chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 as dose 4 (booster), single (Lot number: FJ5602) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Sep2021 as dose 3 (booster), single (Lot number: 035c21a), 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 included: "Ulcerative Colitis" (unspecified if ongoing); "Afib" (unspecified if ongoing); "high BP" (unspecified if ongoing), notes: high BP. Concomitant medication(s) included: VALSARTAN; TAMOXIFEN; ROSUVASTATIN; FLECAINIDE; PSYLLIUM [PLANTAGO PSYLLIUM]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive again; (07Jun2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022, indication: treatment of COVID-19. Tested positive again on 07Jun22 with similar Covid symptoms of congestion. No known allergies.
A report has been received from a Health Professional concerning a 39 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 25-NOV-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Immediately following completion of administration child collapsed to the floor and had 40 seconds of witnessed seizure activity.
MY right tonsil swelled for 2 hours and became red, my tongue turned white for a while,  became fatigued. very bad vivid dreams. Headache since the injection and it has been 3 days. body aches and pain for 2 days.
Patient was administered the Pfizer Bivalent as the first dose in the primary series.  No adverse reactions noted.
7/23 @ 1240- Pt received immunizations at pharmacy 7/24 @ 1800- I received a call from patient that she wasn't feeling well. Felt lethargic & had to miss work. She stated that she had a rash on her left arm at injection site. I spent around 20mins with patient on the phone- Discussed early signs of anaphylaxis (Swollen lips/tongue, difficulty breathing, throat tightness. Patient did not have any of these symptoms. Did not have rash any place else 7/25 @ 0930- Received prescription for Prednisone 20mg- 1 PO TID X 6 days. Called patient to check on her. She did okay through the night but woke up with both eyes swollen and did TeleDoc visit. She came to the pharmacy an hour later. I counseled her- her eyes swelling had gone down significantly and she was able to drive herself.  7/25 @ 1630- I called patient to check on her. She had taken 3 doses of prednisone and said her eyes were almost back to normal. Rash on both arms not spread. She was feeling better and considering going to work the next day
Pfizer vaccine was administered outside of facility- reported by patient  ACUTE PULMONARY EMBOLISM 12/17/2021 HX OF ROBOTIC LAPAROSCOPIC PROSTATECTOMY
Information has been received from a registered nurse concerning several patients, both male and female between 12 to 15 months old, who were vaccinated with PROQUAD (Merck). Subsequently the patients experienced seizures or high fever. At the time of reporting, the outcome was unknown. The patients did not seek medical attention. Upon internal review, seizures was determined to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Patient experienced severe loss of balance.  Treated for dehydration, vestibular neuritis and now assumed to be a central nervous issue in cerebellum. Currently on prednisone.
fever to 101.9 24hr p/vax;very irritable for 7 days p/vax;given motrin for discomfort;
Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.
pt recvd vax & exp a recurrence of fever & body aches, but to a greater magnitude than the first time;
Patient briefly fainted (while seated) a few minutes after receiving vaccine. Patient immediately recovered and stated he was fine. He responded well to all questions and was coherent.
Intermittent red raised itchy rashes on arms, back, hands, and stomach; duration of 15-30 minutes before spontaneously resolving.
fever of 101.6, chills, nausea, lightheaded, loss of appetite, tired, general malaise
Sore arm with tingling down to hand. Very present while running. Tingling not completely gone nearly three weeks later.
intramuscular pain directly after (lasted approx. 24 hours); the following day, mild headache, fatigue and injection site red and slightly swollen; today is the 5th day and the area around the injection site is increasingly swollen, warm to the touch and itchy.
This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs), by a contactable pharmacist. A 71-year-old female patient received PREVNAR 13 (Batch/lot number: W33491, Expiry Date: Jun2020, NDC number: 0005197102), via an unspecified route of administration at 0.5 ml, single on 17Oct2018 for immunisation. The patient medical history and concomitant medications were not reported.   On 17Oct2018, the patient experienced big nodule on arm with outcome of not recovered, when she injected it, and blood gushed out with outcome of unknown.
Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unknown route of administration on 15Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Feb2021. The patient experienced sars-cov-2 infection (covid-19) on 21Feb2021 and the patient wants to know if she can receive her second dose as scheduled. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
administered Anthrax the last week of January that expired December 2018; No adverse reactions; Received a spontaneous report on 05MAR2019 from personnel.  Reported that a patient was administered Anthrax the last week of January that expired December 2018. A patient safety report was filled out and the incident was reported to VAERS. Patient displayed no adverse reactions. Policy changes were made to ensure lot numbers and expiration dates are checked prior to administration.  No further information is expected.
