chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022; Vaccine was expired on 05-May-2022 and administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) outcome was unknown. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Total nine people were vaccinated on 06-May-2022 with Moderna vaccine lot number 084J21A and expiration date 05-May-2022. Of those, all were administered boosters doses except one who had their second dose. The vial did not undergo any temperature excursions. The expired vial was moved from the freezer to the fridge on 29-Apr-2022. The vial was stored in the refrigerator for less than a month ago. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received non-significant information narrative updated. On 11-May-2022: Significant Live follow-up appended- Date on which vial was removed from refrigeration updated
STOMACH PAIN; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced stomach pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and stomach pain was not reported. This report was non-serious.
Severe Muscle ache over entire body.  1st day bedridden.  3rd day improving.  1st evening trying to sleep I had very vivid, realistic dreams.
chills; muscle aches; joint aches; arm pain at injection site; felt like crud/crummy; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose in 2019, refer case US2019AMR117378).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 6 hrs after receiving Shingrix, the patient experienced injection site pain and feeling unwell. On 26th June 2019, the patient experienced chills, muscle pain and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, feeling unwell, chills, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling unwell, chills, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The caller was calling about herself. She mentioned that she was a nurse.  The patient received Shingrix in the deltoid intramuscularly.She said she felt like crud and crummy after receiving Shingrix. Around 3 am woke up with arm pain at the injection site. She says when she woke up later and felt fine but then later developed chills and muscle and joint aches and then slept for 10 hours and felt much better. The reporter consented to follow up.
Given shot in hospita, then within 15 minutes brought to Emergency Room, after I Became non-responsive,  While in Emergency Room had following issues: large rash and itching on upper body,  Bruise down arm from injection site,  extreme Headache,  High Blood Pressure, Loud Ringing in ears, shaking and body tremors. Benadryl given for rash and itching.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 16:15 as dose number (unknown), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: it was reported that, Patient received Paxlovid treatment for COVID 19,Treatment start date: 11Jul2022,Treatment stop date: 15Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath; Coughing; Sore throat; Some Fever; Vomiting; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Some Fever) and VOMITING (Vomiting) in a 35-year-old male 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.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Some Fever), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 mg. At the time of the report, DYSPNOEA (Shortness of breath), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Some Fever), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment details included drug to stop the vomiting. Zofran. Hydration. Injection.
Sore Left Arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm after first vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (Used to get vertigo) in 2018. Concurrent medical conditions included Blood pressure (under control with medications). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Blood pressure abnormal.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm after first vaccine). On 14-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication details was provided.   This case was linked to MOD-2022-480672, MOD-2022-480677 (Patient Link).
Chronic spontaneous Urticaria.  Dermatographia urticaria. Symptoms started 12/6/2021.  Rashes all over body.  Hives all over body.  ?Scratch rashes? all over body. These come and go all day.  The symptoms have occurred every day since 12/6 onset.
Diaphoretic, lightheaded.  Gave bottle of water to drink, removed mask.  Client drank 1/2 of water feeling better and cooling down.  Unable to look around w/o feeling dizzy.  Feeling better after 2 bottles of water. Cooled himself with a damp cloth.
I experienced tachycardia at 110 BPM 30 minutes post vaccination that lasted approximately 70 minutes. Further, almost immediately after my 15 minute observation was over, I experienced some abdominal discomfort that was similar to uterine cramps. In the evening following my vaccination, I woke up feeling flushed with intense itching on my palms and thighs.
sl react? -weak, dizzy, diaphoretic P80, BP 126/72, T99;
Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 65.64 for dose administered on 03-Apr-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 030B21A, it was moved to fridge on 30-Mar-2021 that underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09 AM. The product was moved to clinic on 03-Apr-2021 and beyond use date for the vial was reported as 29-Apr-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I experienced tenderness in the left arm, localized redness. I had a large rash on the 8th day with swelling and the rash grew bigger at the injection site, this lasted three days which then subsided. I also experienced abdominal pain which lasted 6 days.  I contacted my doctor 01-04-2021 which recommended lab work and an ultrasound of the abdomen to rule out pain.  ( I also received my second dose injection 01-27-2021 at 10:30am, lot# 029L20A)
pt recv vax 30JAN97 & 3FEB97 pt devel chest pain, inc heart rate, diff breathing, dizziness, a shingles type severe painful to touch & itchy rash which was located on hips, thighs, waist area & was seen by MD;
Second dose of Moderna Covid-19 vaccine was administered on day 21, prior to the indicated day 24 or later. Patient has experienced no unexpected adverse events at time of report.
21SEP92 pt recvd vax & that day devel fever of 101; 25SEP92 temp was 102; treatment NONE;
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Had previously called neurologist to verify that she could receive the high dose flu vaccine. At 11:30 A was walking out the door after the shot and felt that balance was worse (little harder to walk) but used cane normally. 9PM she tried to sit in a chair and fell, hitting her head. She stated she also lost control of her bowels and vomited. Her scalp was bleeding. 911 was called and she was transported to ER where "9 staples were put in the back and left side of her scalp". She returned home that night. She called her pcp today but he was not there but she has an apt. for 10/16/2018, and then she called Dr., her neurologist, and left a message. As of 1P she had not received a call back. She feels better today 10/10/18.
mom reports pt broke out in hives all over body shortly p/vax;reports pt exp swelling & redness around eyes;no inc temp;no other sx reported;mom tried to reach MD but occurred p/hr;DPH given hives disappeared w/in few hr;
TINY FLAT RED DOTS ON RIGHT ARM (AREA HAS SPREAD A LITTLE BIT); LEG PAIN UNDER KNEE AREA IN BOTH LEGS (AFFECTING RIGHT LEG MORE); HEADACHE/HEAD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced headache. On 09-OCT-2021, the patient experienced headache/head pressure. On 11-OCT-2021, the patient experienced tiny flat red dots on right arm (area has spread a little bit). On 11-OCT-2021, the patient experienced leg pain under knee area in both legs (affecting right leg more). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-OCT-2021, and had not recovered from leg pain under knee area in both legs (affecting right leg more), tiny flat red dots on right arm (area has spread a little bit), and headache/head pressure. This report was non-serious.
