chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt disoriented; Little thickening in the throat; The site started with red; The site started with swelling; The site started with itch; This spontaneous case was received on 23-Nov-2022 from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW22-06036) and concerned 60-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Levoxol (levofloxacin hemihydrate) for unreported indication.   On 06-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same date, five minutes after receiving Flucelvax Quadrivalent, the patient's site started with a severe itch, red and swelling. Patient felt disoriented and had a little thickening in the throat. Patient reported that he was looking to find ingredients in the vaccine because he will have surgery and needed to run the ingredients to his allergist.   On unspecified date in Nov-2022, the patient used treatment medication Benadryl (diphenhydramine hydrochloride).   On unspecified date in Nov-2022, the patient recovered from all events.  The reporter assessed the events as related to Flucelvax Quadrivalent. As reported, the patient believed it was a reaction to vaccine.  Company comment: A 60-year-old female patient experienced vaccination site swelling, erythema and pruritus, felt disoriented and had throat tightness on the same date, five minutes after vaccination with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related for all events based on plausible temporal relationship. The case does not meet Brighton Colaboration criteria for cellulitis at injection site.; Sender's Comments: A 60-year-old female patient experienced vaccination site swelling, erythema and pruritus, felt disoriented and had throat tightness on the same date, five minutes after vaccination with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related for all events based on plausible temporal relationship. The case does not meet Brighton Colaboration criteria for cellulitis at injection site.
This spontaneous report as received from a medical assistant refers to a 24 year old female patient. The patient was not pregnant at the time of this report. None of pertinent medical history and drug reactions/allergies reported. On 16-OCT-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot# not reported). No concomitant medication reported. Approximately on 16-OCT-2013, after receiving the first dose of GARDASIL, the patient experienced hotness, itchiness and a red knot at the injection site. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved. The causality between vaccine and events was not reported. Additional information has been requested.
Vaccines were drawn up and needles attached to  pre drawn syringes by myself and another nurse for 2 clients coming in for immigration vaccines.  I pulled Private vaccines for this clients, as this cilent had , while her partner had vaccines, which I pulled for him also. I accidently pulled out the pediatric dose of the Hep. B and upon adminstering  it, I realized by the volume amount that it was, a pediatric dose  was given and not an adult dose.  So an Adult dose of Hep. B was given to the client after realizing the error.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and local DOH, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
Rec #2 VARICELLA left deltoid on 6/15/09 approximately 9:30 am, child noticed redness, induration and hard bump 36 hr later as he showered, denies pan unless pushed on it.  Returned to prim MD 06/17/09 approximately 4 pm she gave AUGUMENTIN 50 mg BID X 10 days and hot packs, no limits on physical activity
Chills on and off; left arm hurt; Fatigue; headache; muscle pain; fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received PREVNAR 13 (Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had severe rash. The outcome of the event, severe rash, was unknown.
patient was SUPPOSED to recieve 2nd dose of his primary series,  He was given the bivalent by mistake, and I was given guidance to give him one more dose of the bivalent to make that his primary 2nd dose
My son presented for his 6 month shots including the flu shot. He was given 4 injections total which included TDap, oral rotovirus, flu shot, Hib, Hep B, Polio, and PCV13. My son vomited after waking from a nap at daycare the day after his vaccines. They gave him 5 oz of breastmilk after he threw up and he drank the entire bottle. He has not thrown up since. This was reported because my son has never thrown up before.
Patient received MMR vaccine SQ in left arm.  Within five minutes, hive appeared.  Only 1 hive in 30 minutes appeared.
Patient called to report symptoms of fever 102.3, general body aches and chills started today at 5.30am  Treatment modality include taking Tylenol.  He will continue to monitor symptoms
Systemic: Exhaustion / Lethargy-Medium, Additional Details: Pt. stated she felt ok, but said she was extremely tired. Pt. stated she felt like she took a benadryl, or felt like she just ran 20 laps. I gave her a small package of cheez-its and a small water around 3:00PM. Time of vaccine was around 2:45PM. She said that helped a little. She said she hadn't eaten since 10AM, and was starving. Said maybe that had something to do with it? Pt. had to use the bathroom, and left my sight around 3:18PM to go to the bathroom at the front of the store.
