chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brain Fog after booster; Lost Voice after booster; Chills after booster; Fatigue after booster/Too Tired after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 018B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster). At the time of the report, FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided. No treatment medication was provided. Patient states that Every 7 to 10 days has recurring side effects. The doctor did a COVID test and result was Negative. She states that she also had a Flu shot in NOV-2021.   This case was linked to MOD-2021-358836, MOD-2021-358790 (Patient Link).
body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Narrative: Symptoms:  & DEATH DUE TO COVID 01/13/21 Treatment:
Pt experiened an injection site reaction described as a very sore arm w/swelling & erythema within 24 hrs p/immun. Also had fever & chills.
Swelling (11cmx7cm) & tactile warmth. Prescribed Benadryl, cetirizine & mupirocin. Also advised to apply a cool compress & elevate arm. Advised to RTC or go to ER if the redness extended the swollen area that was circled in office.
Patient described feeling light-headed after receiving vaccination; pt was given a bottle of water; after consuming some water patient appeared to faint, spit-up, began seizing and bit his tongue.  After the event resolved the patient commented, "I looked at the needle" (suggesting the cause of the event was his phobia of needles, and not the vaccine itself).
Pt recvd 2 doses of Engerix-B & had a failure to seroconvert p/3 doses; 12mo booster has not yet been given;
A female reported that she inadvertently received an ID injection of TD Toxoids Adsorbed, Purogenated on 7/27/00, instead of PPD. She subsequently, developed an injection site reaction characterized by redness and induration. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
headache; arm pain; This is a spontaneous report from a contactable healthcare professional (reporting for herself) via Pfizer  and Medical information team. A female patient of an unspecified age (Age: 23; Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine today on 11Jan2021 and patient would like to know if she can take Ibuprofen or Tylenol for the headache and arm pain she experienced in Jan2021. The patient stated, "I read on my transact sheet that they say that you are not supposedly to take like ibuprofen before you get the second vaccine. If I have a headache can I take something or should I not?". The outcome of the events was unknown.  Information about lot/batch number has been requested.
ACUTE NON ST ELEVATION MI 3/23/2022 ACUTE NON ST ELEVATION MI  ACUTE CORONARY SYNDROME, UNSPECIFIED 4/7/2022 ACUTE NON ST ELEVATION MI
Patient reports long history of anaphylaxis reactions to many different vaccines and medications.  Patient taken to EMS room. Laid down and given vaccine. Patient reports 2 doctors are pro and 2 doctors are against her getting vaccine. Patient has an autoimmune disease.  Patient waited an hour and had some dizziness but otherwise tolerated injection well.
Lymph node swelling in underarm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm right on 24Apr2021 at 15:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 24Apr2021 at 18:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021, about 24hrs after the dose 2 injection, the patient developed lymph node swelling in underarm and the side effect had been very low so far. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node swelling in the underarm was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
6 days after on February 3, I developed red itchy hives on my torso. 2 on my stomach, 7 on my left side. They were very itchy and red. No fluid underneath. They remained itchy for about 3 days after they developed.
administered vaccine to a 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old) had resolved. 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 medications were provided. No treatment drugs were reported.
3rd day p/vax 3NOV92 had temp elevation of 103 & sz; was admitted to hosp; probable viral gastroenteritis; pt exp fever, vomiting, jerking, eyes rolled back in the head, diarrhea, guaiac-pos stools;
5 min post inject, pt felt light headed. BP 122/40. devel. blotchy rash at site of inject. 15 min. later pt completely fine. several. hr. later rash progressed and by p.m. had hive like blotches over face torso & extremities. -itchy
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 08-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (Lot number: 670820/0660AA) that had expired on 04-AUG-2012. No concomitant medications were reported. No adverse event effect reported. Additional information has been requested.
severe body ache, muscle ache, elevated temp. 37.6C, headache. Second day - right side migraine, severe sensitivity on the right side of the head and face, toothache ( all teeth) on the right side of the face, fatigue.
Myalgia, burning pain in Right face x2week, occasional tinnitus until next dose
Pt stated symptoms started 2 hours after PREVNAR injection. Patient drove himself home where patient had coughing episode and was sweating. Symptoms subsided on their own. Patient also had difficulty breathing. Patient is a smoker.
Patient is involved in High School track, was running in a competion on Saturday, 9/18/10 and had a Grand Mal Seizure.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M003659 with expiry: 20-SEP-2017, for prophylaxis (dosing details not reported).  No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. As of 12-DEC-2016, a return call was received from the nurse. The reporter was unable to provide any patient identifiers or dates of vaccination. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014251:,MERCK 1610USA014627:Mfr number.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient states she bruises easily so that was not necessarily out of the norm, but she has never had itching with a vaccine before
Pt woke up with stiff neck, same night post vax, radiated down shoulder and stayed 4 days, then moved to back of legs. Hurt from back of leg down, could hardly walk, lasted 3 days, went to back of heels. Saw DR 11/22/99 for symptoms and was treated for inflammation with Z-Pack. Saw him on 12/3/99, after heels and feet started swelling. Pt was sent to orthopedic Dr and then went to an Internist, who found enlarged lymph nodes between heart and lungs. Pt had a heavy feeling in her chest, was treated with Zithromax, Cataflam and pt had a list of medicines she was treated with. Pt states she had spots in front of her eyes. On 12/22/99, her skin and eyes were red. Also, had red knots in legs. She saw a Dr on 12/17/99. She also, ran temperature at night during this period. Pt is still having problems with these symptoms. States, also, she had swelling in ankles, skin dry and peeling. Still under Dr's care. Dx with sarcoidosis. Pt is seeing a Dr in Oncology and has an appointment to see Rheumatologist on 3/6/00.
