chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; headache; fatigue; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient received BNT162B2 (Lot number: EJ1685), intramuscularly on right arm on 20Dec2020 07:00 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included emtricitabine/tenofovir disoproxil fumarate (TRUVADA), bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), and valaciclovir (VALACYCLOVIR). Patient experienced nausea, headache, and fatigue on 21Dec2020 07:00. No treatment received for these events. Outcome of the events was not resolved.
Really bad ringing in both ears started a couple weeks after vaccination, have never had ringing in my ears before and it seems to be getting worse.
2-3 days after vaccine pts voice changed. "I'm losing my voice." No other complaints. Denies sore throat
Vaccine was stored in fridge longer than 30 days prior to administration; Vaccine was stored in fridge longer than 30 days prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vial was initially stored in the refrigerator on 27 May 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid. Treatment medication was not provided by the reporter.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 63-year-old, adult patient of unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804087 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot #K010442 with expiration date of 22-JUL-2016 or lot # L001328 with expiration date of 13-JAN-2017 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event was reported due to vaccination with VARIVAX. Furthermore, no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise) One (1) out of four (4) experienced chest congestion. All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914608, and 200914609). Patient outcome is unknown. Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. No further information is expected. Manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product
Patient reported feeling dizzy upon standing up after administered vaccine. Immediately passed out but was caught. Came right to within 20 seconds after passing out and reported feeling nausea for about 10 minutes after vaccine. Patient reports feeling ok after 30 minutes of observation and chose to leave facility prior to ambulance arriving due to long response time. Was advised to wait for medical evaluation by ambulance but chose to leave.
Unsure if this was covid related or vaccine related: 1)  exposed to covid within 3 days of vaccine #2 2)  3 days of mild cough and sinus drainage without loss of taste or smell, no breathing difficulty, temps 97 - 99 (Jan 17 - 19, 2021). 3)  Next week increasing chest tightness and irregular heartbeat 4) Cardiology Appt:  holter monitor with > 5000 PVCs in 24 hrs and a few episodes of short-lived arrhythmias.  Cardiac Stress Test normal and Echo negative for cardiomyopathy.  Started on Metoprolol (weight gain and fatigue, intermittent PVCs and occasional arrhythmias), changed to Acebutolol (less side effects and fewer PVCs). 5)  Next Cardiology visit scheduled for October 20, 2021.
FEVER, CHILLS, NAUSEA, HEADACHE, MUSCLE ACHES
Patient states that approximately around 6:30pm on the evening that she received the vaccine she experienced swelling around the eyes and eyelids (more so on the left eye) along with a sore throat and cough. The swelling began to dissipate within a few hours and has been gradually "going down" since the reaction. The sore throat and cough lasted through to the following day, for which the patient self-treated with OTC analgesic. Patient states that she has "sensitive eyes" as well and perhaps that may have contributed.
Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got the shingles vaccine and felt so sick that  only lasted 5 years. The contact details were not reported hence follow-up not possible.
Long bath friday p.m. noted red skin on awakening nose, eyes and forhead which disappears during day.  Dry skin with white film to skin.  Skin on fingers and thumb peeling off.  Woke one morning c/o eyes hurt - tiny bit swollen currently.  Instructed to repeat this report to primary physician and plan to call back 9/27/06.  9/28/06 P. C to mother - Dr. said may be d.t. virus - unusual s/sx after shots to watch her for now. No changes or increases in symptoms reported.
Vaccinator informed lead PHN  vaccine had spilled when administering  Moderna COVID vaccine (lot # 016C21A, expires 5/22/2021) to client. Per LVN , vaccine spilled from needle hub where it connects to syringe when she had already penetrated client's left arm. Vaccine spilled down clients arm. LVN   disposed  of sharp. PHN contacted supervisor authorized to give new dose on right arm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies reported. patient received vaccine, received other medication in 2 weeks it was Biktarvy.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ARDASIL 9 lot # reported as M001533 with expiration date on 16-OCT-2019 and lot # L036301 with expiration date on 17-JUN-2018 for prophylaxis (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006386: US-009507513-1707USA006388: US-009507513-1707USA006173.
