chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, very sore injection site, tired feeling, nausea, slight headache.  I had the chills, couldn?t get warm.  Got worse during the night.  Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness.   Slept almost  all day 1-19-21.  Spiked low grade fever during the night.  Worked 1-20-21, but extremely sleepy.  Injection site got hot and red.    Slept 12 hours that night.  Went to work 1-21-21 feeling good, just still a little arm soreness.
big localized injection site reaction described as redness, swelling, and pain; redness; swelling; pain; Initial information received regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 08-Nov-2019.  This case involved 2 child patient of unknown demographics who experienced big localized injection site reaction described as redness, swelling, and pain (Vaccination site inflammation) and redness (Erythema), swelling (Swelling) and pain (Pain) while the patient received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.   On 07-Nov-2019, after receiving the vaccine the patient experienced big localized injection site reaction described as redness, swelling, and pain (Vaccination site inflammation) and redness (Erythema), swelling (Swelling) and pain (Pain).  Other relevant tests included No lab data was reported.  Corrective treatment was not reported.  Outcome of the event was unknown at the time of reporting.
Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, who was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (unspecified). Subsequently, the patient experienced severe injection site pain at the time of immunization. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Almost 2 weeks after the first shot I noticed a red ring about 3 inches in diameter where the shot had been given. It itches and is hot to the touch. 4 days after this popped up it seems larger and more itchy
chest tightness, throat swelling, diff breathing, hives, onset approx 1hr p/vax tx w/DPH, solumedrol;transfer to another ER;
Patient is a 83 y.o. male patient of CNP with history of moderate aortic valve stenosis with preserved systolic function, bipolar disorder,  benign prostatic hypertrophy, COPD, hypertension, hyperlipidemia, diabetes mellitus, iron deficiency, and essential tremor.  He was admitted on 12/7/2022 with shortness of breath and dizziness.   Acute hypoxemic respiratory failure Covid-19 pneumonia Presenting with dyspnea, cough, and fever.  Chest x-ray showing patchy bilateral opacities on admission, COVID-19 testing positive Date of onset of symptoms: 2 to 3 days Symptoms present on admission: Cough, dyspnea Date of covid positive test: 12/7/2022 Vaccination status: vaccinated, received 3 mRNA vaccines Imaging: Chest x-ray showing scattered bilateral opacities Oxygen requirements on admission: 2 L nasal cannula Current oxygen requirements: Weaned to room air 12/10/2022 Medical therapy: remdesivir and steroids Consultants following: Infectious disease Anticipated special isolation end date: 12/16/2022   Acute kidney injury: Resolved Suspect most likely prerenal in the setting of decreased p.o. intake from COVID-19.  Home NSAID contributory as well.  Now resolved with IV fluid resuscitation Trend chemistry Avoid nephrotoxins   COPD Community-acquired pneumonia with haemophilus influenza Continue as needed albuterol IV antibiotics with ceftriaxone Discharged home on oral cefdinir   Positive blood culture Rule out sepsis 1 out of 4 blood cultures positive on admission, strep on molecular testing, final speciation pending Repeat blood culture with no growth, suspect most likely contaminant Infectious disease following, antibiotics discontinued with low concern for bacterial infection.   Sinus tachycardia: (Resolved) Likely physiologic in the setting of COVID-19 infection and dehydration Discontinue beta-blocker started on admission Status post fluid resuscitation as above   Hyperglycemia/history of diabetes mellitus A1c 7.6 on admission Hyperglycemia likely stress-induced this admission due to steroids Increase NPH with steroid dose to 15 units Sliding scale insulin  Benign prostatic hypertrophy Continue home finasteride   Depression: Continue home Effexor
He too started a couple days later experiencing these type of situation, these type of pains; he too has suffered from that and to this day;; still have that in our muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ9943) and as dose 2, single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "He too started a couple days later experiencing these type of situation, these type of pains; he too has suffered from that and to this day;"; MYALGIA (non-serious), outcome "unknown", described as "still have that in our muscles". Therapeutic measures were not taken as a result of pain, myalgia. Additional Information: Reporter stated, "Sometimes I don't hear really well. Well, you know, I had the second booster I believe it was like 05Apr and so that mean my fourth shot okay, my fourth Pfizer shot. I had the two regular you know, in the beginning, I had everything recorded in my little card and everything and now I had the first booster and then I had the second booster I think it was like maybe 8 months later. So, I did not had any reactions to the first three but on this particular second booster, I have had a terrible reaction to my muscles and my joints and I have been fighting this since, well I got the shot on 05Apr, it seems like the 6th was fine I had no, by the way I had no, I don't remember you know, anything major with the other ones like red arms or anything like that but this one the first day nothing, second day same nothing but the third day I could not move, I could not get out of bed. My muscles and joints were like frozen, and I just could not move out of bed and it took me quite a while to find and I am an active person by the way it's not like I am not an active person and so, I don't remember exactly how it finally happened. I think, I kept rubbing my leg or trying to make it move or helping it to move with both of my hands, but it was hard to do that too because the main muscles in my upper arms were so sore and my legs. So, when I would stand up it seems like it was just intense pain that went from my I guess just under my shoulders. I guess it was around through the bicep starts you know, the bicep and all the way down my body and I could hardly walk." Treatment for Adverse Event: Reporter stated, "No, he did not. He did not take it; he did not go to the doctor. I went to the doctor and, but he did not, but he experiences the same muscle but not as intense as mine but in the same area the biceps and the hips and the lower back." No follow-up attempts are needed. No further information is expected
The patient's guardian requested Moderna for the underage patient.  The patient was given the Moderna vaccine; however, the patient is not of age to receive the Moderna vaccine. The pharmacist administering the shot was aware of the age and that Moderna is 18 and older; however, still administered the shot by mistake.  The patient's legal guardian was notified of the mistake as soon as the error was caught by the pharmacist that gave the shot.
