chrisvoncsefalvay/vaers-outcomes huggingface dataset:
June 7, 2021 - ER hospital, - Two weeks after cleared to get off of Bactrim, I was attacked by something.  Had Tingling/burning all over body both sides - arms, legs back, stomach, vagina, etc.  Pain was centralized in lower back (never had lower back problems).  I had swollen and painful lymph nodes in left arm.  Headaches.  Exhaustion.  Kept telling them it was like I had internal shingles all over my body.  Covid test was negative.  Chest Xray and bloodwork all negative.  Sent me home with more antibiotics and medicine for a urinary tract infection which I didn't have.  Extensive bloodwork was taken to rule out any Staph infection.   June 16, 2021 - ER hospital - Returned to ER more lethargic and exhausted.  Now running elevated temp in evenings 99.3-100.0.  Burning pain all over continued.  Told me to go to a Neurologist and basically you're not dying.
Patient began feeling lightheaded and had some mild tingling in right hand. Vital signs were monitored for 45 minutes. Patient's initial BP was 71/40, pulse 54, O2 sat 100% on room air. Ending vital signs 118/64, pulse 67, O2 sat 99% on room air. No treatments were necessary. Patient states she felt better prior to leaving facility.
Headache, dizziness, vertigo, diarrhea, vomiting, arm tenderness, fever, lethargy all lasting 2 1/2 days
I received a pneumococcal polysaccharide booster in my left arm on Monday afternoon.  On Tuesday afternoon while changing a shirt I observed that a large area around the injection site was red and swollen.  My upper arm felt tight, as if being squeezed.  By the time I saw a Doctor Wed. morning the swelling and redness had spread further toward the underside of my arm.  It did not itch, but was tender to the touch.  It did not respond to Benadryl (I had taken two doses 6 hours apart on Tuesday night.). There was no treatment prescribed other than ibuprofen, which I declined to take.  Over the next few days the reddened areas turned yellow, then faded completely by week's end.  Five years previously (in Dec., 2014 I had had a metal plate removed from that arm because it was infected with strep.  The plate was surgically inserted to repair a broken humerus in 2006.
I feel shaky; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I feel shaky) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced TREMOR (I feel shaky). At the time of the report, TREMOR (I feel shaky) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Blood glucose: 55 (Low) 55.         Concomitant and treatment information not provided. The patient had a lot of crabs on the evening of 16-May-2021. No information regarding corrective treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received which included second dose information  and event outcome was updated
I woke up today May 27 with COVID arm. Raised but not itchy. Keeping tabs on it. Sent a message to my primary making them aware.  I will enter the info in VSAFE when I receive today's text link.
This case was reported by a pharmacy student and described the occurrence of increased liver enzymes in a male pt in his thirties who received Engerix B. On an unspecified date, the pt received the second dose of Engerix B. At an unspecified time following the administration of the second dose of Engerix B, laboratory analysis revealed that the pt developed increased liver enzymes. The reporter stated that she, "was not sure if alanine or aspartate transaminase increased but the number increased from 40 to 120." The outcome of the event is unknown. Comment: Increased liver enzymes was assesses as medically serious (OMIC) by the manufacturer.
This spontaneous report was received from a 60 year old male pharmacist who was reporting on himself. The patient's concurrent conditions included hypertension. The patient had no allergies. His medical history included shingles. He stated he was healthy, active and muscular. On 02-NOV-2015, the patient was vaccinated with ZOSTAVA 0.65 ml, subcutaneously in the left arm, lot/batch # reported as 15731P, expiration date May 2016. Concomitant therapies included lisinopril (manufacturer unknown) and hydrochlorothiazide, the patient was on his hypertension medications for over 20 years. On an unknown date in approximately November 2015, the patient experienced severe joint pain in both legs, shoulders and his hand. His leg joint pain was so bad his muscle felt like guitar strings pulled tight. He could not even put his legs inside his pants when dressing. At the time of the report, the patient's age were bit better, but still hurt. However, his shoulder muscles were most painful including his hand. The patient sought medical attention, he contacted his physician but at this time no treatment was given. On an unspecified dates, the patient had arterial blood pressure studies on his ankles and wrists performed and he passed with flying colors. He also had blood work drawn which was all within normal limits. The outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
05/09 Woke up with Chest pain/fever/headache 05/17  went to urgent care due to chest pain/diagnosed with Pericarditis 05/20 pericarditis diagnosis confirmed by cardiologist  No other contributing factors
Itching within 15 minutes of injection after giving 2 capsules of diphenhydramine 25mg, she's not itching 4 hours later.
Client is 15 years old and inadvertently received a 1st dose of the Pfizer vaccine.
