chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 10/24/2003 concerning three female vaccinees of unknown age who were inadvertently administered last years vaccine (2002-2003) on an unknown date. No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2003: Follow up report was received from a health care professional on 12/10/2003 which indicated that a 35 year old female vaccinee inadvertently received 1 ml of expired Fluvirin on 10/23/2003. No adverse events were reported to date. Follow up pending.
Information has been received from a physician concerning a 60 year old male patient with asthma, diabetes and hypertension and no drug reactions or allergies who on 12-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 16-OCT-2010 the patient presented to physician's office with flu like symptoms and a "chickenpox" like rash all over his body. The patient was admitted to a hospital. At the time of reporting, the patient had not recovered. Flu like symptoms and a "chickenpox" like rash all over his body were considered to be other important medical events by the reporter. Additional information has been requested. The patient was admitted to Hospital.
Patient stated start having pain in arm after received vaccine, severity is increasing with limited range of motion, pain now spread to her neck all the way to hand. Referred pt to see primary care physician .
she developed a chemical smell and taste; she developed a chemical smell and taste; can't taste her food, and everything smells the same; This is a spontaneous report from a contactable consumer or healthcare professional Nurse (patient). A 63-years-old female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, lot number: EW0150, expiry date: unspecified date in Jul2021) via unknown route of administration in left arm on 05Apr2021 at 16:30 (at the age of 62 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were reported. She stated that she quit taking any other medications to try and rule them out, and she had not yet restarted those other mediations, so she was sure that this event had to be from the vaccine. It was reported that a couple of days after her 1st dose, she developed a chemical smell and taste. She stated that she cannot taste her food, and everything tastes the same on an unspecified date in Apr2021. She said this reaction was still ongoing. Like her bowel movements smell the same as her coffee, same as toothpaste and food. She was wondering how long this would last and if other people have had this side effect. It was reported that if this was a known side effect, then it should be listed on the list of side effects, because it was not on the papers she was given. It was reported that the reporter wanted to know if this was a known side effect of the vaccine, and how long it lasts. She said she had heard of it happening to other people. she got it because of the pressure that she would have to have it in order to travel places, and because she has friends who were concerned to not be around anyone who did not have the vaccine. It was stated that she was frustrated about it because she had not planned for this to occur, it was not life threatening in any way, but if she was going to have this for the rest of her life, she wanted to know it now and said she may need to get herself a tongue and nose transplant. The patient had no other vaccines on the same day as the suspect product and did not receive other vaccines Prior Vaccinations (within 4 weeks). The patient did not visit Emergency Room or physician office due to events. It was reported that the event can't taste her food, and everything smells was related to product. The outcome of the event can't taste her food, and everything smells the same was not recovered and other was unknown.  Follow up attempts were completed. No further information was expected
Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history who on 21-APR-2009 was vaccinated intramuscularly with the first 0.5 mL dose GARDASIL (lot # 661846/1312X). On 16-JUN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose GARDASIL (lot # 658271/0558X). The patient did not have a reaction after the first or the second vaccination. On 27-OCT-2009 the patient was vaccinated intramuscularly with the third 0.5 mL dose GARDASIL (lot # 663454/0672Y) in the left upper arm. There was no concomitant medication. At the end of December 2009 (2 month after the third vaccination), the patient developed a tender nodule at the injection site. The injection site was warm, tender, firm with darkened, scaly skim. The patient also had a hematoma on the left arm above the elbow which the patient attributed to "hitting the arm against a door". The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. At the time of the report, the patient 's status was unknown. This is one of several reports from the same same source. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Headache-Medium
Full body rash; Hives and redness on entire body; Intense itching; Hot, tight skin; Muscle ache; Fatigue; Hives and redness on entire body; Hot, tight skin; This is a spontaneous report from a contactable Other healthcare professional. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included depression, drug hypersensitivity, allergy to chemicals, allergy to arthropod sting. The patient's concomitant medications were not reported. The patient had allergies with penicillins, nickle, bee stings. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Feb2021, the patient experienced Full body rash 6 days after vaccination. Hives and redness on entire body, intense itching. Hot, tight skin. Muscle aches and fatigue. The adverse event resulted in patient to visit doctor or other healthcare professional office/clinic. The patient received treatment with hydrocortisone cream for rash, hives and redness on entire body, intense itching, hot, tight skin. Outcome of the event was not recovered, at the time of this report.  Follow-up attempts are completed. No further information is expected.
The day of and day after my arm was sore at the injection site and hard to lift.  I also had a headache.  Both went away after 2 days.  However, 9, days later I noticed red spots on my thighs that were itchy.  As the day progressed they got worse and bigger and itchy.  They were red raised lesions.  I woke up in pain and noticed the spots all over my thighs; buttox and my lower lip became very swollen.  I went to the hospital they said it was an allergic reaction to something.  I had not done anything out of the ordinary in the last couple weeks other than the 2nd dose of the vaccine and a spray tan. They gave me Benadryl and steroids
Area red, hot and swollen. No treatment needed, instructed parent to watch for SOB and progression, if any, of area getting worse, to report back to the clinic.
Pt vaccinated in the supine position.  Pt reported dizziness and nausea Vitals: 16: 15 122/92, 64, 18 -- > 16:20 HR 78, 16:30 120/80, 72 Pt stable and released from the vaccination site @16:30
STARTING 9/29/23 UNSTEADY GAIT, DIFFICULTY WALKING , WEAKNESS TO BILAERAL LOWER EXTREMETIES AND FALL. PRESENTED IMMEDIATELY TO ER WITH LISTED SYMPTOMS. DX WITH GUILLAIN BARRE SYDROME. RECEIVED IVIG
The shot hurt for the first time in 3 years. Pharmacist is great, always gentle and kind. My arm is very sore and have developed a red rash that is hot to the touch. It is almost 2 days later and the arm still hurts and the rash still is there.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unspecified adverse event. This report was non-serious. This case, from the same reporter is linked to 20210616652.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 31-JUL-2012 the patient was vaccinated with first dose of improperly stored VARIVAX lot # 671861/1907AA. On 17-JAN-2013, the patient was vaccinated with second dose of improperly stored VARIVAX lot # 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Weakness; Dizzy spells; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included MIRABEGRON (MYRBETRIQ), SIMVASTATIN, APIXABAN (ELIQUIS), OMEPRAZOLE, OLMESARTAN, OLODATEROL, METOPROLOL, POTASSIUM, FUROSEMIDE, AMLODIPINE BESILATE (AMDEPIN) and EPOETIN ALFA (PROCRIT) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Tylenol (paracetamol).
Fever, lethargy, dehydration started 3 days after vaccine. Concern for sepsis. Given ICF bolus 2 separate ER visits. Lasted approx 10 days. Concurrent viral illness as well.
Child with no history of nosebleeds is now having spontaneous nose bleeds post booster vaccine on 6 January 2021.
at my routine doctor appt for bloodwork cholesterol and told my doctor I had some itching in my ear PCP prescribed week long regime of steroid Hydrocortisone acetic acid One Left ear continuing to slightly itch Not sure if fully recovered, still itches sometimes
Patient presented 24 hours after injection with redness and swelling, pain in thigh. Given Benadryl for allergic RXN.
paralyzed from head to foot; Initial information was received on 29-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a male patient (age unspecified) who was paralyzed from head to foot (paralysis), when he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was paralyzed from head to foot (paralysis), (unknown latency, serious event) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Reporter stated that it ruined patient's and his family life.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns a patient (age and gender unspecified) who had paralysis after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Headache, Myalgia, Diarrhea, fatigue, redness, swelling Narrative:
covid test result Positive; covid test result Positive; This is a spontaneous report from a contactable consumer (patient). A 61 year old non pregnant female patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: EP6955), via intramuscular, administered in Left Arm on 25Mar2021 (Age at vaccination 61 year old non pregnant) as dose 2, single and intramuscular, administered in Arm Left on Mar2021 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Facility type vaccine was Workplace clinic. Medical history reported none. The patient had no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 22Oct2021 at 12:00, the patient experienced covid test result positive and vaccination failure. The outcome of the event was recovering.  The patient underwent lab tests and procedures which included sars-cov-2 test positive ((NAAT)/RT-PCR Panther System) on 22Oct2021 as Nasal Swab.  No treatment received for the events.  Follow-up attempts are completed. No further information is expected.
