chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe hives; like an allergic reaction; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (severe hives) and HYPERSENSITIVITY (like an allergic reaction) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced URTICARIA (severe hives) and HYPERSENSITIVITY (like an allergic reaction). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at an unspecified dose and frequency and PREDNISONE at a dose of 40 mg twice a day. At the time of the report, URTICARIA (severe hives) and HYPERSENSITIVITY (like an allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications reported was Birth control medication.
top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051022A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer CIVID-19 Vaccine (previous doses). Past adverse reactions to the above products included No adverse event with Pfizer CIVID-19 Vaccine. Concurrent medical conditions included Diabetes.    On 25-Oct-2022, 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 26-Oct-2022, the patient experienced HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.). At the time of the report, HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, Blood pressure measurement: All was good. On 26-Oct-2022, Blood pressure measurement: 222 blood pressure was high and 229/72 has been high since..         Concomitant medications details were not reported by the reporter. On Wednesday, 26Oct2022, after the vaccination patient met with neurologist and top part of blood pressure was high, it was 222 and when patient and his wife got home it was 229/72 and has been high since. On 24-OCT-2022, Patient had A1C blood test and it was good. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666723:Same reporter (Wife Case)
Patient began noticing a large, warm, red area appear on her right upper arm on Wednesday October 3rd near where she received her PNEUMOVAX vaccine. The area spread and became larger over the course of the next 2 days. The patient became concerned and went to the local ER where she was diagnosed with cellulitis of the upper right arm. The patient was started on a course of antibiotics on Friday October 5th.
Pt. reported, swelling, erythema, tenderness, low grade fever. Pt was scheduled to see MD,  cancelled appointement. No treatment, no hospitalization.
Adverse reaction from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema (Lymphedema arm).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction from the vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse reaction from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. The patient had lymphedema arm and wants to take booster dose. The patient had to take the booster dose in the hip just like the flu shot.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received included no new information.
Information has been received from a physician who found a case of a kid who was vaccinated with MMR II and experienced erythema multiforme-like eruptions when the patient got the vaccine followed by amoxicillin. At the time of the report, the patient's outcome was unknown. This is one of three reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
I was positive for COVID-19 on 28DEC2022, I felt like someone ran me over, I felt so weak. I couldn't even drink water or keep it down, It felt like I had a bad flu and bad diarrhea. I went to my primary care and they cleared me after 05JAN2023, they did not give me any medication except for nausea.
Vax - Shingrix (dose 2 of 2)  Unable to enter information in box 17.  Initially experienced arm soreness and redness. Next day had fever, chills, and nausea at work. Returned to work the following day. Feverish, so left early and went to bed around 4:30pm. Currently, arm is still painful, red, sore, and hot to the touch.    Will visit Urgent Care today.
left arm feels like it is growing / left arm feels like poison ivy working; left arm as swollen/left arm is the size of a baseball; left arm as 'itchy; left arm as red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. M#025B21A and M#17B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ATORVASTATIN, IBUPROFEN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red). At the time of the report, SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-100716 (Patient Link).
Information has been received via litigation article regarding a case in litigation concerning a female who was vaccinated with RECOMBIVAX HB (date, dose, route not reported). Subsequently the patient experienced chronic inflammatory demyelinating polyneuropathy. The patient outcome was unknown. Additional information has been requested.
DID NOT COMPLETE DOSES ONE WEEK PRIOR TO TRAVEL; This spontaneous case (PVX2019-1202) was received from a consumer on 14-May-2019. It describes a female consumer who "did not complete doses one week prior to travel", while being on Vivotif for international travel.  Case report: The consumer took the first dose of Vivotif on 07-May-2019 and the last dose on 13-May-2019, respectively. She had an internationally (endemic area) planned travel on 18-May-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete doses one week prior to travel" was considered as not applicable.
Lesion in the injection site as a "magnetic tag"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Lesion in the injection site as a "magnetic tag") 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Lesion in the injection site as a "magnetic tag"). At the time of the report, VACCINATION SITE REACTION (Lesion in the injection site as a "magnetic tag") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment Information was not provided.
