chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 24-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb 2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
he is always sick; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 72 years old male patient who was always sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious event "he is always sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "have a friend that is 72. He got the flu shot. And whatever Rona shots they recommend. Now he is always sick. Not sure if this is the best choice for seniors."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (he is always sick).  At time of reporting, the outcome was Unknown for the event he is always sick.
Patient received an expired vaccine; Possible temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) had resolved.        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.   No information on concomitant medications were reported.  No Treatment medications were reported.  The vaccines were received to nurse on 30-July-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge. The nurse was unaware that the vaccines were initially received and placed in the fridge 08-July-2021. The max temperature reached was 41.4F and min 40.6F.
In the afternoon, I got headache and felt tired. Didn?t think much of it. Then by 6 pm I realized it wasn?t just a headache, it was a migraine, so I took my prescription Rizatriptan (5 mg disintegrating tab).  By 6:30 pm migraine pain severe (worse than I?ve ever experienced in the decade of history of migraines). It went from a migraine to so insanely miserable in minutes that my husband even commented at the rapid speed it came on. Could not lie down as the pressure in my head would get worse (never had that response to a migraine). Stomach extremely upset, started vomiting around 7 pm. It was an MSG type of vomit - where I rapidly vomit 5-7 times in a matter of a seconds; however I didn?t feel better like I do after MSG vomiting. I vomited 3 different occasions between 7 pm and maybe 11 pm. I felt cold and had chills - took temperature at it was 95 degrees. Tub bath increased temp to 96. I was extremely fatigued, walking to bathroom was difficult. Had to use wall for support. Since I couldn?t lie down, I sat in a chair and between 10 pm and 1 am I would dose. Several times I woke up in a hot flash and panicked that I couldn?t breathe. My chest didn?t feel tight or anything, so thinking it was just a panic attack from the severe head pain. Around 1 am the pain in my head lessened, so I went to bed. I slept until 4 am. Around 5 am I noticed my chills subsided. The whole ordeal lasted around 12 hours. No additional symptoms throughout the day, just extremely tired from not sleeping the night before. I took my temp when I got up at 8 am at it was 98 degrees F.
joint pain in entire body, fingers, wrists, shoulders, knees, hips, feet, toes. Would limp from pain while walking. Existing neck pain was a lot worse than normal. Pain would shift from joint to joint. Continued like this for 2 weeks and then made an appt with pcp and was referred to a Rheumatologist. Was put on prednisone for imflammation.
Inconsolable crying that day and days after (doctor said was colic). Red painful rash on neck and chest (doctor said it was eczema, prescribed hydrocortisone which did not help). A stiff neck (had to stop breastfeeding because baby could not turn head. Fevers (101.4) and odd colds. Blank stares and fatigue. Hearing loss (sensioneural, no family history of deafness) Clumsiness. Loss of appetite/overall change in his demeanor/normal behavior.   07/31/2007 MR received from current PCP beginning 6/25/2007.  Initial visit with PE WNL except for ear pulling.  Hearing test failed. ? speech delay.  Sent for ENT consult. PMH: reflux. F/U visit 7/16/07 with note of profound hearing loss gradually lost after 6 month shots. Assessment: Hearing loss.  10/08/2007 MR received from ENT for several OVs dated 7/3, 7/13/ and 7/17 2007.  Evaluation for recent failed hearing test.  Child passed newborn hearing screen and responded to sound up until about 6 months of age.  Child has had fluid in his ears but never treated for OM.  DX: Bilateral hearing loss. 1/19/2010 Child has permanent deafness. He is being considered for a cochlear implant.
Rash on face, at injection site, on chest and legs. Swelling of throat and eyes. Starting at 1700 and became severe at 1900 when treatment was sought by patient. Treated with IM Benadryl and IM Decadron. At home treatment with ibuprofen or Tylenol and Benadryl both q6h.
Swollen lymph nodes within 5 minutes.  After 3 hours, malaise, dizziness, fatigue, weakness, chills, nausea. Symptoms worsened over the past 10 days. Uncontrollable and inexplicable panic attacks, debilitating episodes of sickness.
Redness, ( 4 inch X 2 inch) swelling at site, itching, fever, body aches, nausea, neck pain, headache, chills.