Pain and redness at injection site, followed by shortness of breath, chest discomfort and mild nausea. Pt was seen at the ER and given Benadryl/steroid.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 17-Dec-1980, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported. On 20 Nov 2020 she had a positive pregnancy test.
Pt complained immediate arm soreness. 48 hours later went to ER for arm swelling, given antibiotics, sent home. Returned to ER 24 hours later - more swelling & pain, given more IV sent home. Was returning to hospital on 10/9/11.
Within 24 hours of first shot I developed pulsatile tinnitus.  Continues to present time. Within 24 hours of second shot I developed slight dizziness/imbalance, which progressed to vertigo with vomiting 6 days after shot.  At present there is still a balance issue.
fever 102.9 bilateral arm pain severe lower right abdominal pain feels unwell IV hidration, advil, tylenol, ultrasound abdominal, CT scan, were given. Patient is better except for continued temperature of 100.4 in the evenings.
sudden right sensorineural hearing loss--pt has complete hearing loss in right ear and did not respond to treatment.
allerg rxn w/swelling of hands, itching of skin & hives;pt had flu shot on 11OCT96 7 devel sx by the next day;pt also completed a wk course of med;also had joint inflammation of many joints;
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07-APR-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
sick; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 MALAISE (sick). At the time of the report, MALAISE (sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Apparent mild chicken pox illness-irritable and 10 bumps/small blister.
We received on 29 NOV 2007 from the Regulatory Agency the following information: A 50 or 51-year-old female patient was vaccinated with influenza virus vaccine (manufacturer unknown) in 2006. She developed iritis. The outcome seems to be improved. No further details reported. See also case no. MA2007-1573 (2006/2007). After influenza vaccination in 2007 the patient also experienced iritis (see case nos. MA2007-1571 and MA2007-1572). Company assessment: Seriousness criterion: medically significant. Causality: insufficient data. We have not enough medical details to assess the case definitely. Expectedness assessment according to manufacturer label: The described symptom is unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. ADR 20189179
Baby had increased episodes of apnea, bradycardia, requiring intubation and support for hypotension (Dopamine, hydrocortisone). She expired within.
Generalized maculo-papular rash, all over the body 1wk p/immun was given;
Patient developed headache which was relieved by taking ibuprofen.  Headache returned again on 10/24/16.  Patient does not typically experience headaches.  He plays high school football, no report of blunt force to head.
Patient recieved vaccine 4 days after expiration date. Patient was here for the allotted time of 15 minutes after and had no reactions. Was not caught that vaccine was expired till entered into epic. Provider notified and Moderna was notified that did a Moderna medical inquiry to find the viability of the vaccine after date of expiration.
Patient described her side effects started in the evening after receiving her vaccination.   She reported as having shaking, cold hands; and an overall sensation of chills that entire evening.   Upon standing after she had been resting for some time, she became very dizzy to the point of her falling  in her kitchen. She reported no injuries as a result of the fall.
Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 041821A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) from 18-May-2021 to an unknown date for Body temperature, PREDNISONE for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant products include patient used medicine for liver problems. Patient took Tylenol but the temperature came back. Action taken in response to mRNA-1273 was not applicable.
Red bumps "all over body" that started one day after 1st dose of Moderna. Reports that bumps itch, burn, and hurt.
Pt noticed about 24 days post vaccination redness, swelling, and pain upon pressure to local are where Pneumonia shot was given
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), at the age of 71, in right arm, on Mar 15, 2021, single dose, for COVID-19 immunization. Medical history included gum surgery (unspecified if ongoing); and collagen disorder (unspecified if ongoing). There were no concomitant medications. The patient experienced a headache, onset Mar 2021, with outcome of recovered (2021); and dizziness for 2 weeks, onset 2021, with outcome of not recovered. The events were evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. No further information expected.
Arm from injection site to lower upper arm red,  swollen, and itchy.   Symptoms developed 3 days after shot was given.  Next day (today) all symptoms s diminished.
Round red rash at injection site with swelling has appeared 1.5 weeks after the vaccine