chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area around the injection site started to get itchy, red & hot to the touch; Area around the injection site started to get itchy, red & hot to the touch; Area around the injection site started to get itchy, red & hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch). At the time of the report, VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment product information was not provided.
Pt recvd vax on 16SEP92 & w/in 1 to 2 hrs p/receiving vax pt exp a rash & red welts @ the inject site;
Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756530A, A0756532A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient got a High Dose Flu Vaccine and should of received a regular dose due to only being 64 years old.
Breakthrough case admission after 4 vaccines  Pfizer 2/17/21 Lot# EL9267;  Pfizer 3/9/21 Lot# EN6199;  Pfizer 11/11/21 Lot# FE3590;  Pfizer 5/23/22 Lot# FK9894
I noticed ringing in my ears about a week after receiving my 2nd shot. I have been to my primary care physician and ENT. I still have ringing in my ears  despite two rounds of prednisone, daily use of Claritin, and multiple nasal sprays.
Received 2nd Moderna vaccine for covid-19. Within 6 hours, my entire body was severely itching. I had to talk to an on call doctor who prescibed Attarax.  Three days later, I am extremely uncomfortable and still itching.
pain at injection site radiated and is over the left chest area, spreading over; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at injection site radiated and is over the left chest area, spreading over) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 027A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site radiated and is over the left chest area, spreading over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at injection site radiated and is over the left chest area, spreading over) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sore right  upper arm 03/05/2021 to 03/06/2021.  No other symptoms until 03/14/2021 when I felt my upper right arm was , and still is itchy.  The  skin is red where it is itchy.  It is about 2'' x 5" rectangle.
nervous; Feeling nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (nervous) and NAUSEA (Feeling nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NERVOUSNESS (nervous) and NAUSEA (Feeling nauseous). At the time of the report, NERVOUSNESS (nervous) and NAUSEA (Feeling nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
On 4/23/2021 patient began having pain in his lower legs and feet.  The pain then moved up to his upper legs.  Patient states " I felt like I had a really bad sun burn on my arms and chest".  These symptoms lasted about one week.  Patient states then his lower legs/feet and hands feel "numb and tingly with nerve like pain".  He states the rest of his body has a numb like feeling.  He says his tongue, lips, and back of his throat are really numb.  He continues to have these symptoms.  He says he has decreased taste and due to this has lost 28 pounds.
Developed diarrhea within 1-2 of Rotateq.  Mom noted flecks of blood at home but hemeoccult done on different stools all negative.  Diarrhea persisted 2 wk with initial poor appetite but resolved without sequelae.
Information has been received from a nurse via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (lot #, expiration date, strength, dose, frequency and route unknown). On an unknown date (after receiving GARDASIL 9), the patient stated that he saw orange out of one eye. The outcome of the event "saw orange out of one eye" was unknown. No product quality complaint (PQC) was involved. The causal relationship between the event and GARDASIL 9 was unknown. Additional information has been requested.
10/7/15 Pt came in with Left deltoid area baseball size red warm area from reaction to MCV-4 given on 10/5/15 15:00 PM. Pred dose Pak 5 mg, BENADRYL 12.5mg/5ml given 10/7/15 15:57 PM.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 included: "high cholesterol" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The patient received other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Unknown results; (14Jul2022) Negative, notes: rebound Covid after a negative test 4 days later; (Jul2022) Unknown results, notes: rebound Covid after a negative test 4 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral (Paxlovid) for the treatment of COVID-19 from 05Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling and rash to the wrist and swelling of neckline the following morning (10/19/19). Swelling eventually reduced but still remains slightly.
My left kneecap had an unusual golfball size swelling 8 hrs after shot; Joint pain; Headache; Fatigue; Ache at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021, at 12:45, (at the age of 68-years) as a single dose, for COVID-19 immunisation. The patient did not have any other medical history. The patient had history of allergy to contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included linseed 290mg (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), flax oil (MANUFACTURER UNKNOWN) and turmeric (MANUFACTURER UNKNOWN) for an unknown indication. The patient experienced unusual golf ball size swelling in her left kneecap 8 hours after shot followed by joint pain, headache, fatigue, ache at injection site on 18Mar2021 at 21:15. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events my left kneecap had an unusual golf ball size swelling 8 hrs after shot, joint pain, headache, fatigue and ache at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
lower back pain, brown urine, lasted for 24 hours, maybe 30 hours. I feel about 80% recovered
This spontaneous report has been received from a Registered nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 30-JUL-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # reported as L008660, expiration date: 10-NOV-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
Friday received Flu vaccine and Sunday talked to Dr because of hives all over her body also complained of sore throat. Dr prescribed prednisone. No resp. symptoms.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported. No Concomitant information was reported. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No Treatment information was reported.   This case was linked to MOD-2021-402935 (Patient Link).
