chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose. Muscle soreness first 2 days  joint pain next two days. Dose recieved 4/28/21 Second dose. Upset stomach then loss of appetite the first day. Got better on second day. Very tired on the second day Third day: Hacking cough and sore throat. Could eat, but when drinking caused me to cough. Then started to lose my voice.  6th day. Coughing better but still there voice still weak. Fluids do not make me cough anymore. 2nd vaccine date 5/26/21
Child was taken to ER via EMS with a history of a seizure at home. Mom stated that it started that AM.
Information has been received from the Merck pregnancy registry via a certified medical assistant, concerning a 32 year old female with herniated disc, sulfonamide allergy and drug hypersensitivity to doxycycline and ZITHROMAX and a history of Papanicolaou smear abnormal who on 14-NOV-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot #653938/0954F).  On 22-JAN-2007, the patient was vaccinated with a second dose of Gardasil (lot #654702/0011U).  There was no concomitant medication.  Subsequently, the patient became pregnant.  Total serum human chorionic gonadotropin test on 02-FEB-2007 was 606 and on 05-FEB-2007 was 3255.  The patient's last menstrual period was 31-DEC-2006 and the estimated date of delivery was 06-OCT-2007.  Unspecified medical attention was sought.  There was no adverse experience.  Follow-up information from the certified medical assistant indicated that the patient has an obstetric history of 5 previous pregnancies, 2 full term deliveries and 2 spontaneous abortions.  An ultrasound was performed on 15-FEB-2007.  The result of the ultrasound was 6 weeks, 1 day.  Follow up information from the physician indicated that the patient, who also had a history of Von Willebrand's disease, took prenatal vitamins (unspecified) throughout her pregnancy.  On 28-APR-2007, a maternal serum alpha feto-protein screen was negative.  From 04-SEP-2007 through 10-SEP-2007, slow release iron, and from 10-SEP-2007 through 15-SEP-2007, "Replura" was prescribed for anemia.  On 15-SEP-2007, 3 weeks prior to the estimated date of delivery, the patient gave birth to a normal (no abnormalities and no congenital anomalies), male infant, birth weight 5 lb 15 oz, Apgar score 8/9.  On an unspecified date, however, the infant was diagnosed with necrotizing enterocolitis.  The outcome of anemia and necrotizing enterocolitis was not specified.  Upon internal review necrotizing enterocolitis was considered to be serious as an other important medical event. Additional information has been requested.
Extremely tender injection site, underarm very sore/tender, chills/shakes for receiving Infulenza and Pneumococcal at same time while recovering from bad cold.
This spontaneous report derives from an internet website, where the patient's mother reported on her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient used to be a competitive horse rider and a cheerleader. On an unknown date in August 2013, the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot # and expiration date were not reported). In October 2013, the patient experienced pain, constant state of dizziness and her fingers tingled and burnt. Since an unknown date, the patient walked with a cane (reported as "now"). She had positive Epstein Barr and Pertussis blood tests (date unspecified). In 2014, she was hospitalized five times. The mother stated, that they tried her on everything. They were going to see immunologist in March 2015. Outcome of the events was not recovered. Causality assessment was not provided. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a RN concerning a 6 year old female STUDENT who on 04/17/2002 who was vaccinated SC in the upper left arm with the first dose of varicella virus vaccine live. Concomitant vaccinations on that same day included the third dose IM in the left vastus of COMVAX.  The RN reported that on 02/17/2005, the pt developed a mild case of chickenpox characterized by less than 50 lesions and a low fever. It was noted that the patient was out of school until 18-FEB-2005.  Unspecified medical attention was sought and the pt subsequently recovered from the chickenpox. Additional information is not expected.
Dizziness, cramping, confusion, shortness of breath immediately after the first dose and carried on for weeks after. Second dose on october 5th and days later I was super short of breath and had weird tingling in my legs and mostly my right leg/ right calf/ foot. Progressed into worsening of shortness of breath over the next few weeks. I ended up having left side pains and was dismissed and told all of these symptoms were anxiety. The left side pain got worse and came to the point where breathing hurt or sniffling my nose hurt. The next day I tried to lay down and the pain shot up into my neck, a dull ache. I then went to emergency where they took blood, ecg, x-rays, ultra sound, and a ct scan. ( november 7th) They came back with the results that I have blood clots in my lungs. Since this finding I have been in and out of emergency with severe spasms, pains, tingling and numbness like feelings and pain in my side and chest.
Pregnant pt; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (During current pregnancy, she had marginal cord insertion as a pregnancy complication.). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], COLECALCIFEROL (D3 VITAMIIN) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 26-Apr-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2020, Pregnancy test: positive positive (Positive) Pregnancy test was positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were added.
Patient describes "horrible shooting" pain down arm when moved. Vaccine administered 8-15-12 complaint 8-17-12.
my arm was a little sore; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a patient.   This case involves a patient of unknown age who reported his/her arm was a little sore (limb discomfort), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after initiation of suspect drug therapy, the patient's arm was a little sore (limb discomfort) and reported it was easy trade-off for being protected from the flu.   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.  There will be no information available on the batch number for this case.
