chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported being dizzy, lightheadedness, about 5 minutes after shot. She was given orange juice while sitting in a chair, pt did not want to lay down on ground. After another 5 minutes or so the pt fainted, losing consciousness for about 5 seconds. She continued to feel poorly so 911 was called and pt was taken to hospital.
Lt deltoid swelled, got itchy, red, and hot for a couple hours. Better today but still has a lump by site of injection.
I felt like was getting a cold. I had body aches fatigue, headache, mild sore throat. Around noon I found out from my aunt that she had COVID-19. So I thought that my symptoms were COVID-19 , I test at home and it was negative and I realized that I was getting brain fog. The next day I tested positive for COVID-19. I called my doctor on Wednesday and they told me I needed a positive test for PAXLOVID. I still had body ache, congestion, brain fog, fatigue with bad congestion. I cancelled my PCR test because I had a positive test at home. On Friday I talked to my doctor and got the PAXLOVID. From that point forward I was really weak and tired and could barely sit up for a week. There was no sign of improvement for a while and around 6/30 I started to feel better. I was feeling better 7/3. I was fatigue and little congested after but feeling better. I was really out of it for about 10 days. But there was a progression starting on day 9.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Patient reported dizziness and motion like sicknes after 15 minutes of vaccination, patient also reported taking Clonazepam 15 minutes after vaccination. Patient remained monitored at the pharmacy for an additional 15-20 minutes and drank orange juice and felt much better.
I received a Moderna booster for COVID-19 on 12/7/2021. On 8/5/2022, I began to get an itchy, scratchy throat around noon. Later that evening, my eyes also began to itch. When I woke up the morning of 8/6/2022, I had a mild fever and body aches. I went to a testing site that day and took a PCR test, which indicated that I had COVID-19. After that, I self-isolated for 5 days. During those 5 days, I had fever, cough, body aches, runny nose, and fatigue. By day 5, the fever was gone, as was the fatigue. However, I had a lingering mild cough and nasal congestion. I treated my symptoms with OTC decongestants, pain relievers, and cough suppressants, which all helped. Even though I had a lingering cough and congestion after the first 5 days, I felt well enough to return to my normal activities. When I resumed my normal activities, I always made sure to mask. I am also happy to report that my senses of taste and smell were not affected. Also, I don't know if this is related to the booster or the bout of COVID-19, but in September 2022, I began to feel increasingly fatigued. I was really concerned that this could be a sign of something serious, so I contacted my doctor on 11/17/2022. My doctor ordered blood work to test for diabetes and other conditions. Thankfully, it turned out that I did not have diabetes. However, I did have iron deficiency anemia. I am currently treating it by taking 650 mg of iron a day. I now have more energy, but when I had more lab work done on 12/1/2022, the results did not indicate much of a change since the lab work from 11/17/2022. My hemoglobulin level was 8.8g/dL on 11/17/2022, and it was 9.8g/dL on 12/1/2022.
Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
About 1 or 2 weeks later, started with fatigue/exhaustion and rash across chest. About 3 weeks after vaccination date went to pharmacist did not provide a treatment recommendation other than rest. Later called nurse. Today patient still has rash--it has not changed/improved--, but does not feel as tired as before. At the moment patient is dealing with others medical issues not related to this event. Patient reports that did not have problems after shingles vaccine years ago.
Hello, FYI we don?t have the right that Lot number and we cannot find that but I wanted to report that after the second dose of the Moderna vaccine, I?ve experienced double my period. This means that I am getting a full-fledged, heavier pier than normal every two weeks. It?s an incredible side effect that I am 90% sure it?s coming from the vaccine. I?ve never experienced this before. I am going through ultra which are larger than super plus tampons, every half hour and I have two periods a month, with all the bells amd whistles lol  I have had three rounds of this double period since the second dose of the vaccine.
The day I received the vaccine I did not notice any symptoms. The next day, I woke up feeling nauseous and my vision seemed a bit blurry when driving to work. As the day progressed I noticed feeling increasing dizziness and elbow pain in the arm I received the vaccine in.
The day I received the shot I had no issues the next morning I woke up and felt bad. I felt like a had a temperature but I didn't. I had chill, body aches, headache and back pain and bone pain. I  had a hard time with my left arm when it came to rang of motion because of a lump in my breast ( left). I was suppose to have my annual test but they couldn't because it has to be 10 weeks after my vaccine. Then I went April 11 I got my ultra sound and mammogram.
Urticaria to anterior and posterior trunk beginning approximately 2/21/09 progressing in intensity. No respiratory distress noted.  Patient evaluated by NP and prescribed Prelone and Benadryl.  Caregiver states received a "shot" in 10/08, but at earlier visit, had denied that it was immunizations.  CG brought immunization record and appears that a Varivax had been given at this time.
