chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue) and PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Guillain-Barre syndrome in 1996. Concomitant products included ROSUVASTATIN for Cholesterol, LISINOPRIL for Hypertension.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours) and ASTHENIA (lack of energy). 27-Feb-2021, the patient experienced FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 104.4 degree Celsius High. On 23-Mar-2021, Pyrexia: 99-101 degree Celsius High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported treatment medications included tylenol, ibuprofen and ice packs.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054505 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Followup information was received on 8-apr-2021. Events and concomitant information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054505:1st dose
Pain first started in left chest area near the heart, then moved to left arm. After a couple days of pain in that area, part of my right chest area started to hurt. Tonight I experienced a "pop" in my brain that made me dizzy and lightheaded. I have an "electrical" feeling in my head and my ears. My eyes have started to hurt as well. My left arm and chest are still hurting also.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/18/2023 HEADACHE
Patient states that he went home was slightly fatigued. By 4am patient woke up and was severly fatigued. Patient states this moring it was difficult to wake up because how fatigued he was.
Redness, swelling (L) arm, Pain at site of ADACEL and hep A Fever and vomiting 2-4 d after.
PATIENT CAME INTO THE PHARMACY ON 10-4-20 AND SHOWED THE PHARMACIST ON DUTY HER ARM. FROM THE UPPER ARM STARTING NEAR INJECTION SITE TO PATIENTS ELBOW IS BRUSED IN APPERANCE. PATIENT ALSO REPORTS SORENESS/STIFFNESS IN INJECTION ARM. NO OTHER SYMPTOMS PRESENT IN REVEIWING PATIENT PROFILE PATIENT IS TAKING ELIQUIS 2.5MG. WILL CALL DR TO REPORT REACTION
No adverse event; 7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.; First Moderna dose on 13Feb2023 Second Dose 27Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna dose on 13Feb2023 Second Dose 27Feb2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna dose on 13Feb2023 Second Dose 27Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna dose on 13Feb2023 Second Dose 27Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna dose on 13Feb2023 Second Dose 27Feb2023).    No concomitant medications were reported.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 7 doses of Monovalent vaccine was administered to the patients on 27-Feb-2023 after manufacturer date of expiry.  The vaccine was frozen with no known temperature excursion before being thawed on 27-Feb-2023 for administration. The vial was initially stored in the refrigerator on 27-Feb-2023. The vial had not undergone any temperature excursion.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030, US-MODERNATX, INC.-MOD-2023-713149, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-713027 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter US-MODERNATX, INC.-MOD-2023-713149:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. The medical assistant reported that, on an unknown date of 2014, unknown number of patients were vaccinated with a dose of VARIVAX (Merck) (lot#, dose/frequency and route not reported) which had been improperly stored in March 2014. No adverse effects reported. This is one of two reports (1 MARRS# 1404USA005034 and 1404USA006997) from the same source. Additional information has been requested.
PATIENT ALSO STATED AGE OF 18 ON  SCREENING QUESTIONNAIRE. PRIOR TO BEING VACCINATED PATIENT WAS ASKED TO CONFIRM BIRTHDATE AND SITE OF INJECTION, AND PATIENT CONFIRMED VERBALLY HER BIRTHDATE AS . VACCINE ADMINISTERED BASED ON DATA PROVIDED BY PT.
on Friday 01-01-21 I was feeling a sore throat. On Saturday, 01-02-21, it was even worse. I took over the counter medication and nothing seemed to happen.  On Sunday, 01-03-2021, it was so sore that I could not swallow and the neck was sore to the touch. I went to the emergency room and they ran several tests and it was determined that I experienced an allergic reaction to the dose.  They prescribed two (2) medications.  I followed their instructions and did not report to work on 01-03 and Tuesday, 01-05-21.  The throat is still sore but getting better slowly.
Cold sore on left upper lip. No occurrence of cold sore ever before. Tingling sensation and muscle spasm on left upper lip.
Severe chills, lot of pain all muscles-lasted 2 days. Headache, nausea.
This is a prospective pregnancy case. This 30-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) .5 ml on 5th March 2015 13:30. The subject's last menstrual period was on 14 August 2014 and estimated date of delivery was 21st May 2015. The subject received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included expired vaccine used. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included vaccine used (unknown). The pregnancy was ongoing. Additional information: The last menstrual period was not reported but was calculated with the due date. The vaccine was expired since 15 February 2015. Follow-up information received on 14 July 2015: The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 24th April 2015 after 36 weeks and 1 day, 50 days after receiving BOOSTRIX the subject gave birth to a male neonate via cesarean delivery. The neonate weighed 2268 grams (5 lbs) at birth and lengthed 50 cm. APGAR scores were 8 and 9. It was unknown if the investigator considered the live birth and premature labor to be related to BOOSTRIX.
Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative:  12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.
On 30Mar around 2pm, I had sudden onset of pressure in my right ear, tinnitus, and a feeling of diminished hearing.  The tinnitus was constant for approximately 12 hours and then became intermittent.  I was seen by my otolaryngologist on 1Apr and had a hearing text and exam with no findings.  The symptoms resolved on 3Apr
1st dose 2 years ago, didnt get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 2 years prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The patient did not receive the 2nd dose. The reporter seeking medical guidance as to whether the restart the series or provide just the second dose on reporting date. VAERS details were reported for 1st dose. The vaccine administration facility was the same as primary reporter The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Redness and itching in lower legs beginning after 2 days (2/25/21). Redness of skin on face beginning 2/27/21 with swelling and redness by 3/1/21
Sx started after 1 wk - aching + tingling. There was swelling after 2 days + warmth no redness. MD thinks its nerve pain. No treatment given Area is still swollen + she is still having tingling
Patient accidentally received two Pfizer vaccinations within 14 days of each other. She was a walk in to a booster clinic within our hospital and was not asked if it had been 21 days since her previous vaccination. She saw others getting their booster and just followed the lead. She has did not have any adverse events or side effects.
Days 1-4, starting around 8pm on the day of injection, had flu like symptoms: fatigue, total body and muscle aches.  *** Day 3, starting around noon, the inside of my mouth started to feel very sore, tender and sensitive to touch, heat, eating and oral hygiene. Became increasingly more painful overnight. Day 4, my mouth was filled with ulcers, which were incredibly painful. I had a virtual visit with my primary care physician, who confirmed this was an adverse side effect of the Shingrix vaccine. He put me on Valtrex tid x 10 days, plus ?magic mouthwash? PRN pain. He also advised me not to get the  second dose of the vaccine. Day 5, my lips were swollen and very red on the inside; mouth sores still very painful. Day 6, very slight improvement of the symptoms. Today,  Day 7, symptoms beginning to show signs of real improvement. Ulcers are fading, lips still sore, but not as red, and no longer swollen. I could not find any indication in the literature that this could be a side effect, but my physician told me what I suspected; this was an adverse reaction to Shingrix.
Myalgia, Diarrhea, NauseaVomiting, Fatigue Narrative:
14NOV91 mom phoned & stated pt had t100.9 on 13NOV91 & 100 this AM; also had rash on face & diarrhea; 22NOV91 phoned mom stated pt had seen MD 14NOV91 had throat & ear infect; MD told mom did not suspect a rxn from immun;
There are no adverse events (symptoms, signs, time course) and treatments that I am aware of.
localized swelling, warmth, purplish-red color, to MD on 27APR94;  MD felt pt had react from the pertussis part of the DTP;
Erythematous blanching papules on cheeks, trunk & sparsely on arms & legs.  Lymphadenopathy - submandibular, anterior & posterior cervical.  No fever after day 1 post vaccination.  Good appetite.
I experienced headaches, runny nose and a cough. These symptoms lasted for one month.  I did a at home COVID test and it came back positive.  My husband also had COVID before I did.
Ruptured appendicitis; Upper stomach pain; Severe diarrhea; Nausea; Throwing up; Sore arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ruptured appendicitis, sore arm/pain in extremity, abdominal pain upper, diarrhea, nausea, vomiting.   The patient's medical history was not provided by the reporter. Concomitant medications were not provided.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M02A) in left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced soreness in her left arm which lasted 2 days before resolving. On 19 Feb 2021, she experienced some abdominal pain, nausea, throwing up, and severe diarrhea. On 25 Feb 2021, she was admitted to the hospital. She received 4 CT scans then had surgery for appendicitis. With the surgery they found the appendix was ruptured and they did not remove her appendix. While admitted she was given IV antibiotics and anti nausea medication. She was discharged and continued to have abdominal pain. She was taking Norco, nausea medication, and an oral antibiotic since discharge. She was told by her doctors to wait 2 weeks before receiving the second dose of the vaccine at discharge. They did not want to cause a fever with the vaccine in addition to her appendicitis. She was scheduled to take the second on 03 Mar 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The event sore arm/pain in extremity was resolved after 2 days. The event ruptured appendicitis is unknown. The events abdominal pain upper, diarrhea, nausea, and vomiting were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: 5 MINUTES AFTER ADMINISTRATION, PATIENT EXPERIENCES SEIZURE FOR ABOUT 5 SECONDS, PUPIL FIXED, PALE SKIN, SWEATING, LOSS OF BALANCE. HYPOTENSION (BP 104/61) . BRADYCARDIA (HR 49). PT RECOVERED FROM BRADYCARDIA IN ABOUT 15 MINS, AND HIS LIPS COLOR RETURNED BACK TO RED/PINK. PT WAS ABLE TO COMMUNICATE HE'S FEELING BETTER. AFTER 30 MINS HIS BP 115/87 THEN 123/88. HR 70 THEN 76. OXYGEN LEVEL 99.  FOLLOWED UP WITH PATIENT. HE IS HOME AND FEELING FINE.
