chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area; Severe discomfort in kidney area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area). The patient was treated with ACETAMINOPHEN for Pain kidney, at an unspecified dose and frequency. At the time of the report, RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area) outcome was unknown.            No concomitant medications were provided.. Action taken with mRNA-1273 in response to the events was not applicable.
Info has been received from a consumer, a 32 year old female, who was vaccinated with 2 doses of varicella virus vaccine live, 1 dose on 12/4/05 and a 0l5 mL booster on 1/3/06. On 1/5/06, the pt awoke in the morning with fever, chills, body aches all over, headache and nausea. The pt was seen in the ER and given steroids and Benadryl. It was noted that the physician wanted to hydrate with IVF but the pt refused as she was afraid of needles. The pt slept all day and "still felt awful". It was noted that the "ER felt it was a reaction to the vaccine". At the time of the report the pt's outcome was unknown. Additional info is not expected.
COVID Breakthrough case . Tested positive on 07/22/2022 Symptoms -nasal congestion, headache, cough  Still positive  Prescribed Molnupiravir 200mg last dose was on  7/25/2022. Tested positive for COVID again on 8/1/2022. As of this report I am COVID positive
Information has been received from a certified nurse midwife concerning a 21 year old female with lactose intolerance who in November 2006, was vaccinated with a first dose of Gardasil. There were no concomitant medications. Subsequently, 12 to 24 hours after the first, the patient experienced "extreme weakness" and fever > 100 F. Unspecified medical attention was sought. Subsequently, the patient recovered from "extreme weakness" and fever > 100 F. On an unspecified date, the patient was vaccinated with a second dose of Gardasil. Subsequently, 12 to 24 hours after the second, the patient experienced "extreme weakness" and fever > 100 F. Unspecified medical attention was sought. Subsequently, the patient recovered from "extreme weakness" and fever > 100 F. Additional information has been requested.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 4 months old male patient who experienced generalized rash all over, while he received vaccines IPOL and ACT-HIB. The patients past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DTAP for Immunisation, PREVNAR for Immunisation, and ROTAVIRUS VACCINE for Immunisation, Lot number, dose, site, route of administration not reported for all vaccines. On 12-Jun-2018 date, the patient received injection of suspect IPV (VERO) lot N1G51, expiry date 02 Aug 2019, dose not reported via intramuscular route in the right thigh. On 12-Jun-2018, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI917AA via intramuscular route in the right thigh. The patient developed a non-serious generalized rash all over fourteen days following the administration of HIB (PRP/T) VACCINE and following the administration of IPV (VERO). Final diagnosis was generalized rash all over. Lab data was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for generalized rash all over. List of documents held by sender - none.
Fever, headache, aches. Treat at home with NSAIDS, push fluids, and rest.
Rash right arm. No itching. Onset approximately 30 minutes after vaccination. Benadryl given.
Patient felt achy and pain radiated down the right side of her body and could barely move her arm. The arm was swollen and she applied an ice pack and took warm showers to relieve the discomfort. It took a "few" days to resolved.
SPOTS ON SKIN THAT STARTED PINK THEN TURNED BROWN, DIME TO PENNY SIZE MARKS AND BIGGEST WAS ABOUT 2 INCHES AND SOME PINPRICK SIZE DOTS OR DOTS  WITH A CIRCLE OVER IT; FELT WOOZY, KIND OF DIZZY; This spontaneous report received from a patient concerned a 57 year old female. 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 was not reported, administered on 10-APR-2021 for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported.  On 10-APR-2021, the patient experienced spots on skin that started pink then turned brown, dime to penny size marks and biggest was about 2 inches and some pinprick size dots or dots with a circle over it. On 10-APR-2021, the patient experienced felt woozy, kind of dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt woozy, kind of dizzy on 10-APR-2021, and had not recovered from spots on skin that started pink then turned brown, dime to penny size marks and biggest was about 2 inches and some pinprick size dots or dots with a circle over it. This report was non-serious.