Immediately following administration of vaccines (TDaP, Menveo and HPV respectively), patient slumped in chair, eyes rolled back, patient because shaking and arms contracted for approx. 20 seconds. Patient 2 person assisted to exam table to lay down. patient was diaphoretic and pale, requested for lights to be turned down as she c/o headache. Patient able to recite back her name, age, her whereabouts and the date. Vital signs obtained and RN in to care for patient. Patient seen my MD, and received a full exam. Discharged home via wheelchair with mother approx. 1 hour later (patient's brother in clinic for well check).
Sore arm, chills, fever, nausea, elevated heart rate (137 bpm), headache and body ache.
I woke up and my arm slept sore - I thought I slept wrong. It was about 4 inches by two inches - a red welt (warm to the touch - raised a little) where I got the injection. It felt very sore. I called my doctor - by the next day, when I had the doctor appt,  the red mark was pretty much not visible. The Doctor could see a little bit of it but it was nothing comparable to the previous day. Doctor told me to monitor it.
Immediate metallic taste in mouth - headaches off and on throughout the week - upset stomach - COVID arm after 9 days
Armpit swelling arm vaccinated; Slight redness to breast; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration on 31Mar2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced armpit swelling in vaccinated arm  and slight redness to breast on 03Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Dizziness and weakness, progressively worse over the course of the first 10 minutes, gone immediately after 15 minutes post-injections
She still doesn't feel like her self; Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5); 102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F; Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (She still doesn't feel like her self), FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR OD) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone). On an unknown date, the patient experienced FEELING ABNORMAL (She still doesn't feel like her self). At the time of the report, FEELING ABNORMAL (She still doesn't feel like her self) outcome was unknown and FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Body temperature: 99.4 (High) 99.4 F. On an unknown date, Body temperature: 102.6 f (High) 102.6 F temperature. On an unknown date, Polymerase chain reaction: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported.   This case was linked to MOD-2021-294235 (Patient Link).
Outbreak of Genital Herpes which caused infection, swelling of leg, spreading to other leg, nerve pain.
parents states pt less respondent, extremely sore legs, t107 occurred 24-27 hr later;rxn reported to clinic by phone & mom was instructed to go to ER;ER gave pt APAP & motrin & sent pt home w/rx for ATB;fever stayed down during that noc
1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any vaccines in the 4 weeks prior to COVID-19 vaccine and did not had any medical condition.    On 23-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 21-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)).    Concomitant drugs were not reported. It was reported that patient did not had other vaccinations concomitant to the COVID-19 vaccine. It was reported that vaccine was inadvertently given from the vial with the NDC number 8077728302 dark pink cap and label with yellow box.  Treatment medications were not provided.
From time of waking severe hysteria, panic, anxiety attack and Obsessive Compulsive behavior. Trouble understanding directions and hearing. Lasting for hours at a time a few times a day for the following three months.  After three months, attacks reduced to once daily. Continues to this day.
I felt fine until 2 hrs after shot. Then became very drowsy. Needed 3 hr nap. Then got up for a few hours. Went to bed 2 hrs early. Slept very soundly that night.  For the rest of the week, I needed a 5 to 6 hrs extra sleep every day.  I missed a week of work because of fatigue.  On 3rd and 4th days after shot I had diarrhea. On 3rd and 4th days after shot I had slight nausea.  Slight ringing in ears on days 2, 3, and 4 after shot.  Only slight fatigue on 5th day after shot. All other symptoms gone.  6th day after shot all symptoms gone. I feel fine. I'm glad I was vaccinated.
