chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
he had his arm very painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (he had his arm very painful at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL, ATORVASTATIN, ENALAPRIL, GLIBENCLAMIDE, SITAGLIPTIN, LEVOTHYROXINE, FUROSEMIDE, METFORMIN, TAMSULOSIN, Rivaroxaban, FINASTERIDE, DILTIAZEM and INSULIN GLARGINE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (he had his arm very painful at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of dosage form. On 07-Jan-2021, VACCINATION SITE PAIN (he had his arm very painful at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-016351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: phone call and left VM On 01-Apr-2021: Contact info added
COVID ARM; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID ARM) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID ARM). At the time of the report, VACCINATION SITE REACTION (COVID ARM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Rash covering the majority of my face when I woke up the next day. No hives and did not itch. Red patches and blotches. Not really bothersome. Got a little better every day until it was hard to see any a week later. Momentary dizziness, also the next day, like a three second flash, when rising from laying flat, laying flat from standing or sitting, or rolling over while laying down. Passes and I can sleep and not notice it unless I am awake enough, and cognizant enough, to notice it when I roll over. Once standing and moving about there is no problem except a feeling, I have seen described as brain fog, of being a little off mentally. Not sharp, but no dizziness. Can maintain normal activity that includes bending over, kneeling down, driving and riding in a car without any dizziness. Have tried eply maneuver, something I can do, but have not had any improvement. Brain fog seems to improve with normal daily movement and I have been trying to avoid my normal caffeine intake.
1st vaccine on 10/24/2019 and have not received 2nd or 3rd doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on 24th October 2019, intramuscularly).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was not recovered/not resolved.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received 2nd and 3rd dose, which led to incomplete course of vaccination. The reporter consented to follow-up.
Severe swallowing and breathing difficulties, resulting in immediate hospital admission. Diagnosed with MG.
No additional AE reported; Improperly stored then administered; This non-valid spontaneous report was received from an office manager and refers to two patients of unknown demographics. No information regarding the patients' medical history, concurrent condition, drug reaction or allergies and concomitant medication was provided.  On 17-AUG-2020, the patients received 2 improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), lot # S031497 was confirmed to be valid, expiration date 07-OCT-2021, (exact dose, route and site of administration were not provided) for prophylaxis. Administered doses of vaccine were exposed to the temperature of -13.7 degrees Celsius (C) for 4 minutes. There was no previous temperature excursion. The call was because of a digital data logger. There was no adverse event reported.   This report is non-valid due to lack of patients' identifiers.
Woke up the next day with: 105 fever Swollen and red at injection site Extreme headache and body ache Swollen lymph nodes Fatigue
during 15 minute monitoring period, patient reported of left arm where she received injection to be swollen with her fingers starting to swell. pt was given benadryl otc 2 tablets to take and refered to urgent care/ER since pt has no PCP.
While having a Bowel Movement she stain by injuring her lower back/ hip area on the right side; Itching on the scalp on the forehead; This spontaneous case was reported by a consumer and describes the occurrence of BACK INJURY (While having a Bowel Movement she stain by injuring her lower back/ hip area on the right side) and PRURITUS (Itching on the scalp on the forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-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 BACK INJURY (While having a Bowel Movement she stain by injuring her lower back/ hip area on the right side) and PRURITUS (Itching on the scalp on the forehead). At the time of the report, BACK INJURY (While having a Bowel Movement she stain by injuring her lower back/ hip area on the right side) and PRURITUS (Itching on the scalp on the forehead) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Patient also stated that canceled her 2nd shot and this week will be 5th week. Patient wanted to know if it was okay to take 2nd dose after 42 days.   Reporter did not allow further contact
Patient started having pain starting on arm (site of injection) radiating to neck, back, lower back and buttocks. Patient has had X-rays done, which did not show anything. MRI pending.
6 hours after receiving the flu vaccine and developed shaking chills, dizziness and high temps with a Tmax of 103.2. Symptoms lasted 14  hrs.
Received his first dose  of Pfizer covid vaccine on  March 23 and he tested positive a week later; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient medical history, concomitant medications and past drug history were not reported. Reporter stated he already spoke to the safety department but did not have any reference number to provide. He received his first dose of Pfizer covid vaccine on 23Mar2021 and he tested positive a week later. On 12Apr2021 he tested negative. He wanted to know when he could get his second dose. The outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: O31L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: O31L20A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: O17F21A), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: O59w12A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022 at 13:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral Product (Paxlovid) from 01Jan2023 for COVID-19 Treatment. Rebound five days after ending Paxlovid treatment, from 07Jan2023 09:00 AM, received no treatment and was not recovered at the time of this report.
