chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One month after my second shot of the Moderna I have struggled with exercise intolerance; Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated) 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 (The patient recovered and waited two weeks before resuming a modified running program, very light. The patient was progressing nicely and feeling good.) in December 2020.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated). At the time of the report, DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient had second dose of the vaccine a month ago. It was reported that ever since then the patient noticed exercise intolerance every time she tried to go for an easy run. The patient struggled with exercise fatigue. It was daunting and very maddening and frustrating seeing that. The patient could barely run 5 minutes without feeling exhausted and winded and totally defeated.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional event was added.
He had a syncopal event witnessed by his wife. He was leaning to the left when the staff came to be by his side. He was unable to speak, fixed stare with dilated eyes. He became pale and diaphoretic. During this time he had a strong pulse. He He quickly (within 5 seconds) was oriented and speaking again. He did this twice. His blood pressure was 110/60. He was then moved to a bench and his feet were elevated. He was able to drink and eat some crackers. 10 minutes later his BP was rechecked and was 100/60.  He was no longer pink and was easily conversing. By 20 minutes later, he was able to be sitting up, normal color, pupils at normal size, stating he feels much better. BP was 110/64 at that time. He did state he has done this before when getting blood drawn. His wife was able to walk him out and drive him home.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) had resolved. It was reported that events starts a week after vaccination and lasts for months. This case was linked to MOD-2022-544380, MOD-2022-544381, MOD-2022-544382 (Patient Link).
Possible local rx to Comvax. Initially red, warm and indurated. Minimal erythema but induration of about 1.5cm persists with tenderness.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: Ehlers-Danlos, myasthenia gravis, Hashimotos, and sulfonamide allergy. The patient had previously received two doses covid-19 vaccine (Unspecified manufacturer) (Dose number in series 1) (form of admin, rout of admin, Batch number and expiry date were not reported) dose and start therapy dates were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following two doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 18555835 expiry: unknown) dose was not reported, 1 total administered to left arm on 06-DEC-2021 at 13:00 for covid-19 prophylaxis. Age at time of vaccination 57 years old. Concomitant medications included levothyroxine, and methadone.  On an unspecified date, the patient experienced covid-19 (coded to suspected covid-19 infection) (Dose number in series 2). The patient received non-company suspect drug Paxlovid (form of admin, rout of admin, Batch number and expiry date were not reported) dose and frequency were not reported from 15-JUL-2022 to 20-JUL-2022 for covid-19 treatment. On 22-JUL-2022, the patient reported as sore throat, and headache were remained post treatment with Paxlovid. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection. This report was non-serious.
I have experienced longer menstrual cycles with much heavier bleeding than normal, beginning April 1 to present.
Pt had greater than 3 hours of crying, difficulty consoling for 48 hours. Wired, irritable, agitated. No fever. Would not sleep for 11 hours. No site redness nor swelling. In retrospect similar reaction occurred at 2 month shots but attributed to bad yeast infection b/w baby and breast feeding mom. Did have fever but low grade. Mom gave Tylenol and did not call us about either event until unrelated sib follow up on 09/10/2005.
Child received Pfizer covid vaccine in right deltoid at 1630. Child received flu vaccine in same arm at 1632. Although nursing staff explained to mother that it is preferred to vaccinate in different arms for more than one vaccine, the mother insisted that the flu vaccine be administered in the same arm. Nursing staff proceeded and spaced injection appropriately. As child got up from chair and started walking away, he became weak and started falling to the floor. His father caught him and lowered him to the floor. There was a brief loss of consciousness, approximately 10 seconds or less.  EMS was alerted. Pulse was 45 initially. No seizure activity, nausea/vomiting or loss of bladder/bowel control occurred.  When child gained consciousness, his speech was clear and appropriate, although oral mucosa was significantly dry, skin was pale and dry, and eyes were glassy. Vitals were obtained at 4:42pm as follows: 98/56, 70 heart rate, 100% O2 sat and temperature 96.9. Bottled water was provided but child refused to drink. EMS assessed and released child to the care of his parents who did not wish to proceed to the hospital ER.  Parents took child home and did not wish for further treatment.
