chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator : 26-OCT-2021  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received both MMR (right thigh) and separately VZV (left thigh) vaccine on 6/25/18 in setting of known chronic neutropenia. On 7/5/18 the family presented for a visit given on 7/4/18 he woke up fussy and annoyed. Tactile temp was noted but no temperature was measured initially. Overnight into 7/5/18 the patient  felt hot to touch and temporal/rectal thermometer showed a temp of 99.7 F. Exam on 7/5/18 in clinic reported a fussy infant and shotty cervical adenopathy along with an 1 cm x 1 cm erythematous lesion on the left lateral thigh along with some sparse red dots on skin. Tmax was 100.2 F. Given patient's fussiness, labs were collected (including a blood culture) and given a dose of IM ceftriaxone. Plan made if still neutropenic to admit. ANC was (accounting for bands) 90 (prior level on 6/4/18 was 474) so patient admitted on 7/5/18 PM. Patient received ceftazidime empirically and was monitored. No frank fevers noted and patient was subsequently discharged 7/7/18 after ANC slightly improved (1%-- >4% ANC 188) and blood cultures were no growth.
Heart palpitations; Premature contractions in the mitral valve; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: FW0181) via an unspecified route of administration, administered in Arm Right on 23Jun2021 09:45 (at the age of 32 years old) as single dose for COVID-19 immunization. Medical history included known Known allergies: Penicillin. Concomitant medications included ibuprofen taken for occasionally for headaches. It was reported that the patient had the vaccine on Wednesday and this morning on Friday on 25Jun2021 07:00, (two days later) started having heart palpitations which she never had before. They've been on and off. She went to the doctor this morning and had an EKG, she said she had premature contractions in the mitral valve. No treatment was received for the adverse events. The adverse event resulted in Doctor or other healthcare professional office/ or clinic visit. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included electrocardiogram: premature contractions in the mitral on 25Jun2021. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Patient called the pharmacy on 11/9 and reported that he may be experiencing an allergic reaction to the flu vaccine he recently received on 11/6. Symptoms reported started on 11/8 included rash, itchiness, and hives that started on his back and spreading towards the back of his shoulder and arms. No swelling, redness, or rash on site of injection. No flu-like symptoms such as fever or chills. Patient claimed he didn't perform any activities or ate anything out of the ordinary over the weekend that may have triggered the allergic reaction. Patient had the flu shot before in the past with no issues. Confirmed that patient is not allergic to eggs. Patient taken Benadryl with some relief. Recommended patient during the telephone encounter on 11/9 to continue taking Benadryl and to seek urgent care if rash is not improving/ going away.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 21-MAR-2017,  the patient was vaccinated with one of the improperly stored doses of M-M-R II  lot # M028130, expiration date 03-MAR-2018 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The dose of M-M-R II was in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was previous temperature excursion as 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001059: US-009507513-1704USA000553: US-009507513-1704USA001058:
severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 14-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 17:00 as dose 1, single (Lot number: 4628) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe headache". Therapeutic measures were taken as a result of headache.  Additional information: No other vaccines received in four weeks of COVID-19 vaccination. Prior vaccination, patient doesn't have COVID-19. Post vaccination, patient was not tested for COVID-19. Patient was treated with Advil and Tylenol.
Head jerking back and forth; High Blood pressure; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), DYSKINESIA (Head jerking back and forth) and HYPERTENSION (High Blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016321A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness). On 14-Apr-2021, the patient experienced HYPERTENSION (High Blood pressure). On 15-Apr-2021, the patient experienced DYSKINESIA (Head jerking back and forth). At the time of the report, DIZZINESS (Dizziness), DYSKINESIA (Head jerking back and forth) and HYPERTENSION (High Blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller consulted two HCP and the patient will get their recommendation before receiving the second vaccine. Caller was informed dizziness can be a sign of severe allergic reaction and to consult HCP.
