chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had mild fever; body aches; and fatigue that lasted 24 hours. And then for three days, I had what could be a UTI - pain with urination. At day 3, I sought treatment and they did a urine sample - they saw signs of blood and leukocytes in the urine that indicated Inflammation. They started me on an Antibiotic. They are culturing the sample to see if it's bacterial or inflammation response only.  Day two today of antibiotic.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (soreness of the arm for 2 days), FATIGUE (some fatigue) and PAIN (little body ache) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 25-Mar-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (soreness of the arm for 2 days), FATIGUE (some fatigue) and PAIN (little body ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 16-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 17-Jan-2021, FATIGUE (some fatigue) and PAIN (little body ache) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (soreness of the arm for 2 days) had resolved.            The date of patient's positive pregnancy test was AUG-2020  The patient previously had a live full-term birth on 19-APR-2019
Erythematous blanchable rash on trunk, neck, face and head several hours after PENTACEL and PREVNAR injections.
Patient reported to ED four days after receiving H1N1 vaccination at work for complaint of arm, shoulder and neck pain. Currently under care of neurologist for complaints. Also has ortho referral.
Within 15 minutes, ringing in left ear, inner ear canal pain, loss of hearing left ear.  Ringing ended in 3-4 hours, ear pain and loss of hearing lasted around 2 days.
Fever, extreme back pain, nausea, lightheaded, headache, chills, redness, bruising and swollen arm where injection was given.
fatigue; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:15 (Lot number: ER8737) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma (controlled). Concomitant medication(s) included: CYANOCOBALAMIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ISIBLOOM; TOPIRAMATE.  The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of fatigue, headache, pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Patient had reaction to vaccine and experienced a rash on her left arm where vaccine was injected. Patient also stated that the rash was itchy for about 10 days.
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 a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:18 PM, 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.   No concomitant medication information was provided. No treatment medication information was provided. Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on  03-Nov-2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or 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 excursion issues had happened.   This case was linked to MOD-2021-402935 (Patient Link).
5cm x 4cm area of redness at vaccination site with very small vessicles in the center.
diagnosed Covid positive at some point after the first dose; diagnosed Covid positive at some point after the first dose; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. This Physician reported same events for 2 patients. This is 2nd of 2 reports. A patient of unspecified gender in their 40s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed Covid positive at some point after the first dose. The physician wanted to know what the recommendations for the patient, if patient can get the second dose or wait. Outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like vaccination date and COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021161690 same reporter/event/drug, different patient
I63.9 ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY 8/20/2023 ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY
Difficulty breathing and tightness in chest  after 2nd dose Moderna. Resolved after 15 minutes.
This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 (at the age of 39-year-old) as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced covid 4 months later on 13Aug2021. No therapeutic measure was taken. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 13Aug2021. The outcome of events was not recovered. Information on the Lot/batch number has been requested
2 1/2 hrs following vax pt awakened screaming cont for @ least 4 hrs; t103 seen by MD who stated it was reaction to vax; area red & edematous
Monovalent doses administered after the BUD to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was reported. 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A No treatment medication information was reported.
Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of chest. Symptoms continued to get worse.  After 45 minutes went to ER   Vital signs taken + EKG, observation.   After approximately 3 hours breathing, dizziness, swelling of face  improved.  Some rash remains.
came down with COVID symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (came down with COVID symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 026D21A, 029A21A and 013M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (came down with COVID symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 22-Mar-2023 for COVID-19, at an unspecified dose and frequency. On 26-Mar-2023, COVID-19 (came down with COVID symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2023, SARS-CoV-2 test: Positive. On 26-Mar-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the 2nd of two reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced cellulitis and swelling in the arm that lasted over a week on an unspecified date. Outcome was unknown.  The events required treatment with antibiotics. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016541208 same reporter drug event different patients.
Felt dizzy after standing to leave @ 30 min dismissal time.  Sat back down and drank water.  No other complaints. Alert and no difficulty breathing.  VS @ 0923: 130/90, HR 65.  Monitored for another 30 minutes.  No progression of symptoms.  VS @ 0953 125/90, HR 70.  No distress.  Dismissed @ 1010.
pt recvd vax 30NOV93 mom gave APAP q 3 hrs following; started 7PM w/high pitched uncontrollable cry-cont until 9PM; MD was called-gave instructions to give DPH; t102ax;
my son had swelling in his throat and mouth  , confusion  and mild delerium after the second dose ,   fever of 101-103. vomiting , Muscle aches , migraine headache
Patient complains of a rash (very itchy but not painful) inferior to vaccine site after TDap given 7 days ago. Patient's vital signs are WNL at time of office visit. Provider's general examination of skin: small, approximately nickel sized ecchymosis area of injection superior aspect of deltoid. Just inferior to this there is a rash - confluent wheals, lightly erythematous, dry, no vesicles. Provider prescribed and recommended hydroxyzine prn for itching and rash, as well as topical hydrocortisone and ice for discomfort.
Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ, orally (lot#, expiry date, dose unspecified), that was stored improperly. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client had gotten Moderna previously at a different site on 9/13/2021. Pfizer was inadvertently given today.
8 days after the vaccine I started with neck pain and itchy/sensitive scalp.  A few days after that a rash appeared on my scalp and neck (left side of my head only).  14 days after the vaccine is when I was official diagnosed with shingles.
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 87-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (the patient has not had shingles since she had the vaccine). Concurrent medical conditions included shingles (the patient had shingles three times), heart disorder, cancer and allergic reaction to antibiotics. On 13th July 2018, the patient received the 1st dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced generalized pruritus, scratch, burning leg, headache, cold feet and injection site erythema. In July 2018, the patient experienced rash. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the generalized pruritus, scratch, burning leg, rash, headache, cold feet and injection site erythema were recovered/resolved and the outcome of the skin discoloration was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus, scratch, burning leg, skin discoloration, rash, headache, cold feet and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: First shingles happened when she was 19 years old. Second time it was not known. The patient received SHINGRIX vaccine up on her shoulder. The next day the patient was feeling itchy and she was scratching all over her body. The night after having the injection the patient felt her feet ice cold. The patient's legs were burning. In addition, the patient did experience redness at the injection site with SHINGRIX, but the redness went all the way down to her elbow. The patient also had a headache. Less than a month after receiving vaccination, the patient visited her physician about two weeks later and her physician told her that she had a rash all over her arm where she received the injection. It was unknown when the patient started experiencing a rash on her arm. Less than a year after receiving vaccination, one of her leg had a darker spot about an inch and a half. The spot was rough and the quality of the skin in that spot was different. She does not believe she had that spot prior to the SHINGRIX injection.
Information has been received from the physician concerning an 18 month old pt who was vaccinated with a dose of varicella virus vaccine live and was diagnosed with herpes zoster. It was noted that the child was not hospitalized. Unspecified medical attention was sought. No further information was provided. Follow up information on 05/22/03 revealed that "the child would not be coming in for a specimen". Additional information is requested.
This spontaneous report was received from a physician via a company representative, referring to an 18 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in June 2017, reported as last week, the patient received the first dose of GARDASIL 9 for immunisation along with meningococcal vaccine (unspecified) (dose, route, lot numbers and expiration dates of both therapies were not provided). On an unknown date in June 2017, the patient became sick with fever and "feeling really bad". He visited the physician's office but it was unknown if any lab diagnostic studies were performed. No treatment was given for the adverse events. At the time of the report, the outcome of the events was unknown. The causal relationship between the events and GARDASIL 9 and meningococcal vaccine (unspecified) was not reported. Additional information has been requested.
nauseated & fainted;BP 123/89;pulse 100-clammy & cyanotic on face & lips-ammonia inhaler used pt passed out again;to ER given epix2;tightness in chest;pain in throat, arms hurt;tired, weak, w/pain;BP 127/90, P90;BP 133/70, P97;BP 110/87,P94
Pt @1055 reported tingling and numbness, then flushed through all body and felt palpitations for a minute.  @ 1125 pt verbalizes that she "feels fine" and denies any new or continuing symptoms.  States that her throat is dry but declines to drink water stating she has water in her car and will just get that.  @1204 attempted to contact pt on mobile phone for FU but no answered.  LVM
Patient received PNEUMOVAX 23 in left deltoid muscle. She experienced muscle soreness on 10/22 and 10/23, but on 10/24, she developed a warm, red, swollen area on her left arm above her elbow, but below the injection site. She didn't report pain or itching. She just said the area was hot.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
worst headache i have ever experienced, delirious, high fever, skin felt like it was on fire, every bone in my body hurt too much to move, nausea, indeterminate lower gut pain, couldn't walk, ringing in ears  patient received IV benedryl, carbamazine?, and motrin , day after taking on doloneurobien(sp?)  feels much better
Information has been received from a nurse practitioner, concerning a 16 year old patient of an unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, when the patient was 14 year old, he/she was vaccinated with the first dose of GARDASIL 9 (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. Then, 2 years later (reported as: at "16 years old"), the patient was vaccinated with the second dose of GARDASIL 9 (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
BODY ACHES; CHILLS; FEVER; HEADACHE; PAIN IN ARM AT VACCINATION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022) dose was not reported, once a total administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced pain in arm at vaccination site. Laboratory data included: Body temperature (NR: not provided) 102.9 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-MAR-2021, chills, and fever on 08-MAR-2021, and headache on 09-MAR-2021, and was recovering from pain in arm at vaccination site. This report was non-serious.
Headache, Arthralgia, Pain/Discomfort, redness, and swelling at injection site, fatigue Narrative: