chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition was not reported. On 20-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016) (dose, frequency and route unknown). No concomitant therapy was reported. On an unspecified date of May 2016 the patient experienced a large red itchy spot at the injection site, upper arm swelling. The pharmacist had instructed the patient to apply BENADRYL cream or hydrocortisone cream for the itching and oral ibuprofen for the swelling. The patient had recovered from all the events in 2016. The causality was not reported. Pharmacist had requested a lot check. This is one of 4 reports received from the same reporter. Additional information has been requested.
Headache, breathing problems, leg cramps (severe), body aches, tiredness, neckache, upset stomache (4 days) still having difficulty breathing 12/2/09
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received the Anthrax vaccine on 2/16/03, 3/15/03, and on 4/13/03. With each of the vaccines, I had large lumps at the site of the injection. With the first immunization, I was terribly dehydrated and was ill as in having the flu. Since taking these, I feel that I get dehydrated easier, have some dizziness, memory loss, and shortness of breath. (OMIC)
Cough, dizzy, faint, short of breath, headaches at onset. These are the symptoms since May 22nd through today, June 9th. Cough still persists,  along w/ headaches and dizzy. Still short of breath...
Headache, Arthralgia, Fever, Nausea Vomiting, fever of 102, slightly swollen tongue Narrative:
This is a spontaneous report from a contactable consumer. A male infant (age unknown) received a dose of PREVNAR 13, Lot number 916598) on an unspecified date. Relevant medical history and concomitant medications were not provided. The patient experienced a lot of redness at the injection site and crying for several hours after being administered the vaccine. Therapeutic measures taken as a result of the events included treatment with TYLENOL. About 30 to 40 minutes after treatment to mitigate any pain, the patient had settled down. Outcome was unknown. Follow-up (30Aug2011): New information reported from this contactable consumer includes: patient and physician informed and lot number.
Patient evaluated by the ER for c/o cough, SOB and fever at home.  He was diagnosed with Covid and admitted for evaluation and treatment.
Muscle aches and extreme fatigue lasting over 24 hours, muscle tension in neck and shoulders, headache, tenderness and hard at injection site, rash at injection site
After 5 minutes of getting her second Moderna COVID-19 shot (during her 15 minutes monitoring time), she stated that she felt faint. I reported to the store manager and pharmacist about the situation. The ambulance came, but she declined to go to the hospital. 10 minutes later, she stated she felt much better and went back home. A couple of hours later, pharmacist called to follow-up on her situation. She stated that she is ok.
Patient presented to the office around 10:45 am 01/11/13 with pain, redness, swelling, & reduced motion in (L) arm. Patient encouraged to use cold compress. Reaction site measured 15 cm x 9 cm and outlined with non-washable marker. She will return to our office Monday for f/u. Patient eval. today for first time.
STOMACH ISSUES; VOMITING; HEADACHE; DEHYDRATION; ABDOMINAL PAIN; FATIGUE/FEELS WIPED OUT; This is a solicited report from a non-Pfizer sponsored program (PSP-CVSLEN-US-01) from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-095398).  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral at 20 mg, 1x/day, from 28Jun2021 to 2021, then from Jul2021 to an unspecified date, for kidney cancer. Medical history was none. Concomitant medications included pembrolizumab (KEYTRUDA) and amlodipine. The patient experienced stomach issues, vomiting, headache, dehydration, and abdominal pain on 30Jun2021, fatigue/feels wiped out on 29Jun2021. The events were serious per hospitalization. The patient underwent lab tests and procedures which included blood pressure: 130/65, 105/60 on 21Jun2021 (taking amlodipine), 128/78 on 29Jun2021. The action taken in response to the events for lenvatinib mesilate was permanently withdrawn on an unspecified date. The outcome of events abdominal pain and fatigue was unknown, outcome of other events was resolved on 04Jul2021. The reporter's causality for lenvatinib mesilate with all events was unrelated. The reporter's causality for bnt162b2 with events stomach issues, vomiting, headache, dehydration, and abdominal pain was related, reporter's causality for bnt162b2 with event fatigue/feels wiped out was not provided.  The reporter's assessment of the causal relationship of the event, fatigue/feels wiped out, with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the  information in the case report and a plausible temporal relationship, a possible causal relationship between the event Abdominal discomfort, Vomiting, Headache, Dehydration, Abdominal pain and suspect drug BNT162B2 cannot be excluded"  Event Fatigue unrelated to suspect drug BNT162B2  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Date of Admission:  1/29/2022   Chief Complaint:  AMS   Source of Information:  Patient, Spouse   History of Present Illness:  This is a 65y.o. male with past medical history significant for bipolar disorder, T2DM, neurogenic bladder with chronic suprapubic catheter, cirrhosis secondary to hepatitis C infection present to the hospital for aggressive behavior noted by family. Patient was recently discharged 1/21/2022 for TIA and community-acquired pneumonia. Since discharge, family has noted increased aggressive behavior and resistant to help from family. Per spouse, she has noted some behavioral changes since 2018 and had extensive neuropsychiatric evaluation for potential Lewy body dementia. However behavioral changes were thought to be secondary to medications, attempted to wean off Risperdal and Lyrica without benefit and was reinitiated on medications. She states that patient was evaluated by Dr. with neurology who did not attribute the symptoms to an underlying Lewy body dementia. She does endorse hallucinations and believes the patient to be responding to internal auditory stimuli. Patient is aggressive but denies any suicidal or homicidal ideation. During time my examination, patient is without acute complaints. He states "my family thinks I am crazy". When asked about prior hospitalization, patient states that he was feeling better and thus decided to leave AMA. He endorses a cough without sputum production but otherwise is without any acute complaints. He denies any fever, chills, nausea, vomiting, chest pain, palpitations, abdominal pain.   