chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous pregnancy report as received from a consumer (the patient's husband) refers to a 25 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unspecified dates, the patient was vaccinated with the first and the second dose of GARDASIL (dose, lot number and route were not provided). On 22-OCT-2013 the patient was vaccinated with third dose of GARDASIL (dose, lot number and route were not reported). There was no concomitant medications. The patient done at home pregnancy test and found out that she was pregnant, also reported that she found out last week, in an approximately November 2013, that she was 8 weeks pregnant. The patient's last menstrual period (LMP) was in an approximately September 2013. There was no treatment given for the patient's event. The patient did not seek medical attention. At the time of report, the patient outcome was unknown (outcome pending). Additional information is not expected.
This spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # N008079, expiration date 02-DEC-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 0 degrees Celsius and 1 degrees Celsius (also reported as 0.7 degrees Celsius) for 5 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Developed severe epigastric pain and had a syncopal episode while at lunch. Individual lost consciousness for a few seconds and returned to baseline with in a minute. No further care was needed or given.
Employee of hospital received the 3rd shot of the second series #6 of Engerix B in the morning. Within 30 minutes he noted a tingling on his chin. 30 min later splotches on his neck were noted. 2 hrs after the vaccine he noted swelling on chin was also rock hard and numb. Blisters noted on throat by an ER doctor. Given Allegra 180mg po qd; no other problems. Resolved by next day.
Redness and swelling on the left arm. Width of 5 cm and length of 15 cm. Hot site to touch and acute itch. Symptoms began 8 days after the dose and lasted 7 days.
redness at injection site; swelling at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST, FLUTICASONE and AZELASTINE for Asthma.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Tenderness at injection site). On 09-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE PAIN (Tenderness at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) outcome was unknown.        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.   She stated she didn't take anything for it and take prescribed asthma medications called Montelukast, Fluticasone nasal spray, Azelastine nasal spray, Fluticasone Falmetcrol powder inhaler and a acid controller.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a physician refers to an hundred (unspecified) patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with ROTATEQ (lot # K001198 and expiration date 25-OCT-2015) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. Additional information is not expected as the reporter was not receptive to follow up or contact.
Extreme lethargy and malaise, headaches, low fever. Has progressed over the past 13 months to include altered cognitive function, paresthesias of legs, arms, head, occasional heart racing and irregular rhythm, weak legs with soreness, abdonimal bloating with some vaginal gas, deep leg pain, irregular meses, cold intolerant, vision disturbances all at present time (over 13 months since third Gardasil injection).
Narrative: 85yo male pt died in hospital (community hospital). No information given about pt's death. Pt had received covid vaccine on 2/24/21 & 3/29/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration
Patient started feeling sinus pressure, followed by uncontrollable sneezing and copious nasal discharge. Patient then had trouble breathing (chest tightness) and used 4 doses of Ventolin, which helped somewhat. This was followed by "painful throbbing" in the head. When patient woke up next morning, patient felt better, but still fatigued.
