chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, fever and unwell. On an unknown date, the outcome of the influenza-like symptoms, fever and unwell were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, fever and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 3 weeks ago, from the date of reporting, the patient received 1st dose of SHINGRIX on an unknown arm. The patient felt ill with flu like symptoms for a few days with a fever of around 101 degree F. the patient also had a very sore arm at injection site to touch. The reporter wants to know if patient should receive the 2nd dose. The reporter agreed to follow up.
Pfizer 4/28/21, 5/22/21. Positive on 5/26/22
Fever 100.7 degrees F x1 day, chills, headache, stomachache, diarrhea, fatigue, body aches
Flu shot while I was seated. Pain in shoulder at onset. Pain intensified and continued to this day. Have had 2 courses of physical therapy and two cortisone shots. Pain continues. Doctors now prescribing surgery.
I had one day of sweats, body aches, and fatigue in which I stayed in bed the calendar day after I got the second vaccine.  I planned to get the vaccine on a Friday when I was off the following day in case this happened so I could rest, but if I had been scheduled to work I would have taken the day off to rest based on the symptoms. I felt normal the next calendar day. I was 31 weeks pregnant at the time, had no adverse events related to the pregnancy, and am due 3/10/21 with a delivery scheduled 3/3/21; baby and mom are doing just fine.
black outs, even passed out; nausea; vomiting; This is a spontaneous report from a contactable consumers received from a Pfizer sponsored program. This is 1 of 2 reports. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EV0178; Expiration date was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced black outs, even passed out, nausea, vomiting on Jul2021. Therapeutic measures were taken as a result of the events. It was reported that patient just recently turned 18 and she had her Covid vaccine on 13Jul2021 (not clarified) and had side-effects. Date was scheduled for 2nd shot of vaccine and consumer stated that it could be 03Aug2021. For treatment in response to vent, consumer stated that the day she had vaccine, she went to the hospital and just gave me pain medicines (further clarification unknown) and some like fluids and then felt better. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Woke up in the middle of the night (2:30 am) achy in all my joints/muscles - including the injection site. HeadacheCouldn't sleep.
Patient received a second bivalent booster, patient's paperwork listed 4 vaccination dates and not the bivalent booster that was given 9/16/22.
POSSIBLE VACCINE UNDERDOSE; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination.  No concomitant medications were reported. On 01-DEC-2021, the patient experienced possible vaccine under dose. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome possible vaccine under dose was unknown. This report was non-serious.  This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209976, 20211210160, 20211210588, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209551, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209884, 20211209912, 20211209921, 20211210019, 20211210058, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210733, 20211210824, 20211212082, 20211212088 and 20211210684.
A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.
sometimes wakes her up at night; Localized Muscle Pain at her injection site; This case was reported by a other health professional and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 31st March 2022) for prophylaxis.   On 23rd September 2020, the patient received Shingrix (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the patient experienced middle insomnia. On an unknown date, the outcome of the injection site muscle pain and middle insomnia were unknown.   It was unknown if the reporter considered the injection site muscle pain and middle insomnia to be related to Shingrix.  Additional details were reported as follows: The patient received dose of Shingrix and experienced localized muscle pain at her injection site. The patient felt pain when she does a pushup and it sometimes wakes up at night. The reporter consented to follow up.
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours  on 3/16 Big Toe throbbing woke me up.  Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg.  Throughout the next 24 hours their would be sharp pains in right ankle.  Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours.  Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me.  It took 4 days for me to start to feel I was returning to normal function,  the fifth day I felt normal.  I thought this was a long time to recover from shot in comparison to what I did hear.
Expired vaccine given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Gynaecomastia (Gynacomastia male) and Anxiety.   On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) to be not related.    The patient had no known allergies. No concomitant medications were reported. It was reported that expired vaccine given with no adverse reaction reported. No treatment information was reported.   This case was linked to MOD-2022-486834 (Patient Link).
Debilitating vertigo in the middle of the night persisted for 2 straight days, accompanied by sweats, exhaustion, headache. After the two days I felt better for 4 days and then beginning on the 5th day I continued to experience light vertigo which makes it challenging to walk and move my head quickly.
Approximately 30 to 60 seconds after receiving the vaccine, the patient blacked out, his eyes rolled back and he slumped over in his chair.  He was extremely diaphoretic.  After a few seconds, he came to and was transported by wheelchair to clinic room table where ice was applied to back of his neck and fan was turned on.   EMS was called for evaluation.  Pt was not transported, vitals were stable.
VOMITING; ABDOMINAL CRAMPS; CANT SLEEP AT NIGHT, SLEEPY DURING THE DAY; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and other pre-existing medical conditions included the patient had unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced abdominal cramps. On MAY-2021, the subject experienced cant sleep at night, sleepy during the day. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, abdominal cramps, cant sleep at night, sleepy during the day, and feeling tired, and the outcome of vomiting was not reported. This report was non-serious.
