chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like a very bad cold, fever, severe headache, sweats, ache and pains. Unable to sleep for past two nights. Unable to do normal daily activities.
Patient was given her first dose (0.5 ml) of Monovalent Moderna on 10/10/22.  Best use by date of vaccine was 10/8/22.  Vaccine had been in refrigerator since 9/8/22. Patient has reported no adverse effects.
dizziness/vertigo since vaccination. hospitalized in April after finding viral cardiomyopathy/viral myocarditis that caused a new left bundle branch block.
it is still affecting him (Bell's palsy), his lip is still paralyzed; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided, expiration date: Jun2021) at the age of 66-years-old, via an unspecified route of administration on 27Feb2021 at 14:00 at single dose for COVID-19 immunization. Medical history included diabetes, high triglycerides, and allergy to beef product. Concomitant medication included lisinopril and ongoing unspecified medications. He did not have any other vaccines within four weeks prior to the COVID vaccine. The patient was administered with COVID vaccine in a pharmacy or drug store. The reporter stated that they read quite a bit about Bell's palsy affecting some people after the second COVID shot but the patient experienced Bell's palsy after his first COVID shot on 04Mar2021 at 06:00 and it was still affecting him, his lip was still paralyzed. This required a physician office visit and the patient was treated with an antiviral drug that did not work therefore he was prescribed prednisone on 14Mar2021. He is supposed to get his second COVID shot on Saturday, they were concerned as far as to whether it was safe for him to get the other shot. The patient underwent lab tests and procedures which included triglycerides which were high on an unspecified date; and blood sugar on an unspecified date and blood work for diabetes on 03Mar2021, both with unknown results. The outcome of the event was not recovered.   Information about lot/batch number has been requested
Extreme fatigue, dizziness, confusion, pins and needles in extremities, rapid heart rate, swelling in feet and ankles
Child received DTaP #4, Hib #4, PCV7 #4, MMR #1 approx. 2hrs after immunization, mother called to report child vomiting. I sent pt to ER. Pt was given treatment for emesis. The next day mther and father both ill with nausea and vomiting. I do not believe this was an adverse reaction.
10/31/23 evening developed weakness and thought process slowed down. 11/01/2023 two episodes of diarrhea, continued with weakness.  Fell that evening and spouse unable to get up.  Was sent by 911 to Hospital ER were he was later transferred to another Hospital.  Was discharged to home late 11/02/23.  11/03/23 received call from spouse who gave these details.  11/3/23 continues with weakness and is slightly aware of what has occurred over last 2 days.
Patient had pain @ injection site (L deltoid) immediately at base of shot.  it continued and the next day she developed a hematoma. The pain increased over the next few days and radiated down her arm and into her shoulder and neck. Seen in ED and given evaluation last pm.
BUMPS, LIKE PIMPLES; PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis and Psoriasis vulgaris.    Concomitant products included OMEPRAZOLE for an unknown indication.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP). At the time of the report, SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP) outcome was unknown.        This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient had liked to get medication delivered early to make sure took it on time. patient was receiving SKYRIZI for about a year since 2020 and it had been worked really well.  After that patient started getting bumps like pimples, itchy scalp and only get psoriasis scalp since Jul 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Migraine headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: valcyclovir. Past adverse reactions to the above products included Migraine with valcyclovir. Concurrent medical conditions included Coronary artery disease, Asthma and Drug allergy (No drugs were reported.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 20-Nov-2019 to 07-May-2022, LISINOPRIL from 20-Nov-2019 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 20-Nov-2019 to an unknown date for an unknown indication.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 1:00 PM, the patient experienced MIGRAINE (Migraine headache). The patient was treated with PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at an unspecified dose and frequency; SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headache) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously receive a COVID-19 Vaccine.
product leaked out from an unknown area and ran down the nurse's arm with no reported adverse event; Initial information received on 25-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 64 years old female patient, the product leaked out from an unknown area and ran down the nurse's arm  with no reported adverse event while receiving vaccine rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Feb-2022, the patient received a dose of suspect rabies (HDC) vaccine at a dose of 1.0 ml total once (strength, formulation: unknown) (lot U18392M; expiry date: 14-APR-2023) via unknown route in unknown administration site for Product used for unknown indication.  On 22-FEB-2022, the product was leaked out from an unknown area and ran down the nurse's arm  with no reported adverse event (occupational exposure to product) (latency: same day) following the administration of rabies (hdc) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .
Pt vaccinated w/Engerix-B non-responder to vaccine 3 doses given. No anti-HBS.
Pt recv vax on 1/18/99;  within several hr pt exp hives
Woke up 1145pm freezing shivering my whole left side from my neck to my foot was bothering me  my left arm is extremely sore all the way to my hand then after freezing I sweat through my pajamas on april 12 7 am I called out of work I was still extremely uncomfortable in pain with headache dizziness nasua weekness neck and body pain throughout my left side and a low grade fever very tired.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 12-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of GARDASIL (LOT# not reported). The reporter said the patient experienced an AE involving GUILLAIN-BARRE Syndrome-like symptoms. Additional information has been requested.
Hives, red raised large spots in a cluster around injection site. Benadryl given and patient monitored in office.
The pain started at 9:00 pm, a 4 on a pain scale of 1-10. By 1:00 am I could not sleep at all; the discomfort had shot to an 8 with a radius of pain around the injection site and arrows of pain that shot down my arm to my wrist and up to my neck. I had lost most of the movement in my right arm. Raising my arm no more than 10 degrees triggered intense pain. I research Covid vaccines and learned that the shot should be administered with the needle going into the arm at a 90 degree angle. My vaccine was administered at almost the top edge of my shoulder! I waited until 8:00 am to take 400 mg of Advil to keep it from inhibiting antibodies. I took more every six hours until this morning when my pain toggled between an 8 and a 9, and it was clear that the Advil wasn't working.
Information has been received from a certified medical assistant concerning an 18 month-old male patient with allergies to amoxicillin and has no other allergies, who on 15-Apr-2003 in the AM was vaccinated IM in the right upper thigh (also reported as right leg top) with a fourth dose of Haemophilus B conjugate vaccine (Lot #641690/1307L). There was no concomitant injections given to the patient in the right thigh on that day, 15-Apr-2003. It was noted that the patient's mother had reported to the physician's office that beginning on 16-Apr-2003 (also reported by medical assistant as 18-Apr-2003), the patient had a reaction to the top of right leg, which was described as the area was black and blue, hardened, hot to touch, red, swollen, which was described as "he had swelling at the site, that "traveled" to the hip area, and he "ran" a fever. It was reported the mother also stated, the leg was sore to the point the patient "couldn't walk" on the leg for a day due to swelling. The medical assