chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date route and dose were not reported). No concomitant medications were reported. On an unknown date, the patient developed shingles 2 years after receiving a dose of ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Patient received 2nd dose of Pfizer vaccine felt tingling on tongue. No swelling. Pt took 50mg of own Benadryl. Observed for total 45min. No progression of symptoms.
"Really bad migraine (nausea, headache, tunnel vision that got so bad my vision almost went completely black). "
After patient recieved IMZ and went to post-vaccination waiting area, was sitting in the chair and became unresponsive. Technician  and I gently lowered pt to laying on the floor and raised legs onto a chair. Pt immediately became responsive. Had pt lay on floor for several minutes with icepack on forehead. He soon said he felt a lot better. Had him sit up and remain sitting on floor for a few minutes. He said he felt fine so had pt return to sitting in chair position. He said he felt fine after his waiting period and left with his companion.
swelling the size of a golf ball at injection site; redness at injection site that went down to elbow; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813290) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 62-year-old female patient who experienced swelling the size of a golf ball at injection site (vaccination site swelling) and redness at injection site that went down to elbow (erythema), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2117 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 12-Oct-2021, the patient developed non-serious swelling the size of a golf ball at injection site (vaccination site swelling) and serious redness at injection site that went down to elbow (erythema) (on the same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "patient reports swelling the size of a golf ball at injection site, redness at injection site that went down to elbow".  At time of reporting, the outcome was unknown for the event.
arm hot; arm tingling; Arm hard to lift; Arm immediately swelled to the size of a golf ball; arm red; fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (arm hot), PARAESTHESIA (arm tingling), MOBILITY DECREASED (Arm hard to lift), VACCINATION SITE SWELLING (Arm immediately swelled to the size of a golf ball) and VACCINATION SITE ERYTHEMA (arm red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm hot), PARAESTHESIA (arm tingling), MOBILITY DECREASED (Arm hard to lift), VACCINATION SITE SWELLING (Arm immediately swelled to the size of a golf ball), VACCINATION SITE ERYTHEMA (arm red) and PYREXIA (fever). On 03-Apr-2021, PYREXIA (fever) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (arm hot), PARAESTHESIA (arm tingling), MOBILITY DECREASED (Arm hard to lift), VACCINATION SITE SWELLING (Arm immediately swelled to the size of a golf ball) and VACCINATION SITE ERYTHEMA (arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Patient complained of extreme arm pain and that injection site was higher than recommended. Patient states shoulder pain did get better after first day but was still being experienced 3 days later. Patient returned to pharmacy 3 days after vaccination and was advised on shoulder massages and gentle  movement and if not better in a wee to contact her doctor
Significant injection site pain lasting for three full days.  Said it felt like the pain was deep, like pain in the bone rather than the muscle.  Difficulty sleeping due to pain.  Minimal relief with Tylenol.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in several adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that, several patients experienced redness at the injection site after receiving a dose of SHINGRIX. The pharmacist did not believe the redness was lasted greater than 2 or 3 days. The inside sales representative was unsure of how to collect the adverse events as the health care professional declined to be transferred to medical information for further handling or share patient information as he was in a hurry. Thus no additional information was collected. No additional details were provided.
upon being injected I had a pain shoot down my arm stopping at the elbow.  My arm started feeling better but when I got the Moderna booster  in October of 2021  my armpit swole up and the shoulder began to ache.  I then lost mobility in my left shoulder (arm injected). I was delayed in seeing a doctor due to covid. My doctor at the time was just taking me on as a patient and refused to see me suggesting that I go to the urgent care if it was that bad.  I did not feel comfortable at the time so I waited and tried several exercises, ointments and acupuncture for several months. I continue to have problems with my shoulder was loosing muscle mass so I had an x-ray and MRI to make sure their was no injury. I was recently diagnosed with frozen shoulder in March-April of this year.
Started with tiredness, then arm got sore and was painful to lift. Later in the day, body and joint aches started. 12 hours after dose, started to get very cold and this turned into violent and uncontrollable shaking from chills. Then headache started 13 hours after dose (the headache lasted for 2 days and was the last symptom to go). Fever fluctuated between 101.5 and 102.1. Later felt very nauseous, felt like I had to vomit but didn?t. Went to the bathroom and there I got dizzy and almost passed out but didn?t.  Fever up and down all day the next day. Could only eat a little Campbell?s chicken noodle soup and a small can of coke. By the next evening (day 2) I started to feel better just exhausted and a headache. Went to sleep early, next day (day 3) still had the headache and was exhausted. By Day 4 I was about 80 % back to normal and feeling much better.  I didn?t take any fever reducers or other medications during this time.  It was all worth it to be vaccinated,
cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; having an allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-adult female consumer reported that.  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 14Mar2021 11:45 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Peanuts allergy from an unspecified date and unknown ongoing and concomitant medications includes Metronidazole and Minerals Nos, Quercetin, Thioctic Acid, Vitamins Nos (EMERGEN-C). On 14Mar2021, 4 hours after the vaccination, the patient experienced cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling. When patient woke up in the morning, face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes. ER DR confirmed was having an allergic reaction. Received a few shots and medication to take as treatment. Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
About 1 hour after vaccine administered developed fever (101.1), chills, dizziness, anorexia, nausea.
feels as though she has the flu; Muscle Weakness; Chills; Pain; her left arm felt as though "it had been punched; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th October 2020, less than a day after receiving Shingrix, the patient experienced muscle weakness, chills, pain and pain in arm. On 20th October 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the muscle weakness, chills, pain, pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the muscle weakness, chills, pain, pain in arm and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix (intramuscular) experienced  muscle weakness, chills, pain, pain in arm and influenza-like symptoms. The patient stated that she felt as though she has the flu because of chills and muscle weakness. The pateint states that initially, her left arm felt as though it had been punched.  The reporter did not consented to follow up. No further information was available.
Breakthrough case admission after 3 vaccines  Moderna 3/13/21 lot# 044A21A;  Moderna 4/0/21 lot# 018B21A;  Moderna 12/8/21 ot# 030H21B
fire/ red sun burn rash; His skin is peeling from head to toe/He has a scaling skin; His skin is peeling from head to toe; This is a spontaneous report from a contactable consumer (patient's son) reported for a patient. A 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 21Jan2021 (age at vaccination was 80 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 21Feb2021 (age at vaccination was 80 years) as dose 2, single for COVID-19 immunization. The patient's medical history included obese (he was already obese). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient developed a fire/red sun burn rash two days after his vaccine. He went to see a couple of specialists including an allergist who prescribed him prednisone. He had a scaling skin. The rash caused itchiness with prednisone it subsided. When he stops taking the prednisone it starts again. It was annoying to see him suffer like that. His skin was peeling from head to toe. The reporter didn't want the patient to take prednisone it made him hungry.On an unspecified date in 2021, he was gaining weight and he was already obese. The doctors said the rash should subside with time, but the reporter was worried and concerned. They were in May and they see no improvement. The reporter wanted to know more if anyone reported this kind of side effects and whether there was any medical treatment other than taking prednisone. The reporter received the response to discuss any alternative treatment plans with the patient's physician. The outcome of the events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
pt recv vax 18OCT95 & 20OCT95 pt began exp neck pain described as cramping in the upper esophagus;sx recurred again on the weekend of 28OCT95 to 29OCT95;
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and  needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite  for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
High Fever and general feeling of being ill. He received the influenza and pneumonia vaccine at 10:30 AM. He is starting to feel better this AM and the fever broke about 7:00AM. The  right arm from the pneumonia shot is very sore and weak.
I felt fine up until I went to bed at about 11 pm. I woke up at 2 am on the 20th of May feeling extremely fatigued and feverish. I took my temperature about an hour later and my temperature was 103.3 F. I experienced a racing heart rate and heart palpitations throughout the night alongside the fever. My temperature didn't lower until another 3 hours, in which I took Tylenol, used cold rags on the skin, and soaked in a cold bath to lower my temperature. My fever went up and down all day during the 20th, wherein I felt generally unwell and feverish. Today, the 21st, my urine is extremely dark and black tea-colored because of blood in my urine, due to a preexisting kidney disorder where blood spills into my urine whenever I contract a virus.
Symptoms: Swelling, pain and rash around administration area, and bruising. Treatment Recommendation for Symptoms: Hydrocortisone Cream and Benadryl.  Outcomes: patient feels fine aside from the symptoms above.
Redness and swelling at injection site on right thigh. Fever. Mother took patient to emergency room on 6/5/2018.
started about 1 hr p/vax in rt arm w/large-approx 10cm red, warm to touch; call to hosp talked to MD; DPH given; pt c/o pain in rt arm; was found was red & warm to touch w/edema extending to shoulder w/ 2 1/2 in of elbow; dx cellulitis;
Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (site, dose and lot# not reported). No other vaccines were administered on the same date. It was reported that the pharmacist heard about this adverse experienced from a mom of a patient who was vaccinated with GARDASIL. She said the mom told her that after her daughter got vaccinated at a physician's office, the daughter had a serious adverse event and ended up in the hospital on life support. They were treating her for extremely high levels of mercury in her blood stream. This happened right after she received the GARDASIL vaccine. Extremely high levels of mercury in her blood stream were considered to be significant disability and life threatening by the reporter. Additional information has been requested.