Patient called 6-27-21 requesting to speak with the pharmacist regarding a medication. upon questioning, the patient reported she was still experiencing side effects from her Moderna Covid-19 vaccine and that she had a significant reaction starting the day after her vaccine was administered. According to the patient, she had tingling lips and felt unusually energetic after the vaccine similar to a manic episode of bipolar disorder. She also reporting starting to have uncontrollable chills. The next day she felt "like a wet towel" where she felt so bad she couldn't talk. She also reported aches and pains, chills, sweating, nausea and vomiting, and clear, watery diarrhea. She also mentioned she stopped urinating probably due to dehydration. Patient reported stopping her medications due to not being able to keep them down. On 6-25-21 the patient went to the hospital to be treated. She said she was given IV treatment including fluids and Zofran. They also gave her Keppra because she has a history of seizures and had stopped her medications. Patient began to feel better and was able to eat and start her medications again so she was discharged and sent home with Zofran tablets. She also reported taking Imodium tablets for the diarrhea. She states she has been feeling well recently, but is still having chills (shivering). She asked whether she could take more Zofran than prescribed and whether she should start her other medications again because she was worried about upsetting her stomach. I told her I cannot recommend she take her medication other than prescribed and I encouraged her to restart her medication due to her history of seizures. I also told her to call her doctor again on Monday to see if they have any other recommendations or concerns.
29-year-old female brought to the emergency room by EMS after syncopal episode at sick all this morning.  Patient states that she receive the Johnson and Johnson coronavirus vaccine yesterday at approximately 1500.  Throughout the evening and overnight she developed the expected side effects of myalgias, mild headache and fatigue.  She states because she was not feeling well this morning she was instructed to give us a call.  She is sick, she was sitting in a chair and when she was called to code forward she stood up, developed tunneling of her vision with spots in front of her eyes, felt dizzy and then passed out.  When she woke up the dizziness had resolved.  She states that she feels dizzy intermittently at basel
Headache, elevated heart rate, fatigue, achy joints, very swollen/painful lymph node on right side under arm of injection site.
No further AE details; HCP called to report that while giving an MMR II vaccine the needle prematurely contracted into the safety syringe, and an unspecified amount remaining in the syringe emptied onto the patient's thigh.; and an unspecified amount remaining in the syringe emptied onto the patient's thigh; MMR II vaccine the needle prematurely contracted into the safety syringe,; This spontaneous report was received from an other health professional and referred to a 30-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter, once, lot #W034714, expiration date: 18-OCT-2023, administered subcutaneously at right thigh for prophylaxis (strength was not provided); and also with sterile diluent solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration and indication were not provided). On that day, while giving the vaccine, the needle prematurely contracted into the safety syringe (Device safety feature issue), and an unspecified amount remaining in the syringe emptied onto the patient's thigh (Accidental exposure to product) (Incorrect dose administered) (AE description also reported as "Vaccine "med." came out from. The syringes were vanish point. Needle connected to the syringe"). No further AE details (No adverse event). The patient would be revaccination.
Janssen COVID-19 Vaccine EUA -  Continuous headache and nausea throughout the day since approximately 48 hours after vaccine.
Muscle pain in arm with slight weakness and "tingling" 2 wks after received immunization.
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-BI-073949(17).  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing), notes: :2 TO 3 YEARS AGO. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (12Jan2022) Increased; Blood pressure systolic: (12Jan2022) 170's; Computerised tomogram: (12Jan2022) CT SHOWED NO WORSENINGCOMPARED TO LAST YEAR; Heart rate: (12Jan2022) Increased; SARS-CoV-2 test: (12Jan2022) Positive; Spirometry: (12Jan2022) PASSED A BREATHING TEST.  Clinical Information: Patient stated she tested positive for corona virus disease (Covid) on 12Jan2022. Patient stated she had a runny nose, tired, body aches, sneezing, and sore throat. Patient stated that she had covid for about 13 days, she was not hospitalized and feels better. The reporter did not provide a causal assessment for event COVID-19, For regulatory reporting purposes, considers that there was no reasonable causal association below therapy and the events COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red circle size of 1/2 dollar at DTaP site and across top of his back to his neck under ear - Itches and red raised area.
Severe abdominal pain, back pain on Sat & Sun 01-30 & 01-31-2016, then Monday 02/01/16 started with hot then cold then on and on, no appetite, ate nothing all day, then later that day diarrhea and bad cramping started, in bed all day, same on Tuesday, and Wed. Back pain eased up on Tues and Wed, but today Thur 2-4 the back pain is back really bad but no more diarrhea. No idea if connected with Pneumonia vaccine, have never had the vaccine before, but no other explanation as food could not be the cause as husband ate the same as I.
Headache, chills, nausea, dry heaves when woke up the following morning (5/1/21) that lasted about 12 hours. Took Tylenol at 2pm and again at 8pm. Symptoms subsided around 6:30pm on 5/1/21.
