chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound COVID-19 infection; Rebound COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21May2022 at 15:00, outcome "not recovered" and all described as "Rebound COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported eventS and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
My father looked awful as soon as he got home from getting the COVID vaccine he received 3/3/21. He said he did not feel good and felt weak. I also found out that he mentioned to someone that he never should have gotten the vaccine.  In the months of April and May he was in the hospital 4 times and passed away 6/2/21. My family strongly believes the COVID vaccine killed him and not the cancer. He  also experienced neurological issues in his right leg and right arm and had trouble swallowing after getting the vaccine. He was able to walk up and down stairs prior to getting vaccinating but not afterwards We don't believe this vaccine should be taken by anyone who has a compromised and weakened immune system and who is battling cancer. We believe it also accelerated the cancer.  I know of someone else who received both doses of the vaccine who had cancer years ago and now fears she may have cancer again. Your vaccine killed my father!
Patient was fully vaccinated with Moderna 3/19/21 and 4/16/21. Patient presented with complaints with intractable nausea, vomiting and diarrhea. Patient also reports subjective fever and chills with fatigue.  She does report an occasional cough. Symptom onset 1/12/22 and admitted since 1/16/22
No adverse event; Pharmacist called to report a16 years old female patient received her 1st dose of GARDASIL 9 on 3/16/2023. Patient missed 2nd dose and it was given on 8/12/2023.; This spontaneous report was received from a pharmacist referring a 16-year-old female patient. Information regarding her concurrent conditions, medical history, drug allergies or reactions and concomitant therapies was not provided.  On 16-MAR-2023, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose description, lot #, expiry date, and route of administration were not provided). The patient missed the second dose, and it was administered on 12-AUG-2023 (inappropriate schedule of product administration). No adverse event was reported.
About a month ago I started experiencing (3) distinct symptoms  1- Bladder control issues 2-Numbness/tingling in my left arm which has spread to my hand and is consistently spreading 3-Trouble walking sometimes, my left leg feels out of my control
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vial did not undergo temperature excursion.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up contains no new information was added.
Pain at injection site  2 days of severe fatigue  Yellow/orange urine despite doubling water intake
21JUL92 pt recvd vax & 4AUG92 c/o pain in rt arm, rt grip was weaker than lt & stated doesn't feel well; refused to go to ER & was sent home to go to family MD; pt was crying & upset; had pain & rash 2-3 days p/vax;
May 29, 2021 Kidney infection. Back pain, blood in urine. Hospitalized for three days treated with antibiotics.  Continued antibiotics for three days after discharge.
Pt received injection on 12/10/08 on 12/11/08 (L) thigh became itchy, red and painful. Afebrile
Helped someone move their household possessions two days prior to adverse effect, so wasn't sure if related. Observed a burning sensation in upper right pectoral major  that moved through right armpit at boundary between biceps brachii and right deltoid. Felt tight during arm movements sway from torso and over head, bringing medium severity burning and tugging sensations under skin. Suspected lymph node irritation from 1st Pfizer shot or damage from moving heavy furniture. After 3-4 days the irritation in right pectoral ceased and burning and tight sensation in deltoid area lessened by approximately 50%. Today as I write this there is little of this persisting - only noticeable in right deltoid area when moving right arm to the most extreme limits of its possible positions, such as above and behind head. This produces a minor burning and tugging sensation in the right deltoid area which encourages slow and careful movement to this extreme position.
On 10/11/2000, the patient developed 3-4 varicella like lesions on her wrist and was seen in a physician's office. No other symptoms were reported. Additional information has been requested.
Head to toe hive like rash which started seven days after received first dose of the Moderna COVID-19 vaccination.The rash spread over entire body within twenty four hours
A rash appeared on arms, chest, upper back and upper legs. It started out as minor and I thought it would go away. When it was still there by December, I contacted my physician. I was seen by a general practitioner twice, an allergist several times, an endocrinologist, and a rheumatologist. The general consensus is that I have developed dermatomyositis, probably as a result of the flu vaccine. I have been on prednisone since January 2015. I am also seeing a nutritionist and have been following a paleo diet and staying away from nightshade foods to reduce inflammation.
