chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA (dose, units, frequency, lot and expiry date were not reported). On an unknown date the patient experienced fatigue. The outcome of fatigue was reported as not recovered. The causality assessment of the event was not reported. There was no product quality compliant reported.
This spontaneous report was received from a nurse and refers to a 4 year-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 03-JUL-2017 at 15:02, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
gave a higher dose than intended; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (gave a higher dose than intended) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (gave a higher dose than intended). On 03-Dec-2021, ACCIDENTAL OVERDOSE (gave a higher dose than intended) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Shaking and chills. Fever 101.2. Nausea, vomiting, muscle and joint pain, headache, fatigue, skin sensitivity. Shaking lasted <1hr, other symptoms lasted<36hrs, except headache 1 week+.
his walking began to decline; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (his walking began to decline) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis and Cane user (Earlier, patient was walking with a cane for long distances, and without a cane for short distance). Concomitant products included FAMPRIDINE (AMPYRA), BACLOFEN and ROSUVASTATIN for an unknown indication.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (his walking began to decline). The patient was treated with Physical therapy (Walking with a cane) for Gait disturbance. At the time of the report, GAIT DISTURBANCE (his walking began to decline) outcome was unknown.            Within six months of receiving the booster shot of Moderna COVID-19 vaccine, the patient's walking declined.  Previously, the patient was walking with a cane for long distances, and was able to drive, and walk a short distance without a cane. Recently, the patient was using a cane for twenty four by seven hours, except when the patient was in the house.
After giving vaccine PT stated she felt weak and lightheaded and she slumped down on exam table. Dr immediately notified and addressed PT condition. Vasovagal syncope after vaccine.
Patient presented to the outside hospital on 6/27 due to having congestion and feeling much worse.  Patient symptoms started on Friday (6/25) with congestion and cough.  This was not able to be remedied by Mucinex.  Patient then went to an urgent care clinic on Saturday and after listening to his lungs was sent to the emergency room.  While in the emergency patient received a CT scan of his abdomen and pelvis which showed signs of liver cirrhosis and Covid.  Patient then had a rapid Covid test that came back positive.  They then obtained a confirmatory test but that is still pending.  Patient then had agitation while he was in the hospital to the point where he almost struck a nurse.  Patient's confusion got a little bit better but was found to have an elevated ammonia which was thought to be the cause of his delirium.
PATIENT RECEIVED SHOT. FEW SECONDS LATER HE  FAINTED. PHARMACY CALLED 911. PHARMACIST CHECKED PULSE AND PT WAS DOING OK. NO EPIPEN WAS GIVEN. EMS TOOK PATIENT TO THE HOPSITAL TO GEIT IT CHECKED OUT.
pt given dose and then felt faint. he was lowered to the floor then taken to med obs 2 for evaluation. 1340 HR 81 BP 157/79 oxygen 98% on room air; patient was given some fluids and felt better almost immediately; 1346 HR 72 BP 120/78 OXYGEN 98%; 1352 HR 80 BP 138/89 OXYGEN 98 %; SHE DID EAT LUNCH; PT LEFT at 1402 with her dad
The night after receiving my second injection for shingles, I had severe chills and shaking and I couldn't get warm. Also, for 2 days after the injection, the muscle in my lower arm hurt when I used it.
Persistent usual disturbances both eyes. Gray, cloudy vision, many tiny dots, impaired depth perception. All vision tests ( 4 so far) show normal, healthy eyes.
Per mom, patient went home, start complaining of left knee pain and then notices swelling of left knee (no swelling/tenderness of thigh where Iz was given).
diagnosed with COVID-19 /tested positive for COVID-19; This is Spontaneous report from a contactable consumer. This consumer reported similar events for herself and 1 patient (her husband). This is a 2nd of two reports. A 52-years-old male patient received the first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 10Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever on 15Mar2021, then the patient felt worse and had to go to a hospital, where he was diagnosed with COVID-19 and was prescribed medicine for the chills. The patient diagnosed with COVID-19 /tested positive for COVID-19 on an unspecified date in Mar2021. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350781 same product and event, different patient
Employee complained of not feeling well.  Rapid tests done on 1/3/22 and 1/4/22 with positive results received for both
gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients).    No concomitant medications were reported. No treatment medications were reported.
covid vaccine (Moderna) at noon on wednesday, by 11:00pm got severe chills, overnight had severe uncontrollable diarrhea, very light headed.  while taking shower passed out and fell, although that was just momentary (no injuries).   laid up in bed two days, finally felt good enough to get out of bed friday night.  symptoms indicate flu, but coincidence 10-11 hours following vaccine???
