chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in sigmoid colon; nose had been running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "pain in sigmoid colon"; RHINORRHOEA (non-serious), outcome "unknown", described as "nose had been running". Additional information: The patient got the asked if it's okay to take pain reliever (Advil) for pain in her sigmoid colon. She also asked if it was ok for her to take daily antihistamine (Zyrtec) after receiving her first dose of Pfizer- Biontech Covid19 vaccine. She stated that her nose had been running since she had not been taking her Zyrtec.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Given FluMist - has complained of chronic abdominal pain since then - almost on daily basis. Periumbilical. no weight loss. Miralax and Prevacid no help.
Mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 01:30 (Lot number: EN6202) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Under active thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "Allerigies: Latex" (unspecified if ongoing); "several antibiotics" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Mild sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient was not Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Bactrim during the time of the first shot within 2 weeks of vaccination. Prior to vaccination the patient was did not diagnosed with COVID-19. Since the vaccination, the patient did not been tested for COVID-19. Allergies to medications, food, or other products: Latex and several antibiotics. The patient reported Event was Mild sore arm day if and after 1st shot.  Slightly more soreness after second shot and still lingers.  Also developed mild redness at injection site after second shot.  Appeared two days after shot and still present.  The patient did not received treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
Child developed rash on 6/9/2006 inwhich parent called Health Department. No fever, aches, swelling at injection site. Parent described rash as petechiae with no itching or problems breathing. Stated son had been sleeping on couch for the past 4 nights and that was the only change in habits from time of vaccination to time of onset of rash. Called back on 6.12 and rash had resolved with no further sequelae.
Rash is red and looks pimple-like; Slight running nose; Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs); Patient feels tired; This spontaneous case was reported by an other health care professional and describes the occurrence of DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired). At the time of the report, DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  At the time of the report the patient had not administered any treatment however, the pharmacist recommended the patient administer Benadryl as treatment for the events.
Patient received dose of Moderna COVID Bivalent Booster that was expired by 5 hours. No reaction to patient. Manufacture contacted and no specific recommendations whether to repeat dose or not- up to treating clinician. Clinician is aware and supports organization recommendation to repeat dose.
This spontaneous report as received from a healthcare worker refers to a 73 year old male patient. On 28-JAN-2009 the patient was vaccinated with ZOSTAVAX (lot number not provided). On 02-MAR-2013 (about a month ago) the patient experienced a mild case of the shingles. The shingles were only in the patient's right upper arm. The patient sought medical attention (unspecified). The outcome of a mild case of the shingles was reported as recovering/resolving. The relatedness was not provided. Additional information has been requested.
- metallic taste in mouth (continuous) - tightened chest (day 1 - 2) - headache (day 1) - nausea (day 1 - evening)
On 1/11/00, immediately after the vax, the pt experienced pain in the upper arm and shoulder and injection site redness. It was noted that the pt thought the pt was injected into her muscle. The pain had not yet subsided completely, but she "would not describe it as pain anymore, just as a bother." On 2/25/00, the pt recovered from the redness. No further information is available.
Pt had 3 doses of Prevnar on; 2/16/01, 4/14/01, 7/29/01 and and then on 2/28/02, had a blood culture  (+) for Strept pneumonia.
Patient called pharmacy at approximately 11am reporting that there was pain, tenderness, and erythema at the site of injection
Myalgia, Arthralgia, Fever, fatigue flu like symptoms which caused employee to miss one day of work.
After getting the vaccine the next day I woke up with chills, vomit, headache, and fever. A week later from getting the vaccine (10 days) I woke up with my vagina feeling sore and then when I checked down there I had 2 white spots which I had never ever had before. They were hurting a little and felt sore so I went to get it checked at the urgent care,  I was told it was herpes. Which I had never had before and have never even had a cold sore before. The doctor said what she saw was minimal. She submitted a culture and said it was herpes, I can not believe it was herpes if before the vaccine I had no symptoms of herpes or of a ?first flare up?. I have not had partners w herpes as well, the only connection I can have is that it is that they are two small vaginal ulcers that came as a side effect of the virus injected into me (Covid vaccine).  One spot has already disappeared w out herpes medication so I believe it is not herpes but an ulcer from the vaccine.