Patient was admnistered with an expired dose of Ipol with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via The Agency (Reference number- 00363528) and transmitted to Sanofi on 18-Nov-2020.  This case involves an 18 year old male patient who received an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) once (batch no: P1E70 and expiry date: 09-Nov -2020) via an unknown route in right upper arm for prophylactic vaccination, on 17-Nov-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS A VACCINE, HEPATITIS B VACCINE and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency same day).  The reporter asked for guidance on how to proceed and if patient needed revaccination. The reporter informed that product was not been used and there was no product technical complaint.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Received dose from a vial punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times). On 19-Nov-2021, ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the health care professional opened a Moderna vial and they were not aware that the vial could only be punctured 20 times, so they puncture the vial 24 times, and the patient received the dosage. The number of doses per vials was 4 doses in 1 vial.  No concomitant medications were reported.  No treatment information was reported.
Pt received TDAP and VARIVOX. Also had wart removed prior. Felt faint with injection and layed down in room and gave cool compress x 10 min. Pt went to waiting area and then fainted after few minutes in mom's arms. Pt layed down again and recovered fully after 20 minutes.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated for doses of oral, ROTATEQ lot # K010221, I011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 06-APR--2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route defaulted as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Approximately 11 minutes after administration, MOC noticed  erythema on patient's forehead. MOC then noticed pt's eyes were puffier than normal and her neck looked swollen. MOC also observed swelling to BUE and BLE extremities. Swelling noted to be getting worse per MOC.  No stridor or increased WOB noted. O2 sats remained >95% on RA. Unable to obtain BP d/t pt compliance.
.025 ml vaccine was administered as the first vaccine dose for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reactions were noted. Parent have been notified to bring infant to clinic for revaccination. This will be a no-cost visit.
I started noticing my heart fluttering in November it is much more often now. After my own research it showed that I have arrhythmia. I have not contacted my doctor yet but I have a appointment scheduled.
Patient received 0.5ml of Moderna Coivd 19 vaccine in left deltoid at 3:15pm. Patient observed for 15 minutes following injection. At approx. 3:30pm patient c/o tingling in bilateral fingers. Vital signs taken at 3:30. Blood pressure 110/70, pulse- 69, O2 sat- 98%, temp- 97.3. Patient denied any c/o shortness of breath, dizziness, chest pain, difficulty breathing or edema. Vital signs retaken at 3:35 pm. Blood pressure 105/62 ,pulse- 62, O2 sat- 99% . Patient continued to c/o tingling in fingers. continued to observe patient. Patient also c/o tingling in bilateral legs. Vital signs retaken at 3:42. Blood pressure 117/70, pulse-62, 02 sat 98%. Patient continued to deny any c/o shortness of breath, dizziness, difficulty breathing, edema or chest pain. Patient observed for 30 minutes post injection.
FLUVIRIN and PNEUMOVAX were administered to the patient on the same arm (left arm).  The area where the vaccines were administered started to get an inflammation and a bruise formed.  She was administered BENADRYL 50mg/ml and the inflammation decreased.
Pt, had TDaP, flu and PPV23 given at 11:30AM 9/22/2009=> pt called PCP office around 5PM c/o severe vomiting and diahrrea. Pt very anxious and advised to go to ER. ER note from 9/22/09 at 6:30PM report s/s resolved.
starting on 4/28 I have had a mild to moderate headache.  this is ongoing and has not stopped as of the date of this report.
This spontaneous report as received from nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N029632 expiry date: 23-OCT-2019) for prophylaxis. The VARIVAX was stored in temperature of 15 degree Fahrenheit (F) to 46 F (31.1 F) for 1 hour. There was previous temperature excursion reported 6 F to 14 F (10 F). A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved. Lot number [N029632] has been verified to be a valid lot number for VARIVAX.