On 1/22, two days after injection of 2nd dose, recipient developed diarrhea, nausea, aches which persisted for 48 hours.
Had injection 4-18. 4-19 noticed redness and tenderness with warmth in BP cuff distribution. (L) upper arm (+) itching and swelling.
Injection site redness, erythema. Possible cellulitis. Treatment with Keflex.
VARIVAX given 7/1/11. 7/2/11 - injection site swollen. In am, size of quarter. At 2pm doctor visit - swollen larger - 12 cm induration, mildly tender on (R) post triceps. Scant vesiculation present.
Felt heart fluttering within a few minutes after receiving vaccination. Became tachycardic with my heart rate increasing to 140s along with light headedness,  nausea and dizziness.
07/09/04 DTaP given right thigh mom noted no rxn until 7/11 and erythema induration and pain. Seen 7/13 in office. +small at vaccine with 3/4 cm erythema induration and warm. 7/14 only scab at site of injection.
I went to the clinic for my Second dose of Covid. Waited my 15 minutes and I went to stand up, I felt bad and had to stay an hour. Then I went home with a headache, bone pain, and I had a fever. After 3 days the pain was gone. That was when I began to feel the pain of the blood pressure that is uncontrolled after the vaccine. I am still monitoring my pressure with medication and with the doctors.
Patient has had constant pain upon movement and at night. The pain is described as constant.  Pain increases when patient attempts to move her arm behind her back. Also says it is difficult to lay on that side.
14May90 pt vax 2nd MMR; 16May90 exp soreness in jaw.  18May90 devel mumps or swelling in jaw area which was painfull.  Temp was noted.  Tx w/ meds & 22May90 recovered.
The patient noticed a red, warm, large reaction on her left arm at the site of the injection. At the time the patient presented to our pharmacy, it had been 24 hours since the time of the vaccination. The patient has had symptoms of nausea and headache since the afternoon the vaccination was given.
Information has been received from a registered nurse concerning a 5 year old male who on 15-SEP-2003 and 29-JUN-2007 was vaccinated SC with the first and second 0.5 mL doses of varicella virus vaccine live (Oka/Merck) (lot# "639445/0658L', 657455/0599U). On 08-NOV-2007 the patient developed 20 chickenpox lesions. Unspecified medical attention was sought. No treatment was noted. The patient was not to be recovering. There was no product quality complaint. Additional information has been requested.
The pattern of ill ide effects generally followed those reported in file except they were more severe and of longer duration extending  thru the day on Friday 3/26.  The severity of the discomfort was such that I would probably refuse a third injection of this type unless it was a clear life or death decision..
Fever over 102, congestion, runny nose, cough, stomach pains, vomiting, virus in eye; lower lid and in nose (got mist).
Itching, red patchy rash onset-Approx 2 hours after inj. Resolved 30 min after injection of Adrenalin 0.2 ml
no adverse events noted @ time of vax; pt expired 18JAN93; COD SIDS; no autopsy rendered;
received three doses of Shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first 2 doses received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received three doses of Shingrix, which led to extra dose administration. The reporter asked for information regarding this situation. The reporter consented to follow up.
Patient said Arm Swell up "like a baseball"...NA..told to go to er
Patient called  provider at about 4:00 pm on 11/1/11 to state she was getting "hives" on her arms and was wondering if it was caused by FLUVIRIN given on 10/31/11. Suggested she go to "ED" but she refused and wanted to take BENADRYL.
Within 2-3 minutes reports dizziness and stated "I'm going down." Then was lowered to floor with assistance. LOC 30-60 seconds. Return of consciousness with diaphoretic sweating, BP stable. EMS called and evaluated and cleared. Guest was stable at discharge. Fully recovered in 20-30 min.
Bloody nose from left nostril. Three incidences and with third incidence had to go to ER since I could not stop the bleeding.
Discovered after receiving vaccine that patient was 17, with birthday in April. Mom had scheduled appointment and did not realize had to be 18 for Moderna vaccine.  Error was reported to for evaluation and course of action. Approval was given to schedule 2nd vaccine after patient turns 18. Patient is special needs- autistic with possible developmental delay. Does not have medical records to provide additional information.  Patient was ~6' tall and at least 200 lbs.
