chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained about chest tightness 15 minutes after vaccination, with no breathing problems. Asked patient to sit by me so that I could observe her. Checked blood pressure and was elevated. Administered Benadryl 50 mg one time by mouth to patient. Checked patient blood pressure a 2nd time and was 138/88 mmHg and patient was starting to feel a little wheezy. Decided that since patient seemed to be having an asthmatic episode that we would call EMS to pick her up and they arrived.
Eyes half closed as going to sleep, arms held straight out and then she shook all over from the waist up.
Severe body aches, nausea, swollen glands under tongue, severe headache, fever of 101, sever pain and difficulty moving shoulder of arm were shot was given, fatigue and body chills.
Report 20010134251 described upper arm edema (injection site) in a four year old male who received Infanrix for prevention of diphtheria, tetanus, and pertussis. The vaccinee had no known drug allergies. His medical history included wheezing and eczema (not affecting the arms). On 05/24/2001, the vaccinee received his fifth dose of Infanrix, inactivated poliovirus vaccine, and MMR vaccine. It was not recalled which one of the concomitant vaccines was administered in the same arm as Infanrix. Within 12 hours, on 05/25/2001, the pt developed left upper arm edema. The arm became swollen from distal to the shoulder to just proximal to the elbow. There was mild, diffuse erythema and local warmth, but no induration or crepitus. The circumference of the affected arm was not measured, but subjectively did not appear to be twice that of the contralateral arm. As of 06/04/2001, the event was completely resolved without sequelae.
Gave client the vaccines and about 4-5 minutes later, she became pale, light headed and started vomiting. Put cool cloths on her head and neck areas and gave her water to drink. She said she did eat prior to coming in. Felt better about 20 minutes later. She left with her mother and driver.
Extreme diarrhea since 9:00pm on April 29 (vaccine received that afternoon). Ongoing problem. It is now the afternoon of Monday, May 3. This is the worst I?ve ever had and that includes trips, etc. I have only been at home and eaten previously purchased food at home. No one else in my household has this.
after 2 days of receiving the vaccine felt numbness at the top 2/3rds of her thumb index and middle finger of her left hand, redness at injection site and blistering on her arm
I was coughing and very tired, heaviness in my chest and had a headache for a while with runny nose. I noticed on 11/29/2022, I started my inhaler and it didn't really help. I tested positive for COVID-19 on 12/2/2022. I had a telehealth visit on 12/2/2022 at 1:35 PM and was prescribed PAXLOVID. I did not take the medication because I did not want to have a rebound but isolated from everyone. I feel like my symptoms were minor. I still have symptoms and will have a chest x-ray and pulmonary test.
GUMS TINGLING, METAL TASTE, TOUNGE SWELLING, HARD TO SWALLOW, FLUSH HOT.  I TOOK BENADRYL THAT I HAD IN MY PURSE, 2 25MG LIQUID GEL TABLETS.  I WAS MONITORED BY EMT'S, VITALS WERE GOOD.I WAITED AN HOUR IN MY CAR AND GRADUALLY FELT NORMAL AND DROVE HOME.  I NEED TO KNOW IF I TAKE DOSE TWO OR NOT. DO I TAKE BENEDRYL BEFORE? IS THERE A DOSE THAT DOES NOT CONTAIN THE INGREDIENT THAT GAVE THE REACTION. I BELIEVE IT WAS THE POLYETHYLENE GLYCOL THAT IS IN BOWEL PREP, NOT CERTAIN.
Side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects from the vaccine) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects from the vaccine). At the time of the report, IMMUNISATION REACTION (Side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the patient-32 out of 63 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Myopericarditis; transferred to level one cardiac center, Trop-Max 6.8 range, EF 35-40, discharged with usual non-ischemic cardiomyopathy meds including beta blocker and ace (that was not here at hospitlaist)
Patient was administered Twinrix instead of Hep A. He had already completed his Hep B series in 1998.  No adverse events were reported.
Anaphylaxis, labored breathing/shortness of breath, color change and body stiffness.
I had the first dose on 1/14/2021 and experienced diarrhea and slight vomiting that night and next day.  Other than a sore arm I felt ok after that until 1/28/2021.  After making dinner that evening I suddenly experienced stroke like symptoms.   My husband called 911 and I was taken to the ER via ambulance.  My heart rate was down in the 30s and 40s.  I was monitored and a heart surgeon was called in.  He said I needed a pacemaker if I wanted to continue living.  The next morning I received a temporary pacemaker and two days later received a permanent unit.
This medically confirmed spontaneous report (initial receipt 05-Mar-2015) concerns a female patient who had a medical history of chronic headaches and gluten intolerance. On 05-Mar-2015, the patient received AFLURIA injection (batch number not reported) for the prevention of influenza. On 05-Mar-2015, following AFLURIA administration, the patient felt that her heart was beating much faster than normal and had a headache. The outcome was not reported.
Left upper arm swelling, heat, and pain from deltoid to elbow but not circumferential (solar surface only).