Upon evaluation in the ED, vital signs demonstrate BP 152/79, RR 18, HR 90, afebrile, stable SPO2 on room air. Work-up is significant for hyperglycemia, normochromic normocytic anemia with associated lymphopenia, COVID-19 infection. Chest x-ray with improved multifocal right lung airspace disease. UA findings consistent with infectious etiology, however suspect chronic colonization given suprapubic catheter. Urine and blood cultures are pending for completeness. Acute TME work-up including CT head, ammonia, TSH, UDS WNL. Patient to be admitted to medicine consult placed to neurology, ID, psychiatry for acute TME.
I started getting very cold - teeth chattering cold.  I went to bed with extra blankets.  About 30 minutes later I was awoken by a very hard hit to my right chest - right above my breast.  The pain felt like a baseball hit me then webbed out in all directions.  It only lasted a couple of minutes.  I didn't have any more pains that night and finally got warm about 4 am.  I continued to have short, much lighter pains throughout the next day, evening, and next day until aprox. 11 am.  I called my doctor and was told to go to the ER.  The ER treated it as a possible heart issue.  They ran an EKG and blood work.  I was admitted with a heart monitor, kept overnight, and had to do a nuclear stress test the next morning.  All test came back clear.  I was released apx. 4:30 Friday afternoon.
I developed a sore throat on the evening of 21 December, and it became significant enough to warrant concern during the morning of 23 December. I tested positive for COVID on the morning of 24 December, and the sore throat continued before symptoms lessened starting 28 December.
Pt devel rash, fever, emesis onset 12JUN; seen in ER 13JUN for these problems;
This spontaneous report was received from a doctor of pharmacy refers to a 63 years old male patient who on 20-AUG-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0562AE, Exp. Date: 20-MAR-2013) on his left arm. No other co-suspects were reported. No other vaccines, unspecified if other concomitant medications. The pharmacist reported that on an unknown date, in approximately August 2012, the patient developed an unspecified localized reaction with rash, approximately 6 inches in diameter around the injection site of his left arm. Treatment was over the counter oral BENADRYL. No lab diagnostics studies were performed. The reaction lasted 5 to 7 days and resolved completely on an unspecified date in 2012. The patient sought medical attention by contacted the pharmacist. The relatedness for patient developed an unspecified localized reaction with rash, approximately 6 inches in diameter around the injection site of left arm was unknown for ZOSTAVAX. Additional information is not expected.
I had like a ball /my shoulder where I got the shot got swollen again; my arm was a little bit swollen/the arm started to get swollen; the arm started to get swollen and very red; it was hard/had like a ball; pain in his bones; pain in his body/it hurts/my body hurts, too; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen) and BONE PAIN (pain in his bones) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen). On 22-Aug-2021, the patient experienced PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen). At the time of the report, PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too) outcome was unknown and INDURATION (it was hard/had like a ball) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.  It was reported that patient's Second dose of vaccine was scheduled on 13-Sep-2021.
Rec'd influenza vaccine to (L) deltoid at 1030am. Within 5 min, pain to (L) wrist. Within 15 min, radiating pain in forearm to fingertips. Pain in collar bone, (L) side of neck. Pain continues as of note, 3 hours after vaccination.
Pharmacy error: The Moderna vaccine with batch/lot#003C21A sent out on 11/24/2021 to our clinic, should have the absolute expiration date of 12/17/2021, not 12/24/2021.
6cm x 6cm area of macular erythema (R) shoulder, warm to touch, no pain or pus.
Very sore arm and rash at injection site, swelling, high fever,  puffy itchy blisters all over back, Insomnia, sore on lip. Required a clinic visit with the PCP. Symptoms lasted for a weak.
Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing) and VACCINATION SITE PAIN (arm pain at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm pain at injection site). On 20-Apr-2021, the patient experienced PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 18-Apr-2021, VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing) had not resolved.            No concomitant medication were reported.  Treatment medication included Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-081636 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081636:Case for dose 1
Saw Dr 11-10-09 left shoulder pain/tenderness lateral shoulder, full ext/int rotation, decreased ahd 90 degrees, no redness or tenderness over deltoid. Pain - shoulder to elbow. Pt used ALEVE with same relief. Exam. Treatment - RELAFEN 750mg 20# BID.
