chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient missed her 2nd dose, more than 42 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery in April 2021.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
tachycardia, dyspnea exertional hypoxia, positional tachycardia, fatigue, Symptoms started about 12 hours after 2nd dose of vaccine. still experiencing symptoms 7 weeks later; no cause found yet
30 minutes after shot arm starting getting really sore. Later that evening severe pain in arm from shoulder to elbow. Severe pain all night and half of next day. For 3 days could not raise arm. Slowly things got better except shoulder. Can't do certain exercises at gym and still wake up at night with shoulder hurting.
12/19/2020 WITHIN 5-7 MINUTES, FELT LIKE I WAS BEING CHOKED. LIKE MY AIRWAY, SOMEONE HAD HANDS AROUND MY AIRWAY. MEDICAL STAFF PROVIDED BENADRYL AND PEPCID; TRANSPORTED TO ER.  ER - TONGUE SWELLING, TINGLING; ELECTRICAL SHOT FEELING FROM HEAD TO TOE; JAW BONE PRESSURE/FLEETING SPENT 90 MINUTES IN THE ER UNKNOWN IF RECOVERED - UPPER GI ISSUES. SEVERE STOMACH PAIN; LASTED SEVERAL DAYS. PROTONIC PRESCRIBED FOR A MONTH.
Delayed urticaria- began 10 days after vaccination. Is ongoing. Rashes and hives on moving spots all over the body. Also had "COVID arm" beginning the day after vaccination and lasting a few days-- rash around injection site.
my nose started bleeding a midnight; I'm kinda freaking out; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out). At the time of the report, EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Skin reaction with big red rash and swelling around vaccine site that burn and itches that still continues on arm. Accelerated heartbeat of over 120 bpm while sitting still, started day after the vaccine. Body aches, fever of 101 that have resolved after 2nd day.  Fatigue, headache, pain on under arm of vaccine site ongoing.
No adverse event; Potential administration error: patient was concern that maybe she received primary series dose instead of a booster; Potential administration error: patient was concern that maybe she received primary series dose instead of a booster; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster), WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster), WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient asked for booster shot on 25-Nov-2022 but when received the vaccine with a new vaccination card, it was unclear whether received a booster dose or a 1st dose of the primary series. When asked the same to the pharmacist, unable to clarify the patient. The information was unknown whether the patient had any adverse events or any treatment provided for the same.  No concomitant medication was reported. The patient received previously the first series of doses (dose 1 and 2) and booster too.   Reporter did not allow further contact
pt stopped breathing about 4 hrs p/receiving vax; was taken to ER Med ctr w/t101.6; has been seen by MD due to prev breathing difficulties;
Pt. started to feel dizzy and HA started while waiting in clinic x15 min.  Pt. able to walk to room to lay down with legs elevated.  Pt. reported feeling better/HA resolved but had him wait in clinic for the remaining 5 min.  Felt fine upon leaving with mom but returned before getting to the car as pt. was feeling shaky, dizzy, nauseous and vision blurriness returned.  Returned to clinic at 5:23 pm and had pt. lay down again with legs elevated.  Took BP/HR at 5:29 pm while supine and WNL.  Had pt. transition to sitting and at 5:51 pm BP/HR again WNL.  Stood without difficulty and discharged at 5:52 pm.
Immediate severe flushing, blurring of vision, difficulty breathing dizziness, elevated blood pressure, weakness. Pt felt terrible - 'like in outer space.' Given Benadryl orally. She was observed in clinic where shot was given for one hour and then released.
