chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warmness around the injection site; redness 2 to 4 inches in diameter around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus (It is reported as the patient takes pain medications for Lupus.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site). At the time of the report, VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Trembling, chills, weakness, vomiting, muscle aches, neck and shoulder pain beginning about 8 hours after vaccine and lasting approximately 12 hours.  Fever of 101.5 lasting a few hours that evening. I felt very, very ill?much sicker than with flus I?ve had in the past.  It resolved the next morning as completely and suddenly as symptoms arrived.
Patient received their first dose of Moderna vaccine on 1.21.2021. Patient reported redness, warmth, and swelling at the injection site on 1.29.21 (8 days) after the first vaccine. Patient states they took benadryl and as of 2.1.21 have seen improvement. Patient also reports that at 7pm on 1.29.21 they experienced non-cardiac chest pain (pain 8 out of 10) that was sharp and felt like muscle pain. Patient is a podiatrist, so took aspirin, monitored vitals, vitals stable. Patient says the chest pain lasted approximately 7 hours.
t99.1, inc crying x 45min, lt leg swollen, warm, red;p/ice compress to lt thigh, APAP;monitored x1hr;cont sx x 24048hr;
02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Tested positive for COVID; Tested positive for COVID; Sore throat; Back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "Sore throat"; BACK PAIN (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Description of Event: Patient is 74-year-old male who received his primary series vaccine and both boosters. He tested Positive for COVID. His symptoms have been going on for 5 days and his symptoms are sore throat and back pain. Name of Product: Pfizer-BioNTech COVID-19 Vaccine Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little dizziness; little sore arm; little nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizziness), PAIN IN EXTREMITY (little sore arm) and NAUSEA (little nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke. Previously administered products included for Tuberculosis immunisation: VACCINE BCG (Her arm blistered up.) in 2005. Past adverse reactions to the above products included Swollen arm with VACCINE BCG.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced NAUSEA (little nausea). On 16-Mar-2021, the patient experienced DIZZINESS (little dizziness) and PAIN IN EXTREMITY (little sore arm). On 17-Mar-2021, DIZZINESS (little dizziness) and NAUSEA (little nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not reported.  Follow-up information received on 12-Apr-2021 included a new event, stop dates for two events and outcome for two events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Major narrative update
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of an unknown age and genders. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # M042853 for prophylaxis. The administered dose of the vaccine experienced a temperature excursion 0 degrees Celsius to 1 degrees Celsius  for 97 hours, and -1 degrees Celsius to -40 Celsius  for 8.5 min as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
Extreme sudden onset of clotted uterine bleeding. Clots were fist size and coming every fifteen minutes along with pelvic cramping. Pads/tampons were useless and overflowing. Bleeding continued from 3:30am until about 10pm when the Tranexamic Acid finally helped slow it. abnormal heavy bleeding persisted for three days after the extreme bout.
Vaccinia reaction on trunk (anterior chest and back) Maculopapular rash. 2 pustules. no treatment given. Rash began Day 12
This case was reported by a consumer and described the occurrence of mouth ulcer in a 58 year old male subject who was vaccinated with hep A vaccine (Havrix) hepatitis B vaccine (Engerix B) for prophylaxis. A physician or other health care professional has not verified this report. The subject reported no relevant medical history and no concurrent medications. On 08Jul05 the subject received 1st dose of Havrix (lot number not specified) and the 1st dose of Engerix B (lot number not specified). Concurrently the pt also received injections of diphtheria, tetanus and acellular pertussis vaccine (manf unspecified), inactivated poliomyelitis virus vaccine (Ipol); measles, mumps and rubella virus vaccine (MMRII); and a tuberculin test. On 12Jul05 4 days after vaccination with Engerix B and Havrix, the subject developed ulcers in his mouth and inside of his lips after biting his tongue a couple of times as well as dry cracked, sore lips. Approx 8 days later, on 20Jul05, he developed a rash on his right knee. Three days later on 23Jul05, he developed a rash on both elbows and up his arms a little. At the time of reporting, on 25Jul05, the mouth ulcers and the dry cracked, sore lips and improved. The outcome of the rash was unspecified.
sick; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced sick while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, dose, expiration date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
PAINS ALL OVER THE BODY; VOMITING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pains all over the body, vomiting, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, vomiting, pains all over the body and headache was not reported. This report was non-serious.
Days 4-5 I had itching around injection site. Days 10- present day (11) my arm is swollen again around injection site. Looks like a large flat mosquito bite, approximately 4-5 cm in diameter. It is inflamed and warm to the touch.
Patient received his Covid-19 injection in home environment; administered by RN. Staff monitored him for 15 minutes following injection. He stated he was feeling in good health prior to injection and his stomach started "doing flip-flops" within approximately 30 minutes of injection. Symptoms progressed to severe abdominal cramping throughout day and developed nausea/vomiting in the evening. He called EMS the following morning.
I was notified that I was given the wrong booster on October 7, 2022.  I should have received the Pfizer-BioNTech Bivalent, but I was given the older Pfizer booster shot.  I now have to wait two months before I can get the correct shot.  I thought I was protected and now I find out that I'm not. This is totally unacceptable and has caused me additional anxiety.