Prolonged sleep, had to be aroused by mom; Intake decreased, vomiting x 1; Temp 101(R); Admitted @ 630PM 11MAR91;
Pt was given DTaP, IPV, MMR, PCV-13 and Tuberculin skin test. Pt returned an estimated hour after receiving vaccines with hives all over the body. We gave him a shot of epi and a dose of BENADRYL.
Shortly after my booster I began having severe pain in my left leg.  I went to the Urgent Care.  They gave me a cortisone injection and refused imaging.  The next day I went to my Primary Care Physician and requested imaging as the pain was at a level 8/9 which started in my calf, and was now in my biceps femoris.  He refused imaging.  He didn't ask if I had been vaccinated, and refused imaging.  A week later the pain returned, again he refused imaging.  On May 12th I was taken by ambulance to ER where they identified a Pulmonary Embolism from the first bout of pain, and another blood clot in my leg that should have been evident by the second bout of pain.  After three days in the ICU I was given a clot breaker, heparin, heparin shots, and after three days, released myself under the condition that I pick up a prescription of Pradaxa on the way home.
she was dehydrated; have soreness in her arms; legs have a rash,left one is slightly worse; more swollen than the right leg; left leg is also more red; warm than the right leg; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg). On an unknown date, the patient experienced DEHYDRATION (she was dehydrated) and MYALGIA (have soreness in her arms). The patient was treated with NYSTATIN ongoing since an unknown date for Rash, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and MYALGIA (have soreness in her arms) was resolving and FEELING HOT (warm than the right leg) had resolved.            Treatment medication: Coconut oil, Eucalyptus oil, CBD oil, and lotion were used for the treatment of rash.
Few spots developed 2 days ago, on face and abdomen. Red spots. Today spread to face. No fever. Normal energy OK. Appetite went down. Complaining of HA. NO abd pain, diarrhea or vomiting. Itchy- benadryl helps with itching.
This spontaneous report was received from a health professional refers to unknown number of unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L039660, expiry date: 04-FEB-2018). No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
1/19/2022 I felt a little crummy. On 1/22/2022 and 1/23/2022 I could not get out of bed, I was so fatigued. I also had tinnitus and dizziness. I was not sick. It just lasted over the week-end. I have lingering fatigue and tinnitus.
COVID19 VACCINE IN THE FREEZER AND HAD TEMPERATURE EXCURSIONS WITH A HIGH TEMPERATURE; MEDICATION ERROR; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid19 vaccine in the freezer and had temperature excursions with a high temperature, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid19 vaccine in the freezer and had temperature excursions with a high temperature and medication error was not reported. This report was non-serious.
Patient reported inability to lift her left arm due to excruciating pain, limited range of motion.  Took a pain pill on Monday night.
Developed hives. Hives have not gone away in 3 months despite starting Xolair.
Uncontrollable seizure like shaking that lasted for about 2 hours until I eventually fell asleep at 2am. Was shaking to the point where I was spilling water that I was attempting to drink and could barely talk or walk. Woke up feeling fine.
received 3rd dose; fever, 102.5 degrees F; This case was reported by a consumer via call center representative and described the occurrence of fever in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received 6 to 9 months before the date of reporting).   On 11th May 2022, the patient received the 3rd dose of Shingrix. On 11th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. In May 2022, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date:12-May-2022 Reporter's comments: This case was reported by the patient's daughter. The patient already had 2 doses of Shingrix in the past and received his 3rd extra dose on the day before the date of reporting. Less than a week after vaccination, the patient started to experience a fever. Initially it was 102.5 degrees Fahrenheit but went down to 100 degrees Fahrenheit after a dose of Tylenol. Fever had not resolved. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Patient stated they had a headache, body ache, and red sore arm. arm was swollen as well. symptoms improved in a couple days
Pt experienced soreness after vax. Pt complained of red, swollen area 3-4" on arm one day post vax.
Patient was asked to stay for 30 minutes due to her allergy to bee stings that required an epi-pen twenty years ago.  28 minutes into the 30 minutes wait period, patient said her throat felt ?tingly? but her breathing was normal.  Patient was given  25mg of Benadryl orally with water and asked to wait in the pharmacy for an additional 30 minutes to determine if reaction was progressing.  At the completion of the additional 30 minutes, patient stated she felt fine and left the pharmacy with her friend who was with her the entire time.    At 5:31pm, I spoke to the patient over the phone and the patient stated she felt fine but was experiencing a mild rash on her chest.  Patient was advised to call 911 if any breathing difficulty was experienced.
11/18/22 early morning hour was able to go to the bathroom but was confused and did not know what day it was according to my sister who called and thought I was extremely tired.  Slept the whole day with no meds or food taken.  11/19, 20, 21 was able to start my day but was feeling nausea, headache and tired.
flu like sx  & 4 days w/2 missed work days;overall muscle aches, mainly focused in shoulders & lower legs, these were stated as prior locations of trauma;
Patient got shingles 1 month aher first dose; I have a patient due for their second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. One month after receiving 1st dose of Shingrix, the patient got shingles, which was totally resolved at the time of reporting. The patient was due for 2nd dose and did not receive 2nd dose of Shingrix till the time of reporting, which led to incomplete vaccination schedule. The reporter asked if  the patient could take a 2nd dose of Shingrix.