I am a breakthrough case and tested positive for Covid-19. I developed symptoms around 01/01/2022. I had a sinus infection, bad head cold, congestion, runny nose, ear fullness, and body aches. I used over the counter drugs to treat my symptoms and then I used an antibiotic.
Temperature excursion for opened IPOL was administered to patient with no adverse event; Initial information received on 25-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who had administered temperature excursion for opened ipol with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jan-2023, the patient received 0.5 ml of suspect IPV (VERO) Suspension for injection lot V1A121M, 15-FEB-2024 via intramuscular route in the left arm for Immunization.  On 05-Jan-2023 the patient developed a non-serious event of temperature excursion for opened ipol was administered to patient with no adverse event (poor quality product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event temperature excursion for opened ipol was administered to patient with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 20 minutes post vax, pt developed areas of redness about 10 cm in diameter. Pt was treated with Benadryl
Fatigue and arm soreness causing work absence Narrative:  Fatigue and arm soreness causing work absence
Chills headache tired; Chills headache tired; Chills headache tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 09:30 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset 04Mar2021 02:00, outcome "recovering" and all described as "Chills headache tired". Therapeutic measures were not taken as a result of chills, headache, fatigue. Additional information: The patient did not have COVID tested post-vaccination. The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient prior to vaccination was an unknown the patient was diagnosed with COVID-19. The patient did not have the patient been tested for COVID-19, since the vaccination. The patient did not have allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 27 year old female who on 09/15/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644973/0195N).  The RN reported that on 09/24/03, the pt developed a case of breakthrough chickenpox characterized by 25 itchy lesions all over her body, some on her face, arm and a papular lesion on her thigh. Unspecified medical attention was sought, but it was unknown if treatment was required. Subsequently, the pt's breakthrough chickenpox and all symptoms resolved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX. The pharmacist mentioned that on an unknown date, during administration of ZOSTAVAX some of the product leaked out of the syringe on the patient's arm. No adverse symptoms reported. The outcome of the events was unknown. The event was not related to ZOSTAVAX. Additional information has been requested.
2-3-12 Received Tdap - that night had HA, arm soreness (no redness), chills, fever, malaise. 2-4-12 Same s/l as above - in bed all day. 2-5-12 malaise, arm soreness. 2-7-12 malaise, arm soreness. 2-8-12 malaise (reported  to HD), arm soreness. 2-9-12 arm soreness. 2-10-12 arm soreness.
Patient  is a 52 y.o. female with a history of Grave's disease, breast cancer (stage 3, dx 2017), COVID in March 2020, who was brought to the ED earlier today after a presyncopal event. In the ED she was noted to be hypotensive and given iv crystalloids with minimal response. Given her persistent hypotension she was started on norepinephrine and transferred to the MICU.    She came to specialty hospital for evaluation of "long-hauler's syndrome." Current symptoms include intermittent headache, arthralgias, dry cough, malaise, fatigue, low grade fevers. In the ED today her COVID swab came back positive. She also describes problems with hypotension for the last 9 months and was currently undergoing evaluation in the outpatient setting to evaluate this further. Due to concern for adrenal insufficiency she was given 100 mg of hydrocortisone in the ED. Upon arrival to the MICU she denies any dyspnea or chest pain.
A 40 year old male pt exposed to rabies from a dog bite developed urticaria after receiving RabAvert.  The pt received his first two doses of RabAvert on days recommended for the post-exposure series.  After his second dose, he developed urticaria and was referred to an allergist.  The allergist gave the pt a dose of Prednisone for generalized urticaria reaction.  Prednisone was subsequently tapered off.  The third dose was given on day nine instead of day seven with pretreatment of Zyrtec and Zantac. RabAvert was given in small fractions until the entire 1mL was administered.  The pt was observed for a period of time and had no further reaction to RabAvert.  Follow up information received on 09/23/03: The pt's allergist provided the following information.  The pt received RabAvert from 08/12/03 to 09/09/03.  On day four of his RabAvert series he developed generalized urticaria and chest tightness. His symptoms were treated with a Medrol dose pak, Zyrtec and Zantac and resolved in five days.  On 09/09/03, after his final dose of RabAvert, his tital IgA was 225mg/dl and rabies antibody screen was greater than 4.5.  Allergy skin testing to PCN, cephalosporins, RabAvert, beef and egg was negative; rabies immune globulin was positive.  The physican assessed these events as non serious and not related to RabAvert.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: First BP 108/68 2nd BP 115/78. Patient complained of feeling hot, sweaty, then dizzy. We had her lay on the ground and gave her some water. She recovered within the next 15 minutes.
The part on the shoulder was swollen very bad, big hand palm size red spot and very hot. Patient had pain as well.