rec'd 2nd dose of covid vaccine (Pfizer) on 1/8/21 & had prolonged upper arm pain / soreness x several weeks - unable to lift arm above shoulder - treated; heat / ibuprofen recovering
mom states pt was excessively sleepy x 2 days; just wanted to eat & sleep; pt taken to ER where woke up more & seemed OK; reflexes were good; ER MD spoke w/MD & pt was released to home;
2 mo ago 4NOV92 had vax & 1 wk later devel pain in rt shoulder joint; pain is worse when sleeping or lying down; treated w/Naprosyn x 4 days;
Initial 1st and 2nd dose were Moderna, 3rd dose given was Pfizer
AM p/vax lt upper arm swollen w/redness shoulder to above elbow;warm to touch, sl tender, +pruritic open area d/t scratching;DPH, cool compresses, Polysporin;
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/11/2021 and 4/8/2021. Patient presented to ED on 12/27/2021 with c/o progressing confusion x3 days, increased weakness, and report of home test positive for Covid. Pulse ox of 85 on presentation. Hospital course complicated by Afib RVR, shock requiring vasopressor/inotrope support, and worsening hypoxic respiratory failure requiring maxed NIV+inhaled Epoprostenol. Patient expired on 1/3/2021.
12/27/2011 9:00 PM severe pain in right arm & headache patient took TYLENOL then oxycodone. 12/28/11 headache all day, fatigue, 100 degrees F temp. 12/29/11 A.M. noticed red patches on right arm, tender to touch & slight swelling. Redness 4" diameter.
On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headache). On 22-Jan-2021, the patient experienced PRURITUS (itch every where) and URTICARIA (hive in the arm). On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS). On 21-Jan-2021, HEADACHE (headache) had resolved. On 24-Jan-2021, PRURITUS (itch every where) and URTICARIA (hive in the arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
3 minutes after client received5 vaccinations she became diaphoretic, pale, nauseated, faint, this continued for about 15 minutes, kept for observation with comfort measures for 35 minutes
Sudden onset of EXTREME PAIN starting at lower left side of spine,  shooting ALL THE EAST down to my foot.   Extreme muscle spasm sensation of buttocks, thigh & calf.  Virtually no feeling in my foot. Top & bottom.   Went to doctor,  neurologist,  and primary care,  pain doctor and was sent to have nerve study done.   The symptoms are consistent with Guilens Barr Syndrome
at 11:09 am -  minutes after receiving vaccine pt reports feeling chills and palpitations. Pt has a history of angioedema to unknown cause.   11:09 BP 143/95 P 71 11:15 BP 134/81 P 84 11:20 129/83 P 69 11:27 120/81 P 70 pt reports feeling better and declines call to EMS
Received the first dose of her Moderna vaccine on 1/5/21 and the second dose on 2/2/21. On 1/6, she experienced pain in her right arm and right rotator cuff as well as bruising around her injection site. Pain persisted and is now affecting her range of motion. She saw a specialist on 1/28 and x-rays of the shoulder were normal. Patient has a history of Lupus and the decreased range of motion was thought to be secondary to inflammation from the vaccine. She was given a 5 day course of prednisone 20 mg daily without resolution of pain. Following her second vaccination on 2/2/21, she developed a fever for 24 hours, 3 days of diarrhea, several episodes of vomiting, joint pain, chills and fatigue.
Numb feeling on left side of face like 3 hours after the shot , and a little after left ear and left part of head . Got better on the Next morning
Information has been received from a health RN concerning a female pt who in 1003 was vaccinated with 2 doses of MMRII. It was noted that the pt received a MMRII "series" in 1978.  It was also reported that the pt never had a record of the MMRII being given. In 11/02, the pt had titers drawn. It was reported that the pt seroconverted for measles and rubella, the results were "high" and the pt had immunity. It was also reported that the pt had immunity to chickenpox. The pt did not have immunity to mumps; the result was 0.67, which is low according to the reporter (anything less and .9).  Unspecified medical attention was sought. Additional information is not expected.
After receiving Tdap and PPD client had syncopal episode about 1 minute later and fell hitting head on floor. Vital signs monitored and patient assessed by staff and EVAC.  After about 30 minutes client declined evac to ER and drove himself home.
