chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PVCs around 3 per minute, constant. Mild pleuritic chest pain, constant. Started at date/time reported on this form, lasted until sometime the following Monday (one week) and resolved with no treatment. Instructions for follow-up if symptoms continued into the following week to come back and start wearing a Holter monitor. No cardiac history, baseline treadmill within the last 5 years was negative.
This case was reported by a consumer via out of hour services and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included Zostavax (injection).  On 17th July 2018, the patient received SHINGRIX. On 18th July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, upset stomach, general body pain and fever. On 19th July 2018, the patient experienced feeling unwell. On an unknown date, the outcome of the headache, upset stomach, general body pain, fever and feeling unwell were recovered/resolved. It was unknown if the reporter considered the headache, upset stomach, general body pain, fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the next morning after receiving a SHINGRIX dose, she experienced headache, fever (body temperature was recorded as 101.3 degree F), aches all over, and an upset stomach. The patient feeling betting, 2 days after receiving a dose of SHINGRIX. At time of reporting, all events have resolved. The patient provided there physician's details.
My left arm swollen and hot. After 3 days, my arm became itchy, and I had a fever. I had body ache and ongoing headaches. But the headaches have continued to this day. My temperature was 101. My headaches are in the frontal lobe, it feels like a stress headache.
Later that evening after the vaccine I got so tired I just couldn't stay awake resulting in me laying down a little earlier than usual. About a week and a half later several times I would get a feeling like I was coming down with a cold with a burning sensation in the chest, a sore throat, severe coughing and sneezing was associated and occurred periodically throughout the day. This occurred off and on for about three weeks, finally about a week and a half ago the cold symptoms diminished. Since the vaccine I have this feeling in my chest as if I have pressure baring down on my sternum area which is still occurring to date causing me to not wear a bra because it feels as if it is on too tightly. When I laid down it felt as if I could feel my heart doing a flip but this also occurred only at rest, when laying down and upon the exhale of breath feeling as if it was skipping a beat and I could feel it in my throat area. No pain is associated but it wakes me up at night sometimes because of the discomfort and it scares the heck out of me. Because of the discomfort and I thought I was going to have a heart attack so on November 16, 2021, I went to the ER and a Chest X-ray, EKG and bloodwork was performed. I was given a solution to try to alleviate the pressure on my sternum but it didn't work. I was monitored for a while and released from the hospital ER. I have an appointment tomorrow with my PCP for further evaluation.
states rt arm @ inject site was swollen, hard, red & sore for 5 days afterwards; area surrounding inject became blistery the last 2 days; & warm to touch; pt instructed to see MD for checkup of arm;
"Foggy" head; Headache; Sore arm; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunisation.  Medical history included COVID-19 (reported as prior to vaccination, the patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced ?Foggy? head, headache, and sore arm on an unspecified date in Dec2020. It was reported that no treatment was received for the adverse events. It was reported that prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms on 9/16/21; tested on 9/20/21. Fully vaccinated
Suffered stroke like symtems on April 12. Severe headache ,right arm tingly and numb, sissy when I got from chair, vision seem blurry. Took 800mg of ibproferin and things improved. Right hand Remains slightly numb
On Tuesday, March 9th, a friend of mine went to my mother's home to take her to a scheduled dentist appointment. Upon arrival, she observed that my mother was disoriented and her vision was impaired. Specifically, her right pupil was completely off to the right side, her eye was irritated and slightly swollen. Per recommendation from the primary care office, my mother was taken to the emergency room. She remained hospitalized for two weeks during which time, several labs and x-rays were performed; several ideas surfaced regarding root cause including Miller Fisher Syndrome, mini-stroke, etc. but no final diagnosis was identified.
