor, muscle weakness.
Developed irritability, low grade temp, runny nose, cough, lethargy, rash on trunk; Seen by MD dx URI;
Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
He had complete loss of his legs in twilight zone; he had a car accident getting home; first day nothing and second day so dizzy at work; couldn't even type and had to call off; he had to stay in bed 24 hours; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-174666 (Moderna).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (disability), outcome "unknown", described as "He had complete loss of his legs in twilight zone"; DIZZINESS (non-serious), outcome "unknown", described as "first day nothing and second day so dizzy at work"; ROAD TRAFFIC ACCIDENT (disability), outcome "unknown", described as "he had a car accident getting home"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "couldn't even type and had to call off"; BEDRIDDEN (non-serious), outcome "unknown", described as "he had to stay in bed 24 hours"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Clinical Course: She was talking to people about her husband's AE and some people described being very dizzy and having nausea. A lady told her "That happened to me the same night of getting the vaccine. She was so dizzy, couldn't do anything at all, she had to stay in bed 24 hours. She had to call off work." Someone else had Pfizer and same thing "first day nothing and second day so dizzy at work, couldn't even type and had to call off, then he had a car accident getting home". He had complete loss of his legs in twilight zone. If this is a common side effects, shouldn't it be listed. She's doubtful we are giving half a dose. She's trying to find out what caused this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Almost immediately I felt light headed and dizzy. I was sitting down and my legs felt weak under me and I felt as though I was going to pass out. My eyes were burning on and off.
Body ache, Fever, Nausea, Vomiting, Fatigue.
Began 10/03/2001 noted lymph node swelling femoral area. Soreness then left neck. On 10/05/2001 stiffness and knots in neck, then right side of neck and moved to right femoral area over a few days each area on 10/09/2001 felt sick. On 10/10/2001 vomiting and low grade fever. On 10/11/2001 just red then 10/12/2001 fever 101. 10/14/2001 last pm hot complained of itching. Rash now.
This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative for 3 patients. This is the 2nd of 3 reports. A patient in his/her 70's patient of unknown race and gender received PREVNAR 13 for immunization at single dose on unknown date.  Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced redness, swelling, and itchiness at the injection site three to four days after the injection. The outcome of the events was reported as recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2018191051 same reporter/drug/event, different patient.
coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer
Excessive somnolence, slept > 24 hrs had to be awaken for feedings.
CDC reports: 3 mo infant developed fever to 102.7, "knot" at inject site, swelling of entire leg, wheezing & screaming episode following DTP/OPV immun. Duration of illness 7 days.
Fever, chills, headache , insomnia . Sweating at night , arm pain at site of injection . All lasting 3 days
I received my Moderna Bivalent Booster on 09/26/2022. My adverse event started on 12/28/2022 in the morning while I was taking shower. I saw small hives under my arm both upper and lower forearms. The hives were circle with a big red spot around. It is on my torso mostly. If any clothes touch my skin it gets red. All of a sudden my lower and upper lip got swollen. It happens between 8:00AM-10:00PM. Early November I went to my Allergist who then prescribed me with ALLEGRA for every morning and night. On 12/14/2022 my lips were swollen. It happened after I had COVID-19 infection. On 01/04/2023 I had hives again under my bra line. It happened from September through December. The hives flared up when I had COVID-19 infection. It also happens when I wear one pair of clothes for long time or the heat. I never had hives before this is something new I am experiencing. The swollen on my lips happens once in a while but the hives happens frequently. My Allergist advised me to track of the food that I ate but it wasn't the food. I think it is more of an Immune response but no one knows for sure. I think the vaccine probably caused it. I use hydrocortisone for the hives  as per needed.
lot 01dm20a      02/19/2021     d2320a: neck swollen on side of neck started this am;
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored dosed of RECOMBIVAX HB (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion was reported and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Full body rash / GI tract discomfort / COVID-19 toes. Treated with oral diphenhydramine and topical hydrocortisone. As of 2/11/2022 symptoms have declined to nearly normal.
Patient developed a red, hard, "goose egg" located 1 finger width around injection sites which started 24 hours after injection. Warm and cold compresses were used without relief.