Patient received vaccine without issues. When she got up, she said she felt a little foggy and warm. Sat the patient down and elevated her legs. I gave her orange juice and she said she felt better. Patient stayed in store for 15min and said she felt better and wanted to leave. Will call and check on her in a few hours.
pt states she had a slight headache, nauseated and headache.  A couple of weeks later on 4/11/2021 her left arm became itchy, red and warm to the touch from the top of the injection site to just below her elbow.  She has been using cortisone cream.  She will also take Benadryl if her symptoms to not subside.
Headache, Dizziness, Nausea, Fainted and hit my head on tile floor. Started at 2:30 a.m. on 1/10/2021 and culminated with fainting on same day at 12:30 p.m. Have continued with weakness, tiredness and dizziness. Other reactions have subsided.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little bit dizzy), HEADACHE (splitting headache), HYPERHIDROSIS (broke out in cold sweat), NAUSEA (felt very nauseated) and PAIN IN EXTREMITY (arm is still sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0201321A) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (little bit dizzy), HEADACHE (splitting headache), HYPERHIDROSIS (broke out in cold sweat), PAIN IN EXTREMITY (arm is still sore) and TREMOR (shaking). On an unknown date, the patient experienced NAUSEA (felt very nauseated). On 31-Mar-2021, DIZZINESS (little bit dizzy), HEADACHE (splitting headache), HYPERHIDROSIS (broke out in cold sweat) and TREMOR (shaking) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is still sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Simple febrile seizure, lasting about 1 minute. Patient otherwise well and returned to baseline.
5 days post 2nd dose, pt woke up with large white patches inside of her mouth and on her tongue, along with "water bubbles" on the inside of her cheeks that were very painful. Pt reports, "I had to pop them as they were so painful rubbing on my teeth, and they kept coming." Pt went to see primary care on 3/3/21 as well as subsequent visits, all work up was negative. On 6/4/21, pt developed large blister on left lower lip and small blisters on upper lip sides.  Variety of prescriptions and topical tried. Lips became "stiff and I could barely talk." Pt then reports that in October she developed fluid filled blisters in her left leg from knee to top of foot. Topical lotion for legs and lips given. Pt then reports she received a steroid swish and spit, that provided some relief in her mouth. Pt reports that she still has soreness in her mouth and presence of blisters on her legs. Pt then said that on 1/4/22, she sought medical care again from primary care as "everything just flared up again." Pt was provided no further treatment. Pt then reports that on 1/27/22, she tested positive for COVID-19 due work exposure. Pt's blisters popped up on leg and mouth even more.
She did not develop rash until 09Dec2018, 6 weeks later. It is all over her body (except face) and itches like crazy; This is a spontaneous report from a contactable consumer who reported for herself, a 71-year-old female patient who received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on Oct2018 (either 25Oct2018 or 26Oct2018) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she did not develop rash until 09Dec2018, 6 weeks later. It was all over her body (except face) and itched like crazy. The outcome of the event was unknown. Information on the lot/batch number has been requested.
COVID symptoms started on 1/12/22: cold and flulike symptoms including: headache, fever, chills, sneezing, congestion, runny nose, sore throat, fatigue, body aches, ear ache on left side, open sores on the roof of mouth (left side). Isolated for the first 5 days. Two- three days of fever, chills, headache, body aches and sneezing. A couple more days of congestion, runny nose and fatigue. Sore throat, ear ache and open sores in mouth lasted about 10-11 days. Used nyquil the first 3 days and drank a lot of fluids for the duration.
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medications were reported.  The pharmacist states they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11 years.  No treatment medications were reported.
EMPTY SYRINGE USED TO GIVE THE VACCINE, NO VACCINE WAS ADMINISTERED
My wife started not feeling well before I did, she was coughing a lot. I suggested she use a home COVID-19 test; it did come back positive. I started having a small cough, headache and a little digestive issue a few days later. I used a home COVID-19 test; my test also came back positive. I called my doctor; he gave me a prescription for the Paxlovid. The first three days I felt the same, but by day four, I was feeling so much better, no lingering cough, no headache. My poor wife got rebound COVID-19.
Headache, Malaise, fever, body aches with very sore neck, cough and head congestion.  High fever lasted 2 days total time ill 4 days.  Stayed home, treated fever and rested.
May be nothing, but 12 hours after first vaccine my left hand started having "trigger Finger" on middle finger.  Still intermittently there even after 2nd vaccine.  This may be unrelated.