chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose being administered with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA343483.  This case involves a 12 years old male patient to whom expired dose was being administered with no reported adverse event for vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2022,the patient received a  0.5ml dose (once) of suspect IPV (VERO) , with an unknown formulation and strength, (lot: T1D482M ; expiry date: 25-Jul-2022 ) via subcutaneous route in the left arm. for immunization.  On 15-Aug-2022 an expired dose was administered to the patient with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (VERO). It was administered by licensed practitioner nurse (LPN).  Action taken : not applicable.  Outcome: unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ACHES; SHORT OF BREATH; CHILLS; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced aches. On APR-2021, the subject experienced short of breath. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced extreme fatigue. Laboratory data included: Blood test (NR: not provided) NORMAL, and Scan (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, headache, chills, short of breath and extreme fatigue was not reported. This report was non-serious.
Developed multi-dermatomal shingles and moderate-severe abdominal . Preliminary read of the CT states - "Minimally distended loops of small bowel with bowel wall thickening and mucosal hyperenhancement, likely enteritis. Normal large bowel."
Patient started running fever on 1/16/2021. Initial temperature was 100.2 degrees Fahrenheit. Fluids were encouraged and temperature monitored closely. At 1800, temperature was 102 degrees Fahrenheit. Patient brought to local emergency department. Rapid covid, flu A/B, and rapid strep all came back negative. Urinalysis collected and revealed 1+ leukocytes. Culture waiting to be grown. On 1/17/2021, patient had fever of 102.3 degrees Fahrenheit at 0545, tylenol 3.75 mL given PO. At 1100, temperature is 99.2 degrees. At 1230, temperature was 103.5 degrees. Tylenol 3.75 mL given PO.
I have not had a reaction to a mosquito bite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have not had a reaction to a mosquito bite".  Additional information: The patient just wanted to mention that ever since patient had Pfizer Covid vaccine, the patient had not had a reaction to a mosquito bite. The patient mentioned they normally love and get multiple welts that lasts days or weeks. The patient knows been bitten but have zero itchy welts! May be something worth looking into.  Follow-up attempts are completed. No further information is expected.
Right arm pain, redness, couldn't lift arm on 8-19-17, hot, sore to the touch, inflammation, puffy.
she has 19 friends who lost their life because of the vaccine; This spontaneous report from a non-contactable reporter(s) (Consumer or other non HCP) Program ID reporting same event under the same suspect product for 19 patients. This is one of 19 reports.  A patient (no qualifiers provided) received BNT162b2 (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: DEATH (death), outcome "fatal", described as "she has 19 friends who lost their life because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200107580 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: she has 19 friends who lost their life because of the vaccine
Moderna COVID-19 Vaccine EUA The day of the vaccine, I was fine besides my arm hurting- the one I got the shot in. That night I went to sleep at 830PM. I woke up a little before 1030PM shaking with chills and nauseated. I couldn't sleep the whole night, going between sweating and shaking. The next day 1/6/21 I was still unwell, didn't go into work, felt weak and sore the whole day and noticed my underarm of the arm I received the shot was swollen and painful,. Today 1/7/21, my underarm is still painful and swollen, but the nausea has subsided. Still slightly going between sweating and being chilled.
Numbness and tingling in fingers. Resolved in about one week after symptoms started. Received influenza vaccine in 2010 and 2011 with no problems
Hives and itching. Started around 10-12 days after vaccination. Still going on after over 5 weeks of vaccination. 10mg Cetirizine seems to keep the symptoms in check. Also happened after the first shot (More severe symptoms at that time but last for only 1 week).
Vaccine reaction began day of injection: sore arm, difficulty sleeping next day: generalized malaise, fever, nausea, vomiting, diarrhea, body aches, cold sweats Transported by EMS to ED for chest pain but patient reports cocaine and beer the night before Admitted for chest pain work-up and patient only has a homeless shelter to return to. Diagnosed with GERD and UTI.
Swollen lymph nodes under left armpit. Pain in left neck shoulder and arm. Fever. Weak
Approximately 2 days after receiving the booster Covid Vaccine I noticed that the area below the vaccine site is swollen, tight, red, and warm to the touch. Lifting my arm is more difficult than normal and it feels as if may be in or spreading to my armpit.
Patient fainted after immunization. EMS was called and responded to evaluate the patient. No treatment was needed. The patient recovered consciousness within one minute but remained altered for 30 minutes then was fully back to normal.
01/21/2022 vaccination. End of Feb, left side flank pain; diagnosed with kidney infection. I took antibiotics but the pain is still ongoing, presently. I feel like my body is breaking down. Any little thing, I feel like my body is not coping well with. Ongoing. Menstrual cycle still irregular since first vaccine with J&J.
Patient experienced problems breathing deeply, had definite wheezing per her mother and then lips started to tingle. Mother said the event probably only lasted 10 minutes from start to finish with only 2 minutes intensity.  This incident occurred about 35 - 40 minutes after administration of her first injection of Gardasil vaccine.  She and her mother sat on an outside bench at a college campus during the intense 1 1/2 -2 minutes until the event was over.
Information has been received from a registered nurse concerning a 19 year old female who on 27-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of Gardasil (lot #654885/1424F). There was no concomitant medication. On 24-DEC-2006, the patient developed a rash up and down both arms. The patient's rash was treated with Benadryl. Subsequently, after three days, the patient recovered from the rash. It was reported that the event did not require an emergency room/doctor visit. Additional information is not expected.