No adverse effect reported; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 07-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1905USA012089: US-009507513-1906USA000539:
bad case of sciatica pain; sciatica pain focused on back; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (bad case of sciatica pain) and BACK PAIN (sciatica pain focused on back) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCIATICA (bad case of sciatica pain) and BACK PAIN (sciatica pain focused on back). The patient was treated with IBUPROFEN ongoing since an unknown date for Sciatica, at a dose of 1 dosage form and CORTISONE ongoing since an unknown date for Sciatica, at a dose of 1 dosage form. At the time of the report, SCIATICA (bad case of sciatica pain) and BACK PAIN (sciatica pain focused on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Consumer reported mild relief with treatment of ibuprofen.  Consumer visited a chiropractor on unknown date, and described receiving "like a cortisone injection."   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Vaccination site discomfort was removed from adverse events. Consumer report of "like a cortisone injection" was referring to a treatment only. On 27-Jul-2021: Patient demographics updated.
Patient having discomfort and pain at injection right arm. Reported by patient at 9:10 am 2/18/2015. Started 24 hours previously. Claimed symptoms worsening. Advised if gets worse go to primary MD/ER.
Vaccine was administered into the subacromial space/joint of right shoulder instead of deltoid muscle.  Patient presents on 1/27/2021 after onset of pain, decreased ROM ongoing since administration.  I was able to visualize ecchymotic area where vaccine was administered and patient has photo evidence.  The physician responsible for the vaccine administration needs to be retrained on where to give deltoid muscle IM injections and to avoid the extremities where recent surgeries occurred (patient had right shoulder labrum repair in October 2020)
Chills-Mild, Confusion-Medium, Dizziness / Lightheadedness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: The patient  received the booster of Moderna vaccine in the right deltoid, patient stated his right eye bothered  him immediately  then he fainted for about 20 sec , provider was instantly called patient woke back up and began to sweat and stated he was feeling nauseous. after watching the patient 15 mins he still did not recover to baseline so paramedics were called and patient was checked out but refused to go to the Emergency room and signed an AMA and left the clinic with his mother.
9pm 1/16 noticed discomfort L shoulder; red, mild bulging,  mild itching, indistinct rectangle at injection site. By 1/18 expanded to oval and reached greatest diameter 3-4ins. Almost set up telehealth appt w MD due to concerns @ poss cellulitis. Began to recede/improve- by 1/24 had resolved.
Pain at and around injection site. Soreness, tenderness, swelling, redness. Pain on movement. Moderate pain somewhat alleviated by acetaminophen. Persisting for two days at tie of reporting but improving.
Starting 12 hours after injection, severe chills, vomiting, fever of 101. Lasted about 3 hours. Then fatigue and nausea for next 36 or so hours.
12 hours after vacc. fever, headache, myalgia and temp 102 degrees F 24 hr after vaccine.
Onset of hives on 9/16/10 in the afternoon hours. Patient denies any swelling or shortness of breath. Hives and itching on bilateral lower extremities and insides of both upper extremities, at waistline, and back. No treatments at this point but advised her to call her pcp.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (strength, dose and lot# not provided) orally (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient experienced pain after receiving vax. Twelve hours later the patient developed erythema and edema. The patient was seen in the ER and treated for cellulitis.
Child reported to nurse one hour [12:15] after being giving Flu shots. Child reported with symptoms of Swelling, Itching and inflammation of Left eye. Ice pack IMMEDIATELY APPLIED.  Mom works at the school also gave BENADRYL 24 mgs that she keeps on hand due to the childs environmental allergies. By 1 pm child reported to be in good spirits eating lunch in cafeteria. Swelling and inflammation had decreased. 8:30 am on 9-25-2018 all symptoms had cleared completely reports School nurse. Mom states symptoms had cleared the same day on 9-24-2018 in evening. NO RESPIRATORY DISTRESS noted at any time. No redness or swelling noted at injection site.
urinary tract infection; This is a spontaneous report from a contactable consumer, reporting for herself, from a Pfizer sponsored program. A female patient of an unspecified age received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The medical history was not reported.  There were no concomitant medications. The patient experienced urinary tract infection on an unspecified date. The patient was prescribed an antibiotic but has not taken the antibiotic yet. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Initially with feet numbness, progressed slowly to knees, and up to hand, associated with muscle weakness, pain, and fasciculation in legs and arms. Started Neurotin 4/14/10. Now on IVIG Gamunex 10/5/10 x5 days, 10/21/10 x2 days.
