chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt under the weather; Initial information was received on 28-Jul-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via email.  This case is linked to case 2020SA200718 (same reporter).  This case involves an unknown demographic patient who felt under the weather (malaise), while the patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not provided.  On 27-Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient felt under the weather (malaise), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  Final diagnosis was malaise.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event (with 2 days duration).  There will be no information available on the batch number for this case.
I felt like I had the flu, high fever, sweating, nausea, vomiting and headaches. I had a lot of muscle pain so I went to the doctor and I was given prednisone.
Received Tdap on 8/23/06. Reported severe achiness and fatigue. Left deltoid swollen and painful reported to Employee health on 8/25/06. On 8/28/06s welling has extended from deltoid to axillary area with redness and firmness and warmth. Was sent to workers comp DR OTC meds and warm socks TID, 8/29/06 warmth, redness less, but still edematous. 9/5/06 resolved.
Sore arm 2 hours after shot.  Took tylenol, went away.
Syncopal episode s/p vaccination. Fluids given, monitored for ~15m, VSS at d/c.
On 8/9/04, patient had received Pediarix, HIB, and Prevnar at doctor's visit. Baby turned pale and was told to wait before leaving. Child got worse and CPR started and fire/rescue called. They continued CPR and were unsuccessfully intubating. Transferred to hospital where baby expired. Nurse follow up on 09/02/04 states: "Pulseless, apnea." Autopsy report stated patient unresponsive and crying.
This spontaneous report as received from a registered nurse refers to an unspecified patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and indication not reported). The second dose in the series was administered on an unspecified date approximately 5-6 months after the first dose of GARDASIL. The third dose of GARDASIL was administered on an unspecified date one month after the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
arm feels like coming out of socket; Arm hurts a lot, dull pain; feels like COVID arm, feels like he blew his arm; Raises hand up, cant do anything, if you lift your arm up or try to reach behind you, it hits you like you broke your arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm feels like coming out of socket), PAIN IN EXTREMITY (Arm hurts a lot, dull pain), VACCINATION COMPLICATION (feels like COVID arm, feels like he blew his arm) and HYPOKINESIA (Raises hand up, cant do anything, if you lift your arm up or try to reach behind you, it hits you like you broke your arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (arm feels like coming out of socket), PAIN IN EXTREMITY (Arm hurts a lot, dull pain), VACCINATION COMPLICATION (feels like COVID arm, feels like he blew his arm) and HYPOKINESIA (Raises hand up, cant do anything, if you lift your arm up or try to reach behind you, it hits you like you broke your arm). At the time of the report, LIMB DISCOMFORT (arm feels like coming out of socket), PAIN IN EXTREMITY (Arm hurts a lot, dull pain), VACCINATION COMPLICATION (feels like COVID arm, feels like he blew his arm) and HYPOKINESIA (Raises hand up, cant do anything, if you lift your arm up or try to reach behind you, it hits you like you broke your arm) outcome was unknown.            No concomitant medication were provided. No treatment given but consumer reported he took 6 Oxycodone a day for back pain and nerve pain medication and he weaned off of those medications 2 weeks ago, he told quit them.
This spontaneous report was received from a medical technologist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 11-OCT-2018, the patient was vaccinated with PROQUAD (rHA) lot number R015742, expiration date on 02-DEC-2019 (strength, dose, dose number and administration route were not reported), for prophylaxis. Concomitant therapies included a properly stored MERCK STERILE DILUENT (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposure to a temperature excursion between 6 Fahrenheit (F) and 14 F for 14 hours, which was registered  by the data logger. There was not previous temperature excursion. This is one of three reports received from the same reporter. Sender's Comments:  US-009507513-1810USA007826.
Acute hives all over body treated with Benadryl and Zyrtec. Still healing after 2 weeks
Moderate to severe chest pain that started on 11/02/21 in the evening. I didn?t go to the hospital until 11/03/21. I have had mild to severe chest pain, shortness of breath, heart rhythm changes, high blood pressure, and fast heart rate. I was seen at ER on 11/03/21 then seen at my PCP on 11/10/21 then sent to other ER the same day by the physician. I was seen again on 11/11/21 by my PCP and received an urgent cardiologist referral and started on metoprolol IR. Seen by the cardiologist on 11/18/21 and started a taper on Aleve and switched to metoprolol ER. And a referral sent for Cardiac MRI with contrast. That was done on 12/01/21 and confirmed pericarditis. Will be starting colchicine 0.6mg  daily for 3 months when insurance approves it.
Swelling in throat; numbness in mouth-hands-feet; dizzy; diarrhea; joint pain; weakness in muscles, panic feeling.
The patient developed gross hematuria shortly after receiving his first COVID vaccine. No etiology was found. Of note, he has a bleeding disorder.