On 01/04/2023, I wasn't very hungry that day. I had eaten some fish for lunch, but then just wasn't hungry after that. When I went to bed, I developed a severe pain across my abdomen. I considered calling an ambulance since my husband wasn't home. The pain got so bad that I became nauseous. I went and stood over the toilet, but since I hadn't eaten, it was more like retching for a few minutes. I laid down with a cool cloth. After that, the pain was more manageable. I called the pharmacy to see if my husband could pick something up. The pharmacist advised Pepto-Bismol. The pain was so bad that I would compare it to labor pain. My husband returned home around 11:00PM. I was able to sleep after taking the medicine. My sister, who is a medical professional, advised that I have a CAT Scan. I took it easy that day and it began to feel more like low level cramps. I read that there had been reports of abdominal pain from people who have had COVID-19, which I had not long ago. My experience with COVID-19 was more like a bad cold. I had read that there could be an abdominal obstruction causing pain in people after having COVID-19. The following week, I was able to get a CAT Scan, but the results were inconclusive. They advised that I go to the emergency room to be admitted to the hospital for a repeat CAT Scan. They admitted and examined me. They reassured me that I did not have a blockage and perhaps did have a virus. I followed up with my doctor who wanted me to see a urologist. They said that they saw a kidney stone in one of my kidneys and thought that I had passed a kidney stone. They stated that I have another kidney stone that is too large to pass, so I will be having a procedure to break up kidney stones. A record of previous CAT Scans showed that I had another large kidney stone that had broken up.
Fatigue and shakiness in diabetic patient.  Fingerstick blood sugar showed low blood sugar of 49 three to four hours after vaccine.  Patient reports no other changes in diet or routine that morning.  Issue resolved on its own with eating.
NO ADVERSE REACTION, NO TREATMENT OTHER THAN OBSERVATION FOR 15".  PHYSICIAN NOTIFIED OF VACCINE GIVEN.  HEALTH DEPT NOTIFIED
UNDERAGE ADMINISTRATION (17 YEARS OF AGE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced underage administration (17 years of age). On 09-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the underage administration (17 years of age) and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
About 2 months after vaccine I contracted breakthrough case of COVID-19. On Tuesday the 5th I had excessive sinus drainage and thought I had a sinus infection. Doctor prescribed antibiotic. Began coughing and tested for COVID-19 and it was positive. Symptoms were mostly gone by Friday.
Menopause; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENOPAUSE (Menopause) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced MENOPAUSE (Menopause). At the time of the report, MENOPAUSE (Menopause) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and Concomitant medicines were not included,  Action taken with mRNA-1273 in response to the event was unknown
Vaccine shot given too high on arm. Arm movement is extremely painful . Unable to lift or move arm.
around injection site: light red skin, skin firm to the touch, slightly warmer in comparison to right arm--this was all reported by nursing staff
Fever, vasculitis (full body) neuralgias commenced 11-27-09 thru present (12/15/09) on Prednisone, Allegra, Atarax.
10 hours after injections given. Parents reported fever of 102-103 degrees, 103.7 was the highest one,was fussy, crying and developed a rash over body of trunk and arms/ legs. That afternoon (6/11/04). See doctor at clinic. On call doctor.
(R) thigh w/ 3x4 cm area erythema distal to injection site, injection site w/o erythema or induration or DC. C/W large local reaction.
Vaccines given at 10:15 AM - became still in chair then slump forward, did not fall out of chair. BP 118/64 P 72 R 16 reg T 98.1/Ax at 10:30AM. BP 122/60 P 72 R 18 at 10:15 AM.
cold symptoms; a little temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "a little temperature", "cold symptoms". The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered", described as "a little temperature".  Additional information: Patient had three doses of the Pfizer BioNTech COVID-19 Vaccine, including the bivalent booster dose that they received three months ago (LOT: GJ3277) (form the day of this report). Patient had a terrible reaction to all of them. It took 2 or 3 days before she got over her reactions. Half the people they knew had the same thing: cold symptoms and a little temperature a day or two and it was gone. Reporter inquired for healthcare guidance for patient concerning past and future vaccinations, specifically how to lessen her symptoms. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202201377994 same reporter/patient/event, different dose;PFIZER INC-202201378899 same reporter/patient/event, different dose;
Ongoing symptoms: severe nausea, dizziness, body aches, chills. Have tried Tylenol and Advil but symptoms are persisting.