No adverse event occured. Storage/handling concern resulted in manufacturer and department of health recommending revaccination due to inconsistent temperature monitoring of the refrigerator used to store vaccine.
Information has been received from a midwife nurse for GARDASIL, a Pregnancy Registry product, concerning a 19 years old female patient with a history of mood disorder. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the first dose GARDASIL (lot number reported as 0624AE; expired date 16-DEC-2014) (0.5 ml, intramuscular, left deltoid) on 21-AUG-2012. No other co-suspects were reported. The reporter stated that there was no concomitant medication. Subsequently, the patient became pregnant with an LMP of 03-AUG-2012 and an EDD of 10-MAY-2013. The patient had taken a home pregnancy test and it was positive then came in for office visit on 06-SEP-2012 and blood labs were performed for gonorrhea and chlamydia with negative results. Reporter stated prenatal blood work labs were recently drawn and awaiting the results. There were no adverse effects reported. The patient had came to the office to seek medical attention. Follow up information was received which stated that 672676/0069AE has been verified as a valid lot number for GARDASIL. Additional information is not expected.
Patient received first Pfizer Covid vaccine and was sent to sit down and wait for 15 minutes. I was in the booth giving second shot, but her mom began to yell for help as patient has passed out and fell onto the floor. After waking up, she was able to answer questions and stated that she has passed of following giving blood in the past.
dizziness (would have passed out if I hadn't laid down), extreme pain on left side under ribs, chills, nausea, diarrhea
No adverse event - patient received outside of recommended age range. To date (12/11), has not experienced any adverse events.
I had COVID-19 in February 2023. I had fever, headaches, upper respiratory infection and felt fatigue for while. I also had a cough as well. I took an at home COVID-19 test on 02/03/2023.  I spoke with my doctor on the phone but did not go to the office. My symptoms lasted for two weeks. I receive Paxlovid medication which helped me to recover.
Diarrhea; Vomiting; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, vomiting,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010A21A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) diarrhea, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), diarrhea, vomiting was unknown.; 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.
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005235:
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown) and a dose of AFLURIA (Lot# unknown) in the same arm at the same time. Concomitantly at that time, the patient received a dose of tetanus toxoid (manufacturer unknown) in the other arm. It was reported that the patient had a reaction in the arm where the patient received PNEUMOVAX 23 and AFLURIA. It was stated that PNEUMOVAX 23 was not supposed to be administered in the same arm with AFLURIA. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
In the months after my shot, my arms have gotten weaker. I have had pain in my spine from the neck to the bottom of my back. In my legs, I have had pain and it has affected my balance. The pain has gotten worse as time has progressed. I have seen a neurologist and a vascular doctor so far. I have had chest pains on and off for the last 5 months and go to see a cardiologist soon for that. Had to go to the urgent care for my feet twice and to the ER because of pain in my stomach.
GARDASIL dose #3 1/27/09 2/17/09 - Dysuria with Lower Abdominal Pain UA - Large Blood, small leuks, Prot > 300 mg/DL cx-neg symptoms lasted 1 week - Repeat urine x 2 - normal.  4/3/09 Received vac records & PCP medical records for 2/17-2/26/2009. FINAL DX: UTI, dysuria Records reveal on 2/17/09 patient experienced pain w/urination, grequency & urgency x 1 day.  Had just completed menses.  Tx w/oral antibiotics.  RTC 2/26 & had felt unwell since 1/27.  Had eye infection 2/4, possible UTI 2/11 & now UTI w/abdominal pain & dysuria.  Exam revealed erythematous blanching rash thought to be drug vs vaccine reaction. Antibiotic d/c.  No further records available.