Symptoms - ?LUMP IN RIGHT ARMPIT, LOWER BACK PAIN/ KIDNEY AREA, PAIN IN OVARY AREAS, BODYACHES, PANIC ATTACKS, SHORTNESS OF BREATH, DIZZINESS, CHEST PAIN, HEADACHES, THROAT PAIN. SAW PCP IN REGARDS TO SYMPTOMS AND PCP SAID IT WAS A BAD REACTION TO THE BOOSTER VACCINE. HAS HX OF OTHER ALLERGIES TO FOOD AND VACCINATIONS.
Ear problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR DISORDER (non-serious), outcome "unknown", described as "Ear problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a rash appeared on my half of my face from left chin to upper right forehead.; Rash is itchy and burns; Rash is itchy and burns; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant adult female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Left arm on 04Mar2021 at 14:15 as First Dose, Single for COVID-19 immunization. The patient medical history not reported. There were no concomitant medications.The patient previously took pitocin [oxytocin] and experienced drug hypersensitivity. The patient did not take any other medications within two weeks of vaccination and no other vaccine within 4 weeks of vaccination. After about 4 hours of the vaccine administration On 04Mar2021,at 19:00,the patient reported a rash appeared on my half of my face from left chin to upper right forehead, rash is itchy and burns. Therapeutic measures were taken as a result of a rash appeared on my half of my face from left chin to upper right forehead, rash is itchy and burns. I have been applying Sarna cream and ice packs. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Mother reported child broke out with red raised rash didn't c/o itching, difficulty swallowing or breathing difficulties. No c/o swelling.
We verified with patient that this was their first dose of any covid vaccine and that they haven't received any vaccinations in the last 4 weeks and he agreed.  However, after receiving pfizer dose it came out in the course of conversation that the patient had previously received J&J Covid Vaccine. J&J vaccine was recieved 3/10/21 according to database.
Sudden onset nausea, lower GI distress, continues somewhat abating over 24  hrs, great fatigue.  GI upset and extreme fatigue continue for a week.
Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Patient received vaccine on Friday morning and began running a fever that night. She developed a temp of 100 to 101 degrees Saturday and Sunday and developed some spots Monday in her hair and some in her labia. She said they didn't itch right now. She called me Monday morning. I told her she should not be at work while she was running a fever or until her spots crusted over.
pt devel red, itching rash following administration of Hep B vax; tx w/Vistrail; lasted 10 days;
part of the liquid came out / didn't know the exact lost volume; part of the liquid came out / dripped onto the patient's arm; part of the liquid came out / didn't know the exact lost volume; This case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received the 2nd dose of Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered were unknown.  Additional details provided were as follows: Health care professional reported that during the administration of the 2nd dose of Shingrix, part of the liquid came out through the needle and dripped onto the patient's arm which led to Inadvertent exposure to vaccine,exposure via skin contact and Incomplete dose administered. Health care professional did not know the exact lost volume and wanted to know if the 2nd dose should be repeated or not. Batch number and expiry date of Shingrix requested but health care professional did not have it. Consented to follow-up was denied.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-AUG-2012, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) (also reported as GARDASIL 9). The patient then received the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) on 30-OCT-2012, and the third one on 23-JAN-2013 (dose, route of administration, lot# and expiry date were not reported). The reporter stated that the patient's third dose of GARDASIL was 1 month and 2 days early. There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Received Moderna dose #2 on 1/22 @ 10 am. Fever started at 1700 same day, chills, body aches; max temp 102 on 1/23; resolved on 1/24. Second illness with identical symptoms on 1/31; lasted approx 4 days, also with fever 101.x; chills, body aches. Unsure if this was reaction or separate illness. Covid swab, both rapid and PCR; done on 2/4/2021; both negative.
pt died of crib death on 24JAN92; coroner exam not remarkable-reported as SIDS;
PT STATED THAT NIGHT AFTER TRAINING AND HIS SHOWER HE NOTICED IT STARTED ITCHING AND A LITTLE SWELLING, THE NEXT MORNING HE HAD MORE SWELLING AND REDNESS.
Euphoria. Dizziness. Brain fog. Fever. Chills. Headache.
Baby developed  red rash / hives all over stomach approximately 4-6 hours after injection. I called the after-hours nurse line and reported it and both the nurse and doctor on call confirmed it was an allergic reaction due to vaccination.
tender arm but was still able to do her daily activities with no issues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues). At the time of the report, VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.
after the vaccine, she had a bacteria in her stomach; Dysphonic; Woke up feeling bad of the throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach) in a 49-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Reported having Coronavirus in December.) in December 2020. On 30-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DYSPHONIA (Dysphonic), OROPHARYNGEAL DISCOMFORT (Woke up feeling bad of the throat) and PYREXIA (Fever). On an unknown date, the patient experienced HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach) (seriousness criterion medically significant). At the time of the report, HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach), DYSPHONIA (Dysphonic), OROPHARYNGEAL DISCOMFORT (Woke up feeling bad of the throat) and PYREXIA (Fever) outcome was unknown.  The action taken with mRNA-1273 (intramuscular) was unknown. Concomitant medications were not provided. Treatment for the events included Clarithromycin.   This case was linked to MOD21-078280 (Patient Link).; 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.