Pt walked in as a 'walk-up' for a COVID vaccine and was advised that this shot would be Moderna since that was the only COVID vaccine that we were administering that day. Pt signed consent form, signed out at the register and received his shot. Upon counseling for his return date and side effects to expect, he expressed that he thought this was the 'one-dose.' He seemed to be confused about which shot was which and told me 'the CDC said this would be the one-dose here.' He was very upset even though I exclaimed that we clarified this was the two-dose Moderna vaccine before the shot was given.
This case was reported by a consumer via call center representative and described the occurrence of mental status changes in a male patient who received BEXSERO for prophylaxis. On 7th June 2018, the patient received the 2nd dose of BEXSERO. In June 2018, less than a month after receiving BEXSERO, the patient experienced mental status changes (serious criteria hospitalization) and unstable feeling (serious criteria hospitalization). On an unknown date, the outcome of the mental status changes and unstable feeling were unknown. It was unknown if the reporter considered the mental status changes and unstable feeling to be related to BEXSERO. Additional details were provided as follows: This case was reported by a CIH (not otherwise specified) who was also the mother of the patient. The age at vaccination was not reported. The patient had been unstable i.e. mental status changed and was in acute psychiatric hospital care since receiving his dose of BEXSERO vaccine. The mother was highly concerned that the BEXSERO vaccine injured the patient's brain. The mother of the patient asked for advice.
began having severe itching, multi whelped rash all over body and  swelling in face, hands, eyes, ears and feet.  Went immediately to the ER where she received IM Benadry, IM Steroid and oral pepcid. Given a Rx for oral Prednisone 20 mg  po q day x 5 days and to continue Benadryl 50 mg every 4-6 hours for 3 days.  Rash and itching last for 5 days. Patient reported reaction to her PCP on 3rd day.
I had my vaccination on 10/07/2022. I started to experience fatigue on 01/02/2023. I tested COVID-19 positive on 01/03/2023. I was not put on any medication because of excellent health. I had biked 37 miles on 01/02/2023. The nurse practitioner sent in the prescription but I didn't take as I was feeling better by day 3.
Headache, body aches, chills, fatigue,. Lasting  7-8 days. Subsided gradually.
Excruciating headache upon waking up 12-18-2020 at 0800 along with vomiting .  Took Tylenol and Fell back asleep for 4 hours which I never do.  Feeling very tired today but functional.
Menveo administered after freezing exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    Additional Information: GSK receipt date: 4-Aug-2022 Reporter comment: The pharmacist reported three patients received Menveo that had been stored in the freezer. The reporter gave consent to follow up. Reporter did not want medical information to store information in medical information database. Additional Supportive Information: The reporter stated that three patients received Menveo that had been stored in the freezer, which led to incorrect storage of product. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022115428:Same reporter. Patient 1 US-GSK-US2022AMR115729:Same reporter. Patient 2
Narrative: 12/11/2020 COVD swab, result: NOT detected COVID infection following COVID vaccine series 02/23, Pfizer, dose#1 03/16, Pfizer, dose #2 08/12 pt cc: chills, cough, fatigue, headache, loss of taste, myalgias, rhinorrhea, dyspnea. sore throat exposure: unknown 08/16 COVID swab, result: detected 08/16 SARS-COV-2 LINEAGE B.1.617.2 08/16 SARS-COV-2 CLADE 21A DELTA
This spontaneous report as received from a physician refers to a 10 year old female patient with prophylaxis. On 10-MAY-2017 the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included M-M-R II and sterile diluent (manufacturer unknown). On 17-MAY-2017, 7 days after onset of therapy the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
Eleven days after the second shot , patients feet started becoming numb, with pain and tingling. Couldn't walk for 10 days then saw neurologist. a
Sometime in the afternoon several hours after receiving the vaccine, the veins in the forearm of the injection arm (left) were noted to be engorgedfrom about mid-forearm through the hand in only this left arm. At various points along the veins, there was ballooning of the blood vessels. It is unclear when exactly this began. The most extreme engorgement was only noted for a few minutes and then began to decrease, though some engorgement was still noted. Shortly thereafter, numbess on the back of the forearm to middle of back of wrist and slightly up into the Left (inject side) hand was noted. This was soon mirrored on the right arm. The side of the left face then became numb. The numbness in the right forearm lasted through the following day. Numbness in the left forearm (injection arm) lasted for a number of days (3 or more). Numbness in the left face, though improved over time, persists to this day. In approximately early November of 2021, the muscles and ligaments of the left upper arm became tender and painful to use, limiting range of motion and ability to carry out regular acts of daily living, with this issue persisting to this day. In December of 2021, a dental procedure was performed with use of a short term numbing agent on the left upper side. Instead of fully wearing off shortly after the procedure, as this medicaiton should, the left sided numbing injury from the vaccine was exasperted, and overall sesation of numbness persisted for much longer. Although, th eoverall sensation of numbness of the side of the left face has overall decreased since both events, it has never returned to 100% normal.