I was sick about 24 hours, still felt bad but not as bad as 2nd vx. Started to have Asthma problems so I was given albuterol to help.
Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am; arms had some pain; chills; headache; a stiff neck pain at the back of her neck; a stiff neck pain at the back of her neck; a trembling pain; This is a spontaneous report from a contactable consumer.  This is the 1st of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated on Dec2020, "she reported that she herself felt fine but her arms had some pain. She was having chills, a headache, a stiff neck pain at the back of her neck, and a trembling pain. Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am. Her pulse was at 62 bpm, Caller is asking for recommendations". The outcome of "her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am" was recovering and other events was unknown.   Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520380 same reporter/drug, different patient/event
Patient received his vaccine on 9/18/21 and in November of 2021 he contracted COVID-19.  He received his second vaccine on 10/16/21.  On August 10, 2022, he contracted COVID-19 again and on August 13, 2022 he suddenly died of a "heart attack, COVID related."
Approx 13 minutes after receiving vaccine, pt became dizzy and was advised to sit on the floor; guided by employee.  No LOC.   Vitals @ 1112 HR 68 Resp 16, BP 151/75 O2 100% Pt rested and released to home
The pt experienced erythematous, papular lesions on face and between breasts. First noticed rash this morning when she woke. No fever was noted. Bilateral tonsilar nodes enlarged. Pharynx and ears appeared normal. Lungs clear bilaterally.
Extreme redness and swelling at injection site. 05/7/16 Chills, fevers of 101.4, joint aches, soreness of arm that I could barely move it and hurt to touch from elbow to shoulder. Went to ER were they treated for possible bronchitis/pneumonia.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 07Apr2021 as dose 2, single (Lot number: EP7533) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 as dose 3 (booster), single (Lot number: 003F21A), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Severe joint and bone pain started within 24 hrs after vaccine administration. Joint and bone pain has been ongoing  since 4/10/21 and continues to date (8/26/21). Pain is in all joints of my body at all times of the day. Bone pain is mostly in legs and arms and worsens at night.   Treatments: Steroids (short term improvement in pain), Doxycycline (short term improvement in pain) Tylenol, Motrin, heat and cold therapy, hydrotherapy and exercise (all with minimal improvement in pain)
Patient falsified DOB when registering for vaccination, stating the minor was 01/01/2005. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
Patient became light headed and lost consciousness for a few seconds.  He felt better, but fainted again a few minutes later.
Excessive itching and burning especially wrist up; Excessive itching and burning especially wrist up; hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011LA20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Glaucoma and Hyperlipidemia. Concomitant products included OMEPRAZOLE, ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up). At the time of the report, URTICARIA (hives) had not resolved and PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Severe anxiety and uncontrollable crying. I also had a severe headache for a few days. These symptoms lasted for one week.
I was having a sore throat on the left side and had bad diarrhea. The next day I had body aches and a fever. My oxygen went down as well. I had a Liver biopsy and was in recovery for that and the oxygen level was going down. I was having the loss the taste of smell. I had done a COVID-19 Home Test which was positive, and they did give me Paxlovid, but I did not take it because of having the biopsy. I was in pain due to the biopsy and then having COVID did not help with this and made it to where I had urinary and incontinence issues.
Chest pain day of vaccine within several hours swelling of face within 36 hours of vaccine Hives approx 14 days after vaccine full torso, head until current time Hand swelling three weeks and again five weeks after vaccine Face swelling and lip swelling five weeks after vaccine
Idiopathic thrombocytopenia purpura--platelet count of 1,000
Fever, nausea and swelling at injection site, went to ER 5/28- received 10 days of doxycycline and Keflex. Have had crippling pain issues since, extreme tiredness, nausea, headaches and left quadrant pain and lymph node swelling-
On 04/29/2021 around waking at 05:00AM I started having chills and hot throughout the day. I had a temperature of 101 degrees and I felt a lot of aches and pains. My main go-through was to go back to bed. I laid on the couch most of the day feeling kind of altered and I had a headache. I felt pretty crummy most of the day. I don't recall but I think I got better later that evening. I didn't feel bad enough to go to the doctor but not well enough to work. At that time, we were 100% remote but I did not feel well enough to work. I feel like the symptoms only lasted 24-48hrs. I can't recall.