Information has been received from a consumer concerning her 14 year old daughter who on 20 Dec 2006 was vaccinated with a first dose of Gardasil. On 24 Dec 2006, the patient developed a full body rash. The patient did not seek medical attention for her experience. At the time of this report, the patient had not recovered. Additional information has been requested. 5/14/2010 Follow up: The patient was seen in the emergency room. A physician in the emergency room indicated that it did not look like a vaccine reaction. The physician prescribed prednisone for the rash. The rash resolved overnight. The patient subsequently recovered on 25-DEC-2006 or 26-DEC-2006. No additional information is expected.
high fever, almost 100; Headache; muscle pain a little bit; pain and chills yes; pain and chills yes; Nausea; not feeling well; Tiredness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. The patient medical history and concomitant medicines was not reported. The patient had a vaccine last Monday (12Apr2021) of Pfizer and patient had some like Monday (12Apr2021) night around 6:55 PM patient had a high fever until 6 o'clock in the morning and then the next day Tuesday (13Apr2021) patient had fever again like almost 100 and yesterday patient didn't had any fever but she still had headache so she took (voice was breaking) and then this morning, she had headache again. So this was been 4 days now (at time of 15Apr2021). In Apr2021, then patient had rest of the side effects that have been it said like you got tiredness, headache she felt that way. A muscle pain a little bit, pain and chill yes and fever yeah, nausea yes, feeling unwell yeah, patient was not feeling well in Apr2021. So she took Ibuprofen. Consumer was not willing to complete the report, hence no further probing could not be done. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 28-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004448: US-009507513-1809USA004449.
Patient request Covid Vaccine on 7/30/2021 got a Moderna dose  but did not mention got a previous Pfizer dose at other non pharmacy location on 6/5/2021.  Pharmacy screening protocol was followed which asked if got any vaccine on the prior eight weeks and he answered "no" .   Patient said he is doing fine, no other symptoms related to the incident.
HEADACHE; EXHAUSTED; This spontaneous report received from a consumer 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and exhausted. This report was non-serious.
Patient felt achy.; sore right arm; minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac) (3 pacemaker). Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 vaccine (Dose 1) and Pfizer Covid-19 vaccine (Dose 2). Past adverse reactions to the above products included Adverse reaction with Pfizer Covid-19 vaccine; and No adverse event with Pfizer Covid-19 vaccine. Concurrent medical conditions included Arrhythmia (Cardiac History significant for an ongoing arrythmia and 3 different pacemakers).    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache). At the time of the report, PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache) outcome was unknown.            No concomitant medication were provided.  It was reported that the patient initially had a Primary Series of the Pfizer Covid-19 vaccine. The patient had a serious reaction to second dose of the Pfizer vaccine and took the Moderna Covid 1 vaccine for the booster.   No treatment details were provided
Red area, warm t touch, lump hard under skin.  Due to other health issues Dr. prescribed KEFLEX 500 (1tid x 10d).
This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1686), via an unspecified route of administration in the left arm on 14Jan2021 10:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with covid-19 prior vaccination. The patient was not tested for covid-19 post vaccination. The patient had no known allergies. On 14Jan2021 11:00, the patient's face starting itching and developed a rash. No treatment was received for the events. Outcome of the events was recovering.
Progressive pain, itching, swelling and redness at injection site started 1 hour after injection. Worsening despite Benadryl x 24 hours. After 48 hours, started on Medrol Pak.
Bump at injection site, soreness, and minor itchiness  Started a week after vaccination on left arm  Initial soreness lasted 2 days (started Saturday and stopped being sore by Monday)