chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Needed to go to the dentist for a gum injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non-health care professional.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient needed to go to the dentist for a gum injection on the 08Feb2021, Monday. The outcome of event was unknown. Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I have that neuropathy in my hands and it hurts.; I can hardly sleep at night; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she has neuropathy in her hands, and it hurts. She can hardly sleep at night. She took the Pfizer shots and will get the booster when she can. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of  bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
I experienced COVID-19 in 08/02/2022 after my fifth dose Moderna vaccine. I was experiencing the symptoms for one day and half before the date of 08/02/2022. I was positive on 08/02/2022. I had a telehealth meeting with my PCP and was given PAXLOVID therapy pack. The symptoms I experienced were coughing, head congestion, nasal drip and just a bad cough. I have recovered from my COVID-19 symptoms.
15-year-old female patient unwell after administering the vaccine. The patient is unconscious, presenting paleness and sweating. Vital symptoms blood pressure 90/60, dextrose 113, pulse 61, oxygenation room temperature 99, 16 breaths and cold temperature. Because the patient responds in time, place and space, she cannot move limbs or speak. The patient only shook her head to answer questions.
Patient complained of small amount of blood (droplets) coming through the skin of her forearm after getting the shot (in the same arm) several minutes earlier. Covered with band-aid. Stopped almost immediately. Patient said she had not bumped or hit her arm on anything before this occurred. Patient did not come back into the store to let us know this had happened. She said the droplets popped up on her forearm and stopped almost immediately. She covered with band-aid to be sure. Came into store on 22nd and mentioned the event to the pharmacist. Her arm showed a small red spot where she said it occurred. Patient said she did not hit her arm or anything on her way out of store. Asked why she didn't come back in and report that day - she said it was no big deal.
Patient presented in clinic today 3/6/17, stating that she had a reaction to the vaccines she received on 2/23/17. Patient stated the reaction started on 2/24/17. Patient stated the left side of her face has began drooping, her left eye was twitching and she stated a rash appeared on both arms and legs and cramping in her hands. Patient stated she did not take any medication and that the above symptoms improved over the past days. Patient states that she has never had a reaction to a vaccine. Today she was seen by Alina Leigh, NP. Today there appeared to be no facial drooping. She did have a small rash on both arms and legs, minimal facial twitching to the left side of her face. Patient denies any fever or pain at this time. Vital signs were 114/87, pulse 80 , temp 99.1. height 60 inches, weight 121 lbs.
Patient currently admitted inpatient stay at (6) days starting 11/20/2021  Patient is a 69 y.o. male who presents today with weakness. He has been in his usual state of health, (which is difficult to define, pt scattered historian; has hospital bed because can't breathe laying down, though has normal echo from April 2021, gets around by walking slowly) till today when felt so weak, he couldn't get out of bed. Does have HH to help with needs. PMH of diabetes mellitus, BPH, bipolar, hypertension.    In the ED, he was stable, with slight tachycardia 90-100 and fever 101F, CXR showed infiltrate left lower lobe, He was given fluids and tylenol, as well as decadron since he tested (+) for Covid. He is vaccinated. He requires admission for sepsis due to pneumonia.   ASSESSMENT / PLAN: Pneumonia due to infectious organism Assessment & Plan -Left sided -Pt is a community dweller, no recent hospitalizations  -Low index of suspicion for MRSA, pseudomonas -Not having productive cough -Maintaining sats on room air -Tx for CAP--azithromycin, rocephin     * Sepsis without acute organ dysfunction  Assessment & Plan -Pneumonia most likely source  -Blood cultures pending -Pt has received 2L of fluid, start LR at 200 as still appears dry, HR 90's     COVID Assessment & Plan -Tested positive, but is vaccinated -Has no hypoxia; eating/drinking well -Cause of sepsis seems to be a bacterial pneumonia -Will give BID lovenox, but hold off on steroids, antivirals for now     Type 2 diabetes mellitus with diabetic autonomic neuropathy, without long-term current use of insulin Assessment & Plan -On multiple antihyperglycemics, not insulin -Lantus 10 HS and SSI   Bipolar disorder in full remission Assessment & Plan -Latuda not in formulary, pt cannot get meds from home -Sub geodon, continue Zyprexa   Benign prostatic hyperplasia with urinary frequency Assessment & Plan -Continue finasteride, tamsulosin   Hypertension, benign Assessment & Plan -Continue losartan, hold spironolactone/Lasix
Noticed Heavier menses than normal and have been experiencing intermittent bleeding/spotting between periods. It started in May. I didn't correlate it with the vaccine at first
Patient came into my office on 5/11/21 with complaints of moderate to severe left arm pain since the second injection date (1/24/21). She did have the injection into her left arm as well. I scheduled her for an ultrasound which showed DVT to the Brachial Vein.  She went to the emergency room and was started immediately on Eliquis 5mg. She is being established today, 5/12/21, for follow up
A few months ago I started having a cough, but no other symptoms. I don't have any chills or anything else. I never tested positive for having COVID-19. I was taking steroids and albuterol, but those didn't help. I am going to see a pulmonologist. I have some medical tests scheduled to see what's wrong. I have been having horrible coughing and a little shortness of breath. The cough started off being dry and then now there is a little bit of phlegm. I was having some tightness of chest as well.