My toes began to hurt me again. My toes had started to hurt me after the first COVID vaccine. After the first one, they (the doctor) had kind of written it off. It was pain on both toes primarily of both feet and my insteps were killing me too. Both of my big toes - they took the brunt of the pain. The other toes would just have a sharp pain every now and then but the Big Toes had pain in them all the time. I went to the doctor because I was in total misery. Again they acted like it didn't have anything to do with the shot. They said that I needed to have surgery on my toe - surgery  in October 15th - my big toe on my right foot. Years ago, I had a knee replacement that had somehow went wrong and it didn't go like it should have and I hadn't been able to feel anything in my foot for years and years but slowly it had started to come back a little - not all the way. But now my big toe on my right foot has really suffered - it has really been in pain after this vaccine. I have a 3:30 pm appt today for it at an Urgent Care.  I haven't been up today except to use the bathroom - I just go in and use it and come back into bed because my foot hurts so bad I don't want to fall. I have to help to do other things. My sister is coming to help me shower.
66-year-old male with a past medical history of interstitial lung disease on chronic prednisone, recurrent DVT/PE on Coumadin, hypertension, diabetes, pulmonary hypertension, OSA on CPAP, obesity who was brought to the ED by EMS for shortness of breath and hypoxia.  Patient states that he has not been feeling well for about 3-10 days.  On 1/4, he notes that he was unable to sleep that night.  Over the last 3 days, he has had diarrhea (watery stools), generalized weakness, poor appetite.  He also thinks that he may have gotten more short of breath.  He has a chronic dry cough which is at baseline.     He went to an outpatient clinic today and was found to be hypoxic to 75%.  He appeared to be in acute respiratory distress speaking in 2-3 word sentences.  Patient was placed on supplemental 10 L/min of oxygen with improvement in his oxygen saturation to 89%.  EMS was called and he was brought to the ED.    In the ED, he was requiring 10 L/min of oxygen to maintain saturation in the low 90s.  Patient tachycardic to low 100s.  Afebrile.  Labs are significant for hemoglobin of 12.5, INR 4.0.  Creatinine was elevated at 1.41.  VBG was unremarkable.  A chest x-ray revealed multiple airspace opacities throughout both lungs, worse in the mid and lower lungs.  Likely acute bilateral pneumonia superimposed upon chronic lung disease.   Patient notes that he has not used his nebulizers for a couple of days.  He denies fevers, loss of smell or taste.  No vomiting.  HOSPITAL COURSE: Admitted January 14 with 9 days of respiratory symptoms.  He was COVID positive on the 14th.  Due to symptom duration he was not a candidate for tocilizumab.  He was treated with IV steroids despite that his respiratory status worsened and he was intubated early January 18.  Post intubation he was extremely tenuous with profound hypoxic hypercarbic respiratory failure.  This was thought to due to both COVID and also aspiration of blood.  Post intubation he had diffuse hemoptysis this is thought due to anticoagulation in the setting of COVID   On top of critical respiratory function he was also in septic shock on 4 pressors.  He had deteriorating kidney function throughout the day with worsening metabolic acidosis needing a bicarb drip to buffer.   In this context we did discuss with his brother that patient is unlikely to survive and he was transitioned to comfort cares.  He was extubated January 18 in the afternoon and passed soon after
Patient received three immunizations Tdap, MENACTRA & Hep A.  After third immunization patient felt dizziness & felt better in 5 to 10 sec.  BP was 90/60.  Elevated legs, called 911.  Pt was taken to ER.
slight headaches; muscle aches; Severe fever 102-103+; low temp of 95.2; sweaty; clammy; AST 57; ALT 203; Alkaline phosphate137; EBV Nuclear 509; EBV VCAIgG>750+; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old non-pregnant female first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198, Expiry date: Jun 2021), via an unspecified route of administration in Arm Left on 01Mar2021 14:30 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothroid, Reynauds, hypertension, allergy to sulfa meds, and had Covid in Dec 2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 04:00 AM, the patient experienced Severe fever 102-103+, low temp of 95.2, sweaty, clammy, AST 57, ALT 203, Alkaline phosphate 137, EBV Nuclear 509, EBV VCAIgG>750+, fatigue, slight headaches, and muscle aches. On an unspecified date, the patient underwent lab tests and procedures which included ALT, Alanine aminotransferase: High; AST, Aspartate aminotransferase: High; Body temperature: 95.2; Alkaline phosphate: 137; SARS-CoV-2 antibody test: positive; and on an unspecified date Dec2021, SARS-CoV-2 test: Positive. No treatment received for the adverse event. Patient went to urgent care 5 days later. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Upon follow-up(22Apr2021), expiry date of dose, past medical history, adverse events, and lab tests were added; patient stated, she was advised to not get the second dose until her liver cleared; there is no product complaint to report; there is no medical information request. She was told that there is a window of time to get the second dose of the vaccine, or she will have to start over. She would like to know more about that. Confirms there are no new events to report. The outcome for all the events was recovered with sequel; outcome of slight headaches, and muscle aches was unknown.  No follow-up attempts are needed. No further information is expected.