chrisvoncsefalvay/vaers-outcomes huggingface dataset:
caught covid; caught covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Shrimp" (unspecified if ongoing); "Allergies: Peanut, Walnut" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; AMLODIPINE; METFORMIN. Past drug history included: Isovue, reaction(s): "Allergies: Isovue"; Cefaclor, reaction(s): "Allergies: Cefaclor".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "caught covid". The event "caught covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) normal, notes: blood pressure maintained normal; SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) negative, notes: covid test was now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: Patient felt weak and faniting.  She drank water and rest for 30 minutes and was fine.   Asked her if she needs us to call 911 she said no she gets like this all the time whenever she gets vaccine/shot
fever; sores; This spontaneous report has been received from a lawyer (reporter), via a Fact Sheet from a case in litigation (MARRS # 2108USA004395), concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, lot #, expiration date and anatomical location were not reported) for prophylaxis. On an unspecified date, the patient experienced fever (values and units were not reported) and sores.     The outcome of fever and sores was unknown and the causality assessment between the aforementioned events and the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) was considered as related.  This is one of the several reports received from the same patient.
Patient went to bed and woke up with shortness of breath, shaking, heart racing, nausea and vertigo. Went to the bathroom. It lasted for about an hour. Drove to the emergency department in the early morning hours on 12/28/2021. It felt like her heart was beating out of her chest. This was the first time she had to seek emergency treatment at an ER. The ER told her to follow-up with an ENT for the vertigo. She had the first two Moderna injections on 5/6/2021, batch/lot# 003C21A and 2nd Moderna injection on 6/3/2021 batch/lot# 049C21A. She had knee pain on the front and back left of one knee starting about 30 days before this adverse event. She said she felt ill after those injections for about 5 hours. She felt continuing nausea and vertigo first week of January 2022. On January 6, 2022, she started to feel ill with COVID-19 symptoms (coughing and runny nose). This was 16 days after the booster shot. On January 10, 2022 she tested positive for COVID-19 (20 days after her Moderna booster shot).
pt recv vax yesterday & began to devel n/v last PM which has persisted today;
I started running a fever. I already had a prescheduled appointment. I assumed that when I was out in the yard all week, it may have been due to my allergies. I took a COVID-19 antigen test and I took that with me to my appointment. The lines on the test was very faint. He told me it was positive. He didn't examined me for sinuses. He told me he would send a prescription for PAXLOVID which I started that afternoon. I didn't have other symptoms other than having a stuffy head and fever. I also have been experiencing a slight fever every now and then on and off for the last 6 to 7 months, but I attribute that to allergies. They are usually around 99. I usually take a ZYRTEC or TYLENOL to help with that.
Injection at 11:00 am symptoms started approx. 3:30 pm (same day) Tuesday Oct 21, 2014. Feeling like I was burning up temp? Aching all over, shaking, bad taste in my mouth severe weakness for 4 days.
I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104617:same reporter
3d s/p vaccine symptoms started w/ SOB w/ exertion, itchy skin, metallic taste in mouth, left sided chest pain that went straight to back followed by heaviness and pressure in chest, and HA
This spontaneous report as received from a Licensed Practical Nurse refers to 6 patients of unknown age and gender. On an unknown date, the patients were vaccinated with single dose of ROTATEQ (lot # J011344 exp 10-MAY-2015) that were improperly stored. No adverse effects were reported. Additional information is not expected. The reporter does not want to be contacted.
Patient seen in the ED on 11/19/22 after feeling poorly approximately a week ago with shortness of breath, sore throat, cough, and decreased appetite. He had been seen at urgent care 2x prior to being seen in the ED. The day prior to coming to the ED (11/18), the patient was seen in clinic and diagnosed with influenza and COVID. Retest in the ED was positive for COVID-19 by PCR and negative for Influenza. Ultimately patient admitted 11/19/22 - 11/21/22 with acute hypoxic respiratory failure secondary to influenza and COVID-19, COPD with possible exacerbation. Supplemental O2 up to 2L NC during admission, however patient was weaned to room air.
22 Month male child c/o redness and swelling to the left and right thigh x 2 days; nodule size of 5cm in duration to left thigh with erythema.  Right thigh had nodule size about 3cm with erythema. No fever, irritations noted from the child. Parent advise after seeing provider to apply cool compress to the site (ice packs) for the swelling and continue to monitor, if any farther complications or concerns to make an appoint with health care provider.
DEATH; This spontaneous report received from a company representative concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the patient died from unknown cause of death after 4 weeks of Johnson and Johnson vaccination. An autopsy was performed on an unspecified date and there was no sign of high blood pressure, heart disease, or diabetes to patient as per report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20210505962-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccine administered on 5/25/11. Dark red hives started to appear on evening of 5/25/11 and by 5/26/11 AM they were all over her body. Mother took her to ER. They administered high dose allergy med. Hives went away by two days later.
This case was reported by a consumer via call center representative and described the occurrence of lower respiratory tract infection viral in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, less than a year after receiving SHINGRIX, the patient experienced lower respiratory tract infection viral (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the lower respiratory tract infection viral was recovering/resolving.  The reporter considered the lower respiratory tract infection viral to be unrelated to SHINGRIX. Additional details were provided as follows: The patient developed a viral lung infection. The patient had denied permission to contact their physician.
lt like ball & socket of shoulder had a constant ache-scale of 1-10 "8";Saturday noc started & until 1 wk later;gone in November last week returned but not as bad
Saw Dr 5/21/12 Pt states local irritation then 2-3 days itching % swelling face saw occ health 5/18/12.