This is a spontaneous report from a contactable consumer (wife). A male patient of unknown age and race/ethnicity received on 28Feb2017 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On 01Mar2017, the patient had arm swollen, bad chills and stomach upset. Outcome was unknown.
Severe dizziness, thought it was vertigo, has lasted 2 and a half weeks; Severe dizziness, thought it was vertigo, has lasted 2 and a half weeks; foggy brain; blood pressure measurement: 127/68; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 57-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:30 (57-years-old at the time of vaccination), (Batch/Lot Number: El1283) as DOSE 1, SINGLE for covid-19 immunisation at School or Student Health Clinic. Medical history included drug allergic to penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 04:45, the patient experienced severe dizziness, thought it was vertigo, has lasted 2 and a half weeks and foggy brain. The patient underwent lab tests and procedures which included blood pressure measurement: 127/68 on 25Jan2021. Patient did not receive any treatment for the events. The clinical outcome of the events was not resolved.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Dizziness; Tingling in hands and feet; Stomach pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000002984.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: DIZZINESS (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling in hands and feet"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain".  Additional information: On 12Aug2022, it was reported that a patient started treatment on an unspecified date with PFIZER BIONTECH COVID-19 VACCINE at first dose for unspecific Indication. It was reported the patient experienced dizziness, tingling in hands and feet, and stomach pain. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was reported that a pt (6 of 7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
felt like I was going to faint/ dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), first dose via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:30 (at 64-year-old) as single dose for COVID-19 immunization. Medical history included Lungs scarred from multiple bouts of pneumonia and bronchitis, known allergies: Bee stings, IVP dye (contrast dye). Patient is not pregnant. Facility type Vaccine was Pharmacy or Drug Store. Concomitant medication included escitalopram and bupropion hydrochloride (BUPROPION HCL ER). It was reported that there is no reaction day of injection at all. Dose was on Thursday (25Feb2021). Sunday evening (28Feb2021 18:30), the patient started experiencing dizziness when she was on her back in yoga. She sat up and felt like she was going to faint. She have had intermittent dizziness since Sunday evening, 28Feb2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Suspected Vaccination failure; got shingles again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with comfrey. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again. The patient stated that, there was something you could do. There was a plant named comfrey, health food stores knew about it. The patient suggested to find someone who had one and stated that, if you made a poultice using this common plant, it would heal within days. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received from a RN concerning a 61 year old female on dialysis with diabetes, hypertension and allergies to PCN, "sulfur", acetaminophen (Tylenol) and "tanorimin" who on 08/19/04 was vaccinated with a 40mcg first dose of Hepatitis B virus vaccine rHBsAg (yeast). On 10/29/04 it was reported that the pt did not receive the second dose "yet" due to hospitalization with other medical issues.  The nurse stated that the "client is frequently in and out of the hospital". There was no product quality complaint involved. Follow up information from the reporter indicated that the pt might be in the hospital, but she was "not really sure" and did not state the reason for her hospitalization. The nurse mentioned "catheter problems and infection". She also stated that the pt was "non-compliant" with her treatment. No additional information was provided. Follow up information from the reporter indicated that there was no adverse reaction noted from the vaccine. It was reported that the pt was hospitalized not due to vaccine related problems. It was also noted that the vaccine was not given timely due to not coming to dialysis regularly. Additional information has been requested.
DOSE WAS GIVEN AFTER THE BEYOND USE DATE. PATIENT REPORTED NO ADVERSE EVENTS.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right (Batch/Lot number: unknown) as dose 2, single and administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "eating disorder" (unspecified if ongoing); "mental illnesses" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. Facility type vaccine reported Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. No Covid tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and vaccination failure  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
12Sep90 pt vax w/ measles live virus and on 13Sep90 pt vax w/ hepta B. 20Sep90 pt exp itchy rash over entire body. Dx as serum sickness.  Pt exp nausea and diarrhea. 5-6 days later; sx resolved.