The patient has received the COVID series and has been hospitalized.  Per the H&P-Chief Complaint   Multiple falls, dizziness. Also states driving yesterday and was getting disoriented and was "all over the place"  Reason for Consultation  Balance Issues  History of Present Illness     The patient is an 81 Right Handed male with a h/o HTN, DM, CAD s/p CABG (2000),  who presents to the ED for multiple falls. Patient says he's been having balance issues for years but has gotten worse in the last 4-5 days. He would recall having falls 5-6x/ year but acutely, has been falling more times than he can count. He has difficulty getting out of bed describing himself as being weak. He says the balance issues start immediately as he stands up.  He denies any chest pain, palpitations or lightheadedness when standing up. He is able to sit upright with no difficulty. He reports that he's hit his head multiple times because of the falls but no loss of consciousness, no nausea, vomiting or associated dizziness. He reports of chronic bilateral tinnitus that has gotten worse in the last few days as well. He usually has his ears cleaned by PCP. He also reports of having a brief period of disorientation while driving. He says he was driving on the main road then suddenly found himself on the emergency lane. Patient also reports visual hallucinations in the last two days described as seeing objects such as cups or glasses on the table that aren't there. Denies any auditory, gustatory, olfactory or tactile hallucinations. He denies any medication changes or supplement use. He denies any chest pain, shortness of breath, abdominal pain, weakness, problems with urination or numbness of the extremities.  Unknown covid vaccine manufacturer, date, and facility received.
In Febuary of 2021 I had a breast cancer diagnosis via mammogram, around the time of receiving my vaccine (I believe the timing of the cancer and the vaccination were mostly coincidental).  I have been undergoing treatment since then. On January 7th, 2022 I was diagnosed with covid-19. It started with mild congestion and coughing (assumed it was allergies). By January 7th I had a constant runny noise and my temperature was high, so then I went and got a test. By Saturday night my throat was so painful I could no longer speak and was coughing heavily. I was off of work for 10 days, all symptoms were upper respiraratory and felt similar to strep. I tested negative for influenza A and B.  Since then I have fully recovered.
Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients; Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Vial did not undergo temperature excursions.  It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022.  Treatment information was not provided.   This case was linked to MOD-2022-525860 (Patient Link).
Information has been received from a certified medical assistant concerning a 21 year old female with drug allergies to BIAXIN, CEFZIL, codeine, decongestants and antihistamines (gets "hyper" when taking) and a history of asplenia and an elevates AST and ALT who on 10-APR-2007 was vaccinated IM into the left deltoid with a 0.5 ml dose of Pneumovax (lot# 655289/0958F). Concomitant therapy included RHINOCORT. On 11-APR-2007 the patient spiked a fever of 102.8 F, was weak, couldn't get around and developed a slightly red left arm. On 12-APR-2007 the patient's arm was progressively hotter to the touch and redder. She also developed a mild runny nose. On 16-APR-2007 the patient came into the office because she was experiencing mild upper respiratory symptoms. Laboratory diagnostic studies included: a complete blood count of 26.4 white count, bilirubin of 1.3, AST of 50, ALT of 45, platelets were 441, neutrophils were 89 with 15% bands and lymphs were 1. At the time of this report, the patient had not recovered. It was reported that the patient couldn't go to school since 11-APR-2007 because she was in bed, was weak and couldn't get around. It was also reported that the patient received 2 or 3 doses of Pneumovax in the past every 5 to 6 years without reactions. No product quality complaint was involved. Fever of 102.8 F, left arm red, hot to the touch, was weak, couldn't get around, mild runny nose and upper respiratory symptoms were considered to be disabling and other important medical events. Additional information has been requested.
FACILITY ADMINISTERED BIVALENT VACCINE FOR A 1ST DOSE INSTEAD OF THE MONOVALENT VACCINE.
Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 12:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient past drug therapy included penicillin (MANUFACTURER UNKNOWN) taken for unknown indication on unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 09Apr2021 at 16:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 19:00, the patient experienced fever, chills, body aches, headache and fatigue. The clinical outcome of the events fever, chills, body aches, headache and fatigue were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had WCC and vaccinations. Prevnar 13, Rotateq, Pentacel, mother states no fever, cried some and had a rash on both arms and one leg. Everything was fine and rash resolved pretty quickly and mother unsure if it were heat related.
Severe diarrhea about a week after. It hasn't stopped. Last week or the week before I contacted my doctor through the email system in the health site and he sent me to a HCF and get a hold of gastrologist and the referral just came in yesterday for me. I took Imodium AD when I was out of town but when I got back into town, I stopped taking it and my symptoms are still just as bad. I haven't noticed any change in anything that would caused it.