Had low grade fever, chills, red hot ears, headaches, slight body aches that following night after receiving vaccine.  The next day, had headaches nauseous for short time then hit with serve body ache, fever, and headaches.
was conducting COVID vaccinations , where client is incarcerated. Client answered 'no' to all questions on his COVID-19 Vaccine Screening Form, including the question that asks if he had previously received a dose of any COVID-19 vaccine. Client was administered a dose of Johnson & Johnson vaccine. Upon return to the  when client's vaccination information was entered into FL SHOTS, it was discovered client had already received his first dose of Moderna vaccine on 1/25/2021.
Fever x 3 days, facial swelling, treated self with BENADRYL, Chinese herbs, developed within 24 hours - not reported until 2-3-17 (one year later).
This spontaneous report as received from a registered nurse referring to a 5 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 17-APR-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M017335 with expiration date of 05-OCT-2017, 5 ml, by subcutaneous route for prophylaxis. No adverse events were reported.
this was 5 months after vaccination and unknown to me if there is any relationship with vaccination. severe headaches and nausea leading to dehydration and inability to sleep. ER admitted to ICU, checked for stroke and aneurysm among other things, none found, pain managed and return to acceptable level after a few days
Narrative: Timing ERROR only, 2nd dose given 72 days after 1st, no ADR
The patient experienced heart palpitations 2/day for a duration of 1 week. Other symptoms included headache (onset 3/18/03; duration 1 day), fatigue (duration 1 week), and dizziness/light-headedness (duration 1 evening).  In September 2001 the patient experienced periodic heart palpitations that lasted 2-3 months.
not feeling well; arm is painful; arm is sore; can't move arm; chills; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling well), PAIN IN EXTREMITY (arm is painful), PAIN IN EXTREMITY (arm is sore), LIMB DISCOMFORT (can't move arm) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced FEELING ABNORMAL (not feeling well), PAIN IN EXTREMITY (arm is painful), PAIN IN EXTREMITY (arm is sore), LIMB DISCOMFORT (can't move arm), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint pain). At the time of the report, FEELING ABNORMAL (not feeling well), PAIN IN EXTREMITY (arm is painful), PAIN IN EXTREMITY (arm is sore), LIMB DISCOMFORT (can't move arm), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse refers to a 4 year old male patient. The patient's medical history included frequent ear infections ear tube insertion, cough and congestion. The patient had a history of unspecified allergies while on therapies with M-M-R II and VARIVAX (Merck) and cough and congestion while on therapy with SINGULAIR (case# 1503USA000578). Concurrent condition included eczema. On 20-FEB-2015 the patient was vaccinated with PROQUAD (strength and dose was not reported, lot # K019101 with the expiration date of 15-APR-2016, subcutaneous. Other suspect therapies included ELOCON (dose, formulation, route, lot number, frequency were not reported) for eczema. On 20-FEB-2015, 1 day after onset of therapy later in the day, the patient developed fever  of 102F. On 21-FEB-2015 the patient experienced measles-type rash on his face. Patient called the office and sought medical attention. No product quality complaint (PQC) was involved. The outcome of pyrexia was reported as resolved on an unspecified date. The outcome of measles-type rash on his face was reported as improving. Action taken with ELOCON was unknown. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Two weeks post vax, this pt had a delayed local reaction of redness and swelling. He recovered.
Starting the evening of 03/11/2022, I developed chills. The next day I felt extremely exhausted but no chills. On 03/13/2022 I started feeling like I was coming down with something and could barely sit in my chair comfortably due to the body aches. On 03/14/2022, I did an at home test which was positive. I called my doctor right away and, because I was coughing a lot, she sent me benzonatate, which helped me to stop coughing. I developed a fever and she said she would send me a slip to give me instructions on what to do. On 03/17/2022, I was told to go to the ER to get an infusion with a drug that starts with the letter "S". After about a week, I felt like I had more energy but still to this day I experience fatigue and the need to recharge more frequently. Also, I have been experiencing "brain fog" on a daily basis, where before contracting COVID-19 it was only rarely when I wouldn't get enough sleep.
