chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 16 year old white female with no pertinent medical history or drug reactions/allergies or illness at the time of vaccination on 19-DEC-2007 was vaccinated with GARDASIL (lot# 659439/1267U) IM in the left deltoid at 9:35 AM. There was no concomitant medication. On 19-DEC-2007 at 9:40AM, the patient was very apprehensive about receiving the vaccination. Approximately 5 minutes later (child was sitting in the chair) child had a syncope episode lasting 2 - 5 seconds. There was no LOC (loss of consciousness). The patient was lifted by the mother onto the exam table and was in a supine position with legs elevated with a cold pack on legs and and neck. The blood pressure measurement was 102/64. The patient was continued to be monitored for 15 to 20 minutes. On 19-DEC-2007, the patient recovered. Additional information is not expected.
FELT BAD FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt bad for a couple of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt bad for a couple of days. This report was non-serious. This case, from the same reporter is linked to 20210637088.
Full body rash; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's mother) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced full body rash on an unspecified date and has been experiencing this from last couple of months. Reporter was provided with the number of Pfizer Medical Information Department. Product details (LOT#, Expiration Date, NDC# and UPC#) and other details could not be probed over the call as the reporter hung up abruptly. Hence, Limited information was available over the call. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
This is a spontaneous report received from a non-contactable healthcare professional. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), as unknown dose number, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient (PT) experienced myocarditis after COVID vaccine on an unspecified date, which was serious per hospitalization. Details were as follows: The reporting physician had a patient who had myocarditis. This was noted as vaccine related, and the patient was in the hospital for a couple of days. It was a nuisance, but the patient recovered fine, and a month later, everything was normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: A possible contribution role of vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of event myocarditis cannot be excluded. The case will be reassessed should additional information become available. 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.
p/vax pt red arm inj site; & swelling; arthralgias; myalgias; low grade fever; chills; pt presented w/anemia; dx serum sickness; sed rate = 150;
I received my flu vaccine on 12/1/2020 and have had upper right arm pain ever since.  I did not have arm pain before receiving the shot.  I had pain on the day I received the vaccine and ever since the pain has continued to get worse.  I have difficulty removing clothing and also have pain with most movements of the arm.  Because I am right side dominant, this has also affected my left side as I have over-compensated using my left arm more.  I have used home remedies such as Aleve, Advil, Tylenol, heating pad, topical creams with very little relief. I had a shoulder x-ray that did not show anything but mild arthritis.  Was sent to PT which provided little help.  Finally saw a MD  for face-to-face consultation. I was prescribed Cymbalta which hasn't help with the pain as I am not able to take a 30mg tablet and work.  The medication makes me extremely tired and yet does not take the pain away. This has been VERY frustrating as it has affected my day to day living/activities and work.  I have received a flu shot for the past 30+ years and have never had a reaction such as this.
Headache; Pain from her lower back on the right side to her toe; Nose was burning, she could smell burn and her "fingertips burning; Head eyes and nose itching; Right hand completely frozen; Joint pain up to upper arm; Dental work done; Sore arm/Pain from her upper right arm; Fatigue; Blurry vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), PAIN (Pain from her lower back on the right side to her toe), FATIGUE (Fatigue) and VISION BLURRED (Blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, Omeprazole, GABAPENTIN (GABAPENTIN "PCD"), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm). On 05-Apr-2021, the patient experienced DENTAL CARE (Dental work done). On 14-Apr-2021, the patient experienced PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Apr-2021, DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HEADACHE (Headache), PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), DENTAL CARE (Dental work done), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cold water, aloe vera, cold showers, Benadry, Tylenol, Hydroxyzine, Allergy patches, cold pack were used as treatments.   This case was linked to MOD-2021-089500 (Patient Link).
Usual sinus allergy symptoms only worse, unmanageable for 2 1/2 days. Nasacort lacked its usual effectiveness, headache powder had no effect on headache. Difficulty breathing, headache behind left eye, pressure, eye constantly weeping. Profound weakness and exhaustion. I had not heard that there might be delayed effects. It scared me to be so useless.  I made an appointment to ask about my hormones. Symptoms let up some by evening of 29 April and I could work some the next day. My doctor told me about delayed reactions of COVID vaccine and asked me to report. I?m fine now.
side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender 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 COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Approximately a few days after my booster shot (Dose 3) I contracted COVID-19 and had the following symptoms: Elevated heart rate and elevated blood pressure. I took Valsartan for medication and so far it has helped me recover with my symptoms. Overall it took about 30 days for me to recover.
significant and immediate cognitive decline ( memory )  within 48 hours from receiving the vaccination. She did receive an MRI from her neurologist and there we no immediate changes . It has been 7 weeks since her second dose and she has not recovered.
pt recv vax 31MAR99 & 1APR99 pt devel severe diarrhea;pt was seen by MD 5APR99 & was hosp d/t dehydration;a stool specimen was positive for rotavirus antigens;
1 1/2 hours post vax, the pt's arm starting hurting and it was swollen, red, and hard. Given Benadryl.