Mother called in and reported pt has swelling of left thigh and left thigh measures one inch bigger than the right thigh in diameter.
lingering fatigue; fever; body ache; chills; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (lingering fatigue), PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy on 23-Sep-2019. Concurrent medical conditions included Alcohol use (1-2 times per week) since 31-Dec-2020.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced DIZZINESS (dizziness). On 23-Jan-2021, the patient experienced PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills). On 24-Jan-2021, the patient experienced FATIGUE (lingering fatigue). On 24-Jan-2021, PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (dizziness) had resolved and FATIGUE (lingering fatigue) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-002697 (Patient Link).
C/O (L) arm redness from elbow to shoulder about 48 hours, hot to the touch.
Two hours following vaccinations, mother noticed redness and a knot at injection site. L thigh, fever started 10/15/14 during the night.  Patient is still moving around like normal and has no change in behavior per mother.  Mother says she does not favor right leg over left leg. Patient in clinic for assessment of L leg which remains red and puffy at injection site with 4 cm in diameter area noted.
I have always experienced AFIB episodes. After the vaccine my AFIB episodes began to last longer and increase in frequency. I currently have been in AFIB for the last week. I am scheduled for an ECG tomorrow with the Cardiologist.
Brain fog starting event morning since the vaccination for over 8 months now.  High intensity tinnitus, difficulty with gait, dizziness, throbbing in head, uncertainty for driving.  Severely debilitating for over 8 months.
I started off with a sore throat on the left side of my throat, which disappeared about 24 hours later. Later, it became sinus and nasal congestion that followed with phlegm discharge. I developed a mild cough. I took an at-home antigen COVID-19 on 12/27/2022 which came back positive. I contacted my doctor that same morning who prescribed me PAXLOVID. I'm currently on day 3 of my prescription and still experiencing a mild cough, but my sore throat and nasal congestion has relieved itself; my condition is improving.
Woke up in the middle of the night  dizzy on the evening of 3/11/21,started  vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with  an abdominal clot size of a grapefruit
The patient came back two days after her vaccination and had a very large bruise & swelling around the injection site and had swelling and redness down her right arm almost to her elbow. she said her arm was painful and was warm to the touch. I recommended that she see her doctor right away. Doctor saw her and said it was cellulitis and he prescribed her some BACTRIM DS which she filled on 5-12-2010. She said it felt better than yesterday.
Rash over body/itchiness -- which was treated with BENADRYL at home.
14 year old was scheduled for Adacel vaccination but ActHIB was given instead/no AE; The Hib portion was given to a 14 yo inadvertently/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 years old patient who was supposed to be given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccination instead HIB (PRP/T) VACCINE [ACT-HIB] was given.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ157AA, via intramuscular route in the deltoid nos.  This is a case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt developed facial itching 15 minutes after  Moderna  Covid  vaccine injection.. Benadryl 25 mg capsule  given po per order Dr. Will be observed x 30 more minutes. 9am C/O oral itching, examined again by Dr.  No SOB or difficulty breathing, 9:15am Tx to AUC per DR.  Was given Benadryl, Solumedrol and Pepcid. To be discharged home with EpiPen
severe body aches, fever, headache, fatigue and week. Administered spot welped up and was red and warm to touch
About 11 hours after the second shot, nauseated, vomiting, low grade fever(99.6), chills the worst  I have ever had. Headache, diarrhea, lost of balance, dizziness, and confused. Lasted about 24 hours. I though I had Covid again. 48 hours later I feel much better except my body feels like a truck hit me and  no energy.
At about 10:50am vaccinator administered 0.3ml of Janssen to the client and clients wife.  After sending them to observation vaccinator realized she only administered 0.3ml  which is not the correct dose.  Janssen's recommended dose is supposed to be 0.5ml.  Vaccinator walked over to Observation where the client was being monitored for 15mins post vax and explained the error to the client and his wife who were willing and okay to receive the remainder of the dose that was supposed to be administered of 0.2ml. Client left fully vaccinated no signs and symptoms of adverse reactions.
started with severe pain and cramping in R calf preventing from standing walking, worse with sitting standing, better with lying down/ flexing leg in the hip and knee joints. This pain was associated with outer 3 toes curling up and paresthesia in the calf/toes. Later I noticed that milder pain was present along the R sciatica up to R buttock. A few days later I had paresthesia in my face and both hands but no pain. Treated with rest and Ibuprofen as needed. Lying down helped the most.
