chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm  to the touch at the injection site; feeling irritated and itchy; feeling irritated and itchy; injection site felt like a mosquito bite; puffiness at injection site/swelling of injection site; redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm  to the touch at the injection site), PRURITUS (feeling irritated and itchy), IRRITABILITY (feeling irritated and itchy), VACCINATION SITE BRUISING (injection site felt like a mosquito bite) and VACCINATION SITE SWELLING (puffiness at injection site/swelling of injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE SWELLING (puffiness at injection site/swelling of injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 30-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm  to the touch at the injection site), PRURITUS (feeling irritated and itchy), IRRITABILITY (feeling irritated and itchy) and VACCINATION SITE BRUISING (injection site felt like a mosquito bite). On 01-May-2021, VACCINATION SITE WARMTH (warm  to the touch at the injection site), PRURITUS (feeling irritated and itchy), IRRITABILITY (feeling irritated and itchy), VACCINATION SITE BRUISING (injection site felt like a mosquito bite), VACCINATION SITE SWELLING (puffiness at injection site/swelling of injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medications included Tylenol, ice, and aloevera lotion
Patient passed out / fainted about 10 minutes after shot. Ambulance was called, medics took patient to hospital after taking vitals. This was the patient's 3rd Moderna shot.
DISCHARGE DIAGNOSES Acute Hypoxic Respiratory Failure - secondary to covid-19 pneumonia   HOSPITAL COURSE 90 year old male who has a history of hypertension came tot he hospital for shortness of breath.  It is noted he is vaccinated against Covid-19 but has not received his booster at this time.  Upon arrival to the ER he had been having symptoms for 10 days prior to admission.  In the ER he was noted to be hypoxic with sats at 76%.  Initially the patient required up to 12 L via high flow nasal cannula, but made steady and fairly rapid improvement over the past 3 days, weaned down to 3 L via nasal cannula.  Patient has been very adamant to go home for the last few days.  Patient passed PT OT.  Slum score was 21 out of 30.  Patient does show ability to make his own decisions.  Case was also discussed with family who will help support him.  With his advanced age, O2 needs, increased risk for decompensation, would prefer patient stay in the hospital at least another 1 to 2 days for additional monitoring, but patient remains adamant he like to go home.  Recommend patient follow-up with with his PCP in 1 week.  Will continue with dexamethasone 6 mg daily to complete a 10-day course.   Acute Hypoxic Respiratory Failure - secondary to covid-19 pneumonia - per the notes he has had these symptoms for ~11 days now.  Sepsis ruled out.  Metabolic encephalopathy due to covid has improved, appears he is back to his baseline.  - Home O2 ordered, 3 L at rest, 4 L with exertion  -CRP trended down from 29.6 -- >  9.9  - procal noted to be 0.16 - no antibiotics indicated  - Patient received Decadron 6 mg IV daily in the hospital, will discharge with another 7 days to complete a 10-day course orally. -Elevated D-dimer due to COVID infection; bilateral lower extremity ultrasounds prior to discharge performed ruled out DVT     AKI - Ruled out.  Did have mild acute renal insufficiency.  creatinine only rose to 1.29, now 1.06.
Hoarseness/laryngitis, Herald Patch of pityriasis rosea appeared.  Next day rash spread throughout body.
4 month old female accompanied by parents with upper respiratory infection symptoms x 6 hours. Primary symptoms include a fever after receiving their vaccination earlier today.  Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel.
no initial reaction.  24 hours post vaccination bruising present at injection site spreading to swelling which spread from the shoulder to the elbow.  patient stated the entire surface of the arm was raised, red and swollen.  1 week after there is no residual swelling and minor bruising left.  no bursitis, no tingling, no pain currently.  injection site based on bruised area was correct.
This spontaneous report as received from a physician via office manager regarding approximately a 63 years old male patient. Patient's current conditions included hypertension and GERD (gastric esophageal reflux disease). Patient had no drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number was reported as H013399 and expiry date was 07-MAR-2014) 0.5 cubic centimeter (cc) once intramuscularly. Dose number was not reported. Concomitant medications included losartan potassium 50 milligrams (mg) and omeprazole 20 mg. Approximately on an unspecified date in November 2012, the patient experienced swelling, tenderness and pain at the site of injection. The physician also stated that the patient had redness at the site, the size of an orange. No diagnostic studies were performed. The patient sought medical attention (consulted office). No treatment was given. The physician also stated that the patient was all better now. The outcome of all the reported events was recovering. Additional information has been requested.