become serverly ill; chronic pelvic pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "become serverly ill"; PELVIC PAIN (non-serious), outcome "unknown", described as "chronic pelvic pain".  Additional information: the patient specified that he/she was forced to receive two of Pfizer covid 19 vaccines for work when the covid virus came into existence and the patient has become severely ill since then. The patient has chronic pelvic pain as a result and no doctors can help.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Nauseous  Tired Joint pain Muscle pain Chills Pain at injection site Have all symptoms next day
This spontaneous report as received from a other health professional refers to a 12 years old female patient. The patient was vaccinated with dose 1, .5 ml GARDASIL on 27-DEC-2010, with dose 2, .5 ml GARDASIL on 25-FEB-2011, with dose 3, .5 ml GARDASIL on 20-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was vaccinated with first dose of GARDASIL 12/27/2010, second dose of GARDASIL on 02/25/2011 and the third dose of GARDASIL on 09/20/2012 with No adverse event. No treatment information was reported. The outcome of vaccinated with first dose of GARDASIL 12/27/2010, second dose of GARDASIL on 02/25/2011 and the third dose of GARDASIL on 09/20/2012 and no adverse event is unknown. Additional information has been requested.
VERY HOT RED SWOLLEN AREA OVER SITE WHERE MMR AND VARICELLA WERE GIVEN WHICH PERSISTED MORE THAN 72 HOURS. REPORTS HE USED ICE TO TRY AND REDUCE SWELLING. HE WAS UNABLE TO REACH THE PEOPLE WHO GAVE IT SO CAME TO SHOW IT TO THE LOCAL HEALTH DEPARTMENT.
mild fever; mild chills; mild body aches; swelling at injection site; itching at injection site; redness at injection site; redness traveling down the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site) and INJECTION SITE PRURITUS (itching at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm). At the time of the report, PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm) outcome was unknown. Not Provided          No concomitant medications were provided.   This case was linked to MOD-2021-066573 (Patient Link).
Vaccine-associated Varicella rash & Hepatitis-started chemo-therapy 8-30-2010, pt taking high dose Prednisone
Forearm of injection arm developed two small bruises with nerve type discomfort; Forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there is tearing or pulling apart inside.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration in left arm on 03Oct2021 at 15:00 (at the age of 61 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included patient had known allergies pennecilin. Concomitant medication in two weeks included levothyroxine sodium. Other vaccine within 4 weeks included influenza vaccine as DOSE NUMBER UNKNOWN, SINGLE from 08Sep2021 to 08Sep2021. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injectio n, Lot number: FC3183), via an unspecified route of administration in left arm on 12Sep2021 at 03:00 PM (at the age of 61 years old,) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Oct2021 patient experienced forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there was tearing or pulling apart inside. Bruises did not appear at same time but few days apart. This happened approx. 2 days after 2nd dose injection. It was not going away. No hospitalization required. The patient did not received treatment due to the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow up attempts completed. No further information is expected.
The pt experienced extreme weakness to the point of nearly passing out, nausea and dizziness. Diagnosed with visual disturbance and increased blood sugar
DVT, and a pulmanari embalis called a saddle embalis, and multiple embalis in the blood. I spent 3 days in the hospital being treated with blood thinners and am now permanently on Eloquiz. I have never had any blood issues, I was in excellent health. Originally these blood clots were attributed to a cut in my leg. Since my haealth has also been  excellent all my life , I can only attribute this condition due to the vaccine. I understand there is a lot of evidence that blood clots are caused by the vaccine
ACHY; MIGRAINE HEADACHE; COULD NOT DO ANYTHING; STARTED FEELING TIGHT IN ARMS; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 01-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced migraine headache. On 02-APR-2021, the subject experienced could not do anything. On 02-APR-2021, the subject experienced started feeling tight in arms. On 02-APR-2021, the subject experienced muscle aches. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine headache, could not do anything, started feeling tight in arms, muscle aches, and fatigue on 03-APR-2021. This report was non-serious.
patient was administered GARDASIL 9 while undergoing a temperature excursion; The medical assistant did not report any other adverse events with the patient; This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 ml, lot # T027789, expiry date 27-FEB-2023 (route and location of administration were not reported) for prophylaxis, which was undergoing a temperature excursion (product storage error). The medical assistant did not report any other adverse events with the patient (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA002604:
Patient received mixed dose series: first dose Pfizer, second dose Moderna due to vaccine site not having any Pfizer vaccine available. Patient was counseled and advised to wait for additional shipment of Pfizer vaccine. Patient refused to wait for second dose Pfizer and demanded administration of Moderna vaccine despite counseling on unknown efficacy of mixed dose series.
2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine.  2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.