Difficulty with word finding and speech with subsequent blurred/fuzzy memory of the timeline of the event. Attempted to call PCP - was told to call vaccine site. Called employee health, told they were not in charge of vaccinations that day. Called the hospital operator and then gave up? the timeline of the adverse event was somewhere between 45 minutes and 2 hours?
Left arm became very sore after about 8 hours after each dose. After the 2nd day after each injection, a wave of exhaustion hit me. About 10 days after the first injection, I felt a tingling in my lip and a cold sore erupted. Then another! I've never had 2 at the same time. One on the top lip and one on the bottom. I haven't had a cold sore in 15 years. I had my 2nd titer on February 3rd. On February 15th I had another eruption of another cold sore.  I didn't think the first recurrence of a cold sore was linked to the vaccine, but the timing of the 2nd one is beyond coincidental, which is why I'm reporting it. Abreva is not helping too much. I haven't had a herpes breakout since 2006.
Left chest/breast area is swollen; Left chest/breast area is / tender to touch still; Rash in the left arm pit; A golf ball swelling in the right side of his forehead; Severe headache on the left side of his head; Sweating / for 2 hours; Shaking, trembling for 2 hours; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrostomy tube insertion. Previously administered products included chemotherapy (finished his chemotherapy for squamous cell carcinoma of his tonsils). Concurrent medical conditions included squamous cell carcinoma (of his tonsils).   On 15th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling. On an unknown date, the outcome of the headache, swelling, chest tenderness and rash were unknown and the outcome of the sweating and tremor were recovered/resolved and the outcome of the forehead swelling was not recovered/not resolved.   It was unknown if the reporter considered the headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling to be related to Shingrix.  Additional details were reported as follows: The patient finished chemotherapy for squamous cell carcinoma of his tonsils and for the past two months (before the Shingles vaccine), the patient was put on a G-tube. The patient received Shingrix vaccine in left arm from the healthcare professional office.  The patient reported that 2 weeks after vaccination he  started to have severe headache on the left side of his head, He reported after 2 weeks of receiving the vaccine, he started to experienced sweating, shaking, trembling for 2 hours. The patient reported that the left chest/breast area was swollen and tender to touch still and rash in the left arm pit. The patient also reported a golf ball swelling in the right side of his forehead, which did not resolved. The reporter consented to follow up.
COVID Breakthrough  Moderna Dose 1 2/12/21 (016M20A) Moderna Dose 2 3/12/21 (029A21A) COVID Positive 8/19/21  8/19/21: The patient is a 66-year-old male who presents the emergency department today with complaints of worsening shortness of breath, fever, and weakness since 08/09.  The patient has a past medical history significant for COPD, chronic hypoxic respiratory failure on continuous 2-3 liter/minute supplemental O2, history of pneumonia, and history of smoking-quit.  Of note, patient follows with pulmonology outpatient and has been calling office for COPD exacerbation treatment every month, given prednisone burst on 06/22, 7/20, and Z-Pak on 08/11.  Patient fully vaccinated with Moderna COVID-19 vaccine.  On arrival to the ED, the patient's temperature is 101.4° F, heart rate 91, respiratory rate 19, saturating 86% on 5 L supplemental O2 via nasal cannula subsequently requiring increased oxygen at 7 L, then BiPAP mask with blood pressure 122/86 and 6/10 severity chest pain with cough.  The patient's laboratory studies were significant for COVID-19 rapid AG positive, Na 133, mg 1.5, CRP 4.8, D-dimer 0.62 age adjusted normal.  Blood cultures obtained x2.  Chest x-ray shows unchanged scarring at right lung base in airspace disease or atelectasis at left lung base.  CT chest shows mild interstitial thickening and ground-glass opacification compatible with viral pneumonia; right upper lobe nodule seen on prior exam resolved; centrilobular emphysema.  EKG shows normal sinus rhythm, heart rate 96, QTC 439 with left anterior fascicular block and nonspecific ST abnormality. The patient was administered acetaminophen 650 mg p.o., NS IV x1 L, levofloxacin 750 mg IV, Decadron 6 mg IV, DuoNeb 6 mL, and albuterol 6 mL in the emergency department. The patient is seen in the emergency department laying in bed currently on 7 L supplemental O2 via nasal cannula with BiPAP at the bedside.  The patient reports he started feeling bad on 08/09.  He reports that 1 of his roommates has been difficult to convince to get vaccinated and he believes that he likely was exposed from him.  He does have a history of positive sputum culture with Pseudomonas in the past.  He is frustrated that he was fully vaccinated and is now hospitalized with COVID-19, we did discuss that his frequent prednisone prescriptions could have made him more immunosuppressed and we have seen more COVID-19 in fully vaccinated patient's who were immunosuppressed.  8/23/21: PT was admitted and given treatment for COVID pneumonia with with IV antibiotics, steroids, bronchodilator therapy.  Encouraged p.o. intake. Monitored and corrected electrolytes. Patient seen and examined on the day of discharge. States he feels well and voiced readiness to be discharged home. He will be discharged home to continue course of po levaquin and steroid. Total time spent on the discharge process 40 minutes.
Bilateral flank pain for 18 hours, then blood in urine for 2 hours.
Patient has serpiginous choroiditis of unclear etiology, diagnosed 2017 with about 6 total lifetime flares with unclear triggers. She had COVID-19 infection 12/2020, with no significant symptoms. She was treated with monoclonal Ab infusion (bamlanivinab) which she received 12/24/20. After the infusion she developed fatigue, headache, nausea lasting for 1 day that were self limited.  Subsequently, her arthritis has significantly worsened since 1/2021 and continues to be very poorly controlled with significant arthralgia.    She received her first dose of Moderna COVID-19 vaccine on 3/26/21, ~90 days after her infection. On 3/28/21, she developed blurred vision in left eye, no other symptoms. Specifically no rashes, no respiratory symptoms, no GI symptoms. She went to her Ophthalmologist on 3/30/21 who noted she has a flare of Serpiginous choroiditis in left eye. She had prior Utiq infusion 1/12/21 still active in left eye. Given flare, her methotrexate dose was increased from 4 tabs to 6 tabs and she was given 4mg intravitreal dexamethasone in left eye on 3/30/21. She was seen by Rheumatology on 4/5/21 who noted her arthralgia could be from viral infection, but did note the source of her current choroiditis flare is unclear and could not advise on whether or not she should receive the second COVID-19 vaccine. She returned to ophthalmology on 4/7/21 when she received a second dose of intravitreal dexamethasone 4mg in left eye. She again returned to Ophthalmology on 4/21/21 where she received a 3rd dose of intravitreal dexamethasone 4mg given persistent inflammation. Her vision has continued to be slightly blurred in left eye, but no worsening since receiving dexamethasone. She was due to receive the second dose of the COVID-19 vaccine on 4/27/21, and she was referred by her ophthalmologist to allergy/immunology clinic 5/3/21 to determine the safety of receiving her second dose of moderna vaccine.   Our team performed a literature review that revealed that vaccines (though not specifically the COVID-19 vaccine) can be associated with serpiginous choroiditis flares, therefore we recommended she not receive her second dose of the Moderna vaccine series given risk of recurrent flare.   Based on chart review completed today, she continues to struggle with this flare and continues to require intravitreal steroid injections.
fussiness, fatigue, fever and vomiting; he also reported some body aches (primarily in his legs)
COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; This is a literature report.  Case Report TOPIC: Chest Infections INTRODUCTION: COVID-19 vaccination while on immunosuppressive therapy response may be "weakened" compared to the general population. CASE PRESENTATION: A 69 y/o F with DM2, hypertension, and psoriatic arthritis-on methotrexate/folinic acid and tofacitinib, presented with progressive cough, dyspnea, and fever x 3 days. She had a known exposure to COVID-19. She received two doses of Comirnaty vaccine (Pfizer), and the last dose was a day before admission. On admission, she was tachypneic and hypoxiemic with O2 satt 75% on room air. Chest x-ray showed diffuse patchy opacities, COVID RT-PCR positive. Due to acute hypoxemic respiratory failure, dexamethasone IV and remdesivir IV were given with improvement. On 4th day of admission, she was found unresponsive, bradycardic and pulseless. ACLS protocol was followed, and ROSC was achieved in 3 minutes. Her course was complicated with septic shock requiring pressors, acute kidney failure, shock liver injury, severe lactic acidosis, metabolic acidosis and hyperkalemia. She was found asystolic on the 5th day of admission but she was not coded because she was made DNR. DISCUSSION: Immunogenicity and efficacy of COVID vaccines are uncertain in rheumatic patients who are immunosuppressed. It is known that they are at higher risk for COVID-19 infection with more complications. Therefore, new guidelines emphasize the need of holding immunosuppressive medications for a certain time to increase the efficacy of vaccination.  CONCLUSION(S): Patient would have benefit from withholding immunosuppressive medications before and after COVID vaccine administration.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 pneumonia and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.; Reported Cause(s) of Death: COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K011562, expiration date 08-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.