Swollen lymph nodes in left arm pit. Pain and discomfort in left arm pit.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue Narrative:  Other Relevant History:
Moderna COVID-19 Vaccine EUA: muscle aches, slight fever (1.5 degree), fatigue, chills
None for first dose, second dose day after aches, sluggish, two days after low grade fever, aches sluggish,throat ache that turned to infected tonsil, needed antibiotic
pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in joints) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY REPORTED.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in joints). At the time of the report, ARTHRALGIA (pain in joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter  No treatment information reported by the reporter
Swollen glands under the arm; Fever; Headache; A spontaneous reportwas received from a consumer concerning a 43-Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, headache and swollen glands under the arm.  The patient's medical history included COVID-19. No relevant concomitant medications were reported.    On 15 Jan 2021, 2 days prior to the onset of the events fever and headache the patient received their first of two planned doses of mRNA-1273 (039K20A) in right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced fever and headache. On 21 Jan 2021, the patient had swollen glands under the arm.  Treatment for the event included Motrin.  Action taken with mRNA-1273 in response to the event was not reported.  On 17 Jan 2021, the outcome of the event fever was resolved. On 19 Jan 2021, The outcome of the event headache was resolved. On 24 Jan 2021, the outcome of the event swollen glands under the arm was resolved.; Reporter's Comments: This case concerns a 43-year-old female, with medical history of COVID-19, who experienced nonserious expected events of fever, headache, and lymphadenopathy. The events occurred 2 days after the first dose of mRNA-1273. Treatment included Motrin. Event outcomes reported as resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Flu like symptoms. Extreme fatigue, body aches, back pain, joint pain, chills and fever.
Patient received the vaccine on 4/23/15. She developed swelling and redness at the time of the injection. Swelling did improve over the course of the week, but the redness seemed to spread to a large area of the left upper arm. She had been using OTC cortisone ointment as the area developed pruritus. She also developed pruritus at other sites on her body. She is being treated by the provider with cool compress as needed, OTC cortisone, MEDROL dose pack, and antibiotics in case it is cellulitis.
Patient called and said was having "pins and needles" type sensation that started after getting shot on Saturday and has not gone away.  Feels numb and tingly in different areas of body.  Advised patient to seek an exam by a medical provider and to let us know of any updates.
Several itchy spots on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Several itchy spots on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph node disorder (lymph node was on her left arm was removed several years ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Several itchy spots on her arm). At the time of the report, PRURITUS (Several itchy spots on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
8/8/02 pt called today to report that yesterday she started experiencing pain in her L arm that is radiating down her arm through pinky finger and across her shoulders and down R arm. Also c/o L ear pain with migraine head also are worse. Will see MD today at 3pm for evaluation.
79-year-old male with breakthrough COVID-19 infection presenting with hypotension and bradycardia. Upon arrival to the Emergency Department, the patient's airway was patent, breath sounds were heard bilaterally, and saturation was 93% on room air. The patient was placed on two liters nasal cannula. No further respiratory intervention was needed. We will continue to monitor and assess while in the ED.    Patient received a 3rd dose on 08/30/2021
7 days after the vaccine I came down with shingles.  Several pain and headache, went to Dr.  and was diagnosed with shingles.  Was sent to optometrist due  to having in the eye as well as left forehead, left side of face and nose.
Woke up with bad migraine on august 31,2021 which is the day after my first vaccine. I have had bad headaches since this day that won?t go away. Some days are a lot worse  than others. I also have severe neck pain and nerve pain that shoots around my neck down my back up to my eye. All of these issues are on my left side of my body. It also effects my reflexes and reaction response to different things. My vision is also effected when my headaches are severe. I have been diagnosed with possible occipital neuralgia and did not have any of these issues before getting the shot.
Felt muscle pain on left arm, Had fever, Running nose, Frozen jaw and Felt chest pain Drank a lot of water, took fever relief pills, using cooling pad, bed rest for two days Symptoms were gone in three days
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and genders. On an unknown date, the unspecified number of patients received an improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, following the flu vaccination, the patient experienced a sore injection site, felt feverish and sensitive skin. Outcome was not reported.
Pfizer vaccine administered after being in the freezer for 11 days past the two-week standard time. Patient notified and given the option for an additional dose.
Pt recv vax on 3/25/99; on same day pt exp fussiness, crying, fever not responsive to medicines, unconsolable
Patient received MMRV instead of MMR. Also had received Varicella  No symptoms were reported since the administration of the immunization
patinet did and almost died; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who did and almost died (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient did and almost died (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Breakthrough case admission after 4 vaccines Pfizer 1/26/21 Lot# EL3249;  Pfizer 2/16/21 Lot# EN6200;  Pfizer 10/6/21 Lot# Ew0183;  Pfizer 7/22/22 Lot# FP7135