chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given at 8 am on 10/16/2020 Side Effects started at 5:45 pm 10/16/2020 1 st came the rigors Fever with Tmax 102 degrees, ( Spike Fevers for the next 24 hrs) Tylenol and Motrin was treatment Pulsating throbbing head ache, 10/10 pain level Muscular body pain  Dizziness Worse than having the Flu 42 hours later, I still feel weak and tire
Pt described red area with blisters at injection site. Dr. diagnosed as shingles 5/28 and prescribed acyclovir - situation resolved. 6/11 Area around both eyes swollen, itchy, red pustules - MEDROL dose pak helping.
Per hospital report Havrix Hep A given up to 18years of age, instead of adult Havrix.
This spontaneous report as received from the healthcare worker refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) injection (lot number, dose, frequency and route of administration were not reported). No adverse events were experienced. The outcome of the reported events was unkonwn. No product quality complaint (PQC) was filed. No further information has been provided. Additional information has been requested.
Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea, weakness, fatigue, Vomiting, Diarrhea. Post operative diagnosis, Ischemic colon/toxic megacolon.
Information has been received from a licensed visiting nurse concerning a 46 year old female housekeeper with no pertinent medical history or drug allergies who on 26-MAY-2007 was vaccinated IM with the first 1.0 ml dose of RECOMBIVAX HB (lot# 655810/1286F) in the left deltoid. Concomitant drug therapy included hormones (unspecified), ZYRTEC-D and LEXAPRO. On 27-MAY-2007 the patient "very cold" the day after vaccination. Symptoms were believed to be resolved in a day. On 27-JUL-2007 the patient was vaccinated IM with second 1.0 ml dose of RECOMBIVAX HB (Lot# 655810/1286F). Unspecified medical attention was sought. There were no labs or diagnostic studies performed. Subsequently the patient recovered. No product quality complaint reported. Additional information has been requested.
Pericarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 32 year old patient (unknown gender) who experienced pericarditis while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (strength, formulation: unknown) produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, pericarditis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Reportedly, since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It goes on and on, and on. it's happening everywhere and is NOT normal!! Event : 32 year old Champion Speed Skater suffered Pericarditis after the vaccine It is unknown if the patient experienced any additional symptoms/events.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Pericarditis).  At time of reporting, the outcome was Unknown for the event pericarditis.; Sender's Comments: Sanofi company comment dated 06-Feb-2022: This case concerns 32 years old patient who experienced pericarditis, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
severe pain around shot area on left arm.  from noon on Oct 23,2021 to Oct 24,2021 at 4:45am.   Drank a lot of water and it all came back out, seemed like every 20 minutes starting in the evening till 2:30am on Oct 24,2021.  Could feel the liquid going around the inside of my body.  Took a couple of Turmeric  supplements  for  pain every 6 hours.   Now just achy and no energy
Pt recvd 2nd dose of Hep B vax & devel flu-like sx; On 27MAR91 was vaxed w/MMR & devel flu-like sx (WAESNUM91051359); pt later recovered;
Information has been received from a physician concerning a 25 year old female who on 05/07/2001 was vaccinated one dose of hep b vaccine recombinant. On 05/09/2001 the pt experienced feelings of fever and chills at 1700 hours daily since then. Unspecified medical attention was sought. Additional info has been requested.
12 year old patient received (PEDS) Pfizer ages 5-11 vaccine lot # FK5618 on 12/15/21.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L014415, expiration date 25-JUL-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. This is one of two cases received from the same reporter (US-009507513-1606USA009149). Additional information has been requested.
Major Stroke as described below:    There is a large left MCA infarct with a hyperdense left MCA vessels sign consistent with a area of acute ischemia. There is medial uncal herniation compressing the left cerebral peduncle. There is compression of the left temporal horn. There is compression of the left lateral ventricle with left to right shift measuring approximately 9 mm. The basilar cisterns are patent. No intracranial hemorrhage.   Bone windows demonstrates no bony lytic or destructive changes   The orbital globes and retrobulbar structures appear grossly unremarkable. The visualized paranasal sinuses and mastoid air cells are well aerated. The bony calvarium is intact.   IMPRESSION: There is a large left MCA vascular territory acute ischemic change with uncal herniation and mild left to right transpleural seen shift described above without hemorrhage. Dense left MCA vessels sign. Results were discussed with doctor in the the ER at 10:45 PM
This case was reported by a pharmacist via call center representative and described the occurrence of hypoglycemic reaction in a 66-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. In February 2019, the patient received SHINGRIX (intramuscular) .5 ml. In February 2019, 1 day after receiving Shingrix, the patient experienced hypoglycemic reaction. On an unknown date, the outcome of the hypoglycemic reaction was recovered/resolved. It was unknown if the reporter considered the hypoglycemic reaction to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that patient called to provide additional timeline details. The patient reported that she received SHINGRIX on a friday afternoon and then developed the hypoglycemic reaction saturday evening.
