chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received from a physician via pediatric medical records concerning a 40 day old female who on 30-JUL-2008 was vaccinated with RECOMBIVAX HB.  Secondary suspect therapy included HIB CONJ vaccine (OMPC) (manufacturer unknown) and ROTAVIRUS (manufacturer unknown).  Other concomitant therapy included PREVNAR.  On 04-AUG-2008 record indicated "well infant".  On 08-SEP-2008 the patient was seen and experienced gastrocolonic response (GCR) versus formula intolerance.  Plan was to change to soy formula.  On 11-SEP-2008 the patient was noted to be with complaints of constipation.  Plan was to go back to Enfamil.  On 22-SEP-2008 the physician diagnosed an upper respiratory infection (URI).  At the time of reporting, the outcomes were unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Redness, swelling of left deltoid.  Pt received Pneumovax on 06/23/03 that was stored to cold.
I was asleep and woke up about 7 times with a dry cough.  My family was experiencing symptoms but tested negative for COVID-19.  About a week before this I had a post nasal drip and it is not unusual for me to have a dry throat and normally hot tea helps with that in the morning.  After a long hike I had a really dry throat and thought I was dehydrated and just drank plenty of water.  I didn't run a fever and took a COVID-19 test the next day and tested positive.  The day I tested positive I called the Dr. and got a prescription for Paxlovid for 5 days.
large red welt very itchy still getting larger on day 3 saw Md on 3/23
9 days after the vaccine shot arm around injection site became red, itchy and swollen.  Lymph nodes in right arm pit swollen and sore and also collar bone lymph nodes swollen and sore.
The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023; No adverse event; A dose of Moderna vaccine was given beyond use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown patient had any allergies to medications, has ever been diagnosed/ tested positive for COVID-19. It was unknown if patient had acute or chronic illness during the time of vaccination.     On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date) and PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023).    Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722084 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case (cluster case)
Right arm- her arm began to burn no tingle and she had a little numbness in this arm also. This was the arm the vaccine was administered. Shortly after she a had a glaze over her eyes. She reports all this in 20 min. of receiving vaccine. She rto to discuss. Felt fine with 1-2 hours; No obvious problems noted, no lesions, eye/vision exam intact.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) in response to mail trail sent regarding confirmation of below mentioned query. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "had a positive PCR test for COVID-19". Description of Event: Myself, is fully vaccinated and boosted (12Feb2022) and had a positive PCR test for COVID-19 on 08Jun2022. [Query]: Please help to confirm which vaccine you received as you did not provide the information of the brand or manufacture. [Response]: All 3 of my doses were manufactured by Pfizer. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects or medical conditions who on 11-AUG-2003 (the patient was 12 months of age) was vaccinated subcutaneously in the right arm with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 645290/0326N). Concomitant vaccinations given the same day included: a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 645262/0098N) given subcutaneously in the left arm and a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (lot# 646073/0367N) given intramuscularly in the left thigh. There was no illness at the time of vaccination. Concomitant medication included Omnicef. On 10-SEP-2006, the patient visited the ER due to painful rash on right arm. No laboratory or diagnostic tests were performed. On 11-SEP-2006 it was determined to be shingles. Subsequently, the patient recovered from painful rash on right arm and shingles. Additional information is not expected.
Immediately after withdrawing needle, patient's arm bled and formed a small bubble or whelp at injection site. Patient complained of soreness at site and tingling sensation. After patient took ADVIL, the small whelp seemed to actually decrease slightly in size. Patient was feeling ok when she left pharmacy. After calling her the next day, patient reported that she had a black/blue bruise at injection site, but otherwise was feeling ok. I also reported the side effect to her personal physician.
pt recvd vax & 3-4 days p/3rd dose exp itching, nausea, diarrhea & elevated function test; pt was seen by MD;
pt recvd vax & 7 hrs following vax exp lower back muscle cramps; pt treated by ER MD w/unspecified pain meds & a muscle relaxant w/o any effect;
got the shot,but still got the shingles\ suspected vaccination failure; got the shingles; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles 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 got Shingles shot but still got the shingles it was bad, but they told that the Shingrix shot helps and it was not as bad as with no shot, but four years and still had two places that gets bad. 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.
Myalgia Chills Narrative:  Per nursing report: "took 2nd Moderna vaccine on Tuesday February, 23rd. C/o chills and body aches the afternoon of the 23rd. States came to work on the 24th but only worked 3 hours due to states was achy and did not feel well. Still c/o body-aching this morning [2/25]."  Other Relevant History:
This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a 63-year-old male patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. In 2015, unknown after receiving BOOSTRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant) and unable to walk (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the Guillain Barre syndrome and unable to walk to be related to BOOSTRIX. Additional information was provided: The caller is a resident of another country, while on vacation, her husband received BOOSTRIX vaccine. He went back home and he could not walk and developed Guillain Barre Syndrome. At the time of reporting, he was still in the hospital. The caller did not have time to answer the rest of the questions.
This unconfirmed, spontaneous report was received from a scientist via a company representative referring to unspecified patients. The company representative heard a news story on television channel. Suspect therapies included GARDASIL or GARDASIL 9 (dose, frequency, indication and route of vaccination were not reported). Reporting scientist claimed to have conducted independent testing of the suspect vaccines and noted there were traces of human blood DNA in formulation of the vaccine which interacted with the aluminum in the vaccine and could cause adverse events. The outcome of the event was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected, because contact details were not provided.
Hive and gardening and swelling of injection spot. Rash has developed and the spot is very hot.
PATIENT INADVERTENTLY RECEIVED A 3RD DOSE OF VACCINE. WAS MONITORED FOR 90 MINUTES AND DID NOT REPORT ANY ADVERSE EVENTS
Patient states that she got a flu shot on 9/18/2011. She states that since then she has problems moving her right arm with very limited ROM. Currently we are treating concertatively with heat, pain meds - she is not able to use NSAIDS related to upcoming surgery - x-ray given. She had some mild swelling at injection site and tenderness and some tenderness at the AC joint. She has very limited ROM.
Sore throat starting about 45 minutes after the shot. Started as a general soreness and now mostly on right side (~7 hours later). Quite painful.
Mild muscle soreness in right arm (injection site) beginning within an hour post-injection, noticeable with movement. Took 400mg of ibuprofen before bed.  At 10.5 hours post-injection (middle of night), right arm soreness was moderate-to-severe at rest and severe, almost unbearable, with movement. Mild muscle soreness and joint pain were present throughout the body; joint pain (wrist, elbows, and knees) was an issue prior to injection and was exacerbated during the event.  I also experienced chills and sharp headache pains. Took 400mg of ibuprofen, 1000mg of acetaminophen, and secured right arm with a pillow, which allowed me to fall back asleep.   At 17.5 hours (following morning), muscle soreness was present in right arm alone and was mild at rest, moderate with movement. All other symptoms were gone. Experienced fatigue that afternoon (approx. 24 hours post-injection), treated effectively with a short nap and vitamin D (through sun exposure).  On the 2nd full day post-injection, right arm muscle soreness is minimal with movement.
have slightly arm sorenes; This is a spontaneous report from a sponsored program. An unspecified age and gender of contactable male consumer reported for himself that he received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had slightly arm soreness. The 2nd shot scheduled 25 days after the 1st dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Night of day of vaccination: fever with sweating. Day after vaccine: fever with significant leg muscle soreness making walking difficult. Night of day after vaccine: in middle of night, waking me up with a start, sharp intense burning pain in both feet effecting identical area in each feet: approx. 5 inch band around top of foot and around bottom of foot. Pain eventually dissipated leaving both feet numb with pins and needles, affecting the entire foot. For 2 weeks numbness and pins and needles during the day, extreme burning pain at night. Third week extreme burning pain all day relieved only by soaking feet in ice water. Fourth week and this week taking Feverfew for pain and wearing ice booties to bed. help. I don't have insurance. Also, I have lost confidence in the competence of my current medical provider. Thought I could ride this out myself, but it's taking too long, the pain is too bad, the numbness is spreading to my ankles and hands, and I think I'm in trouble.  I never had any nerve or foot problems previous to this event. My annual blood labs from 5 months ago indicated normal blood sugar levels. Being a former competitive swimmer, I have stayed fit all my life and work out almost every day.  I  experienced no adverse reactions to the first two Covid-19 Pfizer vaccines, just a few days of fatigue after 2nd one. They were done in March 2021.
Patient was administered first dose of a Moderna vaccine at another location on 12/21/2021. The patient was administered a second dose Pfizer vaccine on 1/13/2022 before the patient was eligible to receive a second dose. The patient was mistakenly administered another (third) vaccine (Pfizer) on 1/20/2022. The patient experienced no adverse effects.
pt given bivalent vaccine as dose #2 of primary series and should have been monovalent vaccine. no adverse effects noted.
BODY ACHES; EXTREME FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue and body aches was not reported. This report was non-serious.
Information has been received from a physician concerning a 19 year old female patient with no pertinent medial history, no concurrent conditions and no known drug allergies, who on 27-JAN-2011 was vaccinated with the first dose of GARDASIL (lot #667866/1437Z). The medical assistant stated that there was no concomitant medication and no other vaccines were given on that day. The physician stated that the patient's parents reported that "after getting the GARDASIL", on an unspecified date, the patient had experienced malaise and feeling weak, lack of energy and tired. The physician also reported that on 28-FEB-2011, the patient was at home and experienced syncope, during which she fell and lacerated her chin on a table. Patient received sutures to treat the laceration. The physician stated that on 18-MAR-2011, the patient was referred to Infectious Disease and on 19-MAR-2011 went through the ER for lab work (results not available at the time of the report). The physician did not know if the patient was admitted At the time of the report, the adverse events did not improve and the patient present status was unknown. The physician stated that the adverse events were not disabling or life threatening, but could change with lab results. No further information is available.