Extreme Itching; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extreme Itching) and PAIN IN EXTREMITY (Sore Arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 18-Feb-2021, the patient experienced PRURITUS (Extreme Itching). On 14-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, PRURITUS (Extreme Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
a little pain in his arm; This is a spontaneous report from a contactable consumer (Patient). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM6198, Expiration date: 30Jun2021), via intramuscular, administered in arm Left on 23Feb2021 at 10:30 am or maybe 10:45 am (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization in Hospital. Medical history not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient explains he gets a flu vaccine every year the last one he had was sometime in late October 2020. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9464, Expiration date: unknown) via intramuscular, administered in arm Left on 28Jan2021 (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization and experienced feels like something inside, he was not normal, feel a little bit dizzy and he was just uncomfortable. In Feb2021, after second dose the patient experienced a little pain in his arm. With the second vaccine, patient did not feel anything but just a little bit of pain in his arm. He put a cold rag on his arm and it felt better within 20-25 minutes. The patient explained that he had the first COVID shot about 25 days ago and he feels like it was something inside. He clarifies for about a day or day and a half, he was not normal and it felt the same way as any flu shot. He thought it was normal to feel a little bit dizzy or feel a little "this". Attempted to clarify further what the caller meant by this statement and he explains he was just uncomfortable. He felt like there was something inside him for about a day or day and a half. He received the second vaccine on Tuesday, 23Feb2021. He explains he just had a little pain in his arm, but he didn't feel anything. His question is, is this unusual? All of his friends over 65 already received the second vaccine, and have something where they didn't feel well. However, he didn't feel anything, nothing. He wants to know is there some problem with the vaccine, was it not administered properly. His main question was does he have to do a test in 3 or 4 weeks to be sure of the COVID-19 vaccine and was there a scale that is used to measure full immunity or light immunity. Tp what degree does he have immunization. He knows the vaccine is supposed to be around 94 or 95% effective, but maybe he was in the 5% that was not. Asked how cautious he has to be. Therapeutic measures were taken as a result of a little pain in his arm. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
This case was reported by a other health professional and described the occurrence of wrong route of administration in a 9-year-old patient who received FLUARIX. On an unknown date, the patient received FLUARIX (intranasal). On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown. It was unknown if the reporter considered the wrong route of administration to be related to FLUARIX.
5 year old received Fluzone HD instead of Fluzone QD/no AE; 5 year old received Fluzone HD instead of Fluzone QD/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age), (overdose) on 11-MAR-2020 for prophylactic vaccination via intramuscular route at the right leg [batch number: UJ310AB,dosing details 0.5 ml and expiry date: 30-JUN-2020]   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine,  developed severe nausea & intense vomiting for several hours associated with severe chills and severe myalgia and severe arm pain (though no redness) at vaccine injection site. Vomiting/nausea continued despite Zofran x 2 and lasted ~ 8 hrs. The intense chills and myalgia lasted ~ 48 hrs- symptoms severe enough to keep me in bed for that time.  Other than soreness at injection site and mild headache the next day, I had no adverse reaction after first vaccine dosage that was given on 12/21/20
This report described the occurrence of an uneasy feeling in an adult male who received Hep B vaccine recombinant (Engerix-B). There was no relevant medical history or concurrent conditions. The subject reported rare alcohol use and denied tobacco use. Concurrent medications were not provided. On 5/16/02, the subject received his first injection of Engerix-B. W/in one hour post immunization he experienced dizziness, sweating, malaise, chills, weakness, flushing, low grade fever of 100.4 degrees F and "felt uneasy." The subject reportedly went home from work and slept, and after 4 - 6 hrs, he felt better. The immunization series was discontinued per the subject's request as he did not feel comfortable receiving the remainder of the series. The reporter stated the events were possibly related to the treatment with Engerix-B. As of 5/17/02 the adverse events had resolved.