stroke (from dvt -- > PE -- > via PFO -- > stroke, disabling)  Received moderna Covid vaccinations 24 March and 22 April 2021  5/19/2021?removal of peripheral neurostimulator electrode array [left], removal of vagal nerve stimulator pulse generator (left), as they were not working to control her drug-resistant epilepsy  6/11/2021?MRI guided laser ablation of right amygdala and hippocampus  6/11/21: US doppler b/l- No evidence of acute DVT in either lower extremity.  CT angio showed right heart strain, no evidence of pulmonary hypertension, limited cardiomegaly, small vessel disease, right hemithyroidectomy  6/12/2021?postoperatively, when she was extubated?she was not able to follow commands and was found to be hypoxic.  CT head demonstrated a new right intraparenchymal hemorrhage with intraventricular hemorrhage along the surgical site. CTA chest?showed acute segmental and subsegmental pulmonary emboli throughout both lungs with additional central with pulmonary artery involvement on the right.  There are persistent findings consistent with right heart strain with RV/LV ratio 1.2, and likely evolving pulmonary infarcts. Patient was reintubated. 6/12/2021?she underwent an attempt at mechanical thrombectomy with interventional radiology but there was no significant pulmonary embolus burden and no intervention was performed.  Probable atrial septal defect or PFO was noted. She underwent IR guided IVC filter placement.  6/11/2021?6/13/2021- no anticoagulation was administered  13 June 2021 CT angio head and neck showed severe stenosis right M2, left M1, left M2, left cingulate infarct, possible medullary infarct  6//14/21: CT head- Moderate to large bilateral MCA territory infarcts greater on the left. Petechial type hemorrhage or conversion within the left basal ganglia infarct. Small anterior right cingulate gyrus infarct. Possible anterior medullary infarct.   6/14/2021?7/1/2021?prophylactic anticoagulation was started with heparin 5000 subcutaneous every 8 hours. Aspirin started on 6/14/21.   6/28/21- V/Q scan- Pulmonary embolism absent.  6/28/21: TEE- No thrombus visualized in the left atrial appendage. Demonstration of a moderate sized PFO in addition to a aneurysmal intra-atrial septum , EF 55%  7/1/2021 CT head showed evolving moderate to large bilateral MCA infarcts with petechial hemorrhage lateral left MCA, right post ablation edema with decreased hemorrhage with improvement in cerebral mass-effect. Started on Lovenox 40mg subcutaneous BID, with concern for possible antiphospholipid syndrome. She was discharged on Lovenox 40mg BID with increase to 80mg BID on 7/16/21.   Hypercoagulable work-up 6/11/2021 Factor V Leiden?negative Factor II mutation/prothrombin gene mutation?negative Antithrombin III?79%, with normal being 80% Cardiolipin IgG/IgM?negative Beta 2 glycoprotein antibodies negative Hexagonal Lupus anticoagulant?4, or negative DRVVT?1.4, increased on 11 June 2021 Protein S ?55.1%, normal Protein C?101 % normal Factor VIII activity 104% 9 INR normal and PTT normal  Fibrinogen had been slightly low at 185 CBC and renal function have been normal No family history of clotting or stroke
Cellulitis of left thigh - following flu vaccine (unknown what specific flu vaccine was used as vaccine was not administered at our site)
As of case investigation on 8/5/21 case symptoms included runny nose and cough.
rash on her chest (mostly right side) that is painful to touch; little red bumps on forearms; little red bumps on forearms; low heart rate, several days; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th September 2022, less than a day after receiving Shingrix, the patient experienced heart rate low. On 16th September 2022, the patient experienced red rash and papular rash. On 19th September 2022, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved and the outcome of the red rash and papular rash were recovering/resolving and the outcome of the heart rate low was recovered/resolved.   It was unknown if the reporter considered the painful rash, red rash, papular rash and heart rate low to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Sep-2022 Reporter's comment: The reporter stated that her wife got her first Shingrix vaccine.  The patient received Shingrix vaccine in left arm. She stated on the day of the vaccine, they noticed that she developed a low heart rate that lasted for several days.  The caller reported that the day following the patient's vaccine, the patient developed little red bumps on her forearms that were gradually getting better. The caller also reported that the patient had developed a rash on her chest mostly right side that was painful to touch.  The reporter did not consent to follow-up.  There was no Healthcare professional for follow up. The permission for consent to follow-up was denied. Additional supportive information: Less than a day after vaccination the patient had heart rate low. 1 day after vaccination the patient had red rash. 4 days after vaccination the patient had rash.
