chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose was administered > 42 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose). On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) 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 concomitant medication was provided No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-162457 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received provided no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162457:
Site was painful to touch for 2 days. Continued ibuprofen for those days.  A bruise appeared afterwards.  Tender to touch but pain tolerable for about 2 more days. Itchy after 5th day. Scratched and became red and bumpy.  Continued to be itchy on Day 8. Anti-inflammatory OTC applied.
BODY SUDDENLY FELT WEAK, TIGHTNESS IN CHEST, SHORTNESS OF BREATH.
Developed lesions on trunk, arms, then remainder of body. (>100). C/o itching, denies fever or other illness. No drainage.
I began to experience a whole body rash in August 2021; I am unsure of the exact day.  Erythematous, raised papules and macules. Pruritic, sometimes painful.  Sometimes began to weep.  The rash occurs in waves, occurring every few weeks, then abating, before recurring again.  I've tried cortisone cream and Benadryl with no sustained relief. I have never had a rash before getting the vaccine.  The only "new" thing that was introduced to my body was in August when I got the vaccine. No PMH.
After taking off band aid from the  injection site I had a bad reaction from where the adhesive part of the band aid was. It was swollen, itching, and hot to the touch.  It subsided after about 5 days.
I developed shingles after vaccine. First day after vaccine developed pain then rash 2 days later
Erythematous rash devel over thigh where vax given; pt c/o pain 1st noted noc of vax; progressed x 1 wk; indurated, edema; resolved spontaneously;
2/10/21 - soreness in the arm and in the lymph nodes below the arm started about 6 hours later and lasted 15 hours 2/18/20 - slight brown discoloration at injection site, itchiness and a red rash about 6? long and 3? wide which lasted for a few hours.   I had a similar rash, though larger, the day after the shingrix vaccine and it lasted longer.
Patient presented to the ED and was subsequently hospitalized for small bowel obstruction on 5/12/2021; within 6 weeks of receiving COVID vaccination.
Per pt parents. Erythema over (R) deltoid area present since pt awoke this AM. Pt has AHCCS. Recommend visit violent care and/or seek medical attention. Respirations non labored, no distress.
This spontaneous report was received from a patient's mother and refers to the 2-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2016, the patient was vaccinated with M-M-R II injection, 0.5 milliliter (route of administration, injection site, lot # and expiration date were not reported) for prophylaxis. On 08-JUN-2016, the patient had a seizure and was brought to the emergency room (ER) at the hospital but was not admitted. No diagnostic test were performed. No treatment was given for the event. The outcome of seizure was reported as recovered. There was no causality assessment between M-M-R II and the event of seizure provided. Upon internal review, the event of seizure was considered to be medically significant. This is one of two reports concerning the same patient.; Sender's Comments: US-009507513-1902USA001457.
Got shingles immediately after the vax; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles immediately after the vax). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a consumer via interactive digital media. The patient got shingles immediately after the shingles vaccine. The follow up would not possible as no contact details were available. This was 2 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR066213:Same reporter US-GSK-US2023AMR066270:Same reporter
recvd shot 29APR92 no problem until Thursday around 8AM lt arm was red-feverish @ inject site; applied cool cloth lt arm was swollen w/blue discoloration around needle hole; edema measured 2.5 x 4", t98 oral, tender to touch;
Patient was given half of a booster dose. The vaccine entered was the "red top" Moderna COVID-19 vaccine (booster = 0.25 mL). However, the vaccine administered was for the "Purple vial/blue top" booster dose vial which should have been 0.5 mL booster dose.  Patient only received 0.25 mL, resulting in a 1/2 of a booster dose.
After 5 hours from receiving the vaccine, I came down with the flu.  Fever, muscle aches, head fog, coughing, sneezing and weakness. Took Advil and Oseltamivir Phosphate (had to stop - diarrhea).
Tasted a metal taste, panic attack, shaking all over, hard to breath, increased blood pressure, tingling in back
Excessive irritability, unusual cry and posture (dorsiflexion of back and neck)
BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and body ache. This report was non-serious.
