chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWEAR I EXPERIENCED THIS BUT NO ONE WILL DIAGNOSE ME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced i swear i experienced this but no one will diagnose me. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i swear i experienced this but no one will diagnose me was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 47 year old male. 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
cough; cold symptoms; second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose). At the time of the report, COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Description of Event or Problem:The HCP stated it has been more than 60 days since the patient received the first dose in the Moderna series   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Followup received contains no new information
Information has been received from a pharmacist (PHARM D) concerning a 21 year old female who in October 2007, was vaccinated with GARDASIL (lot# unknown). On an unspecified date the patient experienced cardiac arrythmias. Medical attention was sought at the physician's office. At the time of reporting it was unknown if the patient had recovered. No further information was available.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: difficulty breathing per patient-Mild, Additional Details: right after 2nd covid vaccine, patient complain she can't breath but then she was able to walk around store shopping. Caregiver said she is OK and mom and patient went home. 2 days later, patient's mom come to pharmacy to pick up amoxicillin order by dr. and compaint that after 2nd covid vaccine, patient was sleeping at night and have problems (?!?!unsure symptoms) and mom call 911. Can't reach Dr.
No additional AEs or PQC reported; Vaccine administered after temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 07-JAN-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliters (ml) intramuscularly (IM) (anatomical site of vaccination and vaccine scheme were not reported; lot number U010534 has been verified to be valid, expiration date reported and established as 31-OCT-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 49.1 degrees Fahrenheit (F) for 5 hours and 9 minutes, 56.3F for 14 hours and 7 minutes, 49.6F for 35 hour and 9 minutes. There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Myalgia, Fever & NauseaVomiting Narrative:  Fever, body ache, chills, fatigue, headache, Nausea and vomiting
Morning after shot was at church and all of a sudden got nauseous and very hot for a number of minutes, then passed out before leaving church. Had a cut lip, nose and have a stiff(sore) neck last day or so.
Patient woke up from afternoon nap with rash/hives.  No fever or difficulty breathing. Parents sought care at urgent care.  Seen by APRN student & licensed APRN.  Diagnosis-hives.  Prescribed Benadryl 1.25ML every 8 hours for 2 days AND Zyrtec 2.5ML daily for 1-2 weeks.  No follow-up visit scheduled.  Message left for parent to return call to Health Department; call never returned.
No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jun-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 17-Jun-2023, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Index number was reported as IOM-0255 Company Comment: This is a spontaneous case of Maternal exposure during pregnancy concerns a 38-year-old female patient with no reported medical history, who experienced the non-serious unexpected, event of no adverse event, after a dose of mRNA-1273 Bivalent .222 (Original and Omicron BA.4/BA.5) vaccine. The event was considered unrelated to the vaccine. The benefit-risk relationship of mRNA-1273 Bivalent .222 (Original and Omicron BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact
HPI: Reaction to Covid vaccine Had second dose today and noted sensation of throat swelling and wheezing approximately 30 minutes after arrival Took 25 mg of Benadryl and 1 albuterol treatment with improvement of symptoms Came to the ER for further evaluation Patient was otherwise well before today had some nausea but no vomiting No rashes, no diarrhea, no pruritus DDX:  Likely allergic reaction to second dose of Covid vaccine No symptoms of anaphylaxis Patient took one Benadryl prior to arrival and DuoNeb, so wheezing has improved will treat with Pepcid, steroids, Benadryl, Solu-Medrol, fluids No indication for epinephrine at this time Pt well appearing and HDS. No indication for emergent intervention at this time. Will continue to monitor
Bradycardia and needed a pacemaker implanted around 8/16/2021. She died suddenly on 9/2/2021 in the afternoon.
No additional AE/PQC.; HCP reporting that patient was administered VAXNEUVANCE after it experienced a supported temperature excursion; This spontaneous report has received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 09-AUG-2023, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), (lot # X004289, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 10-DEC-2024) for prophylaxis (dose, anatomical location, and route of administration were not reported). The vaccine was stored at a temperature of 11.2 Celsius degrees (C) for 2 hours, 36 minutes and 0 seconds. It did not experience previous temperature excursions (Product storage error). No adverse event was reported.
arm is so sore; feel feverish; cannot hardly move my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, fever and mobility decreased. On an unknown date, the outcome of the pain in arm, fever and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient got the shingles vaccine and till the tie of reporting his/her arm was so sore and the patient felt feverish and could not hardly move arm. The follow-up would not possible as no contact details were available.
