chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a weird vascular feeling near his knee; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date in Feb2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient stated that a weird vascular feeling near his knee in the evening following vaccination. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
This spontaneous report was received from a registered nurse and referred to unspecified patients of unknown age and gender. On unknown dates in August 2017 (reported as since 02-AUG-2017), the patients were vaccinated with improperly stored doses of PROQUAD (doses, routes of administration, lot# and expiration date were unknown). The PROQUAD was reconstituted with sterile diluent. No adverse effects were reported. The digital data logger was involved in recording the excursion. The excursion lasted 1 hour and 5 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008066.
Severe all over muscle pain, concentrated mostly in the kidney area.   Shooting  electrical type pains in head.   Sweating.  Headache. Ongoing sluggishness.
Mild cardiac infarction; 19 mm nodule in left breast; This case was received via an unknown source  on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Mild cardiac infarction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in August 2020. Concomitant products included CARVEDILOL, OLMESARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and TICAGRELOR (BRILINTA) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced MYOCARDIAL INFARCTION (Mild cardiac infarction) (seriousness criteria hospitalization, medically significant and life threatening) and BREAST MASS (nodule in left breast). On 06-Jan-2021, MYOCARDIAL INFARCTION (Mild cardiac infarction) outcome was unknown. On 12-Feb-2021, BREAST MASS (nodule in left breast) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: abnormal CT Scan detected 19mm nodule in left breast.   Mammogram and ultrasound after 6 weeks, and nodule had disappeared.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Chest pain, difficulty breathing, severe swelling in area where shot was received, redness, fever.
When she got the first dose she had fever and all symptoms on the list; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient History was not provided. The patient experienced "when she got the first dose she had fever and all symptoms on the list" on an unspecified date. The patient had received the second dose as well. Outcome of the event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Breakthrough COVID, fever, body aches, cough, abdominal pain. Antibody infusion on 01/19/2022. Symptoms for 4 days
First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain night of shot started a couple hours after. Had fever and chills start in the night, Thursday. I woke up to awful body and joint aches everywhere the next day, Friday. On Friday I also lost sense of smell. Had nausea, couldn't eat, fever, sweats awful and some chills off and on. Saturday- not much body aches but sweating awful, very tired/drained feeling. Sunday (today)- still sweats and nausea.
Urticarial, itchy, rash on both arms. She also has a large amount of swelling of left arm with pain from shoulder down arm and numbness/tingling  in fingers. Those symptoms are still present today 3/4/21. She also had headache and body aches on 3/2-3/3 but those have subsided. She is begin treated with decadron 10 mg IM, followed by prednisone taper starting at 60 mg tomorrow and continuing for total  of 9 days. Also claritin 10 mg daily and betamthasone cream 0.1% tid prn itching/rash. She is to recheck if not improved 3/5/21, and otherwise recheck 3/8/21.
pt recv vax 1/9/98 & 3/13//98 pt exp breakthrough varicella w/a few lesions, no fever & no complications;pt recovered;
Patient complained of sore injection site one month after vaccination. She mentioned any soreness is unusual for her.
I have a history of Trigeminal Neuralgia that is chronic, however after about 30 hours after getting the Moderna Booster, (previously had Pfizer) I have a severe flair of the condition. Normally has mild to no symptoms, and now I have severe pain to right side of face.
18 year old patient administered an adult dose of Engerix B; 18 year old patient administered an adult dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) (batch number 79S54) for prophylaxis.   On 13-JUL-2023, the patient received Engerix B. On 13-JUL-2023, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: 18 year old patient administered an adult dose of Engerix B) and inappropriate age at vaccine administration (Verbatim: 18 year old patient administered an adult dose of Engerix B). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-JUL-2023 The pharmacy intern stated that an 18 year old patient was administered an adult dose of Engerix B which led to overdose and inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter.
Dx Fever  Generalized Body Aches Chills   Myalgia  Diarrhea, unspecified type  Exposure to SARS-associated coronavirus
Patient received vaccine after 13 days from first dose (15 days early for 28 days).
Patient came to office on 1/08/16 with swelling and pain at injection site on left arm.
Temporary blindness (lasted about 30 secs to a min), pale skin, sweating, feeling cold, dizziness. Gave water, apple juice and Gatorade to patient and called 911. EMT came in to take he's BP, blood glucose level and both were normal. Stayed at pharmacy for about 45 minutes and patient got better but was still feeling cold. They've decided not to go to hospital but followed up with dad around at 6:30 - 7 pm ish, and confirmed he is doing okay.
Case number PHEH2016US030049, is an initial spontaneous report received from a consumer on 16 Nov 2016. This report refers to a female patient of an unknown age. Past vaccination history included she received the influenza virus vaccine (unknown manufacturer, batch number not reported) every year and had gotten sick. Concomitant medication was not reported. She was vaccinated with a single dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly on 05 Nov 2016. After vaccination, on an unknown date, she had gotten sick. On 08 Nov 2016, she experienced sore throat, headache, mild fever along with nausea and dizziness. Reporter stated that this only happened when she got the flu shot. She did not completely recover and had to take off work. She did not know and was unable to retrieve the name of the vaccine. The final outcome of the events was reported as condition improving. The events were assessed as serious (disability) by the consumer. The causality of the events was not reported. This case was lost to follow up.