Low grade fever, chills, loss of appetite, sore throat - began about 12 hours after injection and persisted for approximately 36 hours Moderate pain at injection site  - ongoing 48 hours after injection
shortness of breath, hypoxia chills/rigors, febrile Narrative: Patient presented to the ED with 1-day history of rigors and chills after receiving the 2nd dose of his SARS-CoV-2 immunization; he reportedly woke up 03/17 with new dyspnea, was "staring off", and was mumbling non- sensical words and phrases. Patient's girlfriend called EMS and was transferred to the ED. SpO2 reportedly in 80%s en route. On arrival, patient's vital signs were significant for temp 102F and transient hypoxia to the 60%s when transferred to ED bed. Patient was notably altered, non-verbal, and not following commands, with an initial GCS of 10 with intact gag reflex. VBG 7.24/69/75/29. but follow-up GCS was 4 with impaired gag reflex. Respiratory therapy was called for intubation.
On 02/04/1999 the pt developed a breakthrough case of chickenpox. No further information is available.
Red, swollen, sore itchy at injection site.  Itching all over body but no swelling anywhere but arm.
sore right injection site arm; headache; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided. No treatment information were provided. As per source document the age at the time of event given is 10.
Bladder pressure and pain; Bladder pressure and pain; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications included Birth Control medications, Concomitant vaccine included influenza vaccine (FLU) on 23Mar2021 for influenza immunisation within four weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not had any allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19 or not. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced bladder pressure and pain with lot of discomfort, UTI, symptoms but no UTI. It was unknown if the patient received any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of bladder pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1.Vaccination Facility Type added. 2.AE: Bladder pressure and pain also coded as Bladder discomfort. 3.Narrative added: Concomitant medications included Birth Control medications.  No follow-up attempts are possible. No further information is expected.
Approximately 5 minutes post-vax the patient had a seizure and fainted. The seizure was not confirmed by the nurses. The patient was pale and slightly disoriented lying down on chairs when observed.
Systemic arthritis, joint pain. Occurred 3 days after vaccination with Flu/Moderna at same time. Has been persistent for 5 days now requiring medical attention.
Patient second dose will be out of the 36 day window if he receives it; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient second dose will be out of the 36 day window if he receives it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient second dose will be out of the 36 day window if he receives it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient second dose will be out of the 36 day window if he receives it) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided    Reporter did not allow further contact
This spontaneous report was received from a pharmacist concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In October 2016 (reported as "between 12-OCT-2016 and 19-OCT-2016"), the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # M028553, expiration date 07-JUN-2018, (route and anatomical location of administration were unknown). The temperature excursion reported was 15 C for 72 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. Additional information has been requested.
Patient reports nerve pain and arm tingling within 24 hours of the vaccine and then it progressed to a rash on her body that she reports was from head to toe that lasted for 4 days. She then got a migraine that lasted another 4 days. The rash subsided and then flared up again and she reported the rash reappeared worse than before. She states her injection site had severe swelling and she experienced severe fatigue with aches and pains.
After each vaccination, the patient had flu-like symptoms for 3-4 hours. In the spring of 1997, the patient experienced an onset of bilateral knee pain and stiffness symptoms that are still present. The dates of vaccination were 04/10/1997, 05/06/1997 and 04/13/1998.
Fever(100F); Body aches; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever(100F)), MYALGIA (Body aches) and MYALGIA (Muscle pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history- no adverse event).   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever(100F)), MYALGIA (Body aches) and MYALGIA (Muscle pain). At the time of the report, PYREXIA (Fever(100F)), MYALGIA (Body aches) and MYALGIA (Muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) 100 F.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Information has been received via the internet from a consumer concerning his or her daughter who was vaccinated with 2 doses of GARDASIL (lot number, date, route and site not reported). Approximately a year later the patient had tested positive for high-risk HPV. The patient suffered SEVERE side effects from them which incapacitated her for 2 1/2 months. The patient continued to experience menstrual problems even though it had been over a year. At the time of the report, the patient had precancerous, high-risk HPV. It was reported that the reporter believe that the patient's HPV was the result of the vaccines because the patient did not have HPV when she received the vaccines. Severe side effects and menstrual problems were considered to be disabling. This is one of several reports received from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
FAINTING; LOSS OF CONSCIOUSNESS; HYPOTENSION; This spontaneous report received from a health care professional concerned multiple patients. Initial information was processed along with the additional information received on 17-MAR-2021. 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The nurse reported on 11-MAR-2021. two patients had hypotensive episodes and fainted in clinic. On 11-MAR-2021, the patients experienced loss of consciousness. On an unspecified date, the patients had fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of consciousness, hypotension and fainting was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and loss of consciousness, hypotension, fainting was possible. This report was serious (Other Medically Important Condition).; Reporter's Comments: This case contains multiple patients.; Sender's Comments: V0: 20210324277- Covid-19 vaccine ad26.cov2.S- loss of consciousness, hypotension, fainting. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Patient received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
pt recv vax 27AUG98 & pt exp redness, warmth, swelling & itchiness of lt arm;the reporter felt that the pt exp were not r/t vax;the pt sought unspecified medical attention;
Vaccinee reports that he has not seroconverted after a series of five injections.
Pt reports previous reaction to tetanus developed fever after receiving booster. Given Tylenol. Chart labeled for reaction. Pt transferred to in pt facility for fever/chills. Given diphenhydramine. Follow up Information received 12/13/2006: Pt was in a residential treatment program for psychiatry. He received tetanus-diphtheria vaccine. Developed high fever and tachycardia. Transferred to inpatient facility. Given TYLENOL and BENADRYL. Reports similar reaction in the past.
Chest tightness, felt like an asthma attack.  Given Predisonolone.  VS stable, pt recovered in 10 minutes.