chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave 0.5ml of flulaval quadrivalent vaccine intramuscularly in left arm. Upon injection, administrator felt a strong resistance from the plunger. Around 1/2 of the vaccine was estimated to have been administered. The dose was re-issued with another flu vaccine in the opposite (right) arm and was successful.   Per CDC guidance,
FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. PARAMEDIC CAME, BP 86/51, HR 49, OFFERED HYDRATION, SX RESOLVED, NO TRANSPORT, AMA SIGNED.
Patient reported experiencing difficulty lifting arm, redness and hear at injection site and muscle aches day after receiving vaccination. Symptoms resolved after 3 days.
Patient was given 0.5mL via IM injection, instead of 0.5mL via SUB-Q injection.
Information has been received from a nurse concerning a female who on 09-APR-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot #655165/1425F). On approximately 23-APR-2007 the patient experienced bruising at the injection site. Medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. At the time of this report, the  patient's outcome was unknown. Additional information is not expected.
8/29/07 Rash started and continued for about 1 week. Rash all over patients body. Appeared to be itchy. No other symptoms.
I got Covid for the first time 3 days after my shot.  I had fever for the first time in 30 years.  The fever lasted one night.  I tested positive by throat and by nose for 5 days with home tests.
11/16/21 Seizure-like activity reported by charge nurse approximately 20 minutes following Moderna booster vaccine. 11/17/21 Shortness of breath/wheezes noted by charge nurse. New orders obtained from LONG TERM CARE for Duoneb 0.5mg-3 ml every 6 hours PRN
Received the 1st dose of Moderna. Within a few hours began suffering from tinnitus. Has persisted off and on since.
Member stated she developed chills, fever, nausea, fatigue. Member also experienced numbness from injections site (right deltoid) to neck.
Severe fatigue, headache, naseau, body pain, inflammation for 7 months.
Fever, rash and shivering. Fussy, decreased appetite. MOTRIN suspension 10mg/kg PO once. BENADRYL 12.5 mg PO once.
Patient alert and oriented x4 complained of back pain, headache, chest pain, left leg feeling numb. Vital signs taken,  bilateral lower extremities elevated, water, crackers offered, cooling packs applied. At 4:13 patient complained of persistent chest pain; EMS activated by . EMS arrived on site at 4:28, and the patient reported feeling better, and left with the EMS.
Red pain area about 6.8" long and 4.5" wide near injection site.
pressure across chest; eyes were very swollen; flu symptoms; severe aches/  Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
On 04/20/2000, the patient came into the center with disseminated varicella. On an unspecified date, the patient recovered. The patient's father believes the patient could have been exposed at school where there has been an outbreak. Also reported was the patient's brother who was vaccinated and experienced similar events. Follow up information received 06/09/2000 from a NP indicated that on 04/20/2000 the patient presented to the urgent care clinic with a generalized varicella rash. The reporter clarified that the patient did not actually have a disseminated varicella infection as previously reported. The patient did not have other signs/symptoms other than a rash. The reporter was unable to provide any history on the patient, but did indicate the patient recovered completely from his experience. No further information is available.
I was fine after the first dose. After the second dose, my arm became sore, hot, red and blistery around the injection site for about 2 weeks after the second dose. Later it became a bruise and is still a little sore to the touch.  I spoke with a nurse while my son was having his first dose this afternoon and showed her a pic of my arm, she suggested I report it here.
Severe chills, fever & body pain first night, Vomiting, headache, unable to eat & severe fatigue the following day, Fatigue, muscle weakness and large swollen gland in neck on second day
Cough; SORE ARM AFTER FIRST TWO COVID SHOTS; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS). On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) was resolving and VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS) had resolved.            No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621168 (Patient Link).
On Day 8 after vaccine, injection site was sensitive to touch (hadn't hurt since Day 2) a little red and slightly warm. On Day 12 injection site had a large red rash and was itchy. Rash grew in size over next 48 hours and then dissipated.
Fever, sweats, achy joints, achy muscles, chills. I tested multiple times to see if I have the virus, but I don't. I still have my sense of smell too.
Patient called on 11/02/2018 stating that she was vomiting for 5 days since she got the 2 immunizations. She stated that she knows that immunizations had caused her to feel very sick in the past and she was hesitant to get it but then she did it because she thought it was the right thing to do. On the same day patient was told that she has trichomoniasis and one of our provider sent antibiotics treatment and ZOFRAN to help with symptoms. Today 11/8/2018 I called patient to follow up. She is feeling better but for 10 days she was not able to work due to her symptoms.