From ER note:  Initial chief complaint was Hives (Meningococcal vaccine on Friday. Saturday "vision just blacked out but still conscious", hands "felt hot". Vomiting and fainting on Sunday, hives appeared to inner arms. Discoloration to arms and legs "they looked purple but then it went away", hives spread to arms and legs now. 15mL of Bendryl at 1315 today for allergies. Hx of allergies of hives and edema as reaction to cold, no allergy symptoms for 4 months until last 3 days. Pediatrician referred to ER for possible infection.), Fainting, Skin problem, and Vomiting     Patient is a 13 year old biological male who presents with hives.  Three days ago, the patient received meningococcal vaccine.  Since then, he is had 2 episodes of presyncope where he has felt lightheaded and like there was a heaviness in his extremities; he has never actually lost consciousness however. Onset after shower. Two days ago, he reports single episode where he vomited 3 times; he is otherwise had no vomiting besides this.  He also denies any diarrhea or any bleeding. No palpitations. No family history of sudden cardiac death or cardiac issues at early age. Today, while walking in the emergency department, he had a transient episode where he developed some blue discoloration on his right calf that has since resolved. Symptoms resolved. He otherwise denies any recent fevers, chills, or neck pain.  Of note, he did have brief contact in the last week with someone who is being treated in the hospital for meningococcus. History of angioedema and hives with cold exposure and hand swelling with minor trauma.
Guillain Barre Syndrome, Epileptic and Stress Seizures, Right Side Paralysis, Facial Palsy.
Symptoms of increased fussiness started on the day of the vaccination and persisted for the next 10 days beyond what one would expect, per Mom report. On day 10 Mom brought the child to Urgent Care with concern for vaccine rx. /fussiness/pulling on ears. There were four small erythematous papules on the upper/outer aspect of the thigh that had cropped up a few days prior that Mom was concerned may represent a rash/reaction. The papules were not in the immediate area of the injection site. They were more posterior/lateral in respect to  where one would expect the injection site to have been and had the appearance of insect bites. The child also was pulling on ears and was found to have an otitis media at the UC visit on 10/26/2023.
hearing problems; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program with Regulatory Authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 18Feb2021 (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient had hearing problems. On 11Mar2021, the patient received the second dose of BNT162B2. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, muscle ache, nausea, general cold symptoms with runny nose and sinus pressure; throbbing ache generating form the vaccine site down the left arm to fingers and us the shoulders, back and neck (most pain is in the left side of the body);
weakness; light headiness; super super sore injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) outcome was unknown.            Concomitant medication included anti-depressant in which the product used for unknown indication.    This case was linked to MOD-2021-242327 (Patient Link).
Increased 50 cent size redness and larger area of swelling tingling tongue & lips local itching.
Terrible" chills that developed today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Terrible" chills that developed today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Terrible" chills that developed today). At the time of the report, CHILLS (Terrible" chills that developed today) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications provided mentioned blood thinners NOS.  Treatment information was not provided.   Reporter did not allow further contact
pt recv varivax 4/16/98 & on 4/21pt devel a fever of 102
Truth it affects people differently I lost a Brother; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult male patient who mentioned it affects people differently i lost a brother while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number with unknown dose not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient mentioned it affects people differently i lost a brother (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) it affects people differently i lost a brother.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (it affects people differently I lost a Brother).  At time of reporting, the outcome was Fatal for the event it affects people differently i lost a brother. It is unknown if an autopsy was done.; Sender's Comments: Sanofi company comment dated 22-Feb-2022: This case involves Adult male patient who mentioned it affects people differently i lost a brother while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Patient received the Varivax on Saturday 1/24/2008. The following day she noticed the area was red and hard and itchy. It continues today, she has taken Ibuprofen for the pain that she is experiencing in this area.
Day 1: Dizziness right away. Severe back pain about 30 minutes later. Cloudy feeling, just overall not feeling well.  Tingling in my face. Really sore arm. Day two: sore arm, still tingling in my face, still cloudy headed, severe back pain.  Day three: mostly ok except for back pain. Day 12: arm rash hot with swelling and continued back pain. Day 13: rash has spread, pain in arm and back. Day14: rash is getting better, back pain remains. Tingling sensation again.