I had the first shot on Thursday evening, I felt fine throughout the evening. Friday woke up with a headache and sore arm. Friday afternoon my headache worsened,  I had a tempature between 101 and 103 and severe chills. I was nauseous and fatigue.  This continued through Saturday. Tempature and chills went way by Saturday evening.  Sunday most all symptoms are gone.
No additional AE; Physician calling to report a TE VARIVAX. HCP stated that the vaccines were administered to a patient on date of administration in July 2023.; This spontaneous report was received from a physician and referred to a 13-year-old patient of unknown gender.   The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unspecified date in July 2023, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # X006981, expiry date: 07-MAR-2025), the second dose for the series (dose, strength and route of administration were not provided) for prophylaxis (Product storage error). The vaccine was exposed to 28 Fahrenheit (F)/14 F to 46 F for 15 minutes 0 seconds. There was no previous temperature excursion. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA007382:
Fever 102 degrees to 104.5 degrees starting 6 hours after lasting 5 days. Systemic confluent erythematous rash starting 4 days after vaccine.
shaking; fever; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case is linked to cases 2019SA276203 and 2019SA276197 (same reporter).  This case involves a 81 years old male patient who experienced with sepsis (Sepsis) and fever (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 01-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient experienced fever (pyrexia) and shaking (tremor) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   No Relevant laboratory test reported.  Final diagnosis was sepsis and fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovered for the events (lasted several hours).
Patient came to see me in the office on 4/12/21 and reported an adverse event that had happened after he got home from the drive thru vaccine clinic on 3/17/21.  He had the vaccine around 11 am and later that evening, he is not positive of the time but between 7-9 pm, he developed severe swelling of his face and lips and tongue, he also felt nauseated.  He called EMS and they found his bp to be low.  He was not given EPI.  His symptoms resolved on their own but reoccured the following evening; he went to ER and was monitored there; he was not given EPI at the ER.  He was not admitted to the hospital.  Symptoms have not reoccured and he is asymptomatic at this time.   He was not sure if this was releated to the vaccine, but could not identify any new environmental or food items that would have triggered the reaction.
SkinRash & Rash Narrative:  Itchy skin rash. Resolved with Benadryl
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted but regained his consiousness shortly after, he was observed for 1 hour after the incident, I called the parent on 4/9/21 and father said that he is doing well and back to normal
energy level dropped to zero; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose), for Covid-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset 26Apr2021, outcome "unknown", described as "energy level dropped to zero".  Additional Information: The patient was in his 40s. His energy level dropped to zero yesterday after he received his 2nd Pfizer Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left sided lower back pain; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stroke.   On 5th November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2022, 1 days after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.     Additional Information: GSK receipt date: 13-SEP-2022 Reporters comment: The reporter was the patient he received the first dose of shingrix and an about 24 hours after started with left sided lower back pain.  The back pain was still present. The reporter did not consent to follow-up. Note-As per narrative about 24 hours after his vaccine, he started with left sided lower back pain ,so the event started from after 24 hours the event onset date captured as 6-NOV-2022 so time to onset auto calculated as 1day that was 24 hours also.
night of 9/23/2020 repeated bathroom trips 10-20 minutes apart   signaled by spasm in abdomen   weakness   compromised balance   not wanting to get out of bed all day 9/23/2020   no hunger   persistent soreness in left arm
Awoke at 5 am 4/27/2021 with left shoulder soreness and chest pain. Intermittent shortness of breath and tingling on left-side of head (over the next few hours) instigated trip to emergency room (no ER in my area; went to ER outside of my area). EKG administered upon arrival at roughly 11 am. Hourly blood pressure monitoring indicated high and low moments, but nothing very worrying. Chest X-ray also performed. I went home around 10 pm after two doses of nitroglycerin.  Second similar event occurred on 4/29/2021 around midnight. Similar tests, monitoring and yielded similar results. Over the next few months, I experienced repeated shortness of breath and what felt like irregular pulse. I was asked to home monitor blood pressure. Often yielding swings of somewhat high to somewhat low. Experienced some chest discomfort and shortness of breath, but never again to the point of needing an ER visit. Could not exercise. I was feeling much better by 7/2/2021.
As soon as vaccine was injected, patient arm swelling and hives appears; swelling continued down arm for over 20 minutes. Benadryl given. Mom was upset and wanted to go to hospital by ambulance. By the time they arrived at ER, swelling was way down.
Patient reports severe swelling, redness and pain (one day after administration of flu and pneumo) in left upper arm. Left deltoid was injection site of pneumo and flu. Pt c/o itching day 3. Tx: ice/MOTRIN.
Allergic rxn 4-6hrs post vax developed swelling & redness of hands & feet; Swelling & redness around mouth; Itching present; Inject site normal x/some soreness;
Sore arm, fatigue, chills & low fever, body aches. Lasted about 48 hours.