Severe heart palpitations, shortness of breath, uncontrollable fluttering of heart.  Symptoms continued for months, died down, then returned.
Day 1 - Intense Itching on Scalp, Eye Lids Day 2  - Rash on Arms, Armpits, Head. Immediately used 1% Hydrocortisone Cream. Took Claritin Antihistamine at night. Day 3 - Rash Progressed to include more areas: Legs, Feet Hands, Face, Groin Creases :). Took Allegra Antihistamine At Night Day 4 - Similar to day 3. Condition is minimal when waking up or after being in cold weather, generally not moving around. Saw dermatologist and started 6 day regimen of methylPREDNISolone. Day 5 - Very low improvement with methylPRENISOLONE after first course. Clear rash occurring or staying around when area is itched, or rubbed. Generally occurs anywhere on body.
sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.
patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA193111, 2019SA193109, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 2 months old male patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date: 04-Apr-2020 via unknown route in unknown administration site) on an unknown date (visit date: 28-Jun-2019), which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
I got my shot at 1:00 pm and my side effects started to begin at 8:30pm. It started off with a slight headache and body aches with pain in my injection spot. My whole body started to shiver uncontrollably. My body aches focused on my spine and I started to become dizzy and nauseous. Around 4:00 am, the worst migraine, I have ever had that encased my whole head, lasted for about 12 hours with hot flashes. After the migraine, my body and head is sensitive to rapid motion and loud noises.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 16-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot# L050909, expiry date: 14-JUN-2017 (dosing details, route and strength were not reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAR-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
breaking out in welts on their face, but no itching after receiving the Pfizer vaccine/her symptoms resolved; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Mar2021, outcome "recovered" (20Mar2021), described as "breaking out in welts on their face, but no itching after receiving the Pfizer vaccine/her symptoms resolved".  Additional information: Caller stated she received her 1st Pfizer vaccine dose on 15Mar2021 and was scheduled for her 2nd vaccine dose on 07Apr2021. The caller was asking If there was any data on a lot of people breaking out in welts on their face, but no itching after receiving the Pfizer vaccine. Caller stated her symptoms resolved by 20Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got infected with Covid19 with more severe symptoms than the previous infection 11 months prior: Sinus drip, head congestion, chest pressure and congestion, fever that would not go away until I took Paxlovid, chills, diarrhea, headache, upset stomach, nausea, vertigo. The first time I had Covid 19 it only affected my head and ended up with a sinus infection. This time no sinus infection but symptoms affected entire GI tract as well as head.
Numbness on (L) arm started after Gardasil injection 10/8/07. Numbness on top of arm - goes to fingers.
A report has been received from a health professional concerning a 4 year old male patient. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST, during Sep-2012. In Sep-2012, the patient experienced that nose totally swelled up, face exploded and rash all over the front of his chest. Patient was observed for one and a half hour and was given BENADRYL and seemed to finally calm him down. The outcome of the events of nose totally swelled up, face exploded and rash all over the front of his chest was unknown. The event of face exploded was considered to be non-serious by the reporting health professional and the company physician assessed the events of nose totally swelled up and rash all over the front of his chest to be not serious.
This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included osteoarthritis. On 20th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2019, 2 hrs after receiving SHINGRIX, the patient experienced facial flushing. On 21st February 2019, the patient experienced joint pain and fatigue. On an unknown date, the outcome of the facial flushing was recovered/resolved and the outcome of the joint pain and fatigue were not recovered/not resolved. It was unknown if the reporter considered the facial flushing, joint pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. About 2 hours after vaccination, the patient's face felt flushed. The next morning, 1 day after vaccination, the patient reported that when she got out of bed, she was fatigued, her feet hurt at the joints, her hand joints hurt, her knees hurt, and her ankles hurt. The patient reported the pain level as 4 out of 10. At time of report, in February 2019, only the face flushing had resolved. The reporter consented to follow up.