chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound CoVid after paxlovid treatment with negative test on day 8. Symptoms returned on day 10 with positive test day 13; Rebound CoVid after paxlovid treatment with negative test on day 8.  Symptoms returned on day 10 with positive test day 13; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: Ek 5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: El 3248), in left arm and on 04Sep2021 as dose 3 (booster), single (Lot number: Fe 3592) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Rebound CoVid after paxlovid treatment with negative test on day 8. Symptoms returned on day 10 with positive test day 13"; COVID-19 (medically significant), outcome "not recovered", described as "Rebound CoVid after paxlovid treatment with negative test on day 8.  Symptoms returned on day 10 with positive test day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Symptoms returned on day 10 with positive test day 13; (21Jul2022) Negative, notes: Rebound CoVid after paxlovid treatment with negative test on day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not had any known allergies. Received Paxlovid as treatment on 14Jul2022 till 18Jul2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 4/7/2022 --RECURRENCE OF SAME SYMPTOMS
Nausea.  Lasted about 4 hours and I took care of it  with two cups of tea.  Minor problem; minor inconvenience.
Syncope approximately 2 min after admin. Pt's eyes rolled, mouth wide open, and arms flailed sporadically approximately 15 s. Went to grab phone for 911 or EpiPen. By time returned (about 15 s later), pt began regaining consciousness. Gave pt BENADRYL and monitored for about 45 minutes. Gave OJ and crackers due to pt potentially being hypoglycemic. Full recovery about 20 minutes.
Itchy, painful Rash/raised hives, bone pain, lower back pain, fatigue, rapid heart rate, rolling hot flashes  I went into chemical menopause after my cancer treatment in June of 2018. My period completely stopped. I got my period today.
Swollen tounge about 12:10ish.  Tired and lethargic by 2:00- 3:00 andtook a nap.  Felt very drowsy/ dizzy over dinner with family about 6:20 ish.  Strange taste in mouth since about 1:00 pm or so. The taste is kind of chemically.  Left arm sore.
Information has been received from a pharmacist referring to 4 newborns (numbered 148, 149, 150 and 151). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0/5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports from the same reporter. Additional information has been requested.
pt recvd vax; soreness into lt wrist; next day reddened & erythema approx 10 cm in diam;appears to be cellulitic;poss mycoplasma infect,bronchitis;local rxn to pneumovax;upper resp infect;;vesicular eruption;bronchitis;sore throat,migraine
Patient states he developed "seizure symptoms" four days after second dose of Moderna COVID vaccination. Patient described "seizure symptoms" as a headache and chest pain severe enough that he was not able to drive. He took an aspirin for his symptoms and symptoms were completely resolved in two hours. Similar episodes occurred Thursday, Friday, and Saturday. Writer advised patient to seek emergency medical care for symptoms on Saturday for further evaluation. Patient was resistant, and writer stressed importance of evaluation of chest pain. Unable to follow up further.
8/12 Headache prior to vaccine administ. Tmax at 101 degrees, <1cm erythema, (+) myalgia, (+) malaise. 8/13 "Perky", afebrile, asymptomatic.
Minutes after administration face red, arms, and legs -- red all over body, very hot all over, high blood pressure, tachycardia heart, throat closing. Medication given immediately after reaction in Medical Clinic. Medication given is unknown to pt.  Pt was then taken to hospital ER Hospital but left afterwards with ER full with patients to be attended. Pt had nausea and heat in stomach for days after keep liquid diet,  fatigue; steroids allergy medication prescribed taking daily.
This spontaneous report as received from a registered nurse refers to a 26-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL intramuscularly (dose, lot# and expiration date were not reported). The patient had no concomitant medications. The nurse reported that the patient experienced discomfort at the injection site immediately after vaccination. On 21-JUL-2016 (reported as "the following day"), a lump formed at the injection site. The patient was seen by her primary care physician on 26-JUL-2016. The nurse stated that it took two weeks that lump went down and then on an unspecified date in approximately August 2016 (reported as "6 days after the lump went away"), there was a painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla. The patient did not receive treatment for the events. The lump at the injection site resolved on an unknown date in 2016. The outcome of the discomfort at the injection site and painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla was reported as recovering. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Pt received SHINGRIX at her pharmacy on 4/17/18, on 4/18/18 pt had overall body aches and fever, this resolved w/in 24 hours.
Headache, Myalgia, Fever, Injection site pain, fatigue Narrative:
DX ON 10/13/11 WITH POST VACCINE ENCEPHALOPATHY BY THE ON CALL NEUROLOGIST WHILE HOSPITALIZED. On 10/10/11 began developing severe myalgias and fatigue that worsened to the point patient only worked a half day on 10/11/11. On 10/12/11 at approximately 12 Noon, she developed confusion, inability to talk or undestand questions, could not spell her name, did not know her birthdate, and developed inability to walk independently. She was seen at Medical Center and was transported via ambulance to hospital in with aphasia and concerns for a CVA or meningitis.
I started feeling itchy. I have no redness or bumps, but terrible itchiness wherever my skin folds. Armpits, across the top and under my breasts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 10:00 (Lot number: 30155ba) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fc3183, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Sep2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 21Oct2021, outcome "not recovered", described as "I started feeling itchy. I have no redness or bumps, but terrible itchiness wherever my skin folds. Armpits, across the top and under my breasts.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus.  Additional information: Patient was not pregnant at the time of vaccination. Patient had no Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Allergy shots within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 reported as yes. Patient reported as started feeling itchy, have no redness or bumps, but terrible itchiness wherever her skin folds. Armpits, across the top and under the breasts. Around the waistband area, the creases of legs, and tops of the feet. It was still itchy at the time of report. Seriousness reported as No.   No follow-up attempts are possible. No further information is expected.
Systemic: Chills, Systemic: Fever, Systemic: Nausea, Systemic: clammy
Pt passed out in the passenger seat while the husband was driving to observation. Pt husband stated that she has a hx of passing out with any shot she gets. Pt confirmed that is true when she woke up 60 sec later.   Ems came to evaluated pts and offered water.   PT stated that she was feeling better and refused the need for any further medical care.  and left with husband at 11:50
Information has been received from a physician concerning a 15 year old female who on 25-MAR-2008 was vaccinated with a third dose of Gardasil (lot # 659182/1757U) IM. There was no concomitant medication. On 25-MAR-2008 the patient experienced a seizure and fainted 15 seconds after receiving the third dose of Gardasil. The patient recovered immediately. The patient was evaluated in the emergency room, but unspecified if she was admitted to the hospital. It was noted that the patient had an unspecified blood test. No other information was available. Additional information has been requested.
A consumer report has been received. The concerns a 45 year old, Male consumer, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient reported that the first half of dose dripped out of nose a little bit which started on 17-OCT-2013. The outcome of the first half of dose dripped out of nose a little bit is unknown. The report was considered to be non-serious.
I feel like crap; High fever; 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 DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever). At the time of the report, DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever) outcome was unknown.            No concomitant medication provided.  No treatment medication provided.   Reporter did not allow further contact
Throat swelling up, unable to swallow, hives, lips swollen, extremity swelling
made me sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient (age unspecified) who was sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
This spontaneous report as received from a 65 years old female consumer refers to her. Medical history were none and no concurrent conditions reported. On 06-DEC-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot#, frequency not reported). Concomitant therapies included XANAX and CELEXA. On 06-DEC-2014, after she was received PNEUMOVAX 23 and had an adverse reaction at the injection site. During the report, the patient also mentioned that she was switched from an unspecified dose of XANAX to an unspecified dose of CELEXA. It caused her blood pressure to drop significantly on 21-JUN-2015 and was taken to the emergency room and released. On 29-OCT-2015, again, the patient was vaccinated with PNEUMOVAX 23. The patient reported that "several hours" after receiving PNEUMOVAX 23. The patient reported that "several hours" after receiving PNEUMOVAX 23 at 2PM, she experienced soreness, swelling and redness at the injection site. The patient could not move her arm over her head. The patient reported that the redness spread over an area on the inside of her arm from the shoulder to the elbow. The redness was approximately the size of "two softballs". Previously on 06-DEC-2014, were the patient had received same vaccine, and had an adverse reaction at the injection site, but not to the degree of this year's (29-OCT-2015) reaction. No lab diagnostics studies performed. The patient sought medical attention, the physician on call prescribed an unspecified dose of Ibuprofen. The patient used 5-500 mg tablets of TYLENOL and unspecified doses of Aspirin. The patient also iced the area and used Aloe. The outcome of soreness, swelling and redness at the injection site, could not move her arm over her head and redness spread over an area on the inside of her arm from the shoulder to the elbow were reported as recovering. The outcome of blood pressure to drop significantly and adverse reaction at the injection site were unknown. Additional information has been requested.
the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022; No Adverse Event; 3 Moderna Bivalent doses were administered after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022).    No concomitant medication were reported.  The injection site was Deltoid. Bivalent vaccine of individual vial in carton. The vial size was 2.5 mL.  The vial was initially stored in the refrigerator on 25-Oct-2022.  The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681955, US-MODERNATX, INC.-MOD-2022-681956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681956:same reporter US-MODERNATX, INC.-MOD-2022-681955:same reporter
cold; swollen neck lymph nodes; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer and Other Health Professional) for a Pfizer sponsored program.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer", start date: 22Feb2021 (unspecified if ongoing). Concomitant medication(s) included: IBRANCE. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen neck lymph nodes"; FATIGUE (non-serious), outcome "recovered", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, vomiting , diarrhea, fever, headache, body aches. Started at 12:30 am, committing continued for 4 hours other symptoms lasted about 30 hours. This was first dose of vaccine.
facial eczema, itchy dry areas  by eyelids, and neck, and forehead, and swelling of eyes
Not sure if this is "adverse: info you want to know about.  Reporting to be helpful.  muscle aches, tender arm at injection site, dizzy after 3 hours of injection.  painful to lay on right side that evening for sleep.  difficult to lift right arm. painful at injection site  Took tylenol every 4 - 6 hours
This is 1 of 3 infants from this facility to devel high fever,inconsolable crying & irritability p/vax w/lot #447832.
Narrative:  73 year old male admitted on July 19 2022 with fever and hypoxia. He had received Pfizer vaccine x 3 on January 22 2021, February 10 2021, December 20 2021 and moderna x 1 on June 7 2022. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 5 days.. He clinically improved on treatment and was transferred off acute care unit on 7/26
At 12:30 pm began to feel tired.  1:30 p.m. exhausted.  5 p.m. noticed body ache 6: p.m. noticed headache 8 p.m. fever and chills 10 pm  Tylenol 4/2/21 6 am Tylenol 12 p.m. Tylenol 3 p.m., noticed symptoms decreasing through resolution at 6 pm
Weakness in both arms and legs, worse in arms then legs, has slowly resolved over 2 weeks.  Still some weakness in left arm (where vaccine was given) on 2/8.  Pt did call MD on 2/4/2013 but symptoms were resolving.  Came in 2/8/13 for reassurance.
DIZZYNESS, NAUSEA, SORENESS OF ARM, BODY ACHES
A non-serious, spontaneous report of positive B strain, flu like symptoms and fever has been received from a registered nurse concerning an eight-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 24-Aug-2009. On 26-Aug-2009, the patient presented with flu-like symptoms including fever. She was tested for flu which came back B positive. The outcome of the events was not reported.
Day after booster dose (3rd) had fever and fatigue and major headache. I?ve had a nighttime severe headache every night since. Headache is severe and painful, sensitivity to light and sound and dizziness are present. It?s been ever single day after my vaccine, i do not usually suffer from these headaches.
Exactly 1 week after the vaccine, patient developed a fever and was very uncomfortable and fussy, all lasting for 3-4 days.
Told by parents over phone that was having trouble breathing-went to ER.  Follow up: prescription not on ER form.
no adverse effect; MMR II vaccine was reconstituted with expired diluent; MMR II vaccine was reconstituted with expired diluent; This spontaneous report was received from a nurse referring to a 21 years old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 22-JUN-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, lot# and expiration date were not reported), subcutaneous for prophylaxis. The vaccine was reconstituted with expired sterile diluent (lot# was M041089, expiration date was 10-JUN-2019) (expired product administered and product preparation error). The nurse could confirm that the sterile diluent was expired on the date of administration and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not expired. No adverse events were reported.
pt reported 4  day of pain around the site, itching locally around the L arm (site of vaccine).  she didn't notify me (provider) until 2 weeks later and by then the symptoms had completely resolved on their own.
This is a spontaneous report from a contactable registered nurse via a Pfizer sales representative and from a contactable physician. A 18-year-old female patient received TRUMENBA (Lot# M95612, Exp date 31Jul2017, NDC# 0005-0100-10 if it was a 10 pack or 0005-0100-05 if it was a 5 pack), intramuscular in the left shoulder on 05May2016 at 03:00 PM at 0.5 ml single. Medical history included innocent heart murmur and family history of rheum, arthritis, hypothyroidism. Drug history, drug or alcohol abuse and drug allergies were reported as no. Concomitant medication included unspecified birth control. On 05May2016 at 07:00 PM the patient experienced muscle aches in left shoulder, swelling almost the size of a golf ball, redness, fever and dizziness. On 06May2016 she experienced headache and nasal congestion. The patient was seen in the office at 03:00 PM the day of the report and still had a fever of 99.9 degrees Fahrenheit. The patient was complaining that the symptoms of muscle aches in left shoulder, swelling almost the size of a golf ball, redness, dizziness, headache and nasal congestion worsened. Her arm was so sore she cold not lift it. All other vitals were stable and no other lab testing was completed. The patient received Ibuprofen and BENADRYL as treatment for the events. The patient recovered from muscle ache, redness, swelling, fever and dizziness while did not recover from headache and nasal congestion. The patient provided information to the physician regarding the reported adverse events with the use of TRUMENBA. The reporter considered that the TRUMENBA has causal effect to the adverse events. Follow-up (31May2016): New information reported form contactable physician includes: medical history, events onset date, treatment required, physician acknowledgment of the occurrence of the events and causality assessment. Follow up attempts completed. No further information expected.
In April I started noticing bright red dots on my legs.  The dots have spread to my stomach.  In May I started experiencing achy legs when I went to bed, which was grown worse and now sometimes interferes with my sleep.