Intense itching of feet & hands  started about 8 hours after booster injection & lasted about 4 hours. No rash.
No adverse effects; Improperly stored VARIVAX was inadvertently administered; Information has been received from a medical assistant concerning to a 12 month old female patient. No concurrent conditions, medical history nor concomitant medications were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S015459, exp. date 20-MAY-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Vaccine administered-Tdap-LD, HPV, MCV4-RD immediately started to lose consciousness, became pale, not diaphoretic, no salivary excretions, no eye movement, pt. fainted no loss of consciousness. Pt responded to directions and opened eyes.
Extreme spike in BP, dizziness/lightheaded, dehydration - all within about 10 minutes. Spike in adrenaline (pr/ EMT). Had to call ambulance. I was instructed to leave the facility after less than 10 minutes waiting. Veins seemed to collapse (dehydration) - I was very well hydrated prior to vaccine
14 year old female received Pfizer covid 19 vaccine for 1st dose and was inadvertently administered Moderna for 2nd.
No additional adverse events; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 02-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) following lot numbers were reported but it was not specified which one was administered to the patient: lot # S020464 and expiration date: 21-JUL-2019 and lot # S021928 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored at the following temperatures: from 15 degrees Fahrenheit to 46 degrees Fahrenheit (mainly at 35.7 degrees Fahrenheit) for 2 hours. The vaccine was reconstituted with sterile diluent, which was properly stored. There was no digital data logger involved and there was no previous temperature excursion.
an expired ACTHIB was given to patient with no reported adverse event; Initial information received from on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 6 months old female patient to whom an expired HIB (PRP/T) VACCINE [ACT-HIB] was given with no reported adverse event.  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) ; POLIO VACCINE (POLIO) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) all for Immunisation.  On 31-Aug-2022, the patient received an expired dose 3 (0.5ml) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection, (Strength; Unknown) (lot UJ521AAA: expiry date 11-Jul-2022)  via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency: same day). Reporter wants to know if they need to revaccinate and if there are adverse effects that they should look out for.  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 87-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks. On 20Jan2023 he took Paxlivid treatment for Covid-19. The patient had no known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
Patient placed in observation for shortness of breath/fatigue, inability to drain Pleurx, and hemoglobin drop
69 yo male patient presents with wife c/o back pain and confusion that began today. Patient has some altered mental staus and is unable to clearly respond to questions.  Patient with generalized weakness and altered mental status, CT showing acute pyelonephritis as well as interstitial pneumonia consistent with COVID-19, rapid swab positive, not hypoxic at this time.  Patient started on antibiotics and will admit for further medical management. uti, pyelonephritis, covid pna, anemia.   hospital stay 6 days
Popliteal Aneurysm; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL ARTERY ANEURYSM (Popliteal Aneurysm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029k20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL ARTERY ANEURYSM (Popliteal Aneurysm). At the time of the report, PERIPHERAL ARTERY ANEURYSM (Popliteal Aneurysm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Itching all over the body (but one certain body region everyday); Sore; Arm was red; Arm hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body (but one certain body region everyday)), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm hurt a lot) and PAIN (Sore) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ERYTHEMA (Arm was red) and PAIN IN EXTREMITY (Arm hurt a lot). On 09-Apr-2021, the patient experienced PRURITUS (Itching all over the body (but one certain body region everyday)) and PAIN (Sore). At the time of the report, PRURITUS (Itching all over the body (but one certain body region everyday)), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm hurt a lot) and PAIN (Sore) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At patient's brother's visit on 11-13-12 his mother reported patient had nausea and vomiting the day of vaccinations after leaving and fevers x 3 days to 104 degrees at 1 time - she refused the booster flu vaccine at that visit.
