chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full blown COVID/ Tested positive for covid antibodies; severe reaction; did not get second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose). At the time of the report, COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Patient developed breathlessness,  chest pressure and palpitations ~30 minutes after vaccination. She was directed to urgent care where she was placed on telemetry. Her symptoms abated within several hours while being observed without intervention
5 1/2 x 4 1/2 area of ecchymosis and induration on upper lateral aspect of left shoulder. Area warm and Tender to touch.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-APR-2013, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot number 671378/0811AA, expiry date was 15-MAR-2013, route and dose were not reported). No adverse effect reported. Additional information has been requested.
slight adverse effect; a little dizzy; Shoulder pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION COMPLICATION (slight adverse effect). At the time of the report, VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased (80-120 mmHg): mmHg High. On an unknown date, Heart rate: increased (High) rapid heart rate of 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Adverse events related information was updated.
Psychiatric hospitalization; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of psychiatric disorder nos in a 19-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of RabAvert. On an unknown date, the patient received the 2nd dose of RabAvert. In June 2019, less than a week after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced psychiatric disorder nos (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the psychiatric disorder nos and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the psychiatric disorder nos to be related to RabAvert.  Additional information was provided as follows: The age at vaccination was not applicable for 2nd dose of RabAvert. The patient was recently admitted to the reporter's  inpatient hospitalization facility. The patient did not received 2nd dose of RabAvert, which he should received on day 3 from 1st dose, which led to incomplete cousre of vaccination. When pharmacist inquired for this, the hospital healthcare professional did not provided details surrounding hospitalization and stated that she was calling from psychiatric facility and the patient was hospitalized for those type of reasons. Vaccination facility information was not provided. The healthcare professional declined provide additional details due to patient privacy.
Pt states he had onset of severe headache four days after completing last dose of Typhoid vaccine. Went to ER within 24 hrs of onset with extreme fatigue, muscle soreness, and general aching. Spontaneously resolved while in ER. Returned to ER following day with same symptoms-kept overnight for observation. Resolved again spontaneously and was released from hospital. No definite diagnosis but the doctor asked about the Typhoid vaccine. Sent home on antibiotics.
This case was reported by a pharmacist and described the occurrence of unable to lift arm in a 39 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included multiple sclerosis. Concurrent medications included interferon beta-la (Avonex) and Cyanocobalamin (Vitamin B12) which were indicated for the multiple sclerosis. On an unspecified date in 2005, before 01 December 2005, the subject received 1st dose of Fluarix in an unspecified arm (lot AFLUA139AA). The pharmacist reported that this was the, "patient's 1st time receiving a flu vaccination." The pharmacist also reported that, "the day after the vaccination, the patient was unable to lift his arm (that received the vaccination) more than 3 inches. There was no paralysis; the inability to move the arm was due to the ache." The subject was seen at a physician's office. At the time of initial reporting, 01 December 2005, the events were ongoing. The pharmacist considered the events to probably be related to vaccination with Fluarix.
This case was reported by a pharmacist via call center representative and described the occurrence of rash mouth in a 72-year-old male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Concomitant products included PREVNAR 13. On 6th March 2018 19:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGIRX, the patient experienced rash mouth and mouth bump. On an unknown date, the outcome of the rash mouth and mouth bump were not recovered/not resolved. It was unknown if the reporter considered the rash mouth and mouth bump to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in unknown deltoid and experienced rash around the mouth as well as lump on the inside of their cheek. On 6th March 2018, the patient received PREVNAR 13 in another arm, in deltoid. The healthcare professional did not know when the reaction started. The healthcare professional reported that the patient had been on all their medications longstanding and did not have anything pertinent to this situation in their medical history.
Patient had very bad migraine the next day. That was the worst symptom.  Also had low grade fever and pain under his arm (lymph node presumably) He rested quietly and we gave him ibuprofin and tylenol.  It resolved but took quite  a few hours and was very painful.  He is wary of taking the bivalent booster which is scheduled for him for next week.
suspected serum reaction to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SERUM SICKNESS (suspected serum reaction to COVID vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SERUM SICKNESS (suspected serum reaction to COVID vaccine). At the time of the report, SERUM SICKNESS (suspected serum reaction to COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Patient was given Moderna vaccine on 5/5/2022 on this date she was only 15 years 7 months old and  Moderna is not FDA approved for children under the age of 18. No harm noted to patient.
pt recvd vax;exp inject site swelling,erythema & tenderness;sxs persisting;tx warm compresses; reported to nurses 7Mar sxs still persisting.