She began to feel sick intial vitals were BP 190/100, O2-99, and 16 RR. After assessment by EMS, BP 154/92, O2-99, and 16 RR. This occured at 4:00 PM.
Patient presented to the ED and was subsequently hospitalized one day after receiving COVID vaccination with acute respiratory failure.
Felt a metallic taste in my mouth within a few minutes after receiving 1st dose of Pfzier Covid-19 Vaccine. Only lasted for a few seconds and then taste was normal again.
RN with the Department of Health administered the COVID-19 Pfizer 12Y+ Monovalent vaccine to this client on 4/6/2023.  The client was 11 years and 4 months at the time.  This occurrence was reported to me (RN's supervisor) on 4/19/2023, and I am writing this VAERs because RN is currently out of the office.  On 4/20/23, I contacted the client's mother, with the assistance of another employee who speaks her language.  The parent was informed of the error and asked if the child has experienced any adverse effects.  The parent stated the child has not had any adverse reactions.
Redness, swelling and itching at injection site. Non-blistering rash on upper chest. Tx: BENADRYL.
This spontaneous report was received from a nurse referring to multiple patients of unknown age. The patient's medical history and concurrent conditions were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M004883, expiration date: 02-OCT-2017, orally (concentration, dose, frequency were unknown). Information regarding concomitant medication was not reported. Additionally, it was also reported a temperature excursion of 33.2 degrees Fahrenheit for 30 minutes due to a data logger. No adverse events were reported. Additional information has been requested.
Swelling to site with redness noted and fever. At time of visit temperature was 99.3. Provider reassured mom that this was a normal reaction to vaccine. Given TYLENOL and Ibuprofen for fever or discomfort.
I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.
gout flare up; severe pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Daughter) reported.  A 63-year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gout" (unspecified if ongoing), notes: long before the vaccine his dad has issues with his gout. The patient's concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "gout flare up"; PAIN (non-serious), outcome "unknown", described as "severe pain". The patient was treated with Prednisone. Therapeutic measures were taken as a result of gout.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 09/06/2021 I received Janssen single shot Covid- 19 vaccine in camp. The doctor who treated me at Hospital and the doctor I have consulted, commented the same that the side effects of the vaccine might be the cause for the sudden development of block in my heart. And there were no health issues found for me in the last medical checkup done for me in November 2020.Here I am assuring you I can deliver the best of me in work like I was doing before.
Patient reporting an injection site red mark, much larger than she has ever had before, bigger than a silver dollar per patient and thinks it may be warm.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # K018965; Expiration date: 15-OCT-2016 and Lot# L007577; Expiration date: 05-MAR-2017) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt presents for possible reaction after first COVID vaccine. She developed hive, tongue swelling, and numbness to face. 50-year-old female with history of having a Guyon Barré type syndrome after flu vaccine who had her initial Covid vaccination today, she was given the Pfizer vaccine and approximately 5 hours later began developing hives on the left side of her neck and left tongue numbness.  Patient denies headache, no trouble swallowing, no shortness of breath.  She denies any chest pain.  Patient has no numbness or tingling in her arms or legs.  She did take 50 mg of Benadryl prior to my evaluation with minimal improvement of symptoms.
This spontaneous report was received from a consumer who was involved in Research regarding a female patient (reporter's friend) of unknown age via a market research agency. Information on pertinent medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date (also reported as just months after the vaccine), the patient developed polycystic ovary syndrome (PCOS) and she was considered as infertile. Outcome of the events was unknown. Causality of the events was not reported. The reporter also stated that she personally did not want to take that risk (details unspecified). Sender's Comments: US-009507513-1711USA008955.
Soreness in arm Tightness/pain in head Pain in chest when taking deep breaths (day 2) General fatigue Diminished appetite  Symptoms continued for two days, took a Tylenol at bedtime on day 2. When I woke up on day 3 the symptoms were gone.  Symptoms were similar to when I actually had COVID 3 months earlier, but not as numerous, severe, or long lasting.
This spontaneous report was received from the administrator referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, three improperly stored doses ROTATEQ (lot# M033337 with unknown expiration date; and lot number reported as M040269 (reported twice) with unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis were administered to unspecified patients. The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Lot number M040269 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent. Additional information has been requested. Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660.
Pt had a positive COVID test 2/3/22 at Hospital; COVID pneumonia; given ABX; DNR; dc'd to home on 2/17/22 with hospice; pt passed away at home on 2/23/22