Expected soreness in upper arm followed by fever of 101 or higher, headache, cough, congestion, fatigue, weakness. Mucus is greenish yellowish.
Woke up on 3/26/21 with hearing loss in right ear.  No warning just woke up that way
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
Patient received Moderna COVID vaccine on 2/24/21, 3/25/21, and 11/11/21. On 12/3/22, patient admitted to our inpatient facility (med/surg unit) with sepsis secondary to COVID-19 pneumonia, superimposed bacterial pneumonia and AKI. As of today 12/7/22, patient is still admitted in the med/surg unit.
pt recv vax OCT96 & 2JAN97 pt started having flu sx;pt was off of work 4 days & was so tired could not move;pt saw allergy MD & pred recommended;pt recovered;
immed following vax pt devel an inject site reaction (size of golf ball), consisting of erythema, induration, swelling & site hot to touch; fever to 103; tx w/APAP & compresses;
At approximately 1039, lead nurse saw patient with her hands around her throat. Patient immediately ran out the room with mother. Lead nurse followed patient outside. Patient vomited outside. Patient's mother reported that her daughter has been coughing for the past week and had a similar vomiting episode last week. Patient's mother reported they did not report this to the patient's vaccinator. Patient's mother reported seeing a doctor for her daughter last week. Their doctor prescribed Mucovibrol C and patient reported taking the medication in the morning. Patient denied difficulty swallowing, difficulty breathing, itchiness, rashes, and hives. At approximately 1045, EMT offered to take patient's vital signs. Patient refused vital signs. Patient and mother given water and sat outside for further observation, accompanied by EMT . At 1104, EMT offered to take patient's vital signs. Patient refused vital signs. At 1107, patient reported she felt good. Lead nurse educated patient and mother on signs/symptoms of when to seek emergency care, to sign up on v-safe, and to follow up with primary care provider. At approximately 1108, patient left facility with unlabored respirations and steady gait.
Underarm itched; bruise spots; red spots on left breast; Swelling of lymh node under left arm; underneath her left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underneath her left arm is swollen), PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 12-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (underneath her left arm is swollen). On 13-Feb-2021 at 7:00 PM, the patient experienced PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm) had resolved. At the time of the report, PERIPHERAL SWELLING (underneath her left arm is swollen) outcome was unknown. Not Provided          No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non significant follow up. Updated Email address was added. On 05-Aug-2021: Follow up received, information about Patient demographic, added events, added event outcome and added event assessment were updated.
really bad vertigo that I never had experienced before; Mild neck pain; tiredness; mild dizziness/feel like passing out; nausea; Increased thirst; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the right arm on 22Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced mild dizziness and some nausea the afternoon of the shot (22Jan2021). Increased thirst started that evening (22Jan2021) and continued till now, regardless of how much she drink. Mild neck pain and tiredness started the next day (23Jan2021 09:30). Then on day 3 (24Jan2021), the patient woke up with really bad vertigo that she never had experienced before. If she move her head, the room spins and she get really nauseous and feel like passing out. She ended up taking motion sickness medication for these and sleeping rest of day. Outcome of the increased thirst was not recovered while of the remaining events was recovering.  Information on the lot/batch number has been requested.
pt recv vax 28APR98 & devel inj site swelling & redness;
Initial and follow up information has been received from a registered nurse concerning a 71 year old white female with hypertension, dyslipidemia, senile dementia, depression and osteoporosis and no known allergies, who on 28-Nov-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included Simvastatin (MSD) Lexapro, Detrol LA, Alendronate, Lisinopril (manufacturer unknown) and Synthroid. On 26-June-2008 at 1:00pm (previously reported as 8:00am) the patient was vaccinated intradermally into her left forearm with a second dose of PNEUMOVAX 23 vaccine (lot# 659199/1541U). On 26-June-2008 at 9:00am, the patient also received a tuberculin purified protein derivative (PPD) intradermally in the right forearm. On 27-June-2008, the patient developed erythema at the injection site, about 6cm in diameter. At 12:30 pm (previously reported as 5:30pm) the patient developed a "red line" going upwards from the rash on left forearm about 11cm. The patient was examined by the physician. On 28-Jun-2008 (previously reported as 30-June-2008), the patient recovered from the 11 cm erythema on the left forearm. Additional information is not expected.
t101.2, painful joints, h/a, sore groin muscles, shins painful;  tx fluids, rest, APAP
Moderna COVID-19 Vaccine  -- rec'd injection on 2/6/21.  Shoulder was sore for two days, then soreness went away.  However, today (2/14/21) I am experiencing itching at the site of injection along with a 2" radius of swelling and bumpiness under the skin in the surrounding area.  I assume I have what is being called "Covid arm."