Information has been received from a health professional concerning a 12 month old female with no known drug allergies and no significant medical history who on 5/18/01 was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live (o.5cc) (lot 637671/1609K). There were no concomitant medications. It was noted that there was no rash at the injection site, post vax. On 5/22/01, 4 days post vax, the pt broke out in "shingles". The 1st lesion was on the right hand then vesicles and pustules on right arm and right shoulder on the C6 nerve root. It was reported that the pt was asymptomatic except the 15-20 clusters of herpes zoster. On 5/26/01, the pt was seen in the doctor's office and was afebrile, however she did have a fever of 101F on 5/29/01 at a follow-up doctor's visit. The child's mother reported she had the fever for a few days and was also irritable. She was not hospitalized. It was noted that the child did not have any known history of chicken pox and that she was dx'd with shingles by an infectious disease physician. It was also noted that the child had no recent exposure to chicken pox or shingles. Follow-up information has been received from a health care professional who reported that the preliminary PCR results from this case's scab specimen were VZV positive. It was noted that the specimen was "positive only at 1 site-the 222 site" so she is not sure if she will be able to get further results. Follow-up information has been received from a health professional who reported that the scab submitted for testing was VZV (+) and the PCR analysis identified the presence of WTV. The child has fully recovered.
Approx 3hrs after vaccination became warm, flushed, diaphoretic, heart racing, weak, hands tingling, nauseated, abd cramping, pale. Could only walk with assistance, cool compresses applied, episode lasted 20 minutes. Transported to ED. EKG, Labs, Vitals..normal.. observed and discharged. 5/15/08 stable/recovered.
abnormal sleep patterns; sleep problems/Sleep is worse after the covid vaccine; sleep problems/Sleep is worse after the covid vaccine; This is a spontaneous report from a contactable healthcare professionals. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 23Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included depression anxiety and ongoing sleep problems. There were no concomitant medications. It was reported that the patient got the first dose and had abnormal sleep patterns on an unspecified date. It was reported that the patient was concerned that the Pfizer vaccine may contain something that could damage her brain and make it so she can't sleep. She stated she has existing issues with sleep so she is unsure if the vaccine has affected her sleep or not. She just wants to know if there is something in it that could affect her sleep. Added that she was able to fall asleep that night and then woke up in the middle of the night but that is not unusual. Added she has problems with sleep anyway and she is wondering if there is anything in the vaccine that could interfere with her sleep or could cause you to not be able to sleep. It was reported that the patient's sleep is worse after the COVID vaccine. She wanted to know if it is because of the vaccine. She is scheduled for the next dose on 13Feb2021.
Shortness of breath started later in day on day of second vaccine (4/20/21) . Presented to hospital 4/25/2021 with chest pain and shortness of breath. Found to have large pulmonary embolism and elevated troponin. Patient was discharged on 4/28/2021 on apixaban. Patient did already have lower extremity vein disease and previous ablation to right great saphenous vein in 2019. Has family history of pulmonary embolism in her sister. Patient was also on depot medroxyprogesterone acetate injections.
Exhaustion, Stayed in bed all day; Slept all day; Sore throat; Swelling in left neck (side of injection); Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)), CHILLS (Chills), FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)) and CHILLS (Chills). On 26-Feb-2021, the patient experienced FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day). On 03-Mar-2021, OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)), CHILLS (Chills), FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included antihyperlipidemic medication.  Treatment for the event included paracetamol.
Mom reports "hard, red lump" at injection site, 7 days, post vax. Noticed several other similar lumps on unvaccinated arm, leg and trunk. Saw MD and was treated with Benadryl. Mom reports lumps are resolving, 12 days, post vax.
Information has been received from a nurse practitioner concerning a patient who on 24-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The nurse reports the products were stored in the wrong spot in the office and varicella virus vaccine live (Oka/Merck) was given inadvertently. She does not feel that this was a product confusion, it was a case of human error. No adverse events reported. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Patient received vaccination and proceeded to post-vaccination waiting area. After being seated approximately 5 minutes, the patient began to slump over but did not faint. The pharmacist approached the patient, who was then reporting that his heart was racing, he was having hot flashes, and felt faint. His blood pressure was 151/106 and HR 116. Emergency services were contacted; EKG was normal and patient did not need to report to hospital for further care. Patient felt better approximately 45  minutes post vaccination and left at that time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: G12524) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Lot number: ER8730), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 30Jan2023 to 04Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine to vaccination failure and COVID-19 cannot be ruled out.
CHILD RECIEVED 2 VARICELLA VACCINE DOSES, 2ND ONE 9/13/07.  DEVELOPED CHICKEN POX DISEASE 8/15/08.  CONFIRMED BY EXAM BY MD
Patient states she received her Pfizer vaccine (1st dose) at pharmacy.  She was at our facility to inquire if she can get her second dose. Pt states she had trouble breathing for 2 days and ended up going to her doctor who stated she was stable at her appointment. Patient states that she also had big lumps in her leg and bruising. She was  cleared and stable.
Patient states that he received the vaccine in his right arm and immediately experienced severe pain. He states that the vaccination was given what looked like to him lower than previous vaccinations.  Patient then says that he had persistent arm soreness for several months. He talked with his PCP and asked them when the pain would go away about 2 months after receiving the vaccine. Patient states that his PCP wasn't concerned and said that it will eventually get better. Patient reports frequently waking up during the middle of the night due to pain. Patient says he still has limited range of motion in his right arm at time of his booster dose which was administered one day short of 8 months in his left arm.