DOSE ADMINISTERED AFTER IMPROPER STORAGE AND HNDLING(E.G.MORE THAN ALLOWED TIME AFTER FIRST VIAL PUNCTURE)
After getting MMR/Chicken Pox, he could no longer talk, comprehend, language further damage. UL DPT on 10/15/2001. Running in circles, loss of eye contact, loss of speech, loss of understanding speech.   A follow up report received 6/5/2003 adds: Diagnosed with Autism 12/02. 60 day follow up received on 8/6/03 states he cannot speak as he did before he got his shots and does not understand language as he did before. Also, lost coordination.
A few minutes following vaccine administration, client became unresponsive with jerking movements which lasted for 15 to 20 seconds. Client became responsive immediately afterward. Juice given and client was observed for 15 minutes. Recovered fully. No injury. No fall.
Information has been received from a physician concerning a 21 year old female who on 17-JAN-2008 was vaccinated with Gardasil. On 17-JAN-2008 the patient experienced swollen eyes. The patient experienced swollen eyes after receiving her second and third doses. No further information about the first dose was available. The patient sought unspecified medical attention. Subsequently, the patient recovered from swollen eyes. Additional information has been requested. Information has been received from a physican concerning a 21 year old female with a history of sulfonamide allergy who on 18-JAN-2008 was vaccinated with HPV vaccine (lot number reported as 046901 around 12:55 pm. At 1:10 pm on 18-JAN-2008 the patient experienced swollen, itchy eyes. The patient experienced swollen, itchy eyes after receiving her  second and third doses. Conflicting information was received during follow up from the physician regarding the date of vaccination and AE onset date. No further information about the first dose was available. The patient sought unspecified medical attention. The patient was given XYZAL and monitored in the office. The patient left at 1:45 pm in good condition. Subsequently, the patient recovered from swollen eyes. No further information was  available.
Patient came in 10/18/22 to let us know her arm is still sore/painful to raise past her shoulder. Received vaccine on 9/8/2022. Patient referred to PCP for consultation.
After vial was needle punctured it was immediately returned to fridge; Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported.  It was reported that the vial was initially stored in the refrigerator on 05 May 2022.  It was reported that the vial was first punctured 09 May 2022 at 5:00 P.M  It was reported that the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F a few seconds  after vial was needle punctured and it was immediately returned to fridge.  No treatment medication were reported.
Pt presented 2 days after vaccine administration with swelling and redness at PCV vaccine injection site with some fatigue, but no fever or other constitutional symptoms. Cold compresses and PO ibuprofen for symptomatic treatment. Was asked to call or return for an appointment if symptoms worsen.
tested positive for COVID-19 on 07Apr2022; AE regarding lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy). At the time of the report, COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive for PCR test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient took booster dose on 05-Jan-2022. No treatment medication was reported.  Company comment:This spontaneous case concerns a patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19 , about 3 months and 2 days after receiving the booster dose and about 1 year, 2 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses of primary series was approximately 28 days. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19 , about 3 months and 2 days after receiving the booster dose and about 1 year, 2 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses of primary series was approximately 28 days. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the parent, reported that a 28-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 vaccination. Medical history included Crohns disease (caller concerned because HUMIRA causes immunosuppression). Concomitant medication included adalimumab (HUMIRA) for Crohns disease. After the first dose, the patient became "deathly sick" with the following: high fever, throwing up, massive migraine. These symptoms occurred approximately 5-7 days post vaccination. The patient went to ER (emergency room) and was given IV fluid for dehydration, no other diagnosis, but was told it could be related to the dose of vaccine. The outcome of the events deathly sick, high fever, throwing up, massive migraine and dehydration was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Vesicular bumps were noticed at the injection site of the varicella vaccine. There were two lesions noted. They did seem to itch the baby a bit. Fever began that evening-101.5F  Reassured that this is likely a moderate vaccine reaction. Baby seemed happy and comfortable. Verified that parents have had chickenpox or the vaccine. Asked to f/u if it worsens. Ok to use Children's Benadryl for itching if needed. F/u if fever lasts more than 3 days or with concerns.
Numbness in arm started the day after getting covid injection, J&J 4 wks ago.  Location of numbness was pinky and fourth finger now pinky and thumb.  Also from elbow down.  Arm feels tired but not weak.  Gets random sharp feelings in arm at times.  Gets an intermittent cooling sensation on arm also.
Information has been received from a physician's assistant concerning a 78 year old male who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Oct 28 2004 the patient was seen in the doctors office and diagnosed with cellulitis at injection site which went down to elbow of left arm. The PA reported that the patient did not have a fever and that she could not read treatment given in the patients chart. It was also reported that the patient recovered (date not reported). It was also reported that one other patient experienced adverse effects following vaccination with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) (WAES0412USA01259). there was no product quality complaint involved. Additional information has been requested.