INJECTION SITE REACTION - AT TIME OF REPORTING TO PHARMACIST AROUND 3 PM 4/20/2019 (NEXT DAY). PT HAD ABOUT A 4 INCH IN DIAMETER RED CIRCLE SLIGHTLY WARMER THAN REST OF ARM SKIN. PT CITED BURNING AND ITCHING ONLY AT RED CIRCLE.
2-4 hours after flu vaccination, itching began on arms and legs, hives on ankles. Patient took a ZYRTEC at the office and when home from work, took BENADRYL 25mg po. She called her MD and was instructed to take an additional BENADRYL 50mg, po. By the next morning, all symptoms had subsided.
Within 3-4 minutes, room spinning, dizzy, nauseated, bad headache, joint pain, body ache, fever, sweating, shaking, asthma, nausea, exhaustion. Took albuterol inhaler, called Dr, said to rest, drink fluids, so went home, rested. Took 5 days to a week to recover.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after use of product, the patient experienced severe swelling in both eyes and muscle general pain. Outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested.
Positional benign vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 13Aug2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 13Jul2021 at 13:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 23Aug2021, the patient experienced positional benign vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 30Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 22Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event positional benign vertigo was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Left facial rash, looks like contact dermatitis. Pink blanching, maculopapular, confluent left ear and neck.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 44 years intramuscular, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination Yes; "Known allergies: Azithromycin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 06Jul2023, outcome "recovering"; DRUG INEFFECTIVE (medically significant) with onset 06Jul2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Vaccine was obtained at pharmacy or drug store. No other vaccine was obtained in four weeks.
Arm is hot four fingers bellow the injection site.; Red is like four fingers bellow the injection site; Felt beaten up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 042L20A and 01A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus-like syndrome and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, Vitamin C and Vitamin D for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up). At the time of the report, VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up) outcome was unknown.            No treatment medication reported.   This case was linked to MOD-2021-314861 (Patient Link).
Informed by staff that patient experienced urticaria and pruritus with slight burning sensation immediately post vaccination localized to MMRV vaccination site. RN at bedside. No SOB, EWOB. Patient not in distress. RN sought guidance from pediatrician. Pediatrician ordered 5mL of Benadryl PO. Medication given as ordered. Patient transferred to pediatrics for further monitoring.  Released home without incident.
This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of GARDASIL (dose number, lot# and expiration date was not reported). LIQUID PEDVAX HIB dose number, lot# and expiration date as not reported, VAQTA dose number, lot# and expiration date was not reported, MMR II dose number, lot# and expiration date was not reported, ROTATEQ dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.
This case was reported by a pharmacist (also the subject) and described the occurrence of injection site inflammation in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in November 2011 the subject received a dose of FLULAVAL (unknown route, unknown arm). The pharmacist reported that the needle used during administration of FLULAVAL was 0.5 inches, instead of the recommended 1 inch. She was concerned that the vaccine may not have been administered intramuscularly. She also noticed that the vaccine was given at a 90 degree angle, but was not sure about the technique used to vaccinate other employees. The pharmacist also noted that the nurse who administered the vaccine "bunched up the tissue". In November 2011, less than one day after vaccination with FLULAVAL, the subject experienced injection site inflammation, hotness at injection site and injection site soreness. At the time of reporting the events were resolved after 2 days.
Expired Vaccine administered to 28 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 28 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 28 patients). In June 2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 28 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Flu-like symptoms that became increasingly severe. By morning, I was too weak to get out of bed, was achy all over, had chills, had a screaming headache, felt nauseous, and eventually threw up. I sipped on a glass of water, and managed to eat a peeled apple that day. I slept on and off all day and through the next night. The next day, I began eating more substantially, but everything tasted bitter, I continued to feel nauseous, and experienced some diarrhea. The next day, I was able to take my morning walk and eat a little more, but had much worse diarrhea, and was fatigued and weak. The following day I was better, but still fatigued, and had a loose, but normal BM.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix day before reporting and he started to experience a fever after his dose. The reporter did not consent to follow-up.
Temperature was 99 degrees Fahrenheit; Almost passed out; Whole right side of my body went numb; Left leg tingly/Whole right side of my body tingly; Dizzy; Hard to stand; Chest pain; Arm pain at the injection site; Nausea; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and LAMOTRIGINE for Anxiety.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea) and HEADACHE (Slight Headache). On 03-Jun-2021, the patient experienced PYREXIA (Temperature was 99 degrees Fahrenheit). At the time of the report, LOSS OF CONSCIOUSNESS (Almost passed out), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea), HEADACHE (Slight Headache) and PYREXIA (Temperature was 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 99 (Borderline) Fever-99 degrees Fahrenheit.         Patient reported that she had not taken anything for her symptoms.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dizziness, difficult to concentrate, headache, fatigue, fear of sound and light starting 5 hours after vaccination. No treatment, went to bed as usual and symptoms were gone the next morning. Arm soreness lasted for around 1.5 days.
pt recvd vax 11AM by 4PM that same day 22JUN93 pt started crying continuously for 3-4 hrs; had fever of 104, limpness, paleness; mom called MD was advised to take pt to ER if crying cont another hr;