This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced not responding to therapy.  The subject stated that she had the hepatitis B series in the past but has no documentation to support this claim.  A random titer was drawn from the subject and the results "came back zero".  The physician stated that revaccination of the subject is planned.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 24 April 2007.  The subject was 42 years old.  She was a social drinker and had never used tobacco.  The subject reported that she had received three "shots" for hepatitis B; however, a laboratory reported that her antibody level was "zero".  On 28 February 2007, hepatitis B surface antibody was "non reactive".  No details were available on the producer of the vaccine, and the lot number and the name of the vaccine were unknown.  The subject reported that she received the hepatitis B vaccine twice, but did not recall the dates of administration.  The subject was not sure that she had completed all three "shots" of each series.  The subject did not have a bad reaction to any of the vaccinations.  Per the reporter, the reason why the vaccine was ordered a second time was not known.  At the time of reporting, the subject had not experienced any adverse events.  The physician considered that the event could not have been associated with the subject's medical history/concurrent illness.  The physician reported that it was unknown if the event could have been associated with lack of efficacy or erroneous administration.
Patient describes receiving her vaccinia vaccine in 1983 during basic training in her left arm. Patient reports developing erythema and edema at the vaccine site approximately 10 years ago that was associated with some local pain. She specifically denies any vesicles or pustules at the site. She also denies any associated systemic symptoms. She denies any associated myalgia, arthralgia, chest pain, dyspnea, or any other symptoms. She states the erythema and edema at this vaccine sites slowly resolved over 3-4 days, and slowly returned back to its normal state. She denies any residual changes or postinflammatory hyper/hypopigmentation. She denies any other associated lesions that developed with this lesion. ~Most currently, patient notes approximately 2 weeks ago (2 July 2013) she developed a similar reaction at the vaccine site manifested by an erythematous papule/nodule. However, this time, she endorses some pruritus with this lesion. Again, the lesion lasted approximately 3-4 days and slowly resolved. Again, she denies any associated systemic symptoms and specifically denies any myalgia, arthralgia, chest pain, dyspnea, nausea, vomiting, or diarrhea. No associated postinflammatory hypo-/hyperpigmentation with this episode as well. Patient states the lesion has completely resolved and is back to his normal baseline. She denies developing any other lesions at the time of this lesion develop. Symptoms: Rash, other nonspecific skin eruption.
Flublok quadrivalent inadvertently administered to pediatric patient, instead of Fluzone Quadrivalent.   No adverse event reported as of 1/14/22.
This spontaneous reports was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-AUG-2016, the patient was inadvertently vaccinated with a dose of expired PEDVAXHIB (lot # J014512, expiration date: 12-AUG-2016, dose and route of administration were not provided). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sudden onset: nausea, headache, extreme tiredness, general malaise. Tx with antacid, heating pad & bed rest. Local area tenderness at injection site. Advised to have "High dose for over 65" No reaction to previous flu vaccines. 15 hours after onset symptoms remain but have decreased in severity.
I was 11 weeks 3 days pregnant with a high risk pregnancy conceived via IVF.  Other than nausea I had no vomiting or other pre-existing conditions prior to my first dose of Moderna. I had never fainted before.  Following the vaccine at 11:40 AM my arm was extremely sore and painful and I had a pounding headache. I took a Tylenol at 10:00 pm to stave off fever when I started to feel warm. At 6:45 AM I got up and walked into my kitchen.  I lost vision and speach and collapsed. A minute later I came to and immediately vomited. My husband took me to the Emergency Room.
Injection site reddened; firm to touch; left deltoid warm. Treated with cold compresses.
No true adverse event. Realized I'd misread her DOB and gave her a 3+ prefilled preservative free flu shot instead of a 6-35 months shot.
no adverse event; HCP reported that a patient missed a dose of VARIVAX; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-AUG-2022, the patient missed a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dosage regimen, lot #, and expiry date were not provided) since the pharmacist was out of sterile diluent to reconstitute the vaccine. The reporter stated that it was unknown if it was the 1st or the 2nd dose for the patient. No adverse event was reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information has been received from the pharmacist on 03-OCT-2022.  This case was previously considered non-valid due to lack of patient's identifiers, but after follow-up information, the case is now valid.   This case was regarding a female patient of unknown age.