tested positive after the 1st dose; tested positive after the 1st dose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (parent) reported on behalf of patient (her son). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his 1st dose of vaccine BNT162B2 on 19Feb2021 and was tested positive after first dose on an unspecified date. The patient was scheduled for second dose of vaccine BNT162B2 on 12Mar2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  It was reported that the facility was unable to download the digital data logger, and the issue needs to be treated as a temperature excursion. The data logger that caller is unable to download were for the months of DEC2021, JAN2022, and FEB2022. Patients had been administered doses while the temperature excursion assessment was ongoing.  No adverse reactions were reported by any patients.  No treatment medications was provided by the reporter.
Initial misuse report received from a healthcare professional on 10 July 2013. A 42-year-old patient was administered MENOMUNE instead of MENACTRA. The patient was administered MENOMUNE intramuscularly instead of subcutaneous route. No adverse event was reported. Documents held by sender: None.
Pt had rash at the local injection site. told the pt to ice the area and she says that it got better
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-NOV-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB intramuscularly (dose was not provided, lot # R013569, expiration date 18-MAR-2021) for prophylaxis. No adverse effects reported. Digital data logger was involved. The vaccine experienced temperature excursions below 32 degrees Fahrenheit (28.4 degrees Fahrenheit) for 80 hours. There were no previous temperature excursions.
No adverse rx or events reported by pt at time of this report.  Pt has been seen since administration of vaccine and did not report anything.
Severe Chills, Severe Body Aches, Severe Fatigue, Low Grade Fever, Overall Weakness all for roughly 36 hours
chills; fever; fatigue; flu like symptoms; This is a spontaneous report from a contactable consumer (the patient) via a company representative. A male patient in his late 30s received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second shot of vaccine and experienced chills, fever, fatigue and flu-like symptoms. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced pain and swelling with erythema on the injection arm which lasted for a couple of days. Medical attention was not sought. There was no product quality complaint involved. No further information is expected.
Patient presented to the emergency room with right sided facial droop including foreheady, +bells sign, no sensation deficits, no other focal numbness or weakness.  Patient also reports  dry eye which cannot close.  In rhe ER he received 60mg prednisone and, 1000mg valtrex.  He received prescription for prednisone (60mg/day for 5 days), valtrex (3 grams/day for 7 days) and hypromellose artifical tear drops).  He as instructed to with PCP and neurology.
I have seen no signs of a reaction w/shots, but mom said he had one, & was in the hospital need information for all health facilities.
Feel bad for a couple of days; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 09-Nov-2020.  This case involves a patient with unknown demographics who experienced feel bad for a couple of days (Feeling abnormal), when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced feel bad for a couple of days (Feeling abnormal), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Local reaction at vaccine site, left deltoid. Redness and swelling of about 2.5cm, some warmth at site.
This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative negative, COVID-19 virus test (NR: not provided) Negative negative, and PCR (NR: not provided) Negative negative.  On 08-MAR-2021, the subject experienced tongue tingling with bumps/mouth with tingling and bumps/lips with tingling. On 09-MAR-2021, the subject experienced pimples on tongue (1 pimple on left side and 3 pimples on right) /with bumps. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced pain on tongue (tip hurts). On 09-MAR-2021, the subject experienced fever and chills. On 10-MAR-2021, the subject experienced low blood pressure. Laboratory data included: Low blood pressure (NR: not provided) 90/58 Unit unspecified. On 11-MAR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure high (NR: not provided) 160/90 Unit unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue tingling with bumps/mouth with tingling and bumps/lips with tingling, and low blood pressure on 11-MAR-2021, high blood pressure on 13-MAR-2021, and fever and chills on 10-MAR-2021, and had not recovered from pimples on tongue (1 pimple on left side and 3 pimples on right)/with bumps, diarrhea, and pain on tongue (tip hurts). This report was non-serious.
The event was a expired vaccine. The vaccine expired 5/27/22 @ 9:45 am and the vaccine was administered 5/29/22 at 1:30 pm. The vaccine is only good for 70 days once transported from the freezer to the fridge.
I had body chills and aches. I also had exhaustion so I was sleeping most of the day. I think I took Ibuprofen or Tylenol to help with pain. The next day I felt much better
Information regarding poliovirus vaccine was received from an attorney regarding a female patient who developed malignant mesothelioma. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On an unspecified date, the plaintiff developed malignant mesothelioma. The attorney alleges that Simian Virus 40 (SV40) contained within the polio vaccine was the cause of the malignant mesothelioma. No additional information was available at the time of this report.