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA012254: US-009507513-1807USA012255: US-009507513-1807USA012263: US-009507513-1807USA012262: US-009507513-1807USA012261: US-009507513-1807USA012260: US-009507513-1807USA012259: US-009507513-1807USA012258: US-009507513-1807USA012264: US-009507513-1807USA012256: US-009507513-1807USA012253: US-009507513-1807USA011606:
Directly post vaccine nothing happened.  8 hours later L arm pain began, then the arm became cold, then the arm became almost entirely numb.  After this generalized body aches, rigor and fever.  After this L jaw pain, Chest pain - more like a squeezing feeling,  7:10 (rating) shortness of breath and sustained heart rate of 140 continued for 6 more hours.  Blood pressure stable. By the morning fever and cardiac symptoms resolved, with expected considerable fatigue.  I am a healthy active 30 year old who enjoys hiking.  I could not make it to my tylenol due to rigors, otherwise the effects might have been better mitigated.  48 hours post vaccine, full return to baseline.
Myasthenia Gravis; 52 year old patient has a prescription for Bexsero/received the vaccine before but will need to have it again; This case was reported by a other health professional via call center representative and described the occurrence of myasthenia gravis in a 52-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced myasthenia gravis (serious criteria GSK medically significant) and intercepted drug prescribing error. On an unknown date, the outcome of the myasthenia gravis and intercepted drug prescribing error were unknown.   It was unknown if the reporter considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pharmacy student. The age at vaccination was not reported for dose received and not applicable for another dose. The patient had previously received a dose of Bexsero and had myasthenia gravis and would be taking treatment that would wipe her immune system out. The pharmacy student stated that the 52 years old patient had a prescription for Bexsero but not yet received, which led intercepted drug prescribing error. Health care professional also mentioned that the patient received the vaccine before but would need to have it again since the treatment would affect her immune system.  The reporter asked that it was okay to administer the vaccine to this patient since she was out of the age range. It was asked to the health care professional if she knew when the patient received Bexsero previously since she stated that she had myasthenia gravis, but she did not have any additional information as the patient was new and just happened to bring the prescription in. The reporter consented follow-up via postal.
Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified) who in October 2007 ("last week"), was vaccinated IM with a 0.5 ml dose of Gardasil.  Following the vaccination, the patient fainted, and received unspecified treatment in the office.  At the time of this report, the patient had recovered from the event (duration not specified).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a registered nurse, concerning a 23 year old female college student with no medical conditions, who  25-OCT-2007, at 3:00 PM, was vaccinated IM in deltoid with the third dose, 0.5 ml. of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Immediately following the vaccination, the patient felt lightheaded (previously reported as fainted), and had to lie down for 15 minutes. At the time of this report, the patient had recovered from the event. Additional information is not expected.
fever; fatigue; chills; headache; This is a spontaneous report from a contactable Other HCP. This 26-year-old male Other HCP (patient) reported that a 26-years-old male patient started to receive bnt162b2 (BNT162B2; brand=Pfizer, lot number=EH9899,dose number=1), via an unspecified route of administration from 25Dec2020 17:15 to 25Dec2020 17:15 at SINGLE DOSE at vaccine location of Left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination, the patient was diagnosed with COVID-19). Patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced fever, fatigue, chills and headache, all on 26Dec2020 09:00 AM with outcome of recovering.  No treatment received for events. Event reported as non-serious.  Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 was not tested post vaccination
MODERNA 2/ (06/30/21 Date) MODERNA 1 (05/28/21)
Broken out with rash from neck down to top of knees front and back, looked like polka dots some were raised.  Fever was not taken but mom states really hot to touch.  Gave him childrens Motrin a few minutes after 6 am.  Fever broke a while later.  The rash lasted 24 hours.  Once fever free rash went away.. since this day runny nose and cough.  Has started headstart on the 15th of Sept.  His Dr was called on 9-15-11 and was told to bring him right away, once mom arrived with shot record from health dept drs office refused to see child told him to take him to the health dept that the child received shots at.
This spontaneous report as received from a 65 years old female patient refers to herself. On 10-AUG-2012, the patient received a dose of ZOSTAVAX (lot #, dose, frequency and route not provided) vaccine, at a pharmacy (unspecified) and then on 17-AUG-2011 she got an eye infection, lasting a month, recovered on approximately 17-SEP-2011. On 21-MAR-2012, she got a second eye infection. The patient at the time of the report was experiencing a third infection approximately in October 2012. The patient was treated with acyclovir, BESIVANCE, ZIRGAN and TOPAMAX. Labs diagnostics studies were not performed. The patient sought medical attention through an office visit. The final outcome of the events was unknown. The relatedness of the events with ZOSTAVAX was unknown. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE GUILLAIN BARRE SYNDROME PERIPHERAL NEUROPATHY 1/20/23 -- RECURRENCE OF SAME SYMPTOMS
rashes all over my body/rash comes and goes; hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt; sensitive skin; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt), SENSITIVE SKIN (sensitive skin), PRURITUS (itchy) and RASH (rashes all over my body/rash comes and goes) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 047A21A. and 012A21A) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] and SPIRONOLACTONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt), SENSITIVE SKIN (sensitive skin) and PRURITUS (itchy). On an unknown date, the patient experienced RASH (rashes all over my body/rash comes and goes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of several weeks everyday. In 2021, PRURITUS (itchy) had resolved. At the time of the report, URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt) and SENSITIVE SKIN (sensitive skin) had not resolved and RASH (rashes all over my body/rash comes and goes) outcome was unknown.            This case was linked to MOD-2021-404415, MOD-2021-404394, MOD-2021-404415, MOD-2021-404534, MOD-2021-404423 (Patient Link).
Headache, nausea, vomiting, diarrhea, tired, sleepy
Patient was given his 6 month vaccinations on November 19, 2001.  These included Dtap, Hib, IPV, and Prevnar.  That afternoon he developed a fever.  The fever did not go away in the next couple of days so I took him to see the doctor.  I was told he had a virus and he would recover in the next couple of days.  He did not and his fever reached 105.  We took him to the ER where he recieved an antibiotic injection.  We were then referred back to his pediatrician.  The pediatrician referred us to the pediatric oncologist.  After many tests and referral to another oncologist, patient was diagnosed with AML, acute mylogenous leukemia.  He recieved 6-7 months of chemotherapy treatment, having to stay in the hospital during that time. He has finished chemotherapy and is now in remission.  There is a 50% chance the cancer will return.
Essentially he had local swelling and pain. Over the subsequent hours some malaise and noted hypotension/tachycardia. Pressures as low as  97/60 after showering with pulses between 100-120 with fatigue. Following day 6/8 pulse and no in normal range but feeling ?wiped out?. 130am 100/64 p 76. Following 6am 107/69 p 72. 7am 128/65 after 120pushups and 20 sit-ups 128/65 p 89. Rest of day felt fine but wiped out. By 6/9 back to normal
None, patient was physically fine and expressed no pain or discomfort after vaccination. Patient was accidentally given a second Pfizer booster when it should have been a Flu vaccine. Patient was informed of the misdose and then still consented and received the Flu vaccine in the same arm, per request, after the Pfizer dose.
Clinic/MD visit on 6/5/2010. Fever and rash on left arm after receiving vaccines on 6/3/2010. MD findings on 6/5/2010 Visit: Pustule on right tonsil. Left shoulder slight redness, no induration.
I received the first Covid vaccine (Pfizer) on 3/24. A week later I started to feel very ill; chills, low grade fever, fatigue, sweaty, head ache in the middle of my face, muscle aches, fuzzy thinking, and later a cold sore. I started taking Tylenol and stayed home from work. It has persisted over the past 4 days but I started to feel better yesterday.
Classic varicella. Child got vax, and exposed to babysitter with shingles.
Patient experienced pain, swelling, redness at injection site starting 1 day post administration; swelling and redness moved down her arm over the next two days and is currently about 4 inches from injection site. Patient also reports chills, fatigue and general malaise.
Fever of 102.5 for about 18 hours, did not respond to Tylenol.  Post herpatic neuralgia  in head for about 72 hours after vaccine. Missed one day of work because of high fever.