hyperkinetic movement/movement that was uncontrollable and involuntary; facial spasm; tremors; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on Sep2021 as dose 2, single for covid-19 immunisation.  Medical history included highly allergic to medications. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date for covid-19 immunisation. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunisation on Sep2021. The reporter informed that her mother, the patient, was now experiencing hyperkinetic (also reported as hypokinetic) movement on Sep2021 (seriousness: hospitalization from Oct2021 (either 05Oct or 06Oct) and ongoing) which was progressing and starting to get worse. The patient also experienced facial spasm and tremors on an unspecified date in 2021. She stated that according to a journalism narrative from (privacy), there was a piece on neurology, and it was explaining that the COVID vaccine can precipitate a functional neurological disorder, it was not actually a functional neurological disorder, but it looks like it through movements and tremors and facial spams. She was just trying to get information because at this point the patient was in the hospital and they have done an MRI, a CAT scan and a spinal tap on an unspecified date in 2021 and nothing was coming up. She added that she was unsure if what the patient has been experiencing was from the Pfizer COVID vaccine, and that was what they were trying to figure out and see what they were looking at. All she can say was that after the 2nd shot, the patient noticed that she started having this movement that was uncontrollable and involuntary. She doesn't know 100% if it was due to Pfizer, at this point they were just investigating. The patient had the vaccine at the end of Sep2021 and this was when that had all started. She asked for information if anyone had neurologic symptoms after receiving the vaccine. The outcome of event hyperkinetic movement was not recovered. The outcome of the other remaining events was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
She received her injections and was told that she needed to sit and wait in the room for 10 minutes.  The medical assistant left the room to get the sister a drink of water and when she came back a minute later the mom said that the patient had passed out on the exam table.  The provider was already in the room with the patient because the sister had reacted to her injections first.
Deep pain in left arm pit , along side left breast , shoulder blade; Swollen lymph nodes; Didnt sleep; Stomach ache; Arm hurt; Bad Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache), SLEEP DEFICIT (Didnt sleep) and AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep). On 11-Jan-2021, the patient experienced AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 07-Jan-2021, VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep) outcome was unknown. At the time of the report, AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
high heart rate, burning sensation in chest, dizziness, extreme weakness. Went to ED, had blood tests (normal), urine (normal, BP and pulse were high, EKG was normal. Once stable, CG was released home. Had doctor?s appt, provider advised against receiving the second vaccination. Still has weakness, occasional burning sensation in chest, shortness of breath with activity. I advised CG to seek medical attention if symptoms worsen or persist.
About 15 hours after vac, tinnitus became severe enough to wake me up and ask wife if she knew where the buzzing noise was coming from. Prior to this, tinnitus was so slight as to be not sure if I had it. Now, it is continuous, although varying in volume. No additional noted after second shot which I had slightly over a month after first shot.
Pain in the back of patient's right calf started after a flight on 6/2/2021.  We ended up in the ER on 6/7/2021.  There he was diagnosed per ultrasound with DVT or having a blood clot in a vein in his right calf.  He was prescribed Eliquis and counseled to follow up with his physician at home. Patient met with our family physician on 6/9/2021, the day we arrived home to follow-up.  After receiving the medical records Dr. advised us to file this report.  We understand that blood clots can happen on flights, but Dr. felt that this event was such an anomally for patient that it merited further reporting. Patient is a completely healthy 16 year old male who is an extremely active athlete who participates in basketball, track, cross-country and other physical activities daily.  For him to develop a blood clot after a 4 hour flight is an exceptional, unexpected event.  Dr. long term plan is to keep patient on Eliquis for 6 months, then take him off of the medicine and then run more blood tests after 2 weeks to fully investigate the incident.
Moderna COVID-19 Vaccine EUA My shot was 3/20/21 Swollen lump in neck 3/24 /21-present Headache 3/25/21-present Injection site itching 3/26/21-present Left arm pain 3/26/21-present Injection site redness and swelling (about the size of. Baseball) 3/26/21-present
Urinary tract infection; sciatic nerve; stressed; can't walk; Cancelled 2nd dose because sick in hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed), GAIT DISTURBANCE (can't walk) and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital). The patient was hospitalized on 17-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed) and GAIT DISTURBANCE (can't walk) outcome was unknown and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment includes IV Antibiotics Bactrim Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Pain armpit pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, administered in arm left, administration date 08Dec2021 16:15 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported.The following information was reported: AXILLARY PAIN (non-serious) with onset 09Dec2021 02:00, outcome "unknown", described as "Pain armpit pain". It was unknown if therapeutic measures were taken as a result of axillary pain. The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID vaccine March multiple PEs and DVT this hospital admission, heparin drip, pneumonia negative for PEs 3 weeks previous to admission  admitted on 7/5/2021
Nausea, excess fatigue, lasting 4-5 days. Fever the first two days. Unable to work the first 2. Nausea washing after 10 days. Hard rash, itchy and painful appeared after 6 days and lasted about 5 days.
Went to hospital and to doctor and neither could give me solution to my swelling in hand, arm and foot and legs from the vaccine.
Patient complained of dizziness, lightheadedness, blurred vision and numbness of face 20 minutes following immunization.  Patient sat down with head between legs with a cold compress for face & neck.  Patient denied any trouble breathing.  BP 150/80 pulse 68.  Then 30 min later 128/76 pulse 60.
Patient was sitting down for about 10 minutes after receiving 1st dose of COVID vaccine. She stood up to ask for some water and a few seconds later she fainted. She was on the floor for a few seconds unconscious but then quickly regained consciousness. We called 911 to get an ambulance to arrive. EMT's tended to her and checked her vitals upon arriving. Patient was able to leave on her own power and have a friend take her home.
Patient developed redness and swelling around the injections site for 1 week. It was the size of a quarter then when away. About 1 week after that the area of redness returned. It had a red center and was hard to the touch in the middle. It was about the size of a quarter and was very red and itchy. This resolved in about 1 week.
Patient tolerated injection well in office at time of administration. The next day Mom called stating school nurse reported area red/swollen size of golf ball. Per Dr. - Mom told this was normal, should go away x2 days. To ER 8/24/12 - arm still red.