Vaccine expired 9-2-18. Merck was notified and they stated that vaccine was still valid even though expired.
This case was reported by a nurse and described the occurrence of headache radiating to neck in a 42-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  The subject does not consume alcohol and is a non-smoker.  The subject had not received prior BOOSTRIX vaccine as an adult.  Concurrent medical conditions included seasonal allergy.  Concurrent medications included ALLEGRA D and VERAMYST.  On 13 April 2009 at 10:46 the subject received unspecified dose of BOOSTRIX (0.5 ml, unknown route, right arm).  On 13 April 2009 at 10:00, approximately 7 hours after vaccination with BOOSTRIX, the subject experienced headache that went from the top of his head to his neck and fatigue.  The subject was treated with a heat pack.  At the time of reporting the events were resolved on 14 April 2009.  The healthcare professional considered the events were related to vaccination with BOOSTRIX.
Extreme fatigue & muscle pain throughout body; headache;  All symptoms lasted approximately 20 hours.
I did not feel any reactions to the vaccine for 4 days after I got it. However, Sunday night I got a really bad headache and my temperature was slightly higher than normal around 99. Then, all day on Monday I had a very intense fever, I was sweating all day, bad headache, and very fatigued. My fever was around 100.4 Monday afternoon around 2 PM and increased, I felt horrible. My fever peaked around 7-8 pm, it was around 102 degrees. I took 2 fever-reducing tylenol on Monday. I scheduled a rapid PCR COVID test for Tuesday morning. However, today (Tuesday. 4/20) I feel great and I do not have any side effects.
No adverse reaction was reported after 15 min monitoring.  Pt was not within the age range for JnJ vaccine.
Systemic: Seizure-Mild, Additional Details: Patient got lightheaded and then began seizing for less than 1 minute. Patient did not disclose that this had already happened to him with the covid vaccine previously. Administrator was notified after vaccine was given. 911 was called. EMTs came to check vitals (all normal after seizure). Patient said he did not want to go to hospital because this happened to him before and he was fine after.
redness and then 10 mm. hive @ site of vaccine administration (approx.5/8 in form needle insertion)on left upper-outer thigh, observed approx. 5 to 10 min. after yellow fever injection. Hive bagan to resolve, but administered 0.2 ml Benedryl.  Hive continued to resolve and patient and mother with mother without further problems. Checked with Mother 10/22/08- reported patient had slight fever 10/21 but is fine today.
Severe swelling of entire upper arm with redness, limited motion due to swelling of soft tissue at shoulder. Oral BENADRYL and prednisone given when seen in ER.
One day after injection,  acted the exactly the same as she did the day she was hospitalized for COVID at  Hospital in Dec 2020. She had fever around 101F, was too weak to sit up or feed herself or do anything other than lay down. She did not respond to tylenol. I got a virtual visit with her doctor,  to decide if to go to the e.r. and we agreed to try one more tylenol in the late afternoon and she got slightly better, so we delayed hospitalization. So after that she slowly recovered over several days. She was weak for about a week. Her doctor suggested she not get the second dose because she probably still has lots of antibodies in her and had an antibody reaction. I'm a reporting this because i want to know if people who had COVID and only one dose of vaccine with a severe COVID like reaction like this can be officially considered "immune " and get a vaccine "passport". Could you let us know.
After patient received vaccines he said he felt flush and like a wave was coming over him. He sat down and was talking but requested water. Drank some water but then his hand began shaking. His wife asked him questions trying to get him to respond but he couldn't. He then passed out and we laid him on the ground and called 911 and got the AED. He never stopped breathing but was gurgling. Was in and out of consciousness. Paramedics arrived and took him to the hospital.
Large red spot and lump on injection site - still prevalent on 2/24 after first vaccination on 2/11.   Pain subsided after 2nd day but site has become itchy at times.
Patient was given PENTACEL, Hepatitis B and PROQUAD injections on 6/16/2014 at 2:15 pm. Within 5 minutes following administration of these vaccines, patient developed a patch of red rash to his forehead. The red rash appeared to be increasing on his forehead. BENADRYL .2 ml(50 mg/ml) given.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-MAY-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability