chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 11Oct2023 to 15Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335934 same patient, different drug/AE.;
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned one of the doctors in his assisted living facility had the dose of SHINGRIX and he did not feel well after. The reporter did not know the name of the patient. The reporter did not give consent to follow up. The reporter repeatedly asked for more specifics regarding not feeling well and he kept repeating that he just did not feel well. This case was 2 of the 3 cases, reported by the same reporter.
Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Jan-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Back and chest pain left side. Shingles rash left side at 11:00 am 03/06/2014. Pain rash nausea headache blood from left nostril body ache over whole body loss of appetite.
After being in remission for well over a year I have entered an arthritis flare. My knees, hip, TMJ, Ankles, and hands are swollen almost all day long and I am frequently in pain. I hadn't changed anything too drastic in my day-to-day life and so there is nothing that I can see triggering my flare beside the vaccine especially after being in remission for so long.
Migraine: started at 8pm, was able to treat with excedrin and ice pacs  Dizziness: started at 1030pm, did not decrease with food or water intake
Severe headache (stabbing pain right temple) caused body to sweat from pain night sweats severe joint aches and pain brain fog memory loss dizzy weak vision impairment tiredness fatigue nausea  severe rib pain (left side) - hard to breath with it
This spontaneous report as received from a registered nurse to a female patient in her seventies(years). The patient was vaccinated with a dose of PNEUMOVAX23 (lot number unspecified) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness and swelling of arm at injection site. No treatment information was reported. The outcome of redness and swelling of arm at injection site was unknown. The relatedness for redness and swelling of arm at injection site was unknown for PNEUMOVAX23. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
4 hrs after shots, temp high, 102-eyes rolling back, arms quivering, not consolable to breast feeding, called ER, advised to give .8ml Tylenol- had given .4ml after his shot. Cooled him down, fell asleep about 6 hrs later physician advised to use DT next time.
Patient called in to clinic on 10/20/23 stating they are experiencing extreme muscle and "bone" aches, red swollen area at site of injection that has grown from a quarter size to a baseball size. Patient denies fever, headaches, vision changes, SOB.   Patient advised to apply ice, and take ibuprofen for the pain.  Be seen in clinic or by ER if symptoms get worse or do not show any improvement.
Redness and itching to face and neck. No other sx. Hep A 3-7-16. Called with sx today 3-9-16. Had CT with contrast yesterday.
pt recv vax & a few hr post vax exp red skin on face, between fingers & on hands, rash, stinging & burning sensation, & swelling of hands & face;an allergist dx pt as having an allergic rxn;tx DPH, SOlu-Medrol IM;
Few days after the vaccine I felt very cold on my chest, both arms, and my toes. A bit itchy and my shoulder, toes, and arms were very stiff. Every morning it would take me a few seconds due to the pain on my knees. After an hour of waking up I get very stiff. I spoke to my doctor online and they advise me to take Tylenol and I did for a month but it didn't help at all so I decided to go to see another MD and referred me to see a Rheumatology Clinic at local Medical Center and I have an appointment was 04/2021 he gave me Meloxicam 15MG 1/2 a day, It did not help so he advised to take the whole pill. I saw him for several months and he kept changing my medication. I do feel a bit better after taking the second medicine. I feel much 50% better. I still feel cold and joint pain. My left shoulder was in so much pain that my doctor gave me steroid shot and prednisone for a month. I have no cold or joint pain. Now, I'm 80% better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-DEC-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23 (dose and route unspecified). Lot number was reported as J014401 and expiry date was 26-NOV-2014. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality complaint was not reported. No further information reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Mother reports headache, vomiting, fatigue, leg pain, and fever 104.1.  Planned to see medical provider today; outcome unknown
Case number PHEH2014US024694, is an initial spontaneous report received from a nurse on 05 Dec 2014. This report refers to a male patient of unknown age. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on an unknown date. Shortly after vaccination the patient experienced flu like symptoms. Outcome of the event was unknown. Seriousness and causality assessment was not reported. No further information was provided.
Right arm swollen and erythematous, about 10 cm mid upper arm, including injection site. Mother reports swelling and redness much less over last 2 days.
same  day felt soreness and pain at injection site, feels hot to touch and redness, itchy, swollen
not able to sleep; caller has been having ringing in ears ever since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: INSOMNIA (non-serious), outcome "unknown", described as "not able to sleep"; TINNITUS (non-serious), outcome "unknown", described as "caller has been having ringing in ears ever since". The event "not able to sleep" required physician office visit. Additional information: The patient was not able to sleep every day throughout the years since having the vaccine. The patient had a lot of issues and a reaction. Had seen all doctors but doctors don't have answers. This made the patient not trust any medications after getting the vaccination. the patient had been having ringing in ears ever since, that was not all, the patient had a lot going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red swollen leg, t105; seen by MD-told rxn to DTP; was given APAP q 4 hr;
Redness and splotchiness around the injection site. Slight feverish feeling the afternoon of the day after the injection which subsided. Arm-lifting muscle was basically unusable the day after the injection, following day was painful but usable.