Body aches in legs, back, neck, injection site (arm), felt weak/drowsy. No fever. Started about 17 hours after shot, lasted about 12 hours. Feet swelling about 8 days later, lasted about 2 days.
Immediately after receiving flu vaccine, I had an immune response reaction. The histamines rose in my body and my acid reflux went into severe mode. I now have erosive esophagitis & terrible stomach lining erosion. I'm on 3 meds: ACIPHEX, ZANTAC, MAALOX.
This spontaneous report as received from a registered pharmacist via a company representative refers to a 66 year old female patient. The patient's concurrent condition included with allergy to Ceftin, Cephalosporins, Doxycycline, Codeine, Meperidine, Morphine and Sulfa drug allergy. The patient's history drug included flu shot taken on unspecified date on September 2013. On 13-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). On an unspecified date after vaccination (unspecified date between 13 and 14 November 2013), patient developed a painful arm (injections site are) with a 4 to 6 inch area of welts at the injection site, body aches (all over the body), itching  (all over the body) and redness (all over her body) and a bad headache (migraine like) following vaccination with ZOSTAVAX. The exact time frame development of the symptoms was unspecified, but the patient called the pharmacist on 14-NOV-2013 to report the adverse event. The pharmacist spoke with the patient on 16-NOV-2013 and the area of welts at the injections site had decreased (no information about the other symptoms). The patient received treatment with Ice packs and Benadryl. The patient sought medical attention, contacted pharmacist. The causality was not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received other medication in 2weeks reported as Yes. The Paxlovid Treatment start date was 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection, lot number M034187; expiration date 17-MAY-2019, lot number M034188; expiration date 20-MAY-2019 or lot number M045206; expiration date: 27-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with LIQUID PEDVAXHIB was 30 minutes between 9 to 25 Celsius degrees. There was no previous temperature excursion and the temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA005140: US-009507513-1703USA009373: US-009507513-1703USA009374:
Immediate flushing, dizziness, feeling hot, followed by tingling in the fingers a few minutes later.
Swelling of the left jaw and left neck for 7 days, pain for 4 wks on the left neck
BELL'S PALSY, SAME SIDE AS THE SHOT. RIGHT SIDE FACE PARALIZED, CAN'T BLINK, CAN'T CLOSE RT EYE, CAN'T SMILE OR SPEAK CORRECTLY. DEPTH PERCEPTION GONE ON RT SIDE, PERIPHERAL VISION AFFECTED ON THAT SIDE.
Headaches, fatigue, joint pain, weakness, soreness at injection site, low-grade fever.
Bilateral crushing arm pain in hands, forearm, and biceps. Hypertension(never had before) 150/90, tachycardia and SOB with very minimal exertion. Bilateral shoulder and neck pain. Caudication in knees, left calf and left foot as well as intermittent in both testicles. Nausea, bloating, reflux, and loss of appetite. Severe occipital and temporal headaches, pre-syncopal episodes concurrent with chills coming on. Ear ringing and fatigue in whole body. Cspine MRI negative. Echo negative. Ct chest arterial and venous phases negative. Venogram negative. All labs normal. EMG scheduled for tomorrow. Tachycardia intermittent, longest was 6 hours, hr 110-125, my wife, a critical care nurse practitioner was monitoring. EKG normal (tachycardia was gone by the time ED at hospital administered it).
Information has been received from a health professional concerning a patient (20 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injected arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
Second Dose as Engerix; Initial Report Received on 24-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a 35-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 19-Sep-2022, dose 1 of HEPLISAV-B (Lot #938794, expiration date 09-Oct-2023, NDC #43528-002-01), route not specified, was administered in the left arm for hepatitis B immunization.  On 24-Oct-2022, the patient received a 2nd dose of another manufacturer's vaccine, Engerix-B, in the right arm. The patient did not report any adverse reactions.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
UTI; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 16Feb2021 12:15 as dose 2, single for COVID-19 immunization (at the age of 65-year-old, non-pregnant). Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient had no covid prior vaccination and covid was not tested post vaccination. The patient experienced UTI (urinary tract infection), frequent urination, amber to brown urine and everything she put into her mouth tasted bitter for a day on an unspecified date. Patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225127 same reporter/drug with different patient, similar AE
Pfizer vaccine was mixed with sterile water diluent instead of the sodium chloride diluent that is provided with vaccine. Patient did not have any adverse reaction. Parent was notified of error. Patient returned to clinic to get 2nd dose vaccine on 4-7-22
Patient  had two seizures after getting these two vaccinations.  He had one at 2 am on 10/20/2023 and another one at 8:00am.  He has never had more than one seizure in a day.  Each lasted about one minute with the convulsions and then ending with him staring off and then falling asleep. NOT SURE WHICH TYPE OF EACH VACCINE HE ACTUALLY HAD.  The Tdap does not state whether it was Adacel or Boostrix.  The meningococcal states ACWY Vaccine.
