chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.   No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication information was provided.  Total 113 Bivalent doses administered after the BUD to patients 12 and up. 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
High fever, irritability, poor feeding. Full sepsis work up 6/19 - negative. IV ABX (Ampicillin, Claforan). Multiple labs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment with anti-viral product, treatment start date 21May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
22Dec97 pt recv 1 dose vax. 07Jan98 pt devel fever of 102f till 09Jan98. 10Jan98 pt noted spots on trunk,arms,legs.She felt "horrible". 10Jan98 pt tx w/acyclovir. 20Jan98 pt had 80 spots. See comments
Skin rash and headache, congestion. Treatment: Diphenhydramine 25 mg QID, acetaminophen 650 mg BID.
Administered after expiration date, no adverse event noted. Moderna's analysis of the event noted that the lot # maintained activity necessary to protect against SARS-CoV-2 virus at the time of administration.
Pt found not breathing at 6am on 04/20/2002. Medical examiner expect from the autopsy to be SIDS. Per F/U autopsy; deceased found unresponsive in bed with an adult. SIDS confirmed.  Follow up on 06/19/2002: "Follow up telephone call from manufacturer on 06/03/2002 to Dr at care center for additional information on patient, Dr stated that without patient's full name she is unable to provide any information.  Dr also stated that the administered product was IPOL and not IPV.  As per regulatory affairs, the lot # (U0179) that had been originally reported for IPV was that of Yellow Fever.  The lot number for the IPOL product was not reported.  From faxed correspondence received at the manufacturer, it was reported: "This report was received from Wyeth-Ayerst for Streptococcus pneumoniae vaccine and was assigned manufacturer control number HQ2420023MAY2002.  Information has also been received from a physician concerning an 11-week old male patient with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/2002 at 15:00 was vaccinated in the right thigh with the first dose (Lot # 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as "Hib(PRP-OMP)).  Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of hepatitis B vaccine recombinant vaccine/tetanus toxoid (INFANRIX), and the first dose (Lot # 485-043) in the right thigh of Streptococcus pneumoniae vaccine (PREVNAR).  It was reported taht the patient had a mild upper respiratory infection at the time of vaccination, and that the patient did not have any wheezing on the day of vaccination.  The patient was not on any medications to the physician's knowledge.  It was noted that the episode of wheezing has not been in the several days prior to the vaccinations.  On 04/20/2002, at 06:00 the patient was found not breathing.  The patient died on 04/20/2002.  The patient had no history of adverse events after prior vaccination.  It was reported that an autopsy was done, but that the results were pending."  Additional information has been requested.
Pt reports "a rash on my forehead, weak, shakey, cold sweats, a fever of 101 that broke this morning around 0520"
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 20-year-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On an unspecified date, the subject received the complete ENGERIX B pediatric series in childhood (unknown route, injection site and batch number); but a recent titer showed a low level. Therefore, a new series was started. In 2014, the subject received 4th dose ENGERIX B pediatric (.5ml, unknown route, injection site and batch number) instead of an adult dose, which led to a vaccine underdose and inappropriate age at vaccine administration. Follow-up information received on 16 September 2014: The date of birth, the weight and the height had been added. The subject repeated titers and at the time of reporting, she had immunity to Hepatitis B.
8 hours after vaccination, at 7 pm developed fever (101.5F).  Given MOTRIN by mother.  Fever was 103F at 1 am, 102F at 5 am, and 100 at 9
By the time we went to swim class at 4:30 his nose was signifigantly congested!  HE RECEIVED THE NASAL VACCINE, NOT NEEDLE.  By 10/17/09 he seemed to have a moderate cold.  By 10/19/09 he had a pretty bad cough (I could hear phlegm in his lungs).  He still has this cough which wakes him at night today, 10/20/09.  He has only had coughs twice in his life.  He generally developes cold symptoms without cough.  He's never had a flu in his life.  I think this moderate to severe cold with cough is directly related to the nasal vaccine.  He has had no fever so far, but it is 4 days after the vaccine, and he's still sick.  I thought this was worth reporting, since it is causing pretty bad coughing.
sick ever; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer (patient).  This case involves a patient (unknown demographics) who was sick ever (illness) since, when received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date (couple weeks ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick ever (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information on the batch number for this case.
Skin at injection site reddened, slightly swollen, mildly painful upon palpation. Erythema diameter = 2 inches, persistent for 3 more days.