Tingling,  Facial flushing, Felt like throat was swelling, Painful in injection site.
pt became rigid & collapsed in moms arms 1-2 mins p/vax; pt pale-placed on floor resp present but slow appeared to have diff breathing; unable to talk/nonresponsive given Epi w/massage;
*Note: The vaccine dose(s) were given at a pop-up vaccine clinic and not by the physician's office listed above. 1) Daily migraines began 2 days after dose #2 and lasted for about 2 weeks before returning to baseline frequency. Treated with current migraine meds. 2) Fatigue and muscle pain began 2 weeks after dose #2 and have continued for nearly 3 months. Treated with OTC pain meds. 3) Polyarthralgias (primarily lower back, hip and knee areas) began 2 weeks after dose #2 and are ongoing. The pain has been severe enough to limit physical activity. Treated with OTC pain meds.
Localized area of erythema; appearance consistent with hives along the arm where the injection was given; pt treated with Benadryl/cool compress.
08/02/2021 the next morning I felt bad and within a week started having trigeminal Neuralgia symptoms. On right eye down to ear. Went to see an ENT doctor, and said it was a nerve issue. Had CT and it was normal. Treated with steroids,  prednisone. Lasted for a month, then it all cleared. Will still recurs, but not as severe.
The day after the shot I lost hearing in my left ear. It has remained gone for the past 3 days, to now.
After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19; After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 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 "After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for Covid-19; positive, notes: tested positive again for Covid-19 vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  Clinical course: Caller, a consumer was calling in tested positive for Covid-19 vaccine and took full dose of Paxlovid. 5 days later, symptoms are gone and travelled to another state. Tested positive again for Covid-19 vaccine. Asking if it had anything to do with continuing and how long after taking a full course should be taken for testing negative. The reporter confirmed that after receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19, according to the recording.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pneumonia, water retention, skin breakout like eczema, and Congestive Heart Failure
Not sure it's related to the shot.  Three weeks after the second shot I started experiencing progressively increasing pain in the left shoulder joint. After each dose the same joint ached but the pain resided after approximately 24 hours. The area is painful to the touch but not hot or red. For 5 days to date I have treated the area with hot compresses with minimal results. For 3 days to date I receive some relief treating the area with voltaren cream (not prescribed for this). Today I began castor oil packs but have not seen any change in pain at this point.
This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Very dehydrated), HEADACHE (Bad headache for a week), PYREXIA (Fever of 102°F for a week) and NAUSEA (Sick to their stomach and wanting to throw up) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Mar-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DEHYDRATION (Very dehydrated), HEADACHE (Bad headache for a week) and PYREXIA (Fever of 102°F for a week). On an unknown date, the patient experienced NAUSEA (Sick to their stomach and wanting to throw up). At the time of the report, DEHYDRATION (Very dehydrated), HEADACHE (Bad headache for a week), PYREXIA (Fever of 102°F for a week) and NAUSEA (Sick to their stomach and wanting to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.    This case was linked to MOD-2021-040770 (Patient Link).
Redness & swelling of upper arm deltoid region. Fever. Not wanting to sleep.
Pt had PNEUMOVAX and FLUZONE admin. on 9/22/09 and developed redness and swelling to entire left upper arm 9/24/09. Seen by his physician and placed on antibiotic.
Patient had no known side effects.; Vaccine Coordinator reported a temperature excursion for ROT ATEQ which was supported. Caller reported that 1 dose of ROT ATEQ was administered to a patient.; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-JAN-2022, the patient was vaccinated with a 1 dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (lot # reported as: 174228, expiration date reported as: 01-SEP-2022; strength was not provided) for prophylaxis (product storage error). Temperature excursion for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was supported. Patient had no known side effects (no adverse event).  This is one of several reports received from the same reporter.  Lot number 174228 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Lot number 174228 does not match any Company product as confirmed by Lot Verification team.; Sender's Comments:  US-009507513-2201USA006297:
Got flu shot, my arm got so bad I could not use it, called doctor went for exam, was given pain pills, arm kept getting worse, called the doctor again, was sent for a xray. Still hurts.