Swollen, red, itchy, and sore.  Saw doctor on 3 May 05.  Take Benadryl for itching and said to come back in three days if worse but said it should get better.
Pt vax 3rd dose & 21Mar91 hepta -B titer indicated no immunity.
Pt recvd vax & exp inject site reaction following vax & dx cellulitis; no cultures taken; no spontaneous drainage; tx included Keflex for 10 days;
Headache and nausea with in hour of vaccine. Vomiting 6 hours after vaccine with extreme dizziness like on a boat.
Information has been received from a 37 year old female registered pharmacist with no medical history and drug allergies who on 30-SEP-2009 was vaccinated subcutaneously with one dose of MMR II (lot number not reported). On 07-OCT-2009 she was vaccinated with a dose of FLUARIX. There was no other concomitant therapy. On 09-OCT-2009 she experienced muscle pains, headache and fever that lasted for about 3 days. On 12-OCT-2009 she experienced itching over her body and red spots that lasted for 3 days and resolved on their own. The pharmacist mentioned that she saw her physician on 15-OCT-2009. No treatment was provided. The pharmacist stated that she had persistent left wrist pain where she could not lift anything heavy or drive due to the pain. She was currently working as a pharmacist but can only perform light duty. There was no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
pt recvd vax & devel a transient extrapyramidal synd; resolution w/in 24 hrs
Fever ? Cough ? Sore Throat ? Generalized Body Aches ? Nasal Congestion  Patient has tried Tylenol.
No specific adverse event. Mother has requested a report be submitted because child has been diagnosed with autism and possible mitochondrial disorder.
Swollen, any time I moved my arm it felt like a needle was cutting through my muscle about 1.5 inches deep. I have taken tylenol a few times and have limited my use of the arm. It still aches one week later and shooting pain in some positions.
Hot, indurated erythema shoulder to elbow, into antecubital space and 95% circumference right arm.
My throat tightened, it was harder to breath, I was dizzy, nauseous, I started shaking, my face and arm were going numb, stomach issues (bathroom).  This started within 5 minutes of taking the vaccine. The nurse offered EMT ot EPI Pen. She said my blood pressure was fine so I decided not to go to the hospital.  She offered me benadryl. These symptoms did not go away for the entire day/night. I had to go to sleep and I was ok the next day. 2 weeks later I became sick with flu symptoms/my heart rate goes up to 150-160 when I stand or walk. This never happened before I had the vaccine. My flu symptoms have been happening for going on 7 weeks.
Event occurred after 2nd vaccine.    She presents to Hospital on 12/20 after EMS was called for respiratory distress.  On presentation patient was only able to respond to help me.  She was found to be hypoxic given submental oxygen  in route.  Upon presentation patient be hypoxic on nonrebreather was placed on BiPAP.  She was tachycardic into the 140s, normotensive and febrile. Remains in critical care, ventilator dependent.  Jan 5/2022
11/06/2003: He developed aches and malaise and redness/swelling at site of immunization (left arm).  11/12: Now mildy improved but with 2 dozen red nodules 6 of which are 1-2 cm with pustule.
Heat in ears; Elevated heart rate; Hives on stomach that began to spread; tingly and pinchy sensation all over body externally and internally; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on stomach that began to spread), PARAESTHESIA (tingly and pinchy sensation all over body externally and internally), FEELING HOT (Heat in ears) and HEART RATE VARIABILITY INCREASED (Elevated heart rate) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included METOPROLOL, ALPRAZOLAM (XANAX), MONTELUKAST SODIUM (SINGULAIR), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced URTICARIA (Hives on stomach that began to spread) and PARAESTHESIA (tingly and pinchy sensation all over body externally and internally). On 01-Feb-2021, the patient experienced FEELING HOT (Heat in ears) and HEART RATE VARIABILITY INCREASED (Elevated heart rate). At the time of the report, URTICARIA (Hives on stomach that began to spread), FEELING HOT (Heat in ears) and HEART RATE VARIABILITY INCREASED (Elevated heart rate) had resolved and PARAESTHESIA (tingly and pinchy sensation all over body externally and internally) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs are Protonic . Treatment  medications are Benadryl , Zyrtec , Steroid Shot , Steroid Pack.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Vaccine was administered in upper deltoid near shoulder joint. Appeared to be too high of a placement. Developed moderate pain the evening of the injection. Pain increased to severe during the night. Woke up with severe pain and limited range of motion. Severe pain and difficulty raising right arm. No redness, swelling or warmth noted. Was evaluated at urgent care clinic 12/20/2020.   Continued rest, mild active and passive range of motion exercises, ibuprofen. Pain gradually lessened and range of motion increased over the next 2-3 days. Missed work 12/21 and 12/22 due to symptoms.   Symptoms mostly resolved by 12/24 with very mild tenderness in right shoulder/deltoid.
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.