chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 9 year old male who on 09-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10-JUN-2007, the patient developed a severe case of chickenpox with about 500 lesions. Unspecified medical attention was sought. No lab diagnostic studies were performed. As of 13-JUN-2007, the patient's severe case of chickenpox persisted. There was no product quality complaint. Additional information is not expected.
Just over a week after the shot, I started itching at injection site. The area is red, swollen, hot, itchy, and a little sore. I've read about it, and I know that there's no reason to think it's dangerous, but I wanted to be of help as you guys are gathering information about "covid arm."
I tested positive for COVID-19 in April 2022. I was semi-conscious on the floor of my room and one of the healthcare workers at the retirement home found me and I was taken to the hospital. I can't recall many symptoms, but I was unable to focus. I can remember that. They said I was extremely dehydrated. They told me I also had a UTI as well. I was given medication, but I am unable to recall the names of them.
BODY ACHES FOR 4 DAYS, ABDOMINAL PAIN ON 4TH AND 5TH DAY, DIZZINESS, VOMITED ON DAY 12, THEN FLU LIKE SYMPTOMS LASTING FOR 7 DAYS BEGINNING ON DAY 15
11/04/2009 contacted clinic complaining pain in the back of head, numbness of face and drooling.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
(Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Tired), MYALGIA (Body aches) and HEADACHE (Headache). On 08-Jan-2021, FATIGUE (Tired), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   This case was linked to MOD-2021-043575 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2017). On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and 30 days after receiving SHINGRIX, the patient experienced generalized pruritus. In March 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 21st March 2019, the patient experienced papular rash, pain localized, pruritus and localized erythema. On an unknown date, the outcome of the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema were unknown. It was unknown if the reporter considered the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The batch number and expiry date were not known. Sometime in January 2019, the patient felt itchy and then resolved. Two weeks before the time of reporting, 85 days after 1st dose and 175 days after 2nd dose of SHINGRIX, the patient began to notice bumps on his arms, pain at those bumps, itching and red marks across his stomach. On 21st March 2019, 175 days after 2nd dose of SHINGRIX, the patient's physician diagnosed shingles and sent him for tests for such as a computed tomography (CT scan) to be sure. The patient wanted a compensation for being off work, doctor and lab bills. The reporter consented to follow up. This case was considered as a suspected vaccination failure since the details regarding laboratory confirmation was not provided.
pt recv vax;17aug95 presented w/ fever,neck stiffness;hosp for workup;cultures done;discharged 2 days later w/ dx of viral synd;test + for enterovirus,probably poliovirus;reported to FDA by reporter;
Patient said she felt sever pain when the vaccine was injected in to him (he said he felt no pain when the needle went in, the pain started as soon as the vaccine was being push in) This pain at injection site did not subside until about 3 days later and the patient described as severe pain.   He also said he felt flu like symptoms but more to the severe side  He felt generalized body ache but severe and almost can not move   He described having severe leg pain  He thought of going to ER at one point.
Ab test came back negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Ab test came back negative) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced ANTIBODY TEST NEGATIVE (Ab test came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (Ab test came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Antibody test: negative (Negative) test showed no Ab levels against COVID-19.         Patient had already discussed Ab test results with both Cardiologist and Family Physician. Patient was scheduled to receive monoclonal Ab treatment on 22Sep2021. No concomitant drugs were reported. No treatment drugs were reported.   This case was linked to MOD-2021-035928, MOD-2021-329925 (Patient Link).
patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 25Feb2021 11:00 (at the age of 44-year-old) as single dose for COVID-19 immunization workplace at Public Health Clinic/Veterans Administration facility. The patient medical history and concomitant medications were not reported. The patient had not any allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The COVID-19 had not prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021 23:00, the patient experienced patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antiviral and pain medicine as treatment for the adverse events. The outcome of events were recovering.  No follow-up attempts are possible. No further information is expected.
ALTERATIONS TO TASTE AND SMELL; BRAIN FOG OR  COULD NOT THINK STRAIGHT; FLU LIKE SYMPTOMS SUCH AS BODYACHE AND NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced alterations to taste and smell. On MAR-2021, the patient experienced brain fog or could not think straight. On MAR-2021, the patient experienced flu like symptoms such as body ache and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms such as body ache and nausea on MAR-2021, and the outcome of alterations to taste and smell and brain fog or could not think straight was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Caregiver starting feeling faint and stated she had a low heart rate in the 50s, Pt taken to lay down. BP 168/86 HR 106 O2 99%, stated she felt dizzy, no shortness of breath or difficulty breathing. Rapid Response was called at 1643. 1657 BP 157/80 HR 95 O2 99%, still dizzy, breathing WNL.  1702 BP 138/74 HR 88 O2 100%, dizziness improved, she requested to be monitored for a couple more hours. Emergency room charge nurse was notified and caregiver was taken down to the ER for monitor.