Please not this adverse effect has not been verified as caused by the COVID vaccine.  The reason for my report is to track/gather info. that others might not be reporting.  There are other family members of mine with similar issues.  My issue  is unexplained hair loss.  My hair has been severely thinning  out for the last two months.  At first I though it was hormonal, but this doesn't run in my family.  I visit the dermatologist early Nov. 2021 about this and they tested me for a couple of illnesses among them thyroid, but test showed negative.  Also note I have no regrets for the vaccine as vaccine can save people.
Patient was light headed and sat back down on the bench...her lips turned blue and she became pale...she became alert again and started talking  to me then slumped over on the bench and seized and was kicking...we had already called 911 and paramedics were on the way...she again became alert and told me she was having no breathing issues and was ok..the paramedics arrived a few minutes later and all of her vital signs were ok..her mother was taking her to the ER for safety...
Patient had booked appointment for 3rd Pfzier vaccine. We confirmed patient was here for 3rd Pfizer. After vaccinating, it was brought to our attention that he had received Moderna for the 1st 2 doses and not Pfizer.
Headache, Arthralgia, Fever & HYPERtension Narrative:
This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever) had resolved. No concomitant medications were reported. Patient had a reaction after every vaccine. Patient got the Moderna and the booster. Patient's doctor told she had an awesome immune system. She reported that her reactions lasted for 24-36 hours. Patient took Tylenol to keep fever down. Patient was scheduled to have a second booster on Thursday. Patient did not like to take medications and was very cautious with keeping safe. Patient did not had COVID, knock on wood. This case was linked to MOD-2022-616436 (Patient Link).
injection site was red; Injection site was warm; Injection site was swollen; injection site was tender; Debilitating body aches; Debilitating body aches; This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced general body pain and debility. On an unknown date, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2022 and 18-JUL-2022 Reporter's Comment: The case was reported by the patient. The patient had debilitating body aches last night/this morning to where went into the hospital over concerns of the reaction. The reporter agreed to follow up from GlaxoSmithKline.
Eight hours after receiving the first dose, I experienced flu like symptoms, muscle aches, joint pain, chills, headache, and a fever. Then those symptoms went away. I had pain in the injection site for two days. In April 2021, I spent 4 nights in the hospital. I was diagnosed with Myocarditis. I was also hospitalized for 3 days in May as well. On the 8th of July, I spent 1 day in the hospital. I received blood thinners when I was in the hospital. I am currently taking anti inflammatory medication.
Patient fainted upon receiving the Janssen COVID-19 vaccine. They were in a chair in the waiting area and did not fall or injure themselves. We gave her no food or drink, took her blood pressure and stayed with her. She then fainted again at which point we called for a paramedic. They evaluated her and took her blood pressure again and her blood sugar. She then recovered and walked out of the store unassisted. She did not go to the ER but chose to go to an urgent care center I believe.
CONGESTION, BODY ACHES, CHILLS, COUGH, FATIGUE
HE SAYS HE WOKE UP THE NEXT MORNING FROM HAVING THE COVID INJ #3 DOSE AND HAD A RASH ON HIS UPPER TRUNK, AND CROTCH, WITH SOME SCATTERED  AREAS ON HIS MOUTH, TONGUE, AND ARMS, AND LEGS.   MEASLE-LIKE ERUPTIONS ARE NOTED TODAY.  IN THIS ERUPTION, FINE ERYTHEMATOUS MACULES AND PAPULES ARE NOTED--MOSTLY ON HIS TRUNK, AND CROTCH AREA,  ALSO HIS LIPS.  LESIONS COALESCE INTO LARGE PLAQUES AND PRURITIC.  APPEARS TO BE A MORBILLIFORM REACTION.
Broke her foot; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of foot fracture in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back disorder.   On 14th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 122 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced foot fracture and drug dose administration interval too long. On an unknown date, the outcome of the foot fracture and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the foot fracture to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 2nd dose. Four months later of receiving 1st dose of Shingrix, the patient broke her foot. The patient just had back surgery, but had back problems for years. The patient received her 2nd dose of Shingrix passed 6 months, delayed than recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up and declined to provide physicians contact information. This case was considered as medication error with harm.
02/10/21:  09:45 PM headache. 02/11/21:   01:45 AM  severe abdominal                          pain.    From ribs to pubic bone.                          And body aches and leg pain. 02/11/21:   Appox. 06:00 PM severe,                           uncontrollable Diarrhea.