4 hours after injection-malaise, fever 101.2, headache, body/ muscle pain, nausea -all lasting 14 hours.  Then malaise, nausea and headache 3days.
temperature excursion for vaccines given and manufacturer deemed vaccines were unsupport and should not have been given.
p/vax pt had immed swelling @ site of shot & then it traveled down underneath arm it remains swollen & tender for about 5 days;also red where swollen;
Pt called today, she is experience what she described as fluid in her neck and shoulder.  It started Sunday morning .  She is going to call her physician to have it checked out.
I felt fine until that night and felt kind of tired. The day after the vaccine, I was very tired and achy. My body was hurting and I was slow. In the afternoon, I electric shock feeling in my forearm into my wrist on both sides that would switch from arm to arm. It was very painful. Short and fast electric shock feeling, like a nerve was pitching. This happened throughout the day. The next day when I woke up, I was fine and no more pain.
Initial report received from a consumer (the patient) on 24 February 2014. A 57-year-old male patient had received a dose of Tetanus Toxoid (manufacturer unknown, batch number, dose number, route and site of vaccination were not reported) on an unspecified date. The patient received concomitant medications with aspirin 81 mg 1x daily at night, SYNTHROID 75 mcg 1x daily in the morning, LANTUS solostar 50 units, NOVOLOG flexpen, 16 units before lunch, before dinner and later night, VICTOZA 0.6 mg in the morning, Metformin XR 500 mg 1 tablet 2x per day, vitamin D3-1000 IU 1x daily in the morning, LOVAZA 1 gm 2 capsules 2x per day, LIPITOR 10 mg 1x daily at night, KEPPRA 1000 mg 1 tablet 2x per day, VIMPAT 100 mg 1.50 tablets 2x per day, COZAAR 25 mg, FLOWMAX 0.4 mg 1 tablet 2x per day and AVODART 0.5 mg 1 capsule daily at night. On an unspecified date, the patient experienced rash, hives and itchy. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Feels like a sunburn on arms face and neck; her arm is not red or anything and that everything is internal. It started in her arms and is just burning.; possibly be a mild allergic reaction; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP-7533) via an unspecified route of administration on 12Apr2021 at a single dose for covid-19 immunisation. Medical history included prebiabetes and other conditions: She states her A1C is great. She was diagnosed more than 10 years ago. She does have a family history of diabetes. The prediabetes is controlled and allergies (she is highly allergic to a lot of things). She states she was diagnosed as a child so well over thirty years ago. Like hay fever and that kind of thing. The patient's concomitant medications were not reported. She states that she does take an inhaler. No prior vaccination within 4 weeks. When she was a child the small pox vaccine never would take so they figured she was immune to it. On 12Apr2021, within 30 minutes to an hour of receiving the vaccine, the patient feels like a sunburn on arms face and neck and her arm is not red or anything and that everything is internal. it started in her arms and is just burning. It was like a hair dryer was blowing. She states that when she checked her temperature that it normal. She wondered if that was a side effect. She states that her arm is not red or anything and that everything is internal. It started in her arms and is just burning. It started in the arm of the inject which was her left arm then went to her right arm. On 13Apr2021 (on the day of reporting), went to neck and face. She states that it has not spread anywhere else. She states that she thought it was from the shot and her immune system is fighting it. She states that her physician did urge her to get the vaccine. She states that her symptoms are just there a little, she was uncomfortable but it has diminished since she has taken Acetaminophen but did not take them away. She had flushing and she checked her temperature and didn't have a temperature, it was like she has been out in the sun and like an uncomfortable burning internally. States it is not on the skin. with the flushing she doesn't have redness or a fever. On15Apr2021 (on the day of reporting of followup), spread into her neck and collar bone area and her arms. She did take Acetaminophen and she doesn't feel that is as intense. She states that her symptoms are just there a little, she is uncomfortable but it has diminished since she has taken Acetaminophen. Caller states she read online this could possibly be a mild allergic reaction and states she is highly allergic to a lot of things. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
felt really sick for 3-4 days; their arm was really big and red; their arm swelled; felt they were about to freeze with 100.2°F fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 last before getting the Moderna vaccine) in 2020. Concurrent medical conditions included COPD.    On 03-Mar-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 COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever). At the time of the report, VACCINATION COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.2 (High) 100.2°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided. Patient was reported to not have taken the second dose of vaccine.