No adverse effects were reported; the patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.  On 26-APR-2019, the patient was inadvertently vaccinated with an expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) (route of administration and doses were not reported; lot # N012619 and expiration date 21-APR-2019) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No temperature excursion. No adverse effects were reported. No additional information provided.
Patient with history of tongue cancer several years ago with partial glossectomy but NED; in January 2022, developed new SSC of tongue on same side as last time.
Patient stated it was his 3rd dose of the pfizer vaccine when it was actually his 6th dose. So far after talking to him he had no side affects.
Starting the evening after receiving these two vaccines, the child woke in the middle of the night for a feeding and had jerking, seizure like spasms every few seconds lasting 5-10 minutes. Her arms and legs would have involuntary spasms as well as some facial muscle spasms. This continues over a week and a half later, with occasional involuntary jerks of the arms throughout the day. Seizures have been ruled out through an EEG but the cause is still unknown.
Pt recvd vax & became red; there is & was no pain, no swelling & no break in skin, just a mild red rash; ATB given;
Beginning day of vaccine -Dizziness, disorientation, extremity fatigue beginning in legs and then moving to the arms and neck. severe arm weakness with muscle tremors from abdomen to hands.  Extreme full body fatigue, difficulty breathing, shingles, pain swelling and tenderness at injection site.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 43-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 43-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
He came to school clinic about hour after receiving FLUMIST. Said he had headache. T 101.8 degrees. Called Mom, when she got here temp was 102.8 degrees. Mom said he had a scratchy throat this morning. Advised Mom to call his doctor.
Fever, aches, chills, dizziness, nausea, diarrhea, headache Treated w ibuprofen and rest
Information has been received from a medical assistant concerning a patient (age and gender unknown). On 07-NOV-2012, the patient was vaccinated with ZOSTAVAX (H016230; 30-NOV-2013) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012, the medical assistant noted that the patient was administered ZOSTAVAX that were exposed to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days). No adverse effect reported. At the time of the report, the outcome of the event of ZOSTAVAX were exposed to  temperature excursion that was not supported (38 degrees Fahrenheit for 14 days) was unknown. Additional information has been requested.
Patient with a PMH of Copd with oxygen at home.  ESRD on HD, and tobacco use.  He presented to Medical Center on 02/21/2022 with complaints of progressive dyspnea on exertion eventually leading  to dyspnea at rest.  Patient stated sleeping in tripod position.  Patient admitted to hospital for respiratory failure, Covid-19 and ESRD.  Chest X-ray revealed bilateral pleural effusions with marked interval increase in large left pleural effusion, left lung atelectasis with bilateral airspace disease.  Patient had ST changes on EKG, and elevated troponin.  Patient expired on 03/09/2022.
Full body rash; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history includes auto-immune disease and hypercoagulation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and hydrochloride; all from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021, the patient experienced full body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of full body rash which included treatment with diphenhydramine hydrochloride (BENADRYL) and cortisone cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hives immediately, ear aches and diarrhea within3-4 days, waking up screaming about her leg hurting5-7 days after. High fever 8 days after. Bumps showing back up near where the hives were from by the MMR vaccine.
Deep pain in arm by second day and had to take Advil during second night. Arm became red and raised by third day and remained red for a week.