After receiving the vaccine the patient stood up and fainted hitting the floor, observed in the office by MD and was then released to go home. Vitals taken all normal.
Rash on arms from deltoid to elbow arm stiffness. Neck & shoulder stiffness (extreme), headache.
Mom noticed patient's lips were swollen this morning. Mom said breathing was normal. Mom sent patient to school. Mom called MD and waiting for Dr's returning call.
Heart flutter; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Heart flutter) outcome was unknown.            No concomitant medication information was provided by the reporter.  The patient received treatment from a cardiologist, who gave her a beta blocker.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 4 months 27 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
received extra dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number xk524, expiry date 8th October 2022) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 1st February 2022, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml. On 1st February 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 2nd dose of Boostrix in left deltoid. The patient received an extra dose of Boostrix accidently, which led to extra dose administered. The reporter consented to follow up.
expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that the vial was punctured on 28-DEC-2021 and used for up to 17 hours post puncture.
Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a 0.5 ml dose of Gardasil.  Subsequently, the patient fainted after receiving the vaccine.  Unspecified medical attention was sought.  Laboratory diagnostic studies included an eye exam.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
day of vax pt felt lightheaded, disconnected, felt sob, couldn't use hands, dizzy. ER stated felt hyperventilated.
Delayed Dermatographia - intermittent urticaria starting 11 days after vaccination
Woke with chills, shaking, fever( up to 103) increased hart rate O2 sat between 92-95%, Symptoms lasted intermittently from 10:30 pm 1/5/21 until 0500 am 1/6/21.  Continued with low grade fever on 1/6/21, fever resolved 1/7/21.  Continued with episodes of increased heart rate baseline 70"s, intermittently up to 100-130.1/8/21 noted a few episodes of increase heart rate 100-120 lasting for only a few minutes.
Unknown if consumer was experiencing chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: EW0181) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Unknown if consumer was experiencing chest pain". Additional information: Can I ask you a question? Can you give me an information on individuals that, I mean not the people who called but are people calling in for symptoms of chest pain?" (further clarification unknown if consumer was experiencing chest pain, hence event captured as-Unknown if consumer was experiencing chest pain).  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a 36-year-old female patient reporting on herself. The patient's current conditions included asthma and allergy to amoxicillin. On 19-JAN-2015, the patient was vaccinated with PNEUMOVAX 23 (in the arm, dose, route of administration, lot# and exp. date were not reported). Concomitant therapies included SYMBICORT. On 19-JAN-2015, the patient experienced injection site pain reaction. The patient stated that she had extreme and intense pain in the injection site arm. The patient also mentioned that she could not stand for a week and she could not lift her arm. The arm she could not lift was the injection site arm. On 19-JAN-2015, the patient's palms turned bright red, her finger tips also turned purple and the patient had difficulty breathing. The patient received FLEXERIL and another unspecified medication (dose and manufacturers unknown) as a treatment for the events. The patient sought for medical attention, she spoke to a nurse. No laboratory tests were performed. The outcome of the events was reported as recovering. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. Upon internal review, the event of not being able to stand for a week was considered to be disabling. Additional information has been requested.
Pfizer-BioNTech COVID-19 vaccine, Bivalent EUA 1/11/23-0547am ER arrival, transported via ambulance. Right hip pain, unable to stand, no injury. Pain radiated across lower abdomen. Mild leukocytosis 13.3 WBC (previous WBC 13.6 01/04/23 outpatient lab). Admitted to hospital. 1/12/23-Orthopedic consult-right hip stable, weight bearing as tolerated advised 1/12/23-Physical therapy consult-Transitional Care Unit (TCU) advised, assist of 1 required 1/12/23-Neurosurgery consult for T12 compression fracture (diagnosis previous to hospitalization)-MRI advised. MRI revealed recent moderate burst compression fracture T12. Advised TLSO brace, outpatient neurosurgery follow up. 1/16/23-GI bleed-3 maroon stools. Hgb drop 1/12/23 13.4 Hgb to 8.6 Hgb 1/16/23. EGD 1/16/23 bleeding duodenal ulcer, APC and cautery performed. No transfusions. Pantoprazole started. Hgb 1/19/23 8.6 1/18/23-Patient reports dysphagia with pills. Speech therapy consult-Bedside swallow, diagnosed oropharyngeal dysphagia due to weakness, no aspiration, plan mechanical soft diet 1/20/23-Dietician consult due to prolonged length of stay. Diagnosis severe malnutrition, BMI 20, Weight 51.6kg. 11% weight loss (6.3 kg) over 4 months. Plan Ensure bid. 1/20/23 Hospitalist goals of care conversation, Patient DNR status, awaiting hospice evaluation.