A red swelling developed that has been increasing in size with time. It has not resolved as yet. My wife is now taking zyrtec, pepcid and Keflin 500 mg 4 times a day  Shingles vaccine
I tracked my symptoms in a notebook because they were so severe on Day 1. Day 1-3: sore arm, headache, dizziness, shortness of breath, foggy brain, unable to focus, chills/uncontrollable shaking for several hours, body aches. Day 4: Same symptoms as above but milder. Bleeding gums when brushing teeth on left side of mouth (this NEVER happens). Painful gums (does happen when very sick with a virus). Day 5-6: Feeling better, but tired. Day 7: Tired, headache, nausea following exercise. Day 8-12: Mild feeling of discomfort while peeing. Tired every day.  A bitt foggy every day but this happens with pollen season. Day 18: tired, trouble breathing on treadmill- I attributed this to pollen as it went away the next day when I closed the window. Day 20 (May 1): While out with friends, after having lunch and a glass of wine, I jumbled a few words and could not say them correctly. There were just about two words in two sentences. I tried a few times and they kept coming out wrong. It was nothing I have ever experienced before. We laughed it off but I felt very unsettled and a bit concerned about driving home. I drove home and was fine. I remain tired and feeling foggy which could be  due to pollen. I have scheduled an appointment with a clinician today and hope to have some blood work done.
Five minutes after shot started losing consciousness, sweating, hot flashes,  trouble breathing, numbness on tongue, seizure ( several minutes) came in and out of consciousness during it, eyes rolled back in head. Arms flailing.
This spontaneous report as received from a 66 year old female patient refers to herself. Medical history was not specified. The patient had no drug reaction or allergies. On 14-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date not reported). Concomitant therapies included LYRICA "high power pain medication", naproxen (reported as naproxin), hydrocodone (reported as hydrocodine), DEMEROL (reported as demoral) and morphine. On 10-OCT-2013, the patient broke out with a case of the shingles. She had a nerve pain starting in her spine and going to her right breast (onset date reported as 10-OCT-2013). The nerve pain was spreading to her head so she returned to the ER (emergency) room (date not specified). The patient had MRI (magnetic resonance imaging) performed because of severe headaches (date not specified) The outcome of shingles, scars around the rash and severe headaches was unknown. The outcome of nerve pain starting in her spine and gong to her right breast and nerve pain spreading to her head was reported as not recovered/not resolved (still ongoing). The patient sought medical attention via visiting the doctor's office twice and returning to ER room. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; This is a spontaneous report from a contactable physician. A 60-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 75 mg daily, cyclic for 14 days on, 14 days off for breast cancer (reported recommended dose 125 mg daily, 21 days on/7 days off). Medical history included breast cancer from an unknown date. Concomitant medication included fulvestrant (FASLODEX) taken for an unspecified indication, since an unknown date. On an unspecified date the patient experienced "feeling bad for four days: she was trying to get a fever. She was at 99.7. She was starting to get into panic mode. On the fifth day she felt normal again". The reported events resolved on an unknown date. On an unknown date the patient underwent lab tests and procedures which included body temperature: 99.7, computerised tomography scan of organs and full body bone scan "looked good". The action taken with palbociclib was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
no adverse effect; On 03-JUN-2019, 1 dose of VAQTA (lot R011952 and expiration date 27-MAY-2019) was administered to 1 patient; This spontaneous report was received from a medical assistant and refers to a 16 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug allergies/reactions were not reported.  On 03-JUN-2019, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (units not reported) (route of administration and anatomical site of vaccination were not reported; lot number R011952 and expiration date on 27-MAY-2019) (experienced expired product administered). Additionally, no adverse effect was reported.
Neck pain; couldn't get out of bed; almost paralyzed; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), neck discomfort and bedridden. On an unknown date, the outcome of the paralysis, neck discomfort and bedridden were unknown.   It was unknown if the reporter considered the paralysis, neck discomfort and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had 1st vaccine and had almost paralyzed for 24 hours. The patient neck was really at worst. The patients pharmacist told that he would report about it and didn't had to take 2nd dose. The patient was afraid to take 2nd dose and could not get out of bed for 2 days.
HEADACHE; BURNING PAIN IN ARM/ARM PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, once a total administered, vaccinated on right deltoid on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced burning pain in arm/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and burning pain in arm/arm pain. This report was non-serious.
Arm pain on first day Tendons stiffness on one arm and both wrists on second night 4th day - Early menstrual period ( 2 weeks early): sudden bright red bleeding without usual signs of menstrual periods (no cramps, very unusual), and large clots in the bleeding Nausea, 2nd day
Joint pain, hands itching, burning, neck pain, fatigue, toes burning , period irregularity
About 6 days after my injection I developed a dry cough, follow in a few days by extreme fatigue, occasional nausea, muscle aches and headache. My daughter asked if anything had changed in the past month and the only thing was my COVID vaccine on March 18th. I have been feeling a little better this week but today the cough and fatigue has returned. I saw my doctor yesterday to report what has been going on. My lungs are clear.
Reportedly, 15-20 minutes after the vaccination, the patient developed wheezing, itching all over and runny eyes. The patient was treated with Benadryl and Albuterol. The patient recovered from this experience.