Received Moderna vaccines on 4/21, 5/19/21 Received Pfizer vaccine on 11/10/21 COVID-19 positive by PCR on  1/9/22 hospitalized from 1/9-1/11/22 for COVID infection
As per pt, received a flu shot on Thursday 11/14/02. Pt noted hives on the back of neck and hands the next afternoon. She took Benadryl for the itching. On 11/16/02 she continued to take Benadryl x 2 for hives. 11/17/02 pt woke up with welts all over her body and legs. She had facial swelling-face was twice its normal size and tongue started to swell. Pt went to ER-received Epinephrine, steroids and Tagamet. Monday 11/18 she feel better but then noted hives-lips started to swell-pt went back to ER got Benadryl injection. She experienced chest pressure and received Nrg without relief. Cardiac w/u was negative. The medical record states dizzy.
patient reported  waking up in the night consistently around 1-3 am with tingling/numbness in the left hand. this was the arm the shot was given in. He said it improved over time.
Arm and shoulder pain, nausea x 2 days. Dizziness and severe headache third evening and day after. Missed work 3rd day.
Mother fell the other day and needs surgery; Rash on injection site arm; Very itching; Rash on opposite arm of injection from elbow up; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Mother fell the other day and needs surgery), PRURITUS (Very itching), RASH (Rash on opposite arm of injection from elbow up) and VACCINATION SITE RASH (Rash on injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Very itching) and RASH (Rash on opposite arm of injection from elbow up). On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash on injection site arm). On 10-Feb-2021, the patient experienced FALL (Mother fell the other day and needs surgery). At the time of the report, FALL (Mother fell the other day and needs surgery), PRURITUS (Very itching), RASH (Rash on opposite arm of injection from elbow up) and VACCINATION SITE RASH (Rash on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. On 18-Jan-2021, the reporter stated that her mother had a rash on the opposite arm from elbow to upper arm and the rash was very itchy. About five days later rash was on injection site of the arm. On 10-Feb-2021, her mother Fell (feel) the and needed surgery. Treatment was the unspecified surgery.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Initial report received on 07 September 2007 from a nurse. A 70 year-old female patient with no concurrent illnesses, and who has medical history of allergy to Codeine, glaucoma, COPD, cutaneous T-cell lymphoma, back pain and depression, had received an intramuscular dose of Adacel, lot number C2769AA, in the right deltoid, and an intramuscular dose of Pneumovax, lot number 06980, in the left deltoid. The following day, the patient experienced "severe swelling and cellulitis at the injections site." The patient was evaluated by a physician and was administered Solu-Medrol intramuscularly. The patient was started on a tapering dose of "Prednisone." The patient was seen by the physician twice. No relevant diagnostic testing was performed. The patient had not received any other vaccinations within four weeks and it was "unknown" if the patient had experienced any adverse events following prior vaccinations. At the time of this report, the patient had not recovered.
Patient was given the Pfizer Covid vaccine at 0938 and was placed to be observed. She started showing signs of SOB at 0950 and was placed in an Exam room. O2 was applied at 0953 at 2 L 911 was called at 0953  Patient was communicating and never lose conscious.  HR 147, O2 stat was 97  Epi 0.3 ml given at 0955  RN and NP were in the room with me assisting.  EMS arrived at 1002. O2 was increased and Nebulizer applied due to reported Rails in lungs Additional Epi was given by EMS  1010 patient said her brother was outside in the car.  She produced her phone and found his number and Her Brother was called who was waiting outside the building and instructed that she was going to be taken to Medical Center and directions were given.
This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medication, drug reactions and allergies provided. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023952, expiration date 12-JUL-2020, for prophylaxis. The vaccine dose was improperly stored for 12 minutes in temperature of -26.5 degrees Fahrenheit. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported.
Histamine-medicated allergic response with periorbital edema, increased lacrimation, pharyngitis and itchiness. Treated with Benadryl, epinephrine and prednisone.
Stung when vaccine administered. At night stretched arm and notice it was swollen, a little red, painful upon touch. Pharmacist recommended ice and took 2 TYLENOL. Pharmacist called on morning of 11/8 to check in. A dull ache remains.