chrisvoncsefalvay/vaers-outcomes huggingface dataset:
retinal artery occlusion; partially blind; elevated COAG; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 94-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration at the end of February or early March in 2021 at 93 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine) in Feb2021 at 93 years old for covid-19 immunization. Caller is a physician calling on behalf of a 94-year-old male patient, who received the second dose of the Pfizer COVID-19 vaccine. Two days post vaccination in 2021, he was diagnosed with retinal artery occlusion, rendering patient partially blind. The patient had elevated COAG. Physician says for treatment the patient went to the ER and they did coags but there was nothing they can do, then literally two days later the patient's coags were normal. He says those doctors felt that some people do have increased coags after the vaccine, so they thought it could be from it but no one could say for sure. According to the hematologist, the condition may be a result of the vaccine. Patient wants to receive the booster dose of the vaccine and is a healthy 94-year-old, but there could be a risk of another occlusion or a stroke of another type if the patient did get a booster dose. The physician is looking for guidance in terms of the eligibility and safety of a booster dose for this patient. He is trying to outweigh the benefits and risks of a booster dose: protection against SARS COVID virus and possible risk of complete blindness considering his age. Patient was hospitalized from Mar2021. Physician said they actually said he wouldn't but the blindness had gotten about 40% better. Physician said the patient was in the hospital for a day while they checked him out, then he was discharged. He said he thought the hospitalization was in March. Physician said that he felt this is medically significant with the patient losing sight in one eye. The outcome of the events retinal artery occlusion and partially blind was recovering, of elevated COAG was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events Retinal artery occlusion,Visual impairment,Coagulation factor increased  and suspected drug cannot be excluded.  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
Sharp chest pain, neck pain, difficult/painful breathing, emergency room trip, diagnosis of Pericarditis
I developed an episodic headache began which is still on going. I also developed drainage in my throat a week later then tested positive for COVID-19 on 10/18/2022.
arm is still red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient received Shingrix three weeks ago and their arm was still red. It was not sore or painful, just red at the injection site. The reporter consented to follow up.
Patient presented 12 days after Influenza vaccine was given with shortness of breath, coughing up blood, weakness and numbness in all extremities, and shaky. He was found to have Guillain-Barre syndrome. Patient had a mild improvement and then proceeded to experience symptoms of numbness again with worsening pain. A month after the vaccination, patient reported feeling better and had no further symptoms. Two months later, patient reports some continued intermittent numbness/weakness of all extremities.
Severe hip pain for first two days,thigh muscle weak, leg numb,extreme skin sensitivity.
56 y.o. male w/ PMH of GERD who presented to the ED with 3 days of SOB and chest pressure.   He states that he got his COVID moderna booster on Friday. He felt fine on Friday but then felt ill and fatigued on Saturday. Then on Sunday he felt much worse with SOB with ambulation and worsening chest tightness.    He presented to the ED today with SOB and chest pressure and was worked up for possible PE. Chest CT demonstrated bilateral main pulmonary, lobar, and segmental pulmonary emboli. PERT was called and he was determined to not be a candidate for TPA or thrombectomy. He was started on a heparin drip and transferred to the floor.   He denies swelling/pain in his legs. He has never had a blood clot before. He does not have a history of cancer and is up to date on all of his screenings except for colon cancer. He had a FIT test 3 years ago which was negative, but has had no colonoscopy or FIT testing since then. Denies any recent trauma. No recent air or car travel or history of immobilization.   ED Course On presentation to the ED he was hemodynamically stable. Afebrile. HR 90-100. BP 120-140/90-100. RR 23. O2 >90% on RA. Labs were significant for D-dimer >9,000, COVID negative, Sodium 140, potassium 4.1, creatinine 0.87, WBC 10.49, Plt 163, , troponin 48, 2-hour 42.   CT confirmed bilateral pulmonary emboli. PERT was called. Pt was not a candidate for tPa or thrombectomy. Heparin drip was started in the ED.
This spontaneous report was received from a registered nurse, and refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly, lot # L019297 with expiration date of 18-AUG-2018, for prophylaxis. It was also reported that the patient's age did not match the age indicated for GARDASIL 9 administration. Additionally, a temperature excursion of 0.8 C for 24 hours and 30 minutes was reported prior to the vaccine administration. No previous temperature excursion and no adverse effects were reported. A digital data logger was involved.
light-headedness, tingly sensation in hands, arms and chest, sweating, sensation of shortness of breath, anxious sensation, involuntary clenching of hands
After his first dose, my husband told me he had the regular soreness that you get from shots in his arm at the injection site, but ever since tells me that he's had soreness from the chest up to his head as well as a persistent headache on the right side of his forehead. He's said rest has helped ease it some, but the symptoms have not dissipated within the "normal" time. There have not been any extreme side effects.
