chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrheal illness onset 6/5/07 w/o fever. 2 mo immuniz's (including Dtap) given 6/6/07. Approx 5 hrs. Later had 2 hypotonic/pallor episodes with biret cyanosis. Subsequently found to be febrile. Admitted for septic work up neg (including LP, cultures of CSF, blood, urine. Rotazyme neg.  7/31/07 Received hospital medical records which reveal patient experienced fever, 101.8, eye rolling, became limp & pale w/blue lips. Patients twin sibling was healthy.  Admitted 6/6-6/8/07.  Tx w/IV antibiotics. FINAL DX: Febrile viral illness.
cough; lost sense of smell; tested positive for COVID-19; feel Unwell; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), MALAISE (feel Unwell) and ANOSMIA (lost sense of smell) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MALAISE (feel Unwell). On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On an unknown date, the patient experienced COUGH (cough) and ANOSMIA (lost sense of smell). At the time of the report, COUGH (cough), SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), MALAISE (feel Unwell) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment medication includes Tylenol and cough syrup.   This case was linked to MOD21-065375, MOD21-065446, MOD-2021-062855, MOD-2021-062855 (Patient Link).
Having the side effects of Covid-19 all over again; Fever; Muscle aches; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 24-Feb-2021, ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
Severe respiratory distress; This is a spontaneous report from a contactable pharmacist.   A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),Lot# lot number: EL1284, intramuscular at right arm on 07Jan2021 12:00 PM,  at SINGLE DOSE for COVID-19 immunization. No known allergy , no other medical history.No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility .No any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications (received within 2 weeks of vaccination) . On 07Jan2021 the patient experienced Severe respiratory distress that resulted in Emergency room/department or urgent care.It was unknown if  treatment was received for the event. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown.; Sender's Comments: A possible causal relationship between Severe respiratory distress and BNT162B2 cannot be completely ruled out considering the temporal relationship.  However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details.  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.
Blood clots around the heart, 70% blockage; Pneumonia; Can barely walk, need walker or somebody need to hold; Hardly talk; Barely sees; Brain stem stroke; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage) and PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement on 29-Apr-2021.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BRAIN STEM STROKE (Brain stem stroke) (seriousness criterion medically significant). On 29-Apr-2021, the patient experienced THROMBOSIS (Blood clots around the heart, 70% blockage) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees). At the time of the report, BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage), PNEUMONIA (Pneumonia), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees) outcome was unknown. Not Provided      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.   No concomitant medication, No treatment information provided. The patient had brain stem stroke after 5 hours of the vaccination. The next day, on 20Apr2021, the doctor found that patient had 70% blockage, blood clot around the heart and they have to put stent.  Company comment: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.; Sender's Comments: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, extreme fatigue, lymph node swelling Narrative:
Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. 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.
Information has been received from a registered nurse referring to an unspecified amount of unspecified patients of unknown age and gender. Concomitant medication included sterile diluent (lot number R028661 expiration date: 31-JAN-2020; N028747 expiration date: 28-MAR-2020). Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. From 11-MAR-2019 to 14-MAR-2019, the patients were administered improperly stored doses of PROQUAD (lot #: R012416, expiration date: 28-OCT-2019; dose, strength, route and frequency were not reported) and VARIVAX (lot #: R023513, expiration date: 16-AUG-2020; dose, strength, route and frequency were not reported) for prophylaxis. Sterile diluent was stored properly. No adverse effects were reported. The vaccines were exposed to temperature of -14 Celsius degree to -10 Celsius degree (-13.8 Celsius degree) for 1 hour and 20 minutes and the data logger was involved. There was no previous excursions. This is a non-valid report with no patient identifiers.
Received DT booster-general health update (10/15/04).  Informed health center of soreness left upper arm and armpit on 10/20 or 21st.  No swelling noted on 10/25.  Notified health center that she has developed pain, blisters left arm to fingers.
This spontaneous case reported by a consumer, describes the occurrence of skin discolouration (black and blue in some spots), erythematous rash (mainly red) and rash all over her body in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced skin discolouration (black and blue in some spots), erythematous rash (mainly red) and rash all over her body. At the time of the report, skin discolouration (black and blue in some spots), erythematous rash (mainly red) and rash all over her body: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Patient getting worse and worse. Reporter said the Moderna vaccine caused a complete reaction/rash and she greatly  suffered. Concomitant medications and treatment information not provided.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Coronary artery bypass grafting x4 on pump. Hospital admission within 6 weeks of receiving the COVID vaccine.
Blood pressure Spike after second dose; This spontaneous case was reported by an other caregiver and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure Spike after second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.     On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure Spike after second dose). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure Spike after second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood pressure measurement: spike spike in blood pressure.         other concomitant medication include single blood pressure medication taken twice daily.  No treatment reported.   patient wants to know if she should continue taking her blood pressure medication given the reaction that she had after her second dose.