8/10 arm pain, chills , fever, malaise a few hours after 2nd dose.  Sx slightly improved today. First dose with minimal SE's.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-MAY-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2017 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one the several reports received from the same reporter. Additional information has been requested.
Rubella vaccine ordered on pt and mumps vaccine was loaded into Pyxis by pharmacy. Nurse removed dose and administered to pt.
EN5318 2/4/2021 EN6203 2/25/2021 FC3180 8/20/2021 FM7553 6/10/2022 Pfizer Bivalent GJ2524 10/31/2022 7/22/2023 - 7/24/2023 (2 days)  102.2 fevers and generalized body aches, was brought into emergency room for evaluation of possible encephalopathy and dysarthria on 07/22/2023
Fatigue, pain, burning at injection site, dizziness, felt a bit off, rib cage area pain and tinnitus worsened. Within hours, immediate pain. It felt like I was punched with a bee for 2 hours straight.
5-6cm diameter reddened, indurated, erythematous patch of skin at injection site. No axillary or cervical lymphadenopathy. Occurred within 1-2 hrs following injection and has persisted for 24 hrs.
Immediate soreness in arm of vaccination. About 2 hours later skin sensitivity. About 10 hours later chills and total soreness. Felt like I was hit by a truck. Nausea. Stuffiness. Return to former wellness about 20-24 hours later. Have had flu vaccines for many years and have never had any reaction except sore arm.
Severe swelling = size increase Noticed PM Itching Redness Some pain/tenderness
Covid-19 right after getting second vaccine but mild symptoms; Covid-19 right after getting second vaccine but mild symptoms; the patient experienced some problems with bowel movements, hard stools; the patient experienced some problems with bowel movements, hard stools; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Covid-19 right after getting second vaccine but mild symptoms"; COVID-19 (medically significant) with onset 2022, outcome "recovered", described as "Covid-19 right after getting second vaccine but mild symptoms "; FAECES HARD (non-serious) with onset 2022, outcome "recovering", BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 2022, outcome "unknown" and all described as "the patient experienced some problems with bowel movements, hard stools". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Clinical course: The reporter's causality for the event(s) of some problems with bowel movements, hard stools with Humira (Adalimumab) was a reasonable possibility whereas no reasonable possibility for the event(s) of Covid-19 right after getting second vaccine but mild symptoms and patient had omicron variant. The reporter considered the event covid-19 right after getting second vaccine but mild symptoms as related to Pfizer Biontech covid-19 vaccine whereas not reported for the events some problems with bowel movements, hard stools.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the current available limited information in the case provided, the causal association between the events faeces hard and bowel movement irregularity and the use of suspect product BNT162B2 cannot be fully excluded.
ADMINISTERED TO 16 YR OLD (OUTSIDE OF EUA ACCEPTED AGE RANGE)
Orthostatic hypotension upon awakening  56/36, 62/38 HR 49. Baseline 105/70, HR 60 . Resolved after fluids, 3 hours. Dizziness, weakness and  aches.  The following day,  nausea and vomiting
6 hours after my vaccine, I felt slight side effect numbness to my right arm, pain went down my right arm but it was not really bad. I talked to my doctor about this at the hospital. I still have these symptoms today and I can also say that my symptoms got worse after the second vaccine.
Fever 102-103 with vomiting and chills for three days.  starting to feel better now.
Pt was given pfizer monovalent Covid vaccine on 3-9-23. Diluent was not mixed with vaccine vial before administering to pt. Lot number FT1551. Medical assistant should have mixed 1.3Ml diluent to 1 vial of vaccine, then administer .2ML dose to pt.   per cdc guidelines, pt does not need to repeat dose, look for adverse reactions.  Diluent (Pfizer-BioNTech COVID-19 Vaccine formulation only [orange cap and maroon cap]), No diluent, resulting in higher than authorized dose ,Do not repeat dose.? Inform the recipient of the potential for local and systemic adverse events.
During monitoring, patient c/o nausea, dizziness and became pale. Vitals: systolic BP 52; pulse ox 88%. Patient lost vision and pupils slow to react. Called EMS and gave 2L supplemental 02 via rebreezer. Patient moved to hospital bed and had legs elevated. Upon recheck blood pressure improved and patient responsive to questions (suspected vasovagal response). After EMS arrived, patient's family declined to send patient to hospital via EMS, and ultimately left the clinic with his family.
This case was reported by a other health professional via sales rep and described the occurrence of meningococcal infection in a adolescent patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 2 years after receiving BEXSERO, the patient experienced meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the meningococcal infection was unknown. It was unknown if the reporter considered the meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1 dose of BEXSERO 2 years before disease onset. The genetic testing of strain showed to expect coverage from BEXSERO. This case was one of 4 case reported by the same reporter. Lab Comments: On an unknown date, the patient's genetic testing of strain resulted in expect coverage from BEXSREO.
Patient left the store after the shot and rode his motorcycle. He got in a wreck and woke up in the hospital. He doesn't remember anything after leaving the store. He sustained cuts to the face and bruises. He had his helmet on.