chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that after receiving the vaccination her injection site immediately became hot, red and swollen. She states that the injection site still burns and tingles when she touches it. She also says that her arm hurts when she lefts her left arm.
foster mom stated that pt devel a temp of 103 & loss of appetite 48hr p/vax;
In afternoon, was very tired. Started having chills at about 7 PM, followed by fever that gradually rose to 102.5 degrees overnight. During night, also developed wheezing/hoarseness. At about 8 AM fever reduced to 99.8 degrees but wheezing persisted. Took to Dr., who prescribed inhaler treatment.
I developed something very similar to Covid19 in 2015 that developed into a longcovid like condition (asthma, migraines, auras, fatigue) and that your Covid vaccine cured it at least so far; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: unspecified) via unspecified route, as dose number unknown, single on an unspecified date for COVID-19 immunization. Medical history included that patient was sick on/off for 6 years straight until the vaccine and asthma, migraine, aura and fatigue from 2015 till unknown date. Concomitant medications were not reported. It was reported that, patient developed something very similar to Covid19 in 2015 that developed into a long Covid like condition (asthma, migraines, auras, fatigue) and that Covid vaccine cured it at least so far. It was also stated that, patient might have had a mild case of MERS back then but did not know as no doctors ever tested patient for anything but was sick on/off for 6 years straight until the vaccine.The clinical outcome for event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
child received incorrect dose of vaccine - patient is 8yo and should have received the pediatric formulation. The pharmacist mistakenly used the 12+ yo formulation and mixed and administered according to the pediatric specifications (1.3ml diluent and 0.2ml dose). Mom reports the child is feeling ok- has a sore arm, reports no other side-effects at this time.
Patient received the COVID vaccine at 1327. After her 15 minute observation she went to the bathroom and noticed red areas on her arm. She came in and alerted the nurse. 1348 she was escorted to a chair. Raised red areas noted on both hand and arms: vs 97.3-108-22 138/87 o2 sat 98%, no difficulty breathing. She has a history of asthma. 1400 patient took her own Benadryl 50mg po. After 15 minutes rash less red: 1415 vs 98-104-20 131/82. 1440 ambulance here assessed pt. No discomfort noted. Pt refused to go to hospital. EMS escorted her to her car, rash faded, no discomfort noted, stated she felt just fine.
Rach all over my body; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received (also reported as 45-year-old, pending clarification) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FA7484, expiration date was not reported), via an unspecified route of administration, in left arm, on 23Jul2021 09:45, at the age of 25-year-old (also reported as 45-year-old, pending clarification), at dose 1, single, for covid-19 immunization. Medical history included environmental allergies and COVID-19. The patient was not having other known allergies and was not pregnant during the time of report. Concomitant medications included diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not tested after the vaccination. The patient experienced rash all over body on 23Jul2021 16:00. The reporter assessed the case as non-serious. No treatment was administered for the event. The outcome of the event was not recovered.
fever, loss of appetite, irritability, feeling tired, headache, chills....temerature 98 to 102.4 over four days...loss of taste, night sweats, 2/28 had dizzy and vision changes.  symtoms severe to cause loss of work for the week
Woke up from my sleep with severe and violent chills that lasted about 1h30m. Then noticed my body was very warm, likely a fever. Did not get temperature. Then in the morning I had a headache and muscle aches.
Started as a local reaction with erythematous, circular, warm "3 X 3" reaction at the injection site with flu-like symptoms the following day.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On  01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Janssen vaccine vial was opened at 0800 on 6/16/2021 at start of clinic day. Patient was a walk-in 06/16/2021 to receive Janssen vaccine. He received his dose at 1530 on 06/16/2021 from the vial that was opened at 0800 that morning. Vial had been left in vaccine refrigerator since it was opened at 0800 but it had exceeded its storage time of 6 hours for an open vial in the refrigerator. Patient had completed his monitoring period and left the building when the error was discovered. Patient had no adverse effects during his monitoring period.
Within 2 minutes of injection, it trigged mild POTS issues - dizzy, faint, blurred vision, increased heart rate. This in turn triggered a panic attack. About 2 hours later injection site started to ache. This morning my arm feels like someone knuckled punched me, I am still unsteady on my feet - dizzy, woozy, faint. Joint pain is worse from head to toe, but this can be from the weather - it is hard to decipher.
Patient states 1 week after vaccine she developed a full body prickly rash on her back, arms, neck, and stomach. Only a little itchy and not located at injection site.  She has been taking Zyrtec with only slight improvement.
received the expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL, LISINOPRIL and CLONIDINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were not provided Patient visited emergency room with elevated blood pressure and was treated by Norvasc and hydralazine. Patient had previously High blood pressure and treated it by metoprolol and lisinopril but never had so unexpected elevations. Occasionally Patient had experienced nose bleeding after vaccination and Physician added clonidine to patient's daily medication to treat the symptoms.   Crosslinked with case MOD21-065683 Caller was returning call from safety, contact information was provided.  The caller does not have a computer, and has no way to receive e-mail.   This case was linked to MOD-2021-063092 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received on 14-MAY-2021, Included no new information
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old white not Hispanic or Latino female. Initial information was processed along with the additional information received on 24-AUG-2021. 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: 1808980, and expiry: 18-SEP-2021) dose was not reported, 1 total administered to the left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced symptoms of Covid (headache, congestion, exhausted, things taste funny, runny nose). On 22-AUG-2021, patient received a result of COVID-19 virus test positive. The symptoms started last week but patient did not realize she had been infected (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190597.; Sender's Comments: V0 20210846287- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Unusual headache base of neck lasting 3 days , five days after refining first COVID vaccine Wondering if delayed side effect vs.unknown exposure to active COVID
After recieving the Covid 19 Pfizer EW0181 vaccinne at pharmacy I expeirienced icing on the injection site a hour later. During the same day i experieced icing on my legs. the next day i saw rashes spreading all over my legs as well as bruises. its been spreading to my chest next and arms. I went to the doctor and he prescribed Triamcinolone Acteonide and Hydroxyzine HCL25MG. I have tried benedryl, cortizon, and providone-lodine, and calimine lotion with no possive effect.  The doctor instructed me to file this form with you and instructed me not to take the second dose
horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Pt received both vaccines above and was told to wait 15 mins after the vaccination.  At around 12 mins after vaccination patient started to report a "lump" in her throat.  Pt was observed for several more mins and there was no improvement in symptoms.  Her HR and BP were elevated.  Pt stated that she got the same symptom with her previous reactions to Iodine and Tree Nuts.  Pt was given one dose of Epi Pen at 9:45am.  Pt reported that her symptoms were improving.  EMS arrived and transported patient to hospital.
Exactly one week after vaccination, I experienced redness, heat, and extreme swelling around the vaccination site. It lasted for 4 days and subsided without treatment. I did not report it at the time.  It was exactly like the experience I had with  Pneumovax about 10 years ago.
high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm red and warm to the touch 8 days after the shot; Arm red and warm to the touch 8 days after the shot; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot). At the time of the report, VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot) had not resolved.        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.   Concomitant medications were provided as birth control pills Treatment information provided as topical steroids and icing the area; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
102°F fever, chills, nausea, diarrhea for 24 hours
I had a memory lapse, loss of memory for an hour went to ER, they did MRI and diagnosed me with a stroke, they ruled out a cardiac event in ER but have not completely ruled out, however I'm wearing a holter monitor for a month. Doctors are ruling out if I even blood clotting disorders or if it was related to an autoimmune disease. When they did the echocardiogram I had no clots in heart. I had showering of clots in my brain.
1 yr old received MMRV 8/15 and was noted to have a measles like rash on trunk + extending to extremities on 8/26/19, about 2 days of diarrhea + fever
10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze).    No concomitant medications were reported. It was reported as unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patients have not reported other side effects.  No treatment medications were reported.  This case contains information for the 06 of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Loss of muscle control, paralized on right side of body.  In bed for three day and still need to have support to walk.
Patient started having a pounding headache, itching all over.  Started to have rash and hives.  bp was elevated.  she did have epi pin on her but did not want to use it due to previous reaction to epi.  50 mg of benadryl was given in the right deltoid.  once this was given symptoms subsided.  ems was called, however she declined transfer.  She was driven home via a family member
given the shot in my upper left arm / experiencing soreness and sharp pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 13:00 (Lot number: FJ1620) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPRIN; LISINOPRIL; PRAVASTATIN; CLOPIDOGREL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 05Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "inappropriate schedule of vaccine administered"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Vaccine Administration Time: 04:00 PM), administration date: 04Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "given the shot in my upper left arm / experiencing soreness and sharp pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: facility at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies. Patient in good health  follow-up attempts are completed. no further information is expected.