5-10 minutes after vaccination, vasovagal syncope: pallor, diaphoresis,  dizziness, tunnel vision, nausea, weakness, tingling in arms/legs, BP 103/69
Client was alert and oriented after the vaccine but stated shortness of breath due to Sinus issues.  she asked a question about using a  inhaler and was allowed to do so. Client did state that she has had previous reactions to vaccines and was in the 30 minute  observation line.   She also reported a history of  tachycardia.  she felt better after using the inhaler and  was monitored by EMS and Dr.  Blood pressure was 157/76 pulse 80 RR 20 and 97% oxygen saturation.  she was advised to seek medical attention post release if needed.
patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 11 pm and included: fever of 100.4 degrees Fahrenheit-relieved with tylenol, headache, body/muscle aches, chills, sore throat
Patient was given Pneumovax23 in the office on 2/23/2021 in left arm. Developed pain, swelling, and erythema same evening but worsening on morning of 2/24/21.  In addition, it is hot to the touch. Patient took a picture of it yesterday-it has worsened Patient denies any systemic symptoms. Patient does have a history of asthma, but does not complain of any chest tightness, coughing, some shortness of breath. Patient has been taking ibuprofen which does help with the pain in addition to using compresses Patient does complain of pain sometimes with arm movement. No other symptoms.
About 12 hours after the vaccination, I got the chills. A couple hours after that I got a fever of about 100. I had a fever of 99-100 for the next 36 hours or so. I also had extreme fatigue for 2 days. After that I was fine. I made another report about COVID arm after my first dose. But it did not happen with my second dose.
After 2nd shot I had a fever (>101), headache, chills, fatigue & weakness.  This went on for about 24 hours.   I also had a miscarriage, diagnosed on 3/25/21.   My due date was supposed to be 11/14/21.
Patient was told that he had UTI but passed out 3 times in the last 30 hours.
Pain/discomfort in right upper arm/shoulder (injection site), getting progressively worse over past 6 weeks and now going all the way down arm to hand.
Persistent diarrhea for 2 months with weight loss starting 3-4 weeks after immunization with no cause found.
Starting the around 10 pm the evening of my vaccine, March 6,  I had chills. When I woke up in the morning I had a headache, muscle aches, slight difficulty breathing with chest heaviness, and fatigue.  At 2 am on March 8 I awoke with dizziness and room spinning, sweating, weakness and lightheadedness, and nausea. Later that morning most of the symptoms subsided except for slight lightheadedness. By March 9 all side effects had resolved.
Confusion; Cough; nausea; fatigue; ache; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), PAIN (ache), COUGH (Cough), NAUSEA (nausea) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (ache), NAUSEA (nausea) and FATIGUE (fatigue). On 02-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion) and COUGH (Cough). On 25-Feb-2021, PAIN (ache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion) and COUGH (Cough) outcome was unknown.            No relevant concomitant medications were reported. Treatment details were not provided.      This case was linked to MOD21-043334 (Patient Link).
Blood clot in superficial vein behind right knee as well as vertigo and nausea.  Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21).  Will continue to take 20mg/day for the next 30 days.  Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination.  I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation.  After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle.  I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL).  The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection).  I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days.  ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day.  The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog.  I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened.  I went upstairs to my bedroom to lay down on my bed and the room started spinning.  I then went to the bathroom and vomited clear fluid.  I started feeling a little better after vomiting but was still slightly dizzy and light-headed.  I made an appointment and went to the doctor around 10:30am.  The doctor suggested doing further bloodwork and a CT scan of my head.  Both tests came back normal.  The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).
Chills, fatigue, fever, congestion, loss of taste, cough, nausea and myalgia.
This spontaneous report as received from a Certified Medical Assistant 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 PROQUAD (Merck) lot # L044055 exp. 02-MAY-2017 or lot # L051102 exp. 17-JUN-2017 (dose, site and route of administration were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of max 10.2 degrees Celsius for 10 hours 45 minutes on an unspecified date. No product quality issue was involved. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Felt tired & weak for a few days headache, tender throat, discomfort swallowing (L) side of neck has swollen lymph node.
Pt was ordered to receive Hepatitis B and IPV vaccines. The medical assistant administered DTaP, IPV, Hib, PREVNAR and rotavirus. Rotavirus was given out of the recommended max age limit.
t104, cried all noc long, screamed x 1 hrs, unconsolable, using APAP;
Reminded that I can get both flu and Covid vaccines at same time however I did that last year and got super sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Reminded that I can get both flu and Covid vaccines at same time however I did that last year and got super sick".  Additional information: Patient stated that she can get both flu and Covid vaccines at same time however patient did that last year and got super sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.