Redness at injection site size of 50 cent piece. Itching, no induration. Ibuprofen, apply ice locally to area.
Patient received Anthrax vaccine 04 March 08 in right arm. He continued to have 2 3/4" x 4" mass in right deltoid. It appears to be in the deltoid muscle and is not cystic or loculated fluid. It is non tender.
Information has been received from a medical assistant concerning a female who on 31-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included REMICADE treatment when the ZOSTAVAX (Merck) was given. On 10-APR-2009 the patient experienced an injection site reaction where vaccine was given. It was reported that the area of the reaction was swollen, warm and red. The patient sought medical attention by visiting the physician's office. At the time of reporting (15-APR-2009) the patient was not recovered. Additional information has been requested.
Extreme swelling of lymph nodes on left side of body (specifically armpit) Fever Muscle Pain Swelling Headache Nausea Vomiting
rash around injection site soreness at injection site fast heart beat approximately 100 bpm for 2 hours fever
Blisters, Papules - 9-10 lesions trunk and face. No prodromal symptoms or any accompanying symptoms
The 1st and 2nd shot crated a large black and blue on my left leg; Contusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2021 11:00 (Lot number: EL1284) as dose 1, single and administered in arm left, administration date 26Jan2021 11:00 (Batch/Lot number: unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Severe allergy" (ongoing), notes: Start date: Years, Ongoing; "Sinus" (ongoing), notes: Start date: Years, Ongoing; "Blood Pressure" (ongoing), notes: Start date: Years, Ongoing. Concomitant medication(s) included: EQUATE [ACETYLSALICYLIC ACID] taken for sinus disorder, hypersensitivity (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); BENAZEPRIL taken for blood pressure measurement (ongoing); EPINEPHRINE; LEVAQUIN; LIDOCAINE. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "The 1st and 2nd shot crated a large black and blue on my left leg"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Contusion". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The 1st and 2nd shot (both administered on left bicep) created a large black and blue on her left leg. relevant to the emergency form each time they over. Technique: Color flow Doppler and Duplex sonographic examination of the venous system of right and left lower extremity was performed. Findings: No thrombus is identified. Impression: No evidence of deep vein thrombosis in the lower extremities.   Follow-up attempts have been completed. No further information is expected.
Called physician one week later and was diagnosed with "COVID arm" delayed hypersensitivity reaction. It was red/swollen, itchy. Physician advised her to receive 2nd dose.
Systemic: Dizziness / Lightheadness-Mild, Systemic: patient cried after a normal shot..then hyperventilate (boyfriend explain that she is afraid of shots and needles and this happen all the time-Mild, Systemic: Hyperventilation-Mild, Additional Details: normal IM shot. No redness or bruise @inject site. No pain reported but patient cried/hyperventilation/feel faint...boyfriend refuse ambulance saying "this happen all the time. she is afraid of shots". then due to hydrpventilating..she feel dizzy and almost faint (but not faint). after sit on floor for 30 minutes, she is able to walk away with her boyfriend. According to her boyfriend, the sight of blood or needle make her very scaried. Boyfriend won't let me call ambulance due to possible cost
Red, raised circular area around injection has been growing since a few hours following injection. It is itchy, and painful to touch, and warmer than the rest of my arm.
Information has been received from a Registered Nurse concerning a 77 year old male patient who on 29-JAN-2008 was vaccinated IM not left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot # 657525/0554U). The nurse stated that the patient developed a painful, reddened arm after receiving the pneumococcal 23v polysaccharide vaccine on 29-JAN-2008. The patient was examined on 31-JAN-2008 and the arm was described as reddened, indurated, and hot to touch from the shoulder to the wrist. He was given ZYRTEC and KEFLEX. The patient was instructed to call back if the treatment was unsuccessful and he had not contacted the physician with any further complaints. No other symptoms and no other information available. The outcome was unknown. Additional information has been requested.
Patient felt short of breath 3 hours after injection. She was seen by nurse practitioner and given epinephrine and 911 was called. She was observed in ER for 1 hour and discharged home.
3:00am - vomiting, headache, dizziness, chills, nausea, fever, extreme fatigue
03/07/2021 at 13:33 pm Observed patient sitting with tears in her eyes, when asked if she felt ok patient stated she just does not feel well. V/S BP 141/102, HR 90. Advised patient to sit for additional 15 minutes so that I can closely monitor her. Water given to patient and had her sit, 13:45 pm V/S BP 123/90, HR 90.  Patient stated at 13:50 pm that she felt much better and good to go.
Rash on face, warm to touch on face. No bronchoconstriction or complaints of difficulty breathing.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Bexsero and Bexsero 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: 01-Sept-2022 Reporter's comment: The licensed practical nurse reported administration of Bexsero, that had an expiration date of 31st July 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.