Patient experienced painful swelling in arm after vaccine administration, pain level prompted pt to see MD, was sent to ER, Dx provided at ER was cellulitis.
IThe day after the vaccine in early morning  is when I experienced the body aches and chills and low grade temperature, and  on 1/9/21 is when all smptoms seemed fine except a noted slight redness around injection site. On 1/14/21, 7 days after the injection, my arm was very itchy at the injection site and I was itching it pretty good as I forgot I had the injection there. I woke up the next morning and itched a little at it again to discover that the area was a red slighty bumpy rash and I had a big hive a few inches below the injection site as well.  It remained that way throughout the day and we drew an outline of it with a pen to track if it got any bigger. I refreined from itching it and the next day the redness was still there and had gone outside of the line we traced a little bit on the top. The redness seemed to have gone away around 1/17 or 1/18
Arm at site swollen tense, hot and red with pale area (nickel sized) at exact site.
On March 10, I became covered in small itchy blisters over the  right side of my entire body other than my buttocks and stomach. On March 11,  the rash had had spread to both sides; bruising began appearing on my joints, and large welts; the rash had gone from small blisters to inflamed welts. My wrist, knee, and ankles joints were aching and swelling. March 12, I went to the clinic. Initially, the PA said it looked like bed bug bites. I had an exterminator come to the house who definitely said there was no sign of bed bugs. (We have never had an infestation issue.) I went to Urgent Care on March 13, She said blisters were Shingles but pattern did not align but definitely viral infection. She put me on predinisone. I called the Clinic back. They had me come back in. I had to PAs and MD state same thing but could not diagnose. They added antiviral and hydrocortizone cream. I am scheduled for an appointment with my IOn days one and two, I had fever and chills and woke up in puddle of sweat. I woke up with a fever again March 14.  Joint swelling and pain is worse. Fewer addtional blisters. I was also retested for Covid - came back negative. I go to PCP tomorrow.
Patient in for Moderna booster 0.25 dose.  Nurse drew up and gave 0.02ml.  Patient returned from waiting area and was given the full 0.25ml dose.
INJECTION SITE WARMNESS WHICH WAS DESCRIBED AS FEVER IN ARM; INJECTION SITE SWELLING WHICH WAS DESCRIBED AS ARM SWELLING; BODY ACHE; ARM SORENESS WHICH WAS DESCRIBED AS ARM PAIN; FATIGUE; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a female 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm soreness which was described as arm pain. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site redness. On 12-MAR-2021, the subject experienced injection site warmness which was described as fever in arm. On 12-MAR-2021, the subject experienced injection site swelling which was described as arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, was recovering from arm soreness which was described as arm pain, and had not recovered from injection site redness, injection site swelling which was described as arm swelling, and injection site warmness which was described as fever in arm. This report was non-serious.
My first vaccine was on Monday March 15, 2020.  8 days later, on March 23rd, I woke up with a blotchy, raised, bumpy rash where the vaccine was administered.  Through out the day, it got bigger and bigger, itchier and itchier.  By nighttime, the blotchy-ness turned into 1 big red/pink rash about 3 by 4 inches.   The next day, March 24th, it was even bigger.  I started taking benadryl which helped a lot!  On this day it stayed around the same, I did draw a pen mark around it and the rash grew a few more centimeters.  The third day (March 25th), it was now the biggest it had been but the middle of the rash started to clear up.  It looked like there was a red ring/oval around the rash.  By Thursday night, the redness has started to clear up.   Friday, March 26th, the rash was almost gone, but I had an itchy rash on my face.  I am not certain this is a cause from the vaccine, or natural allergens in the air.  I typically have allergies through out the year, but have not had a rash like this on my face before.  It was very itchy on my forehead and around my eyes.   All rashes are clear today (March 30th).  My arm does not itch, I can barely see a red hue on my arm from the rash, but it is there.   I took pictures of my arm, day by day, if that would be helpful to see.
pt recv vax; 2 days later, exp tingling in the arm & pain in her arm;f/u:exp tingling & pain at inject site;ache at inject site persisted;24aug94, rxn resolved;
After shot. I was sitting down for the advised 15 minutes. I got up to pass the time and look at an aisle in the store. All of a sudden everything went white and my head got light headed and I had to go down on my knees, I was then weak and advised to stay seated. Eventually it passed but I am shaken up.
pt recvd vax;ran t of 104 starting middle of noc;awoke next am w/ sz,lasted 1 hr a/ MD stopped;has since cont to have sz;
This spontaneous report was received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date in 2012 (reported as last year) the patients were vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported). They received PNEUMOVAX23 with different lot numbers. Patients experienced redness, swelling and hard at the injection site which appeared to be a cellulitis (similar local reactions). Outcome of the reported events were unknown. This is one of the reports received from the same reporter. Additional information has been requested.