Chest tightness, SOB, slight cough, itchiness in back of throat, 72 hours after receiving FLUZONE -> symptoms lasted for 30 min. Then had 4 episodes of vomiting throughout next 10 hours.
Patient developed chest pain, presented to ED on 10/23, noted to have elevated troponin. She had negative diagnostic imaging including coronary CTA, CT-PE, and TTE. Diagnosed with myocarditis in the setting of elevated Troponin and negative imaging. Symptoms stabilized 24 hours after onset. She obtained a cardiac MRI one month after onset of symptoms that did not reveal any inflammation or scarring in the heart, thought to be indicative of resolved myocarditis
Pt started the evening after receiving vaccine feeling fever, body aches and chills.  The next day her arm where she received the vaccine became red, itchy and swollen. Vaccine was administered on a Friday and by Monday (9/27/21) her arm was not getting any less swollen or red. Pt was told to take benadryl by her md.
right side facial drooping and lymph node swelling. I have contacted my physician to be seen and evaluated. I have had neck stiffness, too.
This spontaneous report as received from a nursing assistant. No patient is involved. On an unknown date, there was product confusion between the color of the vial of M-M-R II (therapy type unknown) and the color of the diluent that M-M-R II comes with. The colors of the labels were similar. Because of the color confusion the M-M-R II was accidentally left out of temperature range as it was believed to be the diluent. A product quality complaint (PQC) was not identified. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Side effects - top gums, roof of mouth, throat; tingling like allergic reaction; it stopped about 5 hours later. Bad arm pain lasted 2 days. Bad headache that lasted a week. Also felt like I was getting the flu, had mild body aches
took the shot and shingles 5 months later/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's sister. The age at vaccination was not reported. The reporter stated the patient took Shingrix shot and 5 months later was in dire pain from the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
HIVES ON LEFT SIDE OF NECK, TREATED AT EMERGENCY ROOM WITH PREDNISONE, SWELLING AND PAIN RESOLVED, RASH HAS NOT YET HEALED
Pt recvd vax & exp severe flu sx for several days including nausea & vomiting;
Constant headache Soreness at injection point, also when raising the arm Muscle and joint pain entire body Felt chill every couple of  hours and slight fever up to 99.8 every couple of hours All these went away toward the end of day at around 10: 00 PM.
Date and time of vaccination:  #1 Jan 4, 2021 @1100  #2 2/1/2021 @0900     Brand and lot of vaccine: #1Moderna lot 011L20A #2Moderna lot 012M20N (hard to read)   palpitations
No adverse effects reported.; one patient was administered improperly stored PROQUAD; This spontaneous report was received from a administrator, concerning to a 1-year-old patient of an unknown gender. Information about the patient's concurrent conditions, pertinent medical history and previous drug reactions or allergies was not provided. The concomitant medications included sterile diluent.  On 14-OCT-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) for prophylaxis (strength, formulation, dose number, route of administration and anatomical location of vaccination were not provided; lot number has been verified to be S003861; expiration date 08-AUG-2020) (product storage error). It was reconstituted with a properly stored sterile diluent.  It was reported that on a unknown date, the vaccine was exposed to a temperate excursion from 6 Fahrenheit degrees (F) to 14 F for 420 hours and from 15 F to 46 F, where the highest temperature was above 34 F, for 106 hours. The previous temperature excursion reported was from 6 F to 14 F for 200 hours and from 15 F to 46 F, where the highest temperature was above 34.268 F, for 18 hours. The call was placed because of a Digital Data logger report.  No adverse effects were reported.; Sender's Comments:  US-009507513-1908USA005541: US-009507513-1911USA000511: US-009507513-1911USA000728: US-009507513-1911USA000791: US-009507513-1911USA000804:
Case number PHHY2011US35724 is an initial spontaneous report received from a nurse on 26 Apr 2011. This report refers to a patient of unknown gender and age group. This patient was given only the lyophilized Men-A component of MENVEO (batch number: 100025) intramuscularly on 22 Apr 2011. No other adverse reaction was reported.