24 hours after the shot: Symptoms felt like the beginning of a flu - runny nose for a day and a mild cough that lasted a few days  48 hours after the shot: Started with piercing pains in the left chest that would come and go. Then started getting them on the right side as well. Then pain moved below the ribcage, both left and right side, about 2 inches left & right of the sternum. Pain seemed to move along the ribcage and back.   Sunday April 10th, woke up with the mild pain in my back, both left and right sides, below the ribcage. Left side pain went away later that day, but right side pain moved down to the front, below the ribcage, center between the sternum and my right arm. That pain got became more uncomfortable by Monday.  Wednesday 13th, I contacted my doctor and made an appointment explaining the above. Urine test showed a very small amount of blood and the doctor scheduled a CT scan for Friday 22nd.
Injection site became painful and red after second dose of Shingrix on 6/2/21. As of 6/4/21, the pain had improved but her arm was still red but didn't feel warm. Likely just a reaction but wanted to follow up to see if pain and redness have resolved or if she required medical attention. Attempted to follow up multiple times on 6/7/21 and patient has not been able to be reached
Patient was given the wrong influenza vaccine. Patient was supposed to receive Flucelvax and he received Fluad 65+ instead.
About 40 minutes post-vaccine, patient experienced numbing sensation in both sides of face.  Numbness continued and then spread to the outer right thigh and calf.  Numbness in face started improving after a few days, but reoccurred several weeks post-vaccination.  Numbness. tingling sensation in leg transferred to left leg, and was intermittent.  Patient experienced tightness in chest 36 hours post-vaccination, but upon seeking medical attention, no heart attack or stroke was present.  Numbness has continued for 8 weeks post-vaccine. Paralysis has not occurred and patient has full mobility of facial muscles and limbs.
After receiving vaccines at about 4:25, mother walked client down hall to bathroom. He ambulated without difficulty. After using the bathroom, mom came back down the hall with child about 4:30 and he was pale and lethargic. He was taken to a clinic room and laid down on a bed. He then vomited. Heart rate was slower than when taken earlier, and we were unable to hear his BP. He stated he felt "sleepy". Although lethargic, he did not lose consciousness. EMS was called about 4:35 and he was transported to the hospital ER about 4:50. After examination by the ER doctor, he was discharged home. I spoke with his mother about 3:50 today and she states his arms are sore, but he is feeling better today.
This spontaneous report as received from a nurse refers to a 40 year old female patient. The patient's medical history included positive PPD. On 05-FEB-2010, the patient was vaccinated with the first does of (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous. On an unspecified date, the patient was vaccinated with the second dose of (Oka/Merck) injection, 0.5 ml, subcutaneous. Concomitant therapies included bupropion hydrochloride and quetiapine fumarate. On 27-JUL-2012, a varicella zoster antibody IGG test was 1.39 (positive indication). On 13-FEB-2015, a varicella IGG antibody test was negative. The outcome of the event 'Varicella virus test positive' was reported as not recovered. The patient did not seek any medical attention. There were no product quality complaint (PQC) involved. The relatedness of the event was not reported for VARIVAX (Oka/Merck). No further information was provided. Additional information has been requested.
Vccaine given before 21 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment information were not provided.
Nothing wrong medically, I just wanted to report that I received two different brands of vaccines. I told the clinic I had received Moderna the first time because that was what I thought was written on my first card (can?t be sure since I misplaced it, which was completely my fault). Turns out I had received Pfizer the first time according to the computer. So I was given a Moderna shot as my second dose without the computer first being checked to confirm what my first shot was. My fault for telling them the wrong thing, but I just wanted to let someone know in case there?s anything I should do or anyone I should talk to.
Tingling in fingers and toes turned into a high fever and painful body aches. Could barely move my body hurt so much. Couldn?t sleep at all. Tylenol  wouldn?t  even help ease symptoms.  This continued for 2 days straight
Patient developed chills , dry  cough , and some chest pain  the morning following administration of the vaccine.  On 3/15/22 the patient was treated with a course of Azithromycin 250mg and Promethazine with Codeine, As of  4/4/2022 the patient said that she is gradually  improving with reducing symptoms but she still has the cough sometimes , some chest pain or difficulty breathing
The caller stated they have a patient who got a shot from another Walgreens and thinks she got half the dose when the pharmacist administered it; The caller stated they have a patient who got a shot from another pharmacy and thinks she got half the dose when the pharmacist administered it; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that they had a patient who got a shot from another pharmacy and thought she got half the dose when the pharmacist administered it. The reporter wondered if the patient needed another dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Through quality checks it was discovered that the patient likely did not receive a full dose. Patient notified that it is recommended that they are re-vaccinated. Patient returned for repeat dose on 12/4/21.