Screamed from 3 1/2 hours after 1st DPT. Temp 103.2  Axillary
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 72.34.  Concomitant products were not provided.  On 11 Jan 2021, excursion time was 9 AM and 2 PM and temperature was 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08 Jan 2021 and was moved to clinic on  11 Jan 2021. 09 vials was sent to clinic. Vaccine BUD date was 07 Feb 2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
With  a week of the injection, starting getting itchy welts on head and neck. Was sent to dermatologist, a thyroid specialist and a allergist. Welt have started to spread. Consistent  rash on forehead. Prescribed 4 or 5 steroid ointments that have not been  successful.
Resident began to feel ill at 2:30 am the night after he received 2nd dose of COVID vaccine. Suffered from weakness, chills, and nausea. Felt ill for approximately 2 days, but then symptoms subsided.
Urticarial reaction greater on arms, trunk & buttocks - sparse on legs & face.
About 45 minutes after the vaccine, I experienced tingling in my hands and feet, as well as heaviness in both legs.  The heaviness seemed to subside but was still present.  By day 6, Tuesday 1/5, the heaviness was pronounced and it felt as though I was walking through mud.  The next day it improves slightly but continued for over a week.  On 1/12 I noticed numbness to L thigh as well.   I saw my primary care NP Re following Wednesday 1/13 who had me see neurology 1/14.  The heaviness improved but then pain started in my lower back.  On 1/22, L thumb partial numbness also began.
Approximately 8 hrs after taking my 2nd oral dose of the Typhoid vaccination, I began vomiting and experienced diarrhea and severe aches all over my body. I became severe dehydrated came down with a fever. I experienced these symptoms along w/ prolonged nausea, for 3-4 days.  9/14/07 Reviewed ER medical records which reveal patient experienced fever, vomiting/diarrhea, malaise, fatigue, myalgias, chills.  Temp 101.2 in ER.  Tx w/IVF & antinausea/antipyretic/pain meds w/significant improvement & was d/c to home.   FINAL DX: acute AE reaction to typhoid vax.
felt awful; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingle shot and said that if you did not feel bad on the 1st one did not let it fool, because he/she felt awful on the 2nd one, but still the patient was glad he/she did it. The follow-up would not possible as no contact details were available.
3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine". The reporter knew 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine. The reporter wanted to know have there been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I have only had one period since getting the vaccine 6 months ago. I am usually very regular every 30 days. This is extremely abnormal as I'm still in my 30s.
Fatigue; headaches; muscle pain; chills; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain). At the time of the report, FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
By the time patient got home there was a red spot vaccination site raised like a giant welt.  Contacted doctor and vaccine administrator and was told that reaction was somewhat expected.  On Friday, contacted both facilities since it got worse.   Patient did not have fever and used cold compress but did not take any medication; treatment did not help welt doubled in size by next day.  By afternoon, welt was over 3 inches in diameter.  Contacted both facilities and told to keep watching it for changes, to treat fever with Motrin and give Benadryl if itching.  On Saturday, fever was 101.8, welt spread to size of palm.  Contacted Pediatrician and took patient to Urgent Care since fever kept rising; diagnosis was cellulitis.    Patient prescribed Bactrim. Affected area had expanded to 3 inches up from elbow.  Patient told to keep area clean and dry.  By next day, redness decreased to a milder pink color. Redness resolved within 48 hours.   Fever resolved since Sunday.   Notified Pediatrician that patient was on medication. Today patient is feeling much better; almost back to normal except for a little bruise at vaccination site. Area a little itchy but is not horrible.  Patient took Benadryl on Saturday night and last night.
Patient tested positive for COVID-19; A spontaneous report was received from a healthcare professional concerning a 59-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273  via unknown route for prophylaxis of COVID-19 infection.  On 7 Jan 2021, the patient experienced the event(s) patient tested positive for covid-19.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient tested positive for covid-19 was .
No other adverse events reported; improperly stored GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.  On 31-JAN-2022, the patient was vaccinated with one dose of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose and route not reported, lot # T039467, expiration date: 20-MAY-2023) for prophylaxis (product storage error). The vaccine was exposed to temperature 33.4 degrees Fahrenheit (F) for a time frame of 2595 hours. There was no previous temperature excursion. No other adverse event was reported.  This is one of the several reports from the same reporter. ; Sender's Comments:  US-009507513-2203USA007997: US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA008053: US-009507513-2203USA008063: US-009507513-2203USA008097:
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 19-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Fevers, myalgias and fatigue. (3rd Imovax/R1252-3/RA/2; 4th Imovax/R0958/LA/3; 5th Imovax/R0958-2/RA/4) Lot number not available on 1st dose.
Employee given Pfizer for Dose #2 instead of Moderna. Error.  No adverse reaction.
Upper extremity (arms) stiffness, eyes rolled back, paleness, loss of consciousness, lasting for about 5 seconds. Seizure like event was witnessed by staff physician.
Infant began inconsolable crying and local reaction at DTP/HIB injection site, within 1 hour of vaccination. Leg swelled from "knee to hip" and was "bright" red and hot to touch. He was taken to ER and was given Benadryl. States temperature was 101F.
No adverse reaction.  Pt's series completion date was checked after vaccine administration. Pt had second dose of series in July....so she wasn't do for a booster. AKA booster was administered before 6 month