I started having a bad cough and sore throat and I had pink eye, headache, nose running, and sick from the chest up and they thought I had asthma and going through so many test and I had to get rid of my plants and they did allergy tests and tested allergic for mold and the dr. made me think there is a loop whole in my system and that I was sick because of the vaccine and he placed me on one medication Pyridoxin and I have been taking that for months and now I take Acedia medication. I haven't been sick for months now.
child started with red rash (head to toe) @ 12:30pm on 9-7-07 mom called hospital, referred to CMC-ER. No fever report.
experiencing joint and muscle pain; experiencing joint and muscle pain; This is a spontaneous report from a contactable consumer (Patient).   A 86-years-old female patient  received first dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9269), dose 1, shot in her left arm on 11Feb2021 as dose 1, single for covid-19 immunisation. Medical history included Mild heart attack from 1996 to an unspcified date Additional Information for Other Conditions: Stent placed and thyroid surgery, intestine problem with antibiotic and anxiety from an unknown date and unknown if ongoing. Concomitant medication(s) reported as ongoing included clopidogrel (CLOPIDOGREL), 75 mg, by mouth, once a day for mild heart attack and a stent put in, levothyroxine (LEVOTHYROXINE), 75 mcg, by mouth, once a day for thyroid surgery, lorazepam (LORAZEPAM), 0.5 mc, by mouth, 3 times a day for Anxiety, probiotics (PROBIOTICS), 4 mg, by mouth once a day for intestine problem with antibiotic, vitamin d3 (VITAMIN D3), 400 iu, by mouth, once a day. On 02Mar2021, patient experienced experiencing joint and muscle pain. The The outcome for the events was not recovered.    No follow-up attempts are possible. No further information is expected.
SEVERE HEADACHE; This spontaneous report received from a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache. This report was non-serious.
Patient had a rash develop around neck and face. Slight difficulty breathing. This happened night/day after vaccination. She took Benadryl and was fine. Reported to us days afterwards at same time as vaccine patient also started using new sheets (bedding) but couldn't determine which of the two caused the reaction. (no rash around injection site).
the day p/vax pt had violent head shaking, extreme resp problems, loss of control of limbs & general confusion;MD called;pt seen by MD 27JAN96;they said pt had Tourette like sx which they placed pt on clonadine;
14 hours post vaccine developed severe body and joint ache, severe arm pain to point couldnt move or touch arm, chills, weakness, low grade fever (99-100).  This lasted 12-18 hours.  About 48 hours post vaccine I started having spells of dizziness/virtigo.  This seems to be getting worse and more frequent and is still affecting me.
significant kidney damage; This spontaneous case was reported by a consumer and describes the occurrence of PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein) and RENAL DISORDER (significant kidney damage) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein). On an unknown date, the patient experienced RENAL DISORDER (significant kidney damage). At the time of the report, PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein) and RENAL DISORDER (significant kidney damage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Protein urine: 1.8 milligram. On 25-May-2021, Protein urine: 1150 milligram. On 25-May-2021, Urine abnormality: abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever; Chills; Headache; loss of appetite; dizziness; tingling in extremity; cervical soreness; This is a spontaneous report received from a contactable consumer(patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number: FC3180 and expiry date not reported) via an unspecified route of administration, at the age of 53-year-old, on 24Aug2021 12:15, at the right arm, at dose1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history included COVID prior vaccination. The patient no known allergies. Concomitant medications was reported as none. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. It was unknown if the patient was tested for covid post vaccination. On 24Aug2021, 20:45, the patient experienced fever, chills, headache, loss of appetite, dizziness, tingling in extremities, cervical soreness. It was unknown whether the patient took any treatment. The outcome of the event was unknown at the time of report.
felt very tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-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: "arthritic knees" (unspecified if ongoing), notes: has arthritic knees not she does not have good bones.; "she does not have good bones" (unspecified if ongoing), notes: has arthritic knees not she does not have good bones. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt very tired the next day". Additional information: The caller mentioned she was 90 years old and has arthritic knees and she does not have good bones. She also mentioned that with her previous doses she felt very tired the next day and asked what was going on with the fatigue. She mentioned that it was concerning, but that probably apart from being more tired that she has been with the previous vaccination, caller suspects she will not suffer from anything unusual, and that she will make an appointment to receive the vaccine.  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-202201253856 same patient/ drug/ event, different dose number;US-PFIZER INC-202201253858 same patient/ drug/ event, different dose number;US-PFIZER INC-202201253857 same patient/ drug/ event, different dose number;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced numbness in 3 fingers in her left hand on 1/22/15. Numbness continued to her left hand and stopped at left elbow.  No Medical attention sought by patient. Patient stated today on 1/29/15 numbness is improving and is only located in left hand and finger tips. The numbness comes and goes. She stated work/activity at home may have been a contributing factor.