5 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA282006 and 2019SA282007 (same reporter).  This case involves a five years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
pt recv vax 29SEP95 & 28DEC97 pt presented w/full blown varicella;tx w/Duricef for strep throat;29DEC97 pt had 50+ lesions over body;pt afeb, comfortable & taking fluids;lab eval revealed pt was RS+;
0.3ML OF JANSSEN WAS GIVEN AS A 2ND BOOSTER (4TH COVID DOSE) THAT WAS SUPPOSED TO BE PFIZER.  THIS PATIENT IS 1 OF 2 PATIENTS. IT IS NOT CURRENTLY KNOWN WHICH PATIENT RECEIVED THE INCORRECT VACCINE.
Pt with increased leg pain after vaccine- presented to an outside hospital and was diagnosed with a DVT to left leg from toe to groin, started on anti-coagulation therapy
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving first dose of Pfizer Covid 19 vaccine NDC 59267-1000-02 Lot: 331308A Expiration 2/28/2022 in her right deltoid. Fainting occured about 5 to 7 minutes post vaccine which was after 2:50PM.  Patient came to in about 20 to 40 seconds and was seated in a chair where they were monitored for 30 minutes. Patient was not bleeding externally but did mention that her back hurt where she fell.
No additional AE/no PQCs; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 18-SEP-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that had suffered a temperature excursion (product storage error), administered for prophylaxis (lot number X007537 has been determined to be an invalid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)) (strength, lot #, expiry date, and route of administration were not provided). The temperature excursion happened within a timeframe of 3 hours at a temperature of 8.1 Fahrenheit (F). No adverse events were reported for this patient.
Had chills/shakes night of1/31st, on 2/1st, had fever that day plus dizziness and off balance. Next day was better but still kind of dizziy and off balance. The third day,2/2nd seem better.
R.N.    Start Time 4/2/2021 10:43 AM      Filed at 4/2/2021 10:51 AM  Status: Signed    S: Patient is a 24 year old female C/O nausea, general weakness and dizziness 10 min post Moderna vaccine #2.    O: Appearance: oriented to person, place, and time, normal appearing weight, anxious, in mild to moderate distress and ill-appearing BP 114/81 (BP Location: LA-LEFT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult)  | Pulse 75  | SpO2 99%   BS 95 mg/dl.  A: patient is pale and diaphoretic.  Bottom lip slightly swollen initially.  No SOB or chest pain.  BS WNL.  Vital signs stable  P: Stat MD called.  Patient placed on recumbent position.  Oxygen given via NC at 2 l/min.  50 mg given IM at 1012 LD  And Solumedrol 125 mg  Given at 10:15 IM right gluteal  V/o by MD.  Patient taken to NC via W/C by RN for further observation.   BSN, RN, PHN    R.N.    Start Time 4/2/2021 10:52 AM      Filed at 4/2/2021 10:59 AM  Status: Signed    Received patient in Nurse Clinic. Placed on bed, patient alert oriented, appears less nervous but breathing better no hyperventilation .. Denies any chest pain or SOB /no wheezing denies any feeling of swelling of lip or any other sx.  Patient stable. BP 105/75 Pulse ox 100 Patient with mother. Patient doing well.   10:50 report given to MD. Patient already waited 30 in observation. And patient in no apparent distress. Ok discharge per MD   BSN,RN,PHN 10:59 AM
Patient received the vaccine, menactra, and the following day developed hives, intermittent, that responded nicely to benadryl.  The hives were whole body, not localized to the injection site.  I saw her again 4 days after the vaccine was administered with persistent but intermittent hives.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-DEC-2012, the patient was inoculated with ZOSTAVAX at the Pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 25-MAR-2013, the patient was treated in a Hospital for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. The patient was prescribed prednisone and valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. On 28-MAR-2013, the patient sought subsequent treatment by the proponent ear Nose and Throat, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles and Ramsay Hunt Syndrome. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.  Upon internal review Herpes zoster oticus was considered to be medically significant.
Small bumps first appeared on my back. I have a lengthy description of the different courses of treatments I have undergone since the onset of this skin rash. In general, I have been seen by 2 internists, two dermatoligists, and my endocrinologist. I have tried myriades of ointments both prescription & OTC. I have received large dosages of Prednisone on numerous occasions, had three biopsies performed and several blood tests taken. I have also had skin patch tests.