Patient felt dizzy almost immediately after getting the vaccine. He sat down at the nearest chair and was hyperventilating. Patient reported that he felt dizzy and his vision was blurry, and that everything was very bright. Patient did not appear to be in any anaphylactic reaction, and did not appear to be in respiratory distress either. Patient's mom did say he was "all worked up" the previous night, worrying about the COVID vaccine. Mom also reported that patient usually had trouble with blood draw and shots. EMS was called, and they cleared the patient to go home.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired were recovered/resolved. The reporter considered the fever, injection site pain, injection site swelling, fatigue and injection site redness to be possibly related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacist intern at the patient's pharmacy. Concomitant medications were unknown. No other vaccines were given besides SHINGRIX that day. It was unknown if any vaccinations were given four weeks prior to the SHINGRIX administration date. The patient received SHINGRIX in left deltoid. All of the symptoms started within 3 to 4 hours after having the vaccine. The patient notified the pharmacy last week on 28th May 2018. The symptoms lasted from 12 to 24 hours. When asked if the symptoms were disabling to the patient, the reporter said that the patient said that she could not do anything the rest of that day due to the symptoms and just stayed home and went to sleep. No further details were provided. The patient did not take any medications for the symptoms. The patient thought the symptoms were side effects due to the SHINGRIX, and the pharmacist intern thought the symptoms were possibly due to the SHINGRIX.
presented to ER at Med Center with anemia, abd pain, hematemesis , nausea and vomiting and dizziness.  Given IV zofran, promethazine, lorazepam, pantoprazole and IV NS boluses due to bp of 87/50.  He was found to have pleural effusion as well on the right.  Given IV piperacillin -tazobactam.  Transferred to other med Center where he tested + for covid 11-30-2021.  Expired 12-1-2021
Child woke up at 3 am with severe nausea. Within minutes he complained about not being able to breathe. His lips turned blue and he was about to pass out. As I was able to keep him awake, I am not sure whether he would have had a febrile seizure (it very much looked like it) or just fainted. The fever spike was too fast, and his body couldn't handle it. His extreme nausea persisted for four hours (but he didn't vomit). He was completely debilitated. Fever spiked to 103 but stabilized at 102 for the following 24 hrs.
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). The patient fainted. It was reported that the patient recovered with no problems. Additional information has been requested.
auto immune or severe allergic reaction; low grade fever; Urticaria and large "well"; swelling; rash; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER (batch number FD0809, expiry date unknown) for prophylaxis.   The patient's past medical history included chronic obstructive pulmonary disease and pain (Long term pain management). Concomitant products included FLONASE and OXYCODONE.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction, fever, urticaria, swelling, and rash. On an unknown date, the outcome of the allergic reaction, fever, urticaria, swelling, and rash were unknown.   It was unknown if the reporter considered the allergic reaction, fever, urticaria, swelling, and rash to be related to Shingrix.  Additional details were provided are as the case was reported by patient himself. The age at vaccination was not reported. The patient received a dose of Shingrix 2 years ago and had started noticing low grade fever and basically an allergic reaction, he guessed that it would be referred to Urticaria and primarily large, well in one location and then he had started having swelling, and well in another location and all of these was extremely similar to an auto immune or allergic reaction. The patient had received Flonase and Oxycodone as concomitant. The patient was informed about role of Pfizer Drug Safety and stated, he got the shot on Friday and  started noticing the rash on Sunday and he guessed that he was concerned that it might be getting worse, what was the date on Sunday that's, when he started really noticing something. The patient stated tonight (04 November 2021), he just took over the counter allergy medication, half an hour ago, he mentioned that he was not sure to fix it up approximately 2 years ago. The patient had a severe allergic reaction to Shingrix vaccine and following that he ended up having 6 months serious shot of Zovair for that allergic reaction as treatment. The patient stated  that you asking him about the vaccine specifics and he had some documentation but he did not thought that it had that detail of information gave him just a minute and saw what he could found.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient with no medical history or drug reactions or allergies who received two doses of ZOSTAVAX. In May 2010, the patient was vaccinated with the first 0.65 ml dose of ZOSTAVAX (lot# and expiration date unspecified) subcutaneously. On 19-JUL-2013, the patient was vaccinated with the second 0.65 ml dose of ZOSTAVAX (lot # J001729, expiration date 20-OCT-2013) subcutaneously. There was no concomitant medication. On 20-JUL-2013, the patient developed redness underneath an unspecified armpit after receiving his second dose of ZOSTAVAX. The patient was not given treatment for the event. No labs/diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the outcome of redness underneath an unspecified armpit was unknown. This is one of several reports received from the same source (linked with Case# 1307USA014767). Additional information has been requested.
diarrhea; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated after took the first shot last on 14Jan2021 he experienced little diarrhea in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Hospitalization: 12/30/2022 - 1/2/2023 (3 days) Presentation to the ED: generalized weakness, nausea, vomiting, & fever x 2 days.  COVID + date: 12/30/22. Treatment: No indication of immunomodulator/antiviral treatment.  Discharge to: home.  Moderna 032L20A 1/22/2021 Moderna 011A21A 2/27/2021 Moderna 045J21A 12/2/2021 Moderna Bivalent 057F22A 10/6/2022
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or Agency guidance.