Information has been received from a registered nurse regarding a 16 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Patient began to experience psychosis the next day. Patient was admitted to mental health facility for 13 days inpatient. Patient was diagnosed with Brief Psychotic Disorder. Patient experienced delusional thoughts, agitation, manic episodes.
Booster dose was given 49 days after dose number 2-recommended interval 4 months. No adverse reaction.
Pt felt dizzy, lowered gently to floor by staff post vaccination. Aid called and arrived within one minute. HR:41, BP:80/60. EMT moved patient to cot for 10 minutes. Pt HR rose to 65 while lying down. Pt given juice. EMT recommended to pt they pull over and call 911 if they get dizzy driving home. Aid approved pt safe to drive self home.  Pt reported no dizziness or other symptoms prior to leaving post observation. 20 minutes of recovery.
Felt like she was going to pass out; Dizziness; She couldn't function properly; Felt cross eyed; Dull headache; Shoulder pain at injection site; Chills; Fever; A spontaneous report was received from  a customer concerning a 26-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, chills, fever, dizziness, dull headache, feeling cross eyed, inability to function properly, and feeling like she was going to pass out.   The patient's past medical history included migraine and gastritis. Concomitant medication included migraine medication: imitrex, sumatriptan and meclavine.  On 24-DEC-2020, prior to the onset of the events, the patient received a dose mRNA-1273 (lot/batch or dose number not reported) intramuscularly on the right arm for prophylaxis of COVID-19 infection.   On 24-DEC-2020, the patient experienced shoulder pain at injection site, chills and fever that evening. On 25-DEC-2020, the right arm was still hurting. On 26-DEC-2020, she had dizziness, a dull headache felt cross eyed and felt that she couldn't function properly. The headache increased intensity making her to go to the hospital on 01-JAN-2021. She felt like she was going to pass out. Information about whether or not she was admitted was not provided.  Laboratory reports were not provided. Treatment information included taking her migraine medications and going to the hospital.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a consumer referring to her father, a pacemaker user, with diabetes mellitus and unspecified heart condition. The patient had a medical history of three or four outbreaks of shingles (dates unspecified) (each shingles outbreak seemed progressively worse than the last). On an unspecified date after that, the patient received a dose of ZOSTAVAX (lot number, expiration date and dose were unknown), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), warfarin, hydrochlorothiazide (manufacture unknown), simvastatin (manufacture unknown), glipizide and NOVOLIN. On an unknown date (timeframe unspecified), the patient seemed to develop severe itching, redness, a rash and fatigue with sleeplessness since being administered ZOSTAVAX. The patient had gone to four physician follow up visits and also to the Emergency Room and to an Urgent Care for a diagnosis and treatment for the itching. Regular blood work checkups were performed, but the result was unknown, and the patient had been misdiagnosed with having dermatitis and allergic reaction. The patient was given the following treatment for itching: hydrocortisone, hydroxyzine pamoate and ammonium cream. At the time of report, the patient was still having sporadic outbreaks that include severe itching and was up "all last night" because it would not subside. The outcome of the other events was unknown. Additional information has been requested.
Student states she was unable to sleep on 10/6/05 and felt achy all over. She felt weak the next day and had nausea with vomiting 2 times at noon. Felt no nausea 10/8/05, just weak and lack of concentration; felt feverish when vomiting but no temp taken.
her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter; her arm is sore to lift up, tender to the touch; raised, hard, welt on her right arm where she received the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 019B21A and 012A21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Concomitant products included ATENOLOL for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection). At the time of the report, VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection) outcome was unknown.            Patient height reported as 6'0".  Patient received booster dose.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-643519 (Patient Link).
Symptoms: Tingling. Signs: Red rash. Time course: 2 days.
The day after the vaccine was given (02/16/22) I experienced major swelling and pain in my armpit area (right arm) which was the same arm I received the vaccine.  After 5 days the pain and swelling still persist and a slight rash around the armpit area.  The injection site itself I have no issues with.
I started early morning with the shivers and chills then later a low grade temperature.I was very weak and tired.Felt achy all over. Almost like having the flu.It lasted 24 hrs. I only took ADVIL for achyness and low grade temp.
Tiny bumps on my tongue and a burning sensation since friday 4/2  Uncomfortwhem i eat
ON 10/18/2019- PATIENT DESCRIBED CHEST PAIN THAT INCREASED IN SEVERITY AS TIME WENT ON. THIS WAS ACCOMPANIED BY ARM PAIN AND A SENSATION OF WARMTH/SWEATING.
Patient said she had some allergic reactions like itching tongue and cheeks and coughed all night.