Little rash on my ankle; Have a rash on both ankles and on my legs and on my back; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number: FC318O, expiration date not provided) via an unknown route of administration, administered on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not provided. On 13Aug2021, the patient experienced a little rash on ankle and then had a rash on both ankles, legs and on back. The patient wanted to know what could take to reduce it. The patient did not receive any treatment for the events. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient said arm was sore and bruised at injection site and then lymph nodes in right armpit hurt the evening of receiving the vaccinations. The next day her right upper arm became infected.
continued intermittent headaches; Extreme fatigue; sleepiness; This is a spontaneous report from a contactable 58-year-old female Nurse reported for herself that:  Age at vaccination: 58  Pregnant at the time of vaccination?: No  Covid vaccine details:  Product=COVID 19, brand=Pfizer Lot number=GL9261 Lot unknown=False Administration date=29Jan2021 Administration time=12:00 PM Administrator route=Intramuscular Vaccine location=Left arm Dose number=2 Product=COVID19, brand=Pfizer Lot number=EK9321 Lot unknown=False Administration date=08Jan2021 Administration time=10:45 AM Administrator route=Intramuscular Vaccine location=Left arm Dose number=1  Facility where the most recent COVID-19 vaccine was administered:Nursing Home/Senior Living Facility Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No List of any other medications the patient received within 2 weeks of vaccination:Bupropion omeprazole atorvastatin duloxetine  Adverse event: Extreme fatigue, sleepiness and continued intermittent headaches Adverse event start date: 29Jan2021 Adverse event start time: 02:00 PM If patient recovered: Recovered with lasting effects Was treatment received for the adverse event?: No Serious: NO  Seriousness criteria-Results in death: NO Seriousness criteria-Life threatening: NO  Seriousness criteria-Caused/prolonged hospitalization: NO  Seriousness criteria-Disabling/Incapacitating: NO  Seriousness criteria-Congenital anomaly/birth defect: NO  Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:Yes Test Name: PCR mouth swab Covid test date=02Feb2021 Covid test result=Negative  Allergies to medications, food, or other products:Sulfa Other medical history: High cholesterol herniated cervical discs reflux  Vaccine Facility information available. Ethnicity information is available.
Arm was swollen, red and hot to the touch. Swelling started going away after 4 days.
pt reported her cosentyx is not effective anylonger post vaccine and she gets large injection site rash reactions that she did not get before and she has not gotten a menstrual period since the vaccine
Stye developed over right eyelid; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) intramuscularly at left arm on 17Dec2020 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced stye developed over right eyelid on 18Dec2020 06:00. No treatment received. The event is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date in Dec2020.   No follow-up attempts are possible. No further information is expected.
Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, likened to "arm being asleep and waking up".  Writer performed stroke assessment due to patients reported symptoms. Assessment negative. Assessment of injection site negative. Patient remains A&O x4 (person, place, time, and situation).  Patient reports improvement with continued movement with arm.  Patient released to self to home after reported symptoms subsided - ~30 minutes from start to finish
Case previously recorded as MA2009-5489. Initial case report received from a healthcare professional on 20 NOV 2009. This 6-month-old child was vaccinated i.m. for the first time with S-OIV FLUVIRIN (batch no. unknown) in NOV 2009. No adverse event appeared. Reference no. NA09-008608.
Patient has been having intermittent headaches since the evening of the flu shot for 3 to 5 days. Patient has been taking Ibuprofen for headache.
I felt pain in my arm then it moved into my chest especially my lymph area. My back was extremely sore to the point I could not wear a bra. This has persisted for over 2 months. I feel continues deep aches in my breast?s and rib cage and baskside. It is bad enough at times it effects my sleep.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, sweating and fever. On an unknown date, the outcome of the influenza-like symptoms, chills, sweating and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills, sweating and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Each time after receiving the shingle's shot, the patient experienced flu like symptoms including fever, chills and sweats. The patient's physician advised to report these symptoms.