Vaccine given in upper deltoid or above resulted in excruciating, radiating, stabbing pain for over 24 hours now. Symptoms included inability to move arm, numb and tingling arm and hand like pins and needles, feeling of cut off circulation, nausea chills, crying  and screaming.  He reported pain level of 8-9 on scale of 1-10.  In ability to sleep more than 1.5 hours in last 24 hours. Moaning in his sleep. Had a telehealth appointment with Dr. at 4:45p who prescribed 400 mg of ibuprofen every 4 hours, alternating cold packs on/off every 20 minutes and movement of the arm to allow the vaccine to move through the muscle.  At 1:30a (11/12/20) contacted Nurse line. Nurse advised ice treatments and ibuprofen and an immediate doctor appointment.  Seen at pediatrics by Dr. at 11:50a on 11/12/20. She advised alternating 600mg of ibuprofen and tylenol every 6 hours. She suggested Benadryl to help with sleep tonight.  At home now at 1:35p where my son is screaming in pain and still unable to move his left arm.
Chills, headache,sweats,body sore. Back very sore...I believe this is my lungs becoming infected.  This may also be a sign of an issue with heart. On this date of 2/14/22 have not gone to see a provider or hospital yet.
REDNESS, SWELLING TO 3 3/4 INCH CIRCLE ON RIGHT ARM. PAIN, ITCHING.
pruritus, erythema, soreness & swelling @ injection site are reported in a pt receiving 1 dose of fluogen; pt recvd vax in lt deltoid on 5NOV93 & same day exp wide reddened, swollen, itchy area @ inject; tx atarax;
Within 5 minutes the patient experienced diaphoresis, weakness, lightheadedness, and 1 hour later got tinnitus in bilateral ears which has occurred intermittently on an ongoing basis since the vaccine administration, and which had NEVER occurred prior to receiving the vaccine.
Patient received the second dose of the Moderna vaccine early (Dose 1: 1/7/21, Dose 2: 1/26/21). No adverse events reported to date. Patient was notified of the situation and advised to report to us any unusual symptoms.
I started to have a worst issues with itching on 09/22/2022. I contacted my doctor and they prescribe me a cream and medication but I don't recall the name.
itchy pink rash at site of injection, rash size approximately 5 inches by 3 inches
Flush, vomiting, warm 30 minutes after injection. Sent out for evolution by physician at clinic at 3:20PM 5/20/17.
Moderna Covid 19 Vaccine EUA Had chills, fever, body aches, fatigue, headache, nausea, loss of appetite.  Had shot at 10:20 am on Feb. 9 and symptoms started early morning (2:00 am) on Feb. 10.  Lasted all day - was in bed, could not get up.   Next day Feb. 11 was feeling much better.   Didn't receive any treatment, just waited it out.
Arm has significant bruising starting from site of needle insertion and spreading down arm vertically. Bruises are swollen to the touch and have progressively became worse since vaccine was given. Bruises are blue/green in color.
pt recv vax 20MAY96 & 8MAY97 pt devel breakthrough case of varicella that was attenuated consisting of a rash of approx 20 vesicles located primarily on the trunk;
Patient became light headed while sitting in chair 5 minutes after vaccine was administered.  Patient fainted and fell from chair to floor.  Patient was unconscious approximately 1 minute and then regained consciousness.  When patient came to she was alert and oriented x3.  Dr. to see patient.  Patient was assisted under her own strength to reclining chair.    Vital signs stable. BP 106/70,   sat 99% on room air.  pulse 61, resp 18, temp 97.4.  Patient stated she often does this with blood draws.
Extremely sore at the site of injection and is mildly sore to date. Soreness has not completely gone away.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 70-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue. On an unknown date, the outcome of the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue were unknown. It was unknown if the reporter considered the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the healthcare professional for herself. The age at vaccination was not reported but it could be 69 or 70 years. In the evening on the day of vaccination, the patient experienced fever, shivering, fatigue and pain in the left arm. The following day, the patient noted a 2.25 inch by 2.5 inch area about 2 inches below the injection site which was red, swollen, hard, warm to the touch and slightly painful.   The healthcare professional declined to provide an address for follow-up.
I received an Influenza Vaccination at approximately 10:00am on Tuesday, 12 Nov 02. I noticed immediatley after the shot, that this was more painful than the ones in the past. At around 1:00pm that afternoon, I started feeling lightheaded and faint. I was still feeling lightheaded when I left work that afternoon. I thought maybe I was coming down with the Flu. When I arrived home, I noticed my arm was extremely swollen and ver sore. After dinner, around 6:00pm, I sat down to read and watch TV. All of a sudden, everything in the room started spinning. I would move my eyes from the paper I was reading to the TV and back, and it would make it worse. I started getting nauseated. This spell lasted approximately 2-3 minutes. The spinning episodes occurred again 3 or 4 more times before I decided to go to bed. This was approximately 9:00pm. When I laid down in bed, this is when it (spinning) hit me the hardest along with getting nauseated again. Nothing I did could make it go away. It never dawned on me to call my doctor, since I was not aware of any adverse effects from a flu shot and I had not had any effects in the past. This last spinning/nauseated episode lasted approximately 5 minutes, then I dozed off to sleep. In the morning, I awoke with a tremendous headache. By Friday, November 15, the swelling and soreness were gone. The headache would come and go fro the next few days. Saturday, November 16, 2002, the headache turned into a migraine. As of today, Monday, November 18, 2002, my head is still a little sore from all those headaches. i feel a little weak and as though I am getting sick (the Flu?)
Initial report received from a pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch: 104045P1) 0.5 ml once, intramuscular, stored at temperatures as low as 34 F and 35 F on an unspecified date. No adverse event was reported.
Injection site reaction, screaming, erythema, injection site edema, injection site pain, purpura.
Pt. started experiencing side effects on Saturday (lightheaded per her description her vision was white). Sunday morning, in church around 9 AM, pt. fainted and leaned her head on the person sitting next to her in church for couple of seconds then restored consciousness, walked out of church by herself. There was a PA sitting in front of her who asked her questions to answer, then her BP was taken and was normal.
Palpitations- Flu like symptoms - Chills - Nausea - Diarrhea - shooting pain in pelvic region radiating to shoulder on side of injection
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-SEP-2018, the patient was inadvertently vaccinated with a dose of expired VARIVAX lot # M033213, expiration date: 13-JUL-2018, subcutaneously, (dose was not provided) for prophylaxis. On that day, the patient also received sterile diluent. No adverse effect was reported.
Scab; This case was reported by a consumer and described the occurrence of scab in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced scab. On an unknown date, the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the scab to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient just received 2nd dose of Shingrix on an unknown arm and flu shot in another arm on the same day. The patient then ended up with a scab that was now about to come off. The patient did not see that as a side effect, just wanted to report it.
Acute respiratory failure- bilateral pulmonary emboli. Acute renal injury. New onset of atrial fibrillation. Patient in ICU intubation occurred on 4.18.2021
no additional adverse event; HCP reported an adverse event for VARIVAX. Caller explained the VARIVAX was administered after the expiry date. Caller said the VARIVAX had a prior temperature excursion. No additional AE or PQC reported. No additional information provided.  Name of; prior temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 31-OCT-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T035268, expiration date: 15-OCT-2022, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered). Additionally, it was reported that on 20-OCT-2021, the vaccine had a prior temperature excursion at a temperature of 3 Celsius degrees (C) for 13 hours (Product storage error). No additional adverse events were reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot number N009172 with expiration date on 20-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported) administrated with a well storage sterile diluent. The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013807: US-009507513-1802USA013718.
Hives over all of abdomen under arms and breasts,  tongue swelling on one side has gone away
Just after inject - felt dizzy for about 5 minutes 8/29 head & body itching - went to ER & got Hydroxyzine tabs, Inj site red, big, swollen. 9/21 Dr gave Prednisone - itching stopped.
Reports had soreness in right arm 30 minutes after vaccination. States that 3 hours after vaccination felt sharp pain that radiated down arm to fingers. Woke up on morning of 10/17/14 with pain in right index, middle and ring fingers. No redness, swelling or heat noted at (R) deltoid area. States arm pain is less often "few" "not like last week".
3days following vax pt devel fever & fussiness; seen by MD who performed tests;
On 04/05/01, states that arm "bothered him right away." C/O weakness in arm, discomfort when he puts on or lifts. Cant's lift hands over his head without pain. Talked to MD's nurse who told him to take Tylenol. On 05/22/02, better now but still feels discomfort occasionally.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of (Merck) VARIVAX (Lot # not reported) in approximately 2003, "about 10 years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, soon after the vaccination, the patient experienced did not seroconvert after receiving (Merck) VARIVAX. The outcome of did not seroconvert after receiving (Merck) VARIVAX was reported as not recovered/not resolved. Additional information is not expected.
ON 3/3/17 FLU LIKE SYMPTOMS, FEVER, MALAISE, COUGH. ON  3/13/17 IN AM NOTED RED RAISED PUSTULES TO NECK AND CHEST, BOTH ARMS, STOMACH AND BACK WITH ITCHING.
Near syncopal episode; Pale Skin color and light headed feeling.  Pt and Father admitted patient does not like needles and has had similar episodes when getting her Flu shots in the past. Vitals obtained.  Medic unit evaluated her and performed EKG with no negative findings.  Pt signed refusal form.  Pt released to her Father to drive her home.  He will be with her tonight for continued monitoring.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 30-JAN-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date reported as: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
baby had multiple desats (low 44%) requiring stimulation/02 support.  did septic work up.  8/21/07 Received hospital medical records which reveal patient hospitalized from birth 5/24/07-7/24/07.  7/16 progress notes indicate patient had multiple desats into 40-70%, requiring PIP-CPAP during night.  AM ABGs were good & O2 decreased. Dx of R/O sepsis vs reaction to immunizations.  Weaned to RA by 7/17.  Continued on IV antibiotics.  Blood c/s neg.  In NICU from birth to 6/25/07 when transferred to stepdown until d/c home on apnea monitor w/VNA & close f/u in clinics. FINAL DX: Retinopathy of prematurity; bronchopulmonary dysplasia; bracycardia occasional; GERD.