7 hours later developed a rash, like hives; 7 hours later developed a rash, like hives; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporter's aunt). A 68-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date was unknown), via an unspecified route of administration on an unspecified date (at the age of 68-year-old) at dose 1, single for covid-19 immunisation. Medical history included allergic to peanuts and cashews. Concomitant medications were not reported. On an unspecified date the patient experienced 7 hours later developed a rash, like hives. The reporter stated that his aunt got vaccinated a week and a half or two weeks ago with the first dose of the vaccine and 7 hours later developed a rash, like hives. He asked if she should receive the second dose. The reporter asked if there are any issues with getting the vaccine with nut allergies. The reporter asked if the base of the vaccine is the same as the flu vaccine. Explained that Pfizer Medical Information is unable to compare the ingredients with other products. Offered to send the list of ingredients but the reporter declined. The reporter asked what the main base of the vaccine is, offered to send the list of ingredients but the reporter declined. Reporter stated, So I wanted to check about a reaction, my aunt got the COVID vaccination about a week ago, the first shot. About 7 hours later she had a rash, like hives. She slept through the night and it went away but I was wondering if she could get the second shot because of that. Reporter stated she is calling for his aunt. She got the vaccine about a week and a half ago to maybe 2 weeks ago. When she got the vaccine, the first shot, 7 hours later she developed a rash, like hives essentially. He was wondering if he should recommend she gets the second shot. The patient obtained a rash seven hours after receiving the vaccine and it cleared on it's own within six hours. Outcome of the events was resolved on an unspecified date.   Information about lot/batch number has been requested.
Patient came to the ED with complaints of shortness of breath and dry cough for 2-3 days.  Patient was admitted with Covid and treated with remdesivir.
Patient reports experiencing Fever, Generalized headache, muscle soreness, and increased heart rate the following day she received her first COVID-19 vaccination. Patient reports her symptoms have gradually resolved over the past two days and is currently not taking any medications.
Baby seen in ofice 5/8/12 for eval of unsteady gait; refuses to walk on her own. 5/5/12 "tactile temp" slight URI sx, slightly irritable. 5/7/12 devel ataxia. Received MMR and Varivax 4/30/12. Referred to neuro; seen 5/9/2012. Sx almost completely resolved by the time of visit. Post-varicella vaccine acute cerebellar ataxia. no tx recommended. F/u with PCP 5/15/12. Neuro sx resolved; new URI-sx tx.
leg started hurting; couldn't go back to sleep; have cramps in her right leg/ cramps in left leg; I began having a stomach on sabbath afternoon around 6 pm; stomach aches/stomach hurt; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 10:00 am (Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation. Medical history included total thyroidectomy, allergy: Codine, Narco, naproxen. Concomitant medications included levothyroxine (LEVOTHYROXINE); calcium (CALCIUM); colecalciferol (VITAMIN D 3); cyanocobalamin (B 12); black cohosh extract (BLACK COHOSH EXTRACT). The patient began having a stomach on sabbath afternoon around 6 pm on 17Apr2021. On Saturday (17Apr2021), she stated to have stomach aches, making her stomach hurt. Clarifies that she had stomach aches a little, not a lot. Then on Sunday (18Apr2021), the patient began to have cramps in her right leg that finally went away. Monday (19Apr2021), the patient started to have cramps in left leg and have persisted from maybe 2 am in the morning and she is still experiencing leg cramps at this time which is 12:19 pm, she has took some Ibuprofen for the pain. Her left leg started hurting while she was asleep and woke her up this morning so that she couldn't go back to sleep. The patient clarifies that it started cramping while she was in sleep, it woke her up, so she was unable to sleep very well because her leg is cramping. Therapeutic measures were taken as a result of leg started hurting. No treatment received for other events. The outcome of the event have cramps in her right leg/cramps in left leg was not recovered, the outcome of the other events was unknown. The patient is not pregnant at the time of vaccination.  No Follow-up attempts are needed. No further information is expected.
A 52-year-old female patient was in the observation area waiting for her 30 minutes and begins to touch her right temporal area and the partner asks her if she feels well, which indicates that she feels a headache. The Head Nurse on duty, was notified and the patient was taken to the observation area, which was evaluated by EMT. Patient presents headache that starts from the right eye to the right temporal area. His vital signs were: B/P 140/90 mmHg, Sat. 99%, Pulse 73, Dxt 124 and presents clear breaths of 16x min on auscultation. Case was consulted with Doctor and 160mg of acetaminophen was administered. At 6:45pm, the patient was reevaluated and her vital signs were: 98% Sat., 67 for strong and regular pulse, 16 breaths, 95 Dxt, and 130/80 mmHg. Then, the patient reports pain in the upper part of the chest and does not report any other symptoms. At 7:19pm, he reports a headache and decreasing chest pressure. The patient voluntarily did not wish to go to the hospital.
Mild headache on Day 2 and 3, cough, drainage in back of throat. Drainage worsened on day 4 and 5 and continued until recovered.  Coughed up considerable amount of white pustules over course of event. Voice was hoarse. Recovered after 12 days. I had Covid-19 in early November 2020. Symptoms were very similar, but more severe drainage. Headache was not as bad.
Audio disturbance: rushing sound in ears. Later, audio hallucination (banging in left ear). Both incidents lasted only a few seconds
sore arm; chills; fever; body ache; headache; fatigue; nausea; vomiting; brain fog; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0171 and Expiration Date was not reported), via an unspecified route of administration in arm right on 23-APR-2021 at17:30 (age at vaccination: 43 years), as dose 2, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151and Expiration Date was not reported), via an unspecified route of administration, in Arm left, on 02Apr2021 at 7:00 PM (age at vaccination: 43 years), as dose 1, single dose, for COVID-19 immunisation. The Patient did not have Covid prior vaccination. The Patient was Covid tested post vaccination. The patient stated that no side effect other than a sore arm after the first dose. The day after the second dose she had the following symptoms: Sore arm, chills, fever and body aches, headache and fatigue. Symptoms lasted for approximately 36 hours, except the fatigue. She said that she still has fatigue. 8 days after the injection she had the same symptoms plus nausea and vomiting. These symptoms lasted approximately 36 hours. She still suffering from fatigue, headaches that come and go and brain fog. On 24Apr2021 at 09:00 AM, the patient experienced sore arm, chills, fever, body ache, headache, fatigue, nausea, vomiting and brain fog. The patient underwent lab test and procedure include nasal swab (COVID-19 (SARS-CoV2) Molecular Assay By- PCR) negative on 13Apr2021. Outcome of the event fatigue was not recovered; headache was recovering and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
EPIDIDYMITIS; A spontaneous report has been received from a physician via the regulatory authority (RA) thorugh the regulatory authority (RA). The report concerns a male patient (age 2 years, height 88 cm, weight 13 kg).    No medical history was reported.   The following demography was reported for the patient's parent:   Sex: NASK    No concomitant products were reported.    On 08-Dec-2022, the patient received Fluenz Tetra (influenza vaccine live reassort 4v) (batch number PH2082) once/single administration, via nasal route, for influenza immunisation.     No malfunction has been reported for Fluenz Tetra.    On 10-Dec-2022, the patient experienced epididymitis (preferred term: Epididymitis).     It was unknown if any action was taken with Fluenz Tetra.     The patient recovered from the event after 1 week on 17-Dec-2022.     The event was considered serious due to hospitalised by the reporter.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUENZ TETRA  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Epididymitis is not listed in the company core data sheet. Young age of the patient could be possible risk factor for the event. Due to limited information on relevant medical history (torsion of the appendix ,reflux of urine into the epididymis), concomitant conditions (urinary tract infection, inflammation, mumps, trauma), concomitant medications, risk factors (vaccination status), further detailed diagnostic and etiological work up (complete blood profile, urine profile, ultrasound of scrotum) the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the event and suspect drug.
Patient experienced severe shoulder, neck and jaw pain that prevented her from eating. Onset was 12-24 hours. The symptoms resolved without intervention after 3 weeks.
At around 2:00 p.m. my neck on my left side started to hurt and it went to the shoulder area as well.  It progressed more intense as time went on.  I took some ibuphropen and tylenol but did not seem to help.  The next day it was worse and could hardly move my head without pain.  I had a couple tablets of Orphenadrine and I took 2 on Saturday and 1 on Sunday.  Monday morning it was even worse so I called my Dr. office and he refilled the prescription of Orphenadrine and after a couple days it was better.  I took them for about 1 week but pain never went away totally.  I was afraid to get the second dose but my Dr. said it should go better the next dose.  So I did get a second dose on February 4.  Pain happened again but not as severe.
Pain immediately after given the shot, took ibuprofen, used warm and cold compression's, massaged the area, nothing worked, the pain hasn't gone away, the pain has increased involving the shoulder, arm and upper back. I now have reduced range of motion, and my arm is weak. It's been more than 5 months now, and I haven't been able to sleep well due to the pain I feel when I move while sleeping.