Extreme vomiting lasting from 1AM until 8AM. Vomiting occurred every 15 minutes or less.  Also had chills and body aches. No fever. Had no reactions to shot 1
Pain with movement of right arm, area hot, swollen, ran fever of 101.2, vomiting--no treatment--symptoms subsided by next morning.
feels cold; all body hurts; had pain where shot was given; felt weak / very weak; ill; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feels cold), ILLNESS (ill), ASTHENIA (felt weak / very weak), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 77C21A and 012B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ILLNESS (ill). On 17-Nov-2021, the patient experienced ASTHENIA (felt weak / very weak). On 18-Nov-2021, the patient experienced FEELING COLD (feels cold), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feels cold), ILLNESS (ill), ASTHENIA (felt weak / very weak), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given) had not resolved.            Concomitant drugs were not reported.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
vaccine was administered post excursion to patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2022SA390611(CLUSTER), 2022SA390948(CLUSTER), 2022SA391393(CLUSTER), 2022SA392234(CLUSTER) and 2022SA392531(CLUSTER).  This case involves a 38 years old male patient to whom vaccine was administered post excursion with no reported adverse event for Influenza quadrival A-B vaccine [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7695JA: strength and expiry date not reported) via intramuscular route in the right arm for Immunization.  It was reported that vaccine was administered post excursion to patient with no reported adverse event (poor quality product administered)(latency; same day)  Action taken :  not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is not an adverse event, but rather an inappropriately administered vaccine. The patient's parent filled out the consent form and gave the incorrect date of birth, making the patient 12 years old. The vaccine was administered to on 7/26. On 8/2, the pharmacy team received an email from corporate stating the Immunization Registry had reached out regarding a potentially inappropriately administered vaccine based on the patient's age. Upon inspection of the consent form, the pharmacist on duty (not the pharmacist filling out this report) stated the consent form indicated the wrong DOB, as was entered into the computer prescription processing system. The managing pharmacist returned the next day and changed the patient date of birth to what was reported by the registry and attempted an insurance search using the computer prescription processing tool, which provided said patient's insurance information, indicating to the pharmacist that the date of birth is actually. This makes the patient ineligible to receive the Pfizer COVID-19 vaccine per the EUA. There have been no adverse events reported. The patient was unable to be notified or contacted regarding any adverse events as no phone number was provided/procured at the visit.
TERRIBLE BODY ACHES; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 19 year old of unspecified sex. 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: 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 terrible body aches, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible body aches, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210439312.
HAD SEIZURE APPROX 4 HOURS AFTER IMMUNIZATIONS.  QUESTIONABLE HISTORY OF SEIZURE THE DAY BEFORE SHOTS AS PER HISTORY GIVEN BY PARENTS 12/15/08-records received for DOS 11/15-11/20/08. DC DX:Abnormal movements, seizure disorder, reflux. Presented to ED with epsiodes consistent with changing sensorium, smacking of lips and generalized movements of arms and legs. Occurred day prior to admission. Video  pH probe and pneumogram showed significant reflux.
Feeling cool / felt like 2-3 days after a cold; Very tired; Very minor chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills). At the time of the report, FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
the next day and for the next 3-4 days my body was in intense pain all over. it hurt to move at all.
presented with a cough, difficulty breathing,  sinus congestions and headache  on 2/7. tested positive for COVID-19. admitted to the hosp. completed 5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21
Pt started with a rash (small irregular bumps that were not clustered) on her legs. It spread the next day to her torso and arms.  In the beginning she had mild itching that she treated with Allegra, but got no relief.  The second day the itching increased and was treated with Benadryl, with little to no relief.  It was suggested that hydrocortizone cream may give her relief and that if the symptoms continue or worsen she should contact her physician. She went to urgent care and was given 10mg prednisone and instructed to take Benadryl continuously.  She report the rash is not improving.