After receiving the vaccine, pt reported fever of 101 degrees Fahrenheit and major chills within hours of receiving the vaccine. The next morning, patient noticed a "rash" around the injection site. The "rash" consisted of redness that spread a little bit down the arm, but went away by the next day. All symptoms resolved within 48 hours of receiving vaccine.
Covid-19 antibody test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive). On 02-Feb-2021, SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.
I have had a moderate to a severe headache for 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Oct2021 at 06:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Oct2021 at 18:00, the patient had a moderate to a severe headache for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had a moderate to a severe headache for 3 days was resolved on 09Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Onset started 30 minutes after vaccination, I have no health concerns, I felt like the COVID-was attacking my body after the vaccination.  I took Aleve for 4 days. I laid in bed and I didn't feel well. The next morning I had welts on my abdomen, right side, lower back. and I took Aleve for 4 days and it didn't go away.  I called my doctor and the doctor diagnosed me with shingles. He feels the vaccine brought out the shingles for whatever reason. The shingles were probably dormant in my body. I was prescribed  Gabapentin 100 mg, valacyclovir 1 gm.    My welts have healed up.
Pfizer pediatric product given to vaccine recipient in an undiluted concentration. 0.2mL given of undiluted pediatric product. No adverse reaction observed or reported. 15 minutes wait time observed. After patient departed, medication error realized and reported to managerial chain and Local Health Authority.
Patient reported sore arm on the same day after vaccine was given.  Two days later, felt more pain in her arm which woke her up in her sleep. She applied Biofreeze, took ibuprofen 800 mg every 8 hours, and did muscle exercises. Still complains of soreness around her shoulder. Patient has not had any adverse reactions to past flu shots.  Will see her doctor on 12/27/16.
NAUSEA, VOMITING, SORENESS, BODY ACHES, DIZZYNESS
Patient was already up to date on shingrix and tdap, and we administered them again (shingrix series complete, tdap given in 2018)
After Administration of Zostavax, patient began seeing redness around the injection site.  On day 2 after injection, the redness has spread to about 6 inches in diameter around the injection site.  Patient claims that the area is slightly itchy with some tenderness in the middle.  Area is not warm and is not raised.  Patient instructed to take Benadryl orally or to use hydrocortisone cream topically as needed.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
pt devel redness & swelling below area of pneumovax inj;no other sx;pt to take APAP PRN & notify of any problems;
Pt was observed sweating and so blood pressure was taken, in which it was low. She was given a Gatorade and the ambulance arrived and she was taken to the ER.
Pt was mistakenly given an additional dose of Fluzone HD QIV (pt had previously received her yearly dose on the week of 9/25/23 from her doctor's office and did not need an additional dose on the date of the event (10/2/23)). Patient had only intended to get the COVID-19 vaccine on 10/2/23,  but the Pharmacy Technician who administered the vaccine accidentally administered the Fluzone HD QIV. The mistake was realized immediately following the vaccination and the patient requested to still have the Moderna COVID--19 vaccine administered. Counselled patient that an additional dose of the flu vaccine would not cause any serious adverse effects, but she should monitor for these and notify us as well as her MD.
Within an hour and half I started to experience Dry Mouth and Nausea, later that day my Lymph  nodes in my neck/jaw were Swollen and I had a Runny nose and Cough. By the evening I was experiencing Body Aches, Chills, Headache, and Fatigue.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Herpes Zoster Vaccine (received a few years before the reporting date). Concurrent medical conditions included back disorder, spinal disorder (two times spine fracture.), sciatic neuralgia and mobility decreased. Concomitant products included PNEUMONIA VACCINE. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 30th April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The reporter stated that she received SHINGRIX on the left arm and Pneumonia vaccine on the right arm. At night, the patient's left arm having difficulty of moving it and went on for 5 days then resolved.  She noted that she could not move both legs or arms due to the sciatic nerves in her legs and she had a history of back and spine issues long before SHINGRIX. The patient stated that surgery was planned in the future because she had nerve on bone areas that are causing her pain.  She would like to get the second dose of SHINGRIX in her backside but stated no pharmacy would gave it to her there.
Inadvertent temperature excursion, vaccine stored in freezer beyond allowable two week excursion protocol per Pfizer, no concern for any other adverse events, recommended repeating dose.
Cellulitis like symptoms. Redness and swelling down to the elbow. Lasted several days and I told her to see her doctor. Unaware of the final result.