testing Positive on 23Mar2023; testing Positive on 23Mar2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 5 (booster), single (Lot number: GJ6742) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8733), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies:shrimp" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Mar2023, outcome "unknown" and all described as "testing Positive on 23Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Mar2023) positive. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot GJ6742, FE3593, FH8020, EW0151, ER8733 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ6742, bulk and fill lots GJ6729, and GJ6736. The final scope was determined to be the reported finished goods lot FP7135, fill lot FP7126, and the bulk formulated drug product lot FP6245. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. The final scope was determined to be the reported finished goods lot EW0151, fill lot EP8691, and the formulated drug product lot EP8588. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
pt recv vax 15JUN96 & 4wk later in JUL96;23SEP97 pt tested negative;
Patient received 2nd bivalent Pfizer covid vaccine; when should of only received one  1st bivalent 9/28/2022 2nd bivalent 12/14/2022
osteomyelitis lumbar spine/Two lesions in lumbar spine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: OSTEOMYELITIS (hospitalization, medically significant) with onset 13Jul2021, outcome "not recovered", described as "osteomyelitis lumbar spine/Two lesions in lumbar spine". The patient was hospitalized for osteomyelitis (start date: 13Jul2021, discharge date: 22Jul2021, hospitalization duration: 9 day(s)). Therapeutic measures were taken as a result of osteomyelitis. He was hospitalized for 9 days beginning 13Jul2021 with osteomyelitis lumbar spine. No risk factors. 6 weeks IV antibiotics completed on 10Sep2021. Hospitalized on 06Oct2021 for another 9 days. Two lesions in lumbar spine. 6 more weeks IV antibiotic with 4 weeks concurrent oral antibiotic. Completed on 10Dec2021. Currently on oral antibiotic until end Feb2022. Drs perplexed a healthy young man has this illness w no risk factors.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt. was in observation lane.  Was feeling dizzy and tingling on arm.  BP was 150/89.  Paramedic assessed pt.  Once symptoms subsided, pt. was released to go home.
Dizziness, nausea, muscle and joint pain, fever, chills, headache, fatigue Treated at home with Epsom salt bath and rest.
Arm soreness wasn't noticeable and now has gotten increasingly worse. Unable raise left arm.
4mth old infant, otherwise healthy, received  Rotateq 3-26-21, on 3-29-21, 2 hours of incontrollable crying and later that night had stool with large  amount of blood/mucus; 4 subsequent stools& blood. By 3-30-21 resolved mostly less blood.
The vial was administered after a temperature excursion; Case reference number US-BN-2021-000163 is a spontaneous case report initially received from other health professional on 03-MAR-2021 and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On unknown date, the patient started therapy with RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for unknown indication. The vial was affected by temperature excursion. Duration of excursion was 12 h, and max temperature reached 8.3 C. The vial was administered to a patient.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  Company comment: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature that reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action.; Reporter's Comments: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature that reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action.; Sender's Comments: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action
Vaccinated with Tdap instead of intended Hep B. Will return for Hep B.
Patient reported that she has had shoulder pain that radiates down her arm since receiving the vaccination on 8/15/17. It has been occurring since vaccination and has not let up. She called the primary care provider. PCP recommended her to take an NSAID and alternate ice and warmth, which she has been doing without improvement.
1 week after injection my upper arm was very swollen and hard to the touch. My whole arm was sore and ached pain going down into wrist & hand.  Ring finger & pinky were sore but numb, pain in wrist when moving. Swelling went down in upper arm in about 5 days. I still have mild wrist pain to date but with both fingers no improvement, maybe worse some days. This includes pins & needles, loss of feeling, sensitivity & constant awareness of it just not being normal. I am assuming nerve damage exists.