Approximately 24 hours after receiving his first SHINGRIX dose, the patient had extreme pain in his left arm. He had trouble moving his left arm. He had overall malaise and what he described as a Rheumatoid Arthritis flare up. This lasted for approximately four days and left the patient extremely debilitated.
Patient presented to ED due to AMS, syncope. Wife reported that he became confused with generalized weakness and dropped his food on the floor and became unresponsive with his eyes and mouth open. Patient was febrile to 103 on admission w/o leukocytosis. He was admitted to hospital medicine for acute encephalopathy with associated loss of consciousness. Neurosurgery consulted but no neurosurgical intervention needed. Patient improved & discharged home 2/24/21.
Red, raised, blotched, itchy around injection area x 4 days.  Also, very sore arm on day 2-4.
Patient was diagnosed with sinus infection and chest congestion.  His brother was diagnosed with pityriasis rosea.
fatigue and headache later  in the evening of the vaccine, as well as the following day. +chills the following day.  Symptoms improved day 3. Mild redness and swelling  (3 cm induration) to injection site. Mild tenderness.  COVID 19 test done on day 3 (day of office visit, test negative)
Presented to clinic with large hand size, red, induration on left leg. Hot to touch- large area of swelling on the leg to the knee: RX Duracef prescribed for possible cellulitis.
Pt's mother came into the Health Department stating that her daughter was having a seizure. Mom stated the daughter had received immunizations and they were just pulling out of the parking lot when the daughter passed out and experienced what the mother thought was a seizure. She came back into the Health Department to seek help for her daughter. When pt's mother came into the Health Department wanting help, the clerk told me the situation and I immediately went to their car to assess the situation. Pt appeared very pale and listless. She was verbally responsive. I sent pt's mother back into the Health Department to request assistance of other nurses and for them to bring emergency equipment. I also advised her to ask someone to call 911. After evaluating pt and after nurses arrived with equipment, we applied cold compresses to her forehead and neck, provided O2 via mask. I monitored respirations and pulse while waiting for BP equipment to arrive. Pt started to respond more verbally and said she thought she might vomit. She sat up and had some dry heaves. When pt started to respond we felt like we no longer needed 911 and advised the clerks cancel the call. Pt reclined again in the car seat and started complaining that her hands felt numb and she was unable to see anything. Her pulse was difficult to find and very faint. We asked for 911 to be called again. Within minutes, the fire truck arrived and ambulance arrived and assumed care. Pt received TdaP, Meningitis, and GARDASIL vaccine. Pt was transported to medical center via ambulance. Her mother called around 12:15 p.m. to say that pt was in a room in the ER, was doing o.k. and they were going to do further testing. I plan to call the mother as follow-up tomorrow. 5/19/2011 T.C. to pt's mother. States she remained in the ER until about 3 p.m. They did a CT scan, UA, and bloodwork. All tests were WNL. Mom reports pt is up and about today and has resumed her normal activities.
left axillary lymph node swelling and pain that started 5 days post vaccination of the same side arm. swelling and pain subsided in 3 days and completely disappeared. symptoms were mild.
sever head ache and severe weakness legs heavy, hand shaking uncontrollable. Lasted until 10/15. Inside felt like jelly. 10/11 went to Urgent care then urgent care sent to ER. Labs, imaging and additional tests completed. Tested for Covid and was negative. High WBC 18,000.
Eyesight significantly affected.  Illuminated and dark areas, with a jagged edge.  worst was for in excess of an hour.  Seen about 5 times.  Generally less each time.  Recorded events were; Feb 23 2021, Apr 2021, Mar 20, 2022, May 9 2022.
Within hours post vax, the pt developed a rash at the injection site that extended from the deltoid to the elbow. The pt recovered within 2-3 days.
Patient was 16yo received her vaccination before the indicated age. Per CDC recommendations, the second dose in the series was given. No other adverse events occurred.