This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included coeliac disease. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, via unknown route in the left arm for prophylaxis. On unknown dates, the patient experienced activities of daily living impaired, syncope, presyncope and fatigue (which lasted for 2 months). The outcome of activities of daily living impaired, syncope, presyncope and fatigue was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Patient admitted to an outside hospital on 12/29/2021 due to Covid 19. She had rapid progression of respiratory failure and required intubation and was transferred to hospital for higher level of care. When she arrived, she was already on heparin drip due to a right-sided PE and Levophed due to hypotension. While here she had a drop In hemoglobin with heme positive stool which was from upper GI bleed, EGD was done which showed bleeding from her erosions. Her hospital stay was complicated by possible superimposed bacterial pneumonia treated with antibiotics, ARDS from COVID, acute renal failure requiring hemodialysis. After her paralytics and sedation were removed she had poor mental status so CT head was obtained which showed large right-sided MCA stroke with hemorrhagic transformation. After catastrophic stroke was found family decided to transition to comfort care and patient was terminally extubated on 1/18/2022. Time of death 12.:58
14OCT97 pt recv vax & 15OCT97 c/o severe arthralgia/myalgia;16OCT97 pain in chest area upon inspiration;17OCT97 c/o nausea, c/o dehydration, nausea, chills but afeb;WBC 4900;dx dehydration poss rxn to flu vax;t103;back pain,vomit, dizziness
Diarrhea , fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14
According to patient  "went in for a pneumonia shot and landed up here with fluid in my biceps" according to wife " her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that pt was feeling so bad that he ended up going to the hospital for his arm".
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (dose, lot #, route and site of administration, expiration date were not reported). On an unknown date, the patient experienced warmth and swelling at the injection site and pain that was "going down the arm" (unspecified arm). The outcome of the events was unknown. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Got the JnJ vaccine on 6/15/2021 4 weeks after the shot, the patient's arm  started to hurt at the shot site and there was a lump that has since resolved. Then, 6 weeks after the patient started to bruise easily on the legs without precipitation. Then, the bruises started to heal and then patient began having blood blisters on the skin on the legs which started small. Then, the blisters began spreading to petechiae on the bilateral lower extremeties, bilateral upper extremeties, and the abdomen. She also noticed that her gum were bleeding and that she had mouth sores that were bleeding as well.  Patient presented to the ED with a platelet count of 1. Patient had no thrombosis, negative for HIIT, and normal fibrinogens. ITP was determined as the most likely etiology. No thrombosis on imaging and negative HIIT makes this more suspicious for ITP than VIIT. She was treated with Dexamethose 40mg IVPB Q24H for 3 doses, and IV Immune Globulin 10% 65 grams Q24H for 2 doses. Patient's platelet counts recovered and patient regularly follows up with the outpatient hematology service.
arm is still red; sore to touch like she just got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Patient was not on any medications. Lot number was unknown
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 05-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Mother reports redness in left arm that begins at deltoid & extends to approx one inch above elbow.  Arm is edematous.  Edema begins at shoulder & extends to approx 2 inches above elbow.  white spot at injection site of left deltoid.  Denies fever.  Denies malaise.
The pt experienced erythema on face, left eyelid edema, antecubitals - urticaria.
Pt developed redness and swelling localized. Pt also developed dizziness, achy feeling and chills less than 24 hrs after vaccine. Temp 99.9 in office.
PREVNAR 13 given 10/26/16. States that night had fever, SOB, loss of appetite, runny nose, headache, cough, redness, swelling at injection site. Wheezing, trouble moving arms, weak. Seen 10/31/16. Antihistamines, Prednisone given, CXR. F/U on 11/3/16.
Bad diarrhea; Not feeling too hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV Positive" (unspecified if ongoing), notes: He usually has diarrhea on a regular basis as part of being HIV positive; "Melanoma cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 01May2022, outcome "unknown", described as "Bad diarrhea"; FEELING ABNORMAL (non-serious) with onset 01May2022, outcome "unknown", described as "Not feeling too hot".  Additional information: He got the first dose, second dose, and first booster at a Cancer hospital. Saturday he just went to the regular. What they gave him looks like Pfizer COVID-19 Vaccine A12 plus Gray Cap but was not mentioning RDMA or whatever. The first thing he wants to know was, was the first and second dose and the first and second booster, are they the exact same thing? Because when he got his first and second dose, the lot number started with two letters and four numbers. The first COVID booster had five numbers and one letter, and then when he got the second booster, it was same form as the first and second shot with two letters and four numbers. It made him think for a second to check on if it was related. That was when he got to the lot number. He had bad diarrhea yesterday and was not feeling too hot, but it could be something he ate. Caller declines report. He usually has diarrhea on a regular basis as part of being HIV positive. It was not something to report, it just made him think when he had it. He was unsure of the way processes the shots. Did not answer his questions. He had to ask them for the expiration date, and if they are keeping it in the freezer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Student presented with headache and fever of 101.9F at around 2:30pm the day after receiving her 3rd HPV. 650mg of Tylenol provided and fever decreased after 1 hour of observation.
vomited x 16 through noc 30MAR92 w/fever 103 not controlled w/APAP;