First 72 hrs....Extreme joint stiffness,  cramping,  lower extremities ( both legs to feet) felt extremely hot, chills, , disoriented, weakness in legs while standing, and  extreme fatigue.  The fatigue and weakness has continued and now experiencing headaches and blurred vision with brain fog since the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 22Sep2023 to 27Sep2023.    The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315938 Same patient, different drug, different event;
Information has been received from a physician concerning a 67 year old female with allergy to shellfish, bee stings and fire ants and a cold at the time of vaccination who on 14-DEC-2006 was vaccinated IM with a dose of Pneumovax 23 (lot #654977/0888F).  There was no concomitant medication.  On 14-DEC-2006 the patient developed 101 degree fever and swelling and pitting edema in the arm in which she was vaccinated.  Medical attention was sought and the patient was treated with BENADRYL and TYLENOL.  At the time of the report the patient had not recovered from the fever and the swelling had moved down to her forearm.  Additional information has been requested.
Attendee came in for 1st dose of vaccination and started to look pale, attendee complained of feeling light headed and nauseous.  noticed that attendee looked pale, observeradmin went over to talk to attendee and attendee voiced complaints of lightheadedness and wanting to vomit.  Attendee's skin was clammy, attendee started to dry heave and had a small amount bile emesis.  10:55am Vital Signs: HR:  51   BP:  100/72   RR:   16   O2Sat%:  97   Temp:  97.1      After a cold compress was given to apply to her neck.  AT 11:15am she started feeling better, her father gave her some crackers he had and staff gave her some juice. Had no complaints of discomforts and looking better.
Myosistis; This non-serious case was reported by a nurse and described the occurrence of myositis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myositis (Verbatim: Myosistis). The outcome of the myositis was not reported.   It was unknown if the reporter considered the myositis to be related to Arexvy.     It was unknown if the company considered the myositis to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-May-2023  The reporter's aunt was in the clinical trials for Arexvy.  She reported that her aunt developed myosistis (muscle inflammation) during the clinical trial. The reporter did not know if this report had been previously captured during the clinical trials. She did not administer the vaccine and the patient was her aunt.
Patient attested that he received his second dose of Moderna Vaccine more than six months ago and requested a booster dose of Monderna on 12/28/2021. The Moderna booster was administered to patient per his request. It was then verified in the computer system, that his last vaccine was given on 8/7/21. This discovery indicated that the booster was given prior to current CDC guidelines.
Date of immunization patient had no problems. The next day patient c/o: soreness, swelling, numbness down (Rt) arm. She had a massage on 08/09/14. Patient was worse and went to urgent care. The urgent care provider diagnosed Torticollis and was prescribed anti-inflammatory and muscle relaxers. Pt reports Icing and Emu oil for treatment.
pt recv vax 6JUN97 & 19JUN97 pt to MD w/petechia of the face, trunk & extremities;pt mom indicated that had rash 2-3 days prior to presenting in the MD office;CBC revealed a platelet count 22,00;dx ITP
Mother states client felt unwell, flushed in face--at the library. Client passed out as they were leaving the library to come home. Regained consciousness, put her in the car, came home, and she said her legs wouldn't move and that she couldn't get out of the car. Mother called physician, and was told to bring client to ER right away. Client admitted to hospital from ER, after spending 8 hours in ER.
About 24 hours after dose 1, I started feeling fatigue.  I then woke up with a severe headache.  I was in bed for the next 12 hours with flu-like symptoms, body and joint aches, chills and nausea.  I did not have a fever and did not vomit.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: After recieving vaccine within 10 minutes, patient complained of feeling light headed, dizzy, appeared pale.  Assisted patient to lay down on the floor.  Seen by EMS, Temp 98, Pulse 63, 90/70.  Patient stated that he had taken medication for anxiety prior to vaccination.  Per patients mother, he took \"Hydroxyzine 25 mg Tablet\".  2nd set of vital signs were taken, BP 100/60.  Patient assisted back to chair and observed for an additional 10 mins. Refused transfer, patient went home with mother.