Pt recvd vax 13MAY92 & approx 5 months p/2nd dose devel chronic fever between 98.6 & 100, nausea, vertigo, h/a, sore throat, fatigue, arthralgia, or arthritis; described illness as a serum sickness-like illness; seen by MD;
Persistent headache since receiving vaccine; fatigue; fall asleep multiple times a day and cannot stay awake; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 09:00 (Lot number: Ew0191) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: kiwi" (unspecified if ongoing); "known allergy: Dairy" (unspecified if ongoing); "known allergy: pine nuts and cashews" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "Persistent headache since receiving vaccine"; FATIGUE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fatigue"; SOMNOLENCE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fall asleep multiple times a day and cannot stay awake"; NAUSEA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, fatigue, somnolence, nausea, arthralgia.  Additional information: The patient had not received other vaccine in 4 weeks and had not received other medications in 2weeks. Patient had not had COVID-19 prior to vaccination. Patient had been tested post vaccination for COVID as Nasal Swab with test name was PCR, Covid test and result was negative on 29Sep2021.  No follow-up attempts are possible. No further information is expected.
A slight fever on the day after injection.; Pain in left arm at injection site as well as soreness in left arm as a whole; Pain in left arm at injection site as well as soreness in left arm as a whole.; A Migraine on day of injection as well as the following day; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 01Feb2021, at 09:15 AM at the age of 24 years old at a single dose for Covid-19 immunization in the hospital. Patient was not pregnant at the time of vaccination. The patient's medical history included complex aphthosis. Concomitant medications included probiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received probiotics within 2 weeks of vaccination. On 01Feb2021 at 11:00, the patient experienced pain in left arm at injection site as well as soreness in left arm as a whole. A Migraine on day of injection (01Feb201 at 11:00) as well as the following day. On 02Feb2021, on the day after injection a slight fever. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Pt was slumped over and having jerking motions (movements) lasted for about 30 seconds.
4/13/21 - Lymph nodes in armpit (size of lemon), breasts, and near collar bone became very large and extremely painful. Leg weakness, exhaustion, and dizziness also began.  Contacted doctor when symptoms did not subside.  Visited doctor on 4/22/21 for leg pain and dizziness. Lymph nodes no longer painful or as large but still present. Ordered a doppler on right leg - no clots. Visited doctor on 4/29/21 because legs hurt all the time, still exhausted, still occasional dizziness. Ordered blood tests for 4/30/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included administration of Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a 3rd nurse that works for the agency was hospitalized with a blood clot but is recovering; This is a spontaneous report received from a contactable other healthcare professional. This HCP reported similar events for different patients with the same product; this is the third of three. An adult female of unspecified age received a dose (unspecified dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunization. Relevant medical history included traveling nurse. There were no concomitant medications or past drug history reported. On an unspecified date the patient developed a blood clot and was hospitalized. The reporter indicated a nurse that worked for the agency was hospitalized with a blood clot but is recovering. There was no laboratory testing reported. The outcome of the blood clot was recovering.   Information on the lot/batch number has been requested; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported thrombosis cannot be totally excluded. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, is needed to better assess this report.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021683252 PFIZER (Same reporter/product/event in different patients);US-PFIZER INC-2021688670 PFIZER (Same reporter/product/event in different patients)
An immediate reaction to the vaccine; experienced swollen lymph nodes and throat. Loss of cognitive thinking, next morning experienced increase in the swollen glands. Increase in heart rate, Blood Pressure and Blood Sugar. Menses brought on by vaccine as well.
10/24 to 10/31 general body discomfort. 11/1 to 11/07 vision change with persistent headache/up to 12/08/2010 lost vision on right eye. 11/08 to 11/12 dizzines and vertigo, couldn't walk. Stay in bed 4 days. My doctor prescribed MRI on 11/09. Some vertigo persist up to today 12/08/2010.
This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-201, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms included chest pain, dizzy, nausea, tingling extremities.  Went to ER and treated for panic attack but symptoms persisted and she saw cardiologist later in week who dx'd with pericarditis.
fever, cold chills, nauseated, pain in arm, redness, swelling for 48 hrs;
Patient experienced itching starting 3/21/15. Redness visible around area of vaccine and itching still present as of 3/23/15.
Pain/tenderness and swelling/rigidity at the injection site approximately 2 hours after administration; severe diarrhea later that evening;  persistent headache/migraine, fatigue, gastrointestinal upset the next morning and continuing until this afternoon.
Felt faint and lightheaded. Flushing and feeling "hot around the facial area. Vital signs including pulse and blood pressure were within normal limits. The symptoms resolved completely after 30 minutes of observation. Patient did not require further evaluation.
Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673181, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673869 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673181:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter
Doing 12 month shots, I gave a varicella and I grabbed a PROQUAD instead of MMR.