Pt. received Rotateq vaccine 4/19/07 2 days after developed watery diarrhea, which has persisted for past 3 weeks
Patient started feeling very tired, achy, and lost sense of smell 6 days post vaccination.
3 days of fever, chills, body aches, headache, joint pain, and extreme fatigue. Swelling, pain, redness at injection site. Bedridden then slowly returned to activities- continually plagued by shortness of breath and fatigue.
pt recv vax & devel an inj site rxn & burning & strange sensation  of not being able to lift arm;addtl info was recv 31JUL96;pt recovered;
Soreness, swelling 5cm×5cm, redness, heat at injection site starting 8 days after immunization. Called primary care and was routed to urgent care for immediate treatment. Currently awaiting assessment, diagnosis, and treatment.
20 sec episode in TOTAL; pt looked to side, 8 repetitions of arm twitching; no LOC, back to baseline; no fever; no recurrence.
Premature ventricular contractions (PVCs). Feel chest tightness when PVC happens. The frequency is around 4 times an hour.
Possible Seizure: nausea Dizziness Passed out ~1-2 seconds Soem shaking weakness high blood pressure
Sore arm at site of injection for about 48 hours. Fever, headache, muscle aches beginning about 16 hours after shot and lasting about 24 hours. Hives beginning about 40 hours after shot and lasting about 36-48 hours.
headache; fever; chills; shaking; is very cold; A spontaneous report was received from a consumer concerning a 77-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, fever, chills, shaking/tremor, is very cold.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) headache, fever, chills, shaking, is very cold.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, fever, chills, shaking, is very cold was unknown.
Lt arm-back (SC) Zostavax vaccine injected.  2 days later has reddened area 25 mm in circumf.  Swelling slightly today with itching noted.
Case's palms and soles of feet became very itchy on 10/21/02. Several hours later her arms became itchy and "blotchy". Went to dermatologist. No food eaten that may have caused itch and rash. MD suggested it was "flu shot". Benadryl and Allegra prescribed
Systemic: Dizziness / Lightheadness-Mild, Additional Details: At about 5:30pm on Saturday 07/17/21, patient was given covid vaccine, patient verbalized that she was very nervous while receiving the vaccine. Five minutes after the vaccine was given, patient fell on the floor, no loss of conscious, Alert and oriented x3, able to move all four extremities, no shortness of breath, responded to all questions. Patient assisted to chair by pharmacist and patient father. After 15 minutes patient stated she feels good. Patient refused to go to hosp.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 07-May-2021. Concomitant medication use was unknown Treatment information was unknown
02/22/23 presents to EC ED for "shortness of breath". PMHx of "asthma, skin CA, HTN, HLD"
Hit her (L) arm on a wall the day after vaccine. Now c/o pain, with upward movement. Red/warm 4" around injection site.
Husband stated that she was incoherent, dizziness, body aches, just like flu symptoms 9-7-16.
I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches and a low grade fever. Some nauseous. Really vivid dreams.
03/10/2021 notice a rash to the back of her right calf.  Rash is pin point and red.  Raised bumps to both back arms about 1 inch above the elbows and up about 2 inches.  The rash started on the back of her neck @ the hair line.  The rashes itch especially @ night.
Exactly seven days after the shot I woke up with a very swollen arm from my elbow to my shoulder it was very swollen, itchy, and hot. I just used cold compresses to help with the itching and hotness and swelling. I also took Tylenol to help with the pain.
Flu symptoms, vomiting, diarrhea, tired. Lasted from 1 am thru 10 am on 11/22/99.
cough; stuffy nose; lethargy; sneezing; sore throat; Cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (sore throat) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: over 170.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  She stated this morning she woke up with a severe cough, stuffy nose, lethargy, she was sneezing, and had a sore throat. She had received both primary series and a booster dose.  She had sore throat, sneezing, stuffy nose, feel wiped out, no energy. She went to the gym and she exposed to a lot of people and she did not know if the equipment was clean. Her symptoms seem to be a cold but more severe, she did not know exactly what was going on or what she should do. They stated she had CHF and had episode of heart rate over 170.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2023: On 26-Sep-2023: Live follow-up contains, medical history and new event cold added.