This study case was received from the investigator in a trial on 22 October 2013. A 37-year-old male subject with no reported past medical history had received an injection of ACAM2000 (lot number, route and site not reported) and an injection of Anthrax Vaccine (manufacturer, lot number, route and site not reported) on 09 August 2011. Ten days later on 19 August 2011, the subject had an elevated Troponin I level of 0.14 ng/mL. Troponin I recheck on 22 August 2011 was <0.10 ng/mL and ECG was normal. The subject was asymptomatic and referred appropriately but results were not available. Outcome was recovered on 22 August 2011. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
She has not gotten her period since her first shot (beginning of April)/ had her second one she still hasn't had her period; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old), as a single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother was inquiring about the Pfizer BioNTech COVID19 vaccine. She mentions they all had it no problem. The last person who got it was her 12-year-old daughter. Her daughter has had her period for 2 years. Right before she got the vaccine, she was due for her period. She has not gotten her period since her first shot (beginning of April). Now she's also gotten her second shot and it still did not come. She feels like the only difference in the daughter's life was the vaccine. She wanted to have more information to know how to move forward. She says it's "out of the ordinary, nothing like this has happened since she's gotten her period". Mother wanted to know if we have any reports on the subject. What information was available regarding menstrual changes. There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This is not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. In teens, it is also important to note the natural variability in cycles due to the normal maturation process and the large range of normal menstrual cycles in the first few years after the onset of menses. Stress and weight changes, which have also occurred in many adolescents during the pandemic, can themselves cause these changes. COVID-19 vaccines can be used during puberty and that irregular periods are a common part of adolescence and usually have a wide normal range. The outcome of the event was reported as not resolved.  Information about lot/batch number has been requested.
pt was administered a janssen vaccine. he was asked to sit for 15 minutes and wait. 5 minutes later he passed out and fell to the floor. he came to quickly said he felt ok and wanted water. we took his blood pressure and got him cool towels and ice packs since he was sweating while waiting for EMTs to arrive. EMT's encouraged him to go the er since he had hit his head so he agreed
As soon as the shot was given I started to sob and shake because I felt like I had committed a big sin against God. The nurse asked me if I was ok. I said i dont know because i wanted the vaccine but i feel like God is mad at me now and i am going to burn. She led me to the waiting room and the EMT proceeded to check on me regularly as i went into a full panic attack. Labored breathing, crying and shaking. After 45 minutes I had calmed down and the EMT released me to go
Started with weakness, then shortness of breath, multiple syncopal episodes. Bilateral popliteal DVT, multiple bilateral PE's with no other risk factors. Symptoms started approximately 2 weeks ago. Hospital admission date was 5/26/2021. Obstructive shock from PE, required ICU care, vasopressor therapy, and EKOS therapy, IVC filter. Improved from shock after EKOS therapy, no longer need vasopressors. Heparin infusion post EKOS therapy. Will be going home on oral anticoagulation when appropriate for discharge. Shock liver as a complication from the obstructive shock.
Pt received a pediatric dose/orange cap (0.2ml) of Pfizer instead of an adult dose/purple cap. No adverse reactions noted.
Neuropathy in feet & hands; Walk with a walker; Lost weight; Lost muscle mass; In pain 24/7; 1st dose on Oct2021, 2nd on Sep2022; This case was reported by a consumer via other and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of guillain-barre syndrome (received 1st dose in October 2021 kindly refer case US2022AMR176659 for 1st dose.).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), walking difficulty, weight loss, muscle atrophy and pain. On an unknown date, the outcome of the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176659   Additional Information: GSK Receipt Date: 23 NOV 2022 Reporter's comment:The patient had good health before takign vaccine. The patient received 2nd dose in September 2022,  The patient was walk with the walker, had lost weight and muscle mass. The patient also suffered from neuropathy in feets and hands. The patient still persisted with the pain 24x7. Less than 3 months after vaccination the patient experienced peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain.  The reporter consented to follow up. Additional supportive information: As patient received 2nd dose of Shingrix more than recommended scheduled which led to drug dose administration too long. This case is linked with case US2022AMR176659 same patient.; Sender's Comments:  US-GSK-US2022AMR176659:Same reporter
Notified 09/01/2022 at 2:50 pm that we are no longer to administer monovalent vaccines.
Vaccine administered after the expiration date of 9/30/22, however the manufacturer provided information that the stability was good through 10/19/22. No adverse events, no treatment required. Patient is fine.
She felt the injection hurt more than it should have but didn't think much of it.  Approximately 20 minutes after getting the vaccine and once she had left the clinic she began to have severe nausea and profuse vomiting.  She also had a headache.  Her arm was sore that evening and by the following day she had some localized swelling.  The headache persisted for several days. Yesterday her arm started to swell more and became extremely painful to the point where she felt she could hardly move her arm.  Symptoms continued on 08/14/13 so patient called for appointment.
patient received dose from  vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from  vial beyond 30-day use by date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from  vial beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from  vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Date of refrigeration of the vial was 07-May-2021.
Major headaches, body aches, chills, weakness, rashes, no energy, very little appetite. Visited an Urgent Care facility, a hospital Emergency Room, my doctor?s office, and a Dermatologist.  No one could identify the ailment. Visits occurred between 11/08/22 to 11/18/22.
I was having dinner and suddenly felt a strong numb/tingling sensation with a slight pain in the little toe at my left foot, as well as the bone connected to the toe.  I tried stretching my toes for a while and gradually the sensation went away.  However, when I remove my socks later in the evening, I noticed that symptom area is severely bruised, even though I never experience any external injury.  Not sure if it's blood clot or blood vessel bursting.