Caller had a circle rash around the site of injection/ Rash; if she rubbed the area it becomes raised and It is also hot; if she rubbed the area it becomes raised and It is also hot; itching started first time around; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-year-old female patient received (COMIRNATY, solution for injection, Batch/Lot Number: EL9269, expiration date: not reported) on her left arm via intramuscular route on 03Feb2021 16:55 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included blood pressure. Historical vaccine included that patient previously took tetanus vaccine for immunization and experienced that her arm got as big as a golf ball. Concomitant medications were not reported. The patient did not take prior Vaccinations within 4 weeks. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No additional Vaccines Administered on Same Date of the Pfizer Suspect. On 06Feb2021, the patient had a circle rash around the site of injection. Patient stated that if she rubbed the area it becomes raised and It is also hot. Patient questioned is it normal or Should she worry. It has been about 10 days since she had the first vaccination, clarified it was the Pfizer covid vaccine. She did not have any effects till the third day. She had a rash and a circle around the site and then it went away. Now it is a bigger circle, and it is hot. Asking if this is normal. She clarified that she had the rash for about two days, then the rash went away, she had 24 hours of nothing, then all of a sudden the rash appeared again. The itching started first time around, she took Allegra for a day or two and the itching stopped, then when the itching started again, she took Allegra so she did not get the itching again, states she is trying to get ahead of the itching. The patient stated that she does not think her medication is relevant to add and she takes stuff the elderlies get. She mentioned blood pressure. Therapeutic measures were taken as a result of the events. The outcome of the event caller had a circle rash around the site of injection/ Rash was not recovered, itching started first time around was recovered on an unspecified date in 2021 and if she rubbed the area it becomes raised and It is also hot was unknown.  Follow-up attempts completed. No further information expected.
Expired dose administered to patient; 28 years old patient got Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.   On 05-MAY-2023, the patient received Bexsero. On 05-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired dose administered to patient) and inappropriate age at vaccine administration (Verbatim: 28 years old patient got Bexsero). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. An expired dose of Bexsero was administered to a 28 years old patient, which led to expired vaccine used and inappropriate age at vaccine administration.
Pt came in on 5/23/16 states that after receiving PCV13 she had a discoloration of the upper arm at injection site left deltoid.
Localized allergic reaction to vaccine administration site approximately 10-12 hours after administration, impressive swelling, redness, warm and painful to touch; slight edema of the upper eyelids; Patient complains of Headache and dizziness as well.  Patient treated with Hydroxizine PRN; cool compresses to the area.
Approx 16 hours after vaccination patient began experiencing aching joints and muscle pain approx 20 hours after vaccination he began getting a fever - fever reached 102.7.  Approx 40 hours after vaccination fever would not go down took him to minor emergency where they kept him for 4 hours giving him an iv to re-hydrate him and got fever down to 100.3 and sent us home.  Upon arriving home fever increased again to 102.4.  At approx 52 hours after vaccination fever began to break.  Patient spent 5 days in bed, missing 3 days of work.  Could not eat for 4 1/2 days of this.
Pt received J and J vaccine on 3/16/21 and did not inform the clinic. Pt received moderna vaccine at the clinic on 3/29/21. No adverse reaction noted.
A non-serious, spontaneous report of Influenza A has been received from a physician concerning an 8-year-old male patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 03-Oct-2009. On 05-Oct-2009, the patient experienced sore throat, cough, and fever. On 05-Oct-2009, the patient tested positive for Influenza A. The outcome for the reported adverse event was not reported.
Client stated before injections she was afraid. Immediately after injection client became pale and asked for water. Returning with water. Client appeared to be fainting, then started shaking as if she was having a seizure. Nurse supervisor & charge nurse was called and arrived within 1 minute. Client stated she had never had that reaction before. Given referral to PCP.
RECEIVED FIRST DOSE MODERNA #ER8733 RECEIVED SECOND DOSE PFIZER
GOT GUILLAIN-BARRE SYNDROME FROM THE FLU VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of Guillain Barre Syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got Guilain-Barre-Syndrome from the flu vaccine. This case has been linked with US2020AMR232526 and US2020AMR232534 (same reporter and same events).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232526:same reporter US-GLAXOSMITHKLINE-US2020AMR232534:same reporter
This study case was received from the investigator in a trial on 05 July 2013. A 19 year-old male subject with no significant past medical history had received the following vaccines on 16 September 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax (other manufacturer; lot number, route and site of administration not reported), Hepatitis A (other manufacturer; lot number, route and site of administration not reported), and Hepatitis B (other manufacturer; lot number, route and site of administration not reported). The subject experienced encephalitis following immunization procedures at 8 days post-vaccination on 24 September 2009. The Troponin I result, ECG and Echocardiogram were not performed. Lumbar puncture and MRI of the brain, spinal cord and heart were also not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Information has been received from a physician concerning a 12 month old male who on 07/15/2004 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy that day included COMVAX.  On 06/21/2004 the patient was cranky, sleeping poorly, had fever of 102 and was tugging on ears.  On 06/28/2004 the patient was taken to the emergency room for febrile seizures.  On 07/23/2004 the patient was taken to the emergency room and started on Azithromycin for an ear infection.  On 07/26/2004 the patient was taken by ambulance to the hospital with febrile convulsions, 6 minutes in length of time.  On 07/25/2004 the patient was seen by a physician for follow up visit and no ear infection was noted.  The patient was scheduled for an EEG in August.  No product quality complaint involved.  Upon internal medical review febrile convulsions were considered to be other important medical event.  It was also noted that another patient experienced adverse events following vaccination with MMR II (WAES # 0408USA00365).  Additional information has been requested.
Bilateral leg pain, tingling,  and weakness, abnormal period- one week early, heavy, and painful