My mother passed away sometime in the night or this morning.  I talked to her at 6:30 yesterday and she was gone this morning.  She was covered in what looked like a rash of some kind and her toung was enlarged.  They did say the evening she had a flushed face and her tongue seemed enlarged or swollen.
Shingles; Still have Nerve damage caused from shingles; Rash by shingles which went internally and caused nerve damage; This 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, 4 days after receiving Shingles vaccine, the patient experienced shingles, nerve damage and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the shingles, nerve damage and rash to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the shingles vaccine and 4 days later got the shingles.  It had been almost a year and patient still had nerve damage caused from the shingles.  The shingles did produce a rash but the rash went internally and caused nerve damage.
Pt vax 3 doses; non responder.  4th dose given 18Feb91 & 5th dose given 03Apr91.
Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have  a swollen and sore gland in my collar bone on the same side as my shot was given.
fevers, chills, nausea, vomiting, abdominal pain, diarrhea 1 hour after starting medications severe enough to be admitted to the hospital.
Patient is reporting some arm soreness still. Can move arm but reporting  pain in arm at injection site.
Congestion; No appetite; Bodyaches; Headache; Nausea; Fever; tested positive for COVID-19; pain at my injection site for 2 days; A spontaneous report was received from a Health Care Professional (reporting on self), concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for COVID-19, pain at my injection site for 2 days, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 31-Dec-2020, the patient had experienced pain at the injection site. The patient had recovered from the pain at the injection site on 01-Jan-2021.  On 17-Jan-2021, the patient had tested positive for COVID-19,   On 18-Ja-2021, the patient experienced congestion, headache, nausea, fever (100.8°F), body aches and no appetite.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the event of pain at my injection site for 2 days was recovered on 01-Jan-2021. Outcome of the events of COVID-19, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, for the other events (nasal congestion, decreased appetite, pain, headache, nausea, pyrexia) concurrent COVID-19 may remain as confounder. Further information has been requested.
Swelling at the injection site, large area of redness, chills, overall body pains.
Swelling right thigh, starting yesterday 3" x 2 1/4" induration area.
12/2022 Pt developed sudden onset of eye pan.  Blurriness.  Dx withrecurring branch retinal artery syndrome- extremely rare and related to inflammation and clotting.  Elevated d-dimer, elevated hsCRP 5/2023.  Pending MRA brain
Received Hepatitis B & MMR vaccinations.  I have latex allergy.  Nurse practitioner (2 of them) said disregard latex allergy pamphlet.  I broke out in bad hives & NP checked blood pressure after gave 2 shots it was 110/100.  I was light headed & sick & hives for many months.
severe headache on left side, mild dizziness, moderate to severe jaw and neck tightness on left side, severe fatigue, mild nausea, moderate left arm soreness.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she it was November 2021 and got shingles. Evidently the Shingles vaccine did not work. The pain was excruciating. The patient stated hopefully because he/she got the vaccine it would not last as long. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt felt dizzy and lightheaded, nauseas. ringing in ears, and pt's complexion was pale. Called a triage for pt and was brought back to a room. Pt was instructed to lay down, with feet elevated. She was given an ice pack. Took vital signs until they were at base line/ normal.  Note: pt was at check out when this reaction happened
Vial was in fridge for 5 days longer then recommended by manufacture.   Patient was advised to return for revaccination as per Pfizer phone call.
2-3 days of flu-like symptoms; then 4 weeks of binaural tinnitus.
Severe rash that worsened over the following week.  Spread all over body.  Biopsy one week after - PLEVA (Pityriasis lichenoides et varioliformis acuta).
Presented to XXXXXXXX Hospital per the advice of the on call nurse for XXXXXX Department of Health after scratch on right leg and right thumb from a sick appearing cat which died on day 10 post scratch. The cat died naturally just prior to being euthanized at the vet. I asked for the PEP. I was given two injections of HRIG on the right gluteal area, and one injection on HRIG in the left. Ok, that's acceptable. I was given the rabies vaccine in the left gluteal area, which I learned later is not acceptable. I was also advised that the rabies vaccine and the HRIG should be injected into anatomically different body parts to be effective. My mother is a retired public health nurse and informed me of this the next day. I searched this topic, and it was immediately apparent that k shouldn't have gotten the vaccine in the gluteal and I shouldn't have gotten HRIG and the vaccine in the same body part. I called back to the facility and explained I didn't think the dose was valid and an error was made. I was told to download clinic app and send a portal message to the provider who was not currently working. I explained this was time sensitive and regarding a post exposure to a fatal disease and was told "well he wouldn't have put it there for no reason." Actually, a nurse did the injection, but I had to return to the ED and was advised to wait until my day 3 injection. I don't think that was correct either, and my limited research indicates I should've started over because the first was not valid due to location and proximity to the HRIG. Thankfully, the cat was negative for rabies, but that was a long four days.
Throat closing, sweating, insomnia, headache, wheezing. 12/13/12 swollen lymph nodes. 2/12/13 Eczema.
Employee reports 20 minutes after receiving vaccine she began to have pain across neck and shoulders, stiffness, nausea diarrhea, headache, body ache
Swollen, redness, pain and heat to injection site. Headache, "hot flash", nausea, fatigue. Took Tylenol. Headache, nausea, "hot flashes" have resolved.
10/2/17  received Flu  vaccine, the next day I noticed extreme sorness on left arm and bruising.  within the next few days the soreness was still present along with spasms of uncomfortable sensations radiating from the left side of my neck down to the arm and thumb. Treated 10 /13 at clinic for reaction.  11/17/21 referred to Neurologist.  Went to ER December 2017 was admitted.  Has diagnosed MS after this vaccine.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient's information was updated. On 10-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
she experienced pain in the eye socket; bright red runny eyes; bright red runny eyes; blurred vision; sensitivity to light; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first dose last 01Mar and second was on 22Mar. Last Wednesday (unspecified date) patient experienced pain in the eye socket, bright red runny eyes, blurred vision and sensitivity to light with flushed pain in between eyes. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report was received from a consumer on 30 October 2013 with additional information received on 31 October 2013. An 88-year-old female patient had received an injection in the left arm of Influenza vaccine, lot number reported as "1308101" (manufacturer and route: not reported) on 24 October 2013. The patient also uses LANTUS SOLOSTAR 40 units daily. Within 2 hours of the vaccine, the patient had an incident of "hypoglycemia with a sugar as low as 40". She felt weak when it happened. They called 911, paramedics came and treated her and brought her blood sugar back up. She did not have to go to the hospital but was taken to her HCP later that day. The patient was well now with stable blood sugars. The patient's daughter was unsure if the patient took the insulin dose twice since she was unsure how to use the insulin pen. The patient had a history of insulin dependent diabetes mellitus (IDDM) and no known drug allergies (NKDA). The outcome was recovered on unspecified date. Documents held by sender: None.
Developed joint pain in shoulders, right elbow and right knee. Physician prescribed Naproxen every 12 hours. Some relief obtained but pain persists in left shoulder and right elbow.
The night of the vaccine, my joints and muscles hurt, total exhaustion. I couldn't even pull a blanket over myself because my skin felt like it was on fire. My lymph nodes underneath my arms swelled and hurt. I saw my doctor today because the lymph node under my right arm hurts still. They will be performing an ultrasound soon.
My first covid vaccine I had the chills and a 101 fever. My leg also swelled up and hurt from my lymphedema.  My second shot I started a fever on 4-10 of 100.6. I also have the covid arm very swollen and red, itchy and painful.  I feel my lymph node under my arm is tender and hurting too.  Day 5 on april 13 and arm is still swollen.
second dose scheduled for 22Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm started itching 1/5/21 and by 1/6 a red lump reappeared over the injection site that was firm and hot. I called the clinic to ask if that was normal as the initial shot symptoms had disappeared days earlier.  They advised me to check with my doctor who asked me to come in to be checked. They felt like it was a localized reaction and to take Benadryl and Aleve for a few days.  The lump and other symptoms gradually went away over several more days. They advised me to get the 2nd injection in the other arm.
Symptoms were fussy, lethargic and low grade fever for 24 hours, then lethargy for 2nd 24 hours and mid level fever, then febrile seizure at hour 50 post vaccines
Patient stated after receiving the 2nd dose of Moderna 08/30/2021, he experienced symptoms on 09/01/2021 of severe pain throughout his left arm. He had difficulty lifting and moving his arm with numbness occurring after prolonged lift. No noted primary care provider visit/communication. Still experiencing symptoms.
Client's mother reports that child developed a large reddened, raised area on his right thigh 5 days post vaccination. Child experienced intense itching and discomfort at the site as well. Seen in ER 6 days post vaccination.