This study case was received from the investigator on 31 January 2013. A male subject (date of birth not reported) with a reported past medical history of shellfish and iodine allergy had received on 15 April 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Anthrax (lot number, route, site and date of administration not reported) and two days later, experienced a one time occurrence of mild chest pressure that lasted "only a couple minutes". No treatments were received. On 22 April 2010, a rapid Troponin I level was within normal limits and ECG was normal. The subject did not recall activity prior to the chest pressure. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of chest pressure was considered an other important event and possibly related to vaccination. Documents held by sender: none. Medical assessment: Insufficient information in the case was provided to make a complete assessment. Chest pressure may be a symptom of myopericarditis, a listed event in the reference safety information for ACAM2000, although laboratory investigations and the clinical course do not appear supportive and it is not clear. During the previous studies using ACAM2000, 2 similar events of chest pressure without the mention of potential etiology, were reported as serious adverse events following the use of ACAM2000, assessed as not related to the study vaccine in 1 case and unknown relatedness in another.
High Dose Flu vaccine was administered on Thursday, October 13, 2022, onset of symptoms began on Saturday, October 15, 2022, starting in the afternoon and progressively getting worse throughout the day. He c/o decrease ROM in his Left Arm, having difficulty putting his arm over his head, c/o of his arm aching. He's been taking 200mg of Advil  5x day with good effect. Seeing his PCP today at 11:30 am for this current issue.
inj - light headed walked BP 120/unable 82P ate and drank no H/A, N/V no lightheaded this morning  took this am - PROTONIX, chlor Trimeton, vitamin 12/0 anxiety with shots
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt left the pharmacy with paramedics
chills and aching joints 2 and 3 days after shot. day 5 lymph nodes swelled on the same side of the body as the injection. chills returned.
general arm pain when moving the limbs; itchy sensation; swelling at injection site; redness and tenderness at injection site; swollen lymph nodes under the arm pit area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information as reported by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Nov-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area). At the time of the report, PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area) had not resolved.            Concomitant medication include for Birth control.  No Treatment information was reported.
broke out in hives resolved in one week with no intervention  s/p 2nd vaccination wait 30 minutes
tightness in throat, hot, dizzy EMS called and pt refused to go to hospital reaction resolved
I was fine at first.  A  couple hours later I noticed I  was fatigued. When I arrived home that evening, I was still fatigued and  I had a low grade temp. I woke up the next morning and was fine and then started to get chest  pain which I ignored for a few days and then I woke up Sunday morning with dizziness and blurred vision  I checked my blood pressure and it read 180 over 120. I Immediately went to the ER. I was admitted for 24 hours for observation. I was connected to a heart monitor during that time.
Pain and tightness at injection site, extreme chills and body shakes all night long, repeated vomiting, horrific headache.  By the following morning I was almost unable to move my arms and legs, felt accute flu-like symptoms, body aches and headache, continued vomiting. Symptoms lasted for 48 hours at full blown level, but still experiencing body aches, headache and moments of nausea 72 hours after vaccine shot.
Patient was in extreme pain, he couldn't walk and had a high fever became really lethargic and stopped talking or interacting. He never spoke again till he was about 3 1/2 and his speech development was slow.
Information has been received from a nurse referring to a 21 year old male patient. No relevant medical history or concurrent conditions were reported. On 29-APR-2016, the patient was vaccinated with PROQUAD (Merck) (dose, dose number, route, lot# and expiration date were not reported) (inappropriate schedule of drug administration). No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to unspecified patients. On an unknown date unspecified patients were vaccinated with doses of GARDASIL (lot #, expiration date and dose unspecified), in the gluteal muscle. No adverse effect reported. Additional information has been requested.
had both shingle shots / had mild cases of shingles/ Suspected Vaccination failure; had mild cases of shingles / not looking for a severe case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received both shingle shots and had mild cases of shingles and patient not looking for a severe case. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.
We do not have the lot number etc. as we are not the administrating provider. Pt reported the illness began Friday with PND, nasal congestion, sinus pressure. Pt reported felt hot, no chills, + sweating, fatigue. Tmax 99.8F. She slept well overnight. Her fatigue is better today. Her appetite is ok. Pt had some fleeting lightheadedness yesterday and body aches. These sx's are all better today.
This spontaneous report was received from a Medical Assistant regarding an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL, lot number K023432, expiration date 18-JUN-2016, lot number K008931, expiration date 04-MAR-2017 and lot number reported as L013190, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports from the same source. Lot number L013190 is an invalid lot number for GARDASIL. Additional information has been requested.