Information has been received from a pharmacist concerning an 8 month old male infant who one month ago on approximately 07-SEP-2008 was vaccinated with a first dose of oral ROTATEQ.  Subsequently, the patient developed diarrhea after receiving his first and only dose.  The patient was taken to the hospital for hydration but was not admitted.  He did not have weight loss.  It was unspecified if lab studies were performed.  It was noted that after the patient received the vaccination, the patient was prescribed ZITHROMAX for unrelated infection and he developed a rash.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from the physician assistant. "It has been determined that the diarrhea experienced by the infant is unrelated to ROTATEQ. Additional information is not expected.
no adverse event; given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.; 6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.), UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter) and NO ADVERSE EVENT (no adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 26-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.) and UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.), UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.) and UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter).    Concomitant product use was not provided by the reporter.  It was reported that reporter HCP wants to know what was the concentration of the two vials so she can figure out if she gave a lower or higher-than-authorized dose to the patient and the dose counts or not.  Treatment information was not provided.
Incredibly severe right hip pain, very much like reactive arthritis. Took Advil, Tylenol and Nucynta 50 mg. This feels like bone pain, not normal hip pain, but was isolated to the right hip. So severe it was almost enough to send me to an ER. It took approximately four days for it to come back down, and started right after the vaccine.
Patient developed sever immobilizing shoulder pain, which has persisted 15 days. Patient notes high should administration. Probable bursitis/tendonitis.
got Covid Virus after receiving her 1st dose of Covid Vaccine; got Covid Virus after receiving her 1st dose of Covid Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got covid virus after receiving her 1st dose of covid vaccine on an unspecified date. Her 2nd dose of the Vaccine schedule is due this week (as reported). She wanted to know if she can take that, or she should wait 90 days. The patient underwent lab tests and procedures which included sars-cov-2 test: got covid virus on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Day 1: soreness at injection site, which was approximately 3cm higher than that of first dose, in left deltoid. Day 2: fatigue and severe chills, achy joints.  Treated with one dose (400mg ibuprofen) Day 3: symptoms resolved Day 4: Onset of "covid arm" - red, slightly itchy rash on/near injection site of upper left deltoid, rash spread to approximately 11cm x 7cm, oval.  Pronounced itchiness at precise point of injection of 2nd dose. Rash left untreated. Day 5: Continued rash, did not worsen, redness diminished by approximately half. Pronounced itchiness at injection site for BOTH doses.  Rash untreated.  Day 6: Continued rash, unchanged from day 5. Rash untreated. Day 6 is date of filing; symptoms as yet unresolved. Anticipating symptoms will resolve on their own with time, not anticipating complications.
Within first seven minutes of receiving shot, felt a flush and weak (sat down at chair provided).  Felt quezy and weak.Symptoms disappeared by 15 minutes post injection and I felt comfortable in leav; Felt quezy and weak; weak (sat down at chair provided); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 65-year) in Left Arm on 17Feb2021 at 02:00 PM as dose 2, single for COVID-19 immunization. Medical history included Known allergies: allergic to dust, printing ink, swiss chard, halibut fish, all from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9262) administered in left arm on 27Jan2021 at 02:00 PM for COVID-19 immunization. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. The patient received no other vaccine in four weeks. On an unspecified date the patient experienced within first seven minutes of receiving shot, felt a flush and weak (sat down at chair provided), felt quezy and weak. Symptoms disappeared by 15 minutes post injection and she felt comfortable in leaving pharmacy and driving home within 25 minutes. The patient received no treatment for the adverse events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Dose given on 3/22/21. Patient called into pharmacy on 3/29 stating that on 3/28 she began feeling mouth discomfort (gums and teeth). She noticed upon waking up on 3/29 that her lips were swollen and she took a Benadryl. Unknown if symptoms have continued post telephone conversation.
Patient is well appearing and presented to clinic for varicella vaccine. Patient received first varicella vaccine too early (before one years old)and rececived a second varicella on 9-17-07. Patient also presented for flu vaccine. Patient has had flu shot in the past and denies any allergies to eggs or egg products. Patient received 0.5cc flu shot into Right deltoid without incidence. Patient received 0.5cc varicella SC into back left upper arm. Approximately 5 mins after injections patient complained of itchiness in left arm. Left arm injection site redden and had localized swelling approximately the size of a half dollar. Dr. was called to evaluate patient. Patient continued to complain of itchiness, but now spreading to throat and rest of body. Orders for benadryl 25 mg po. after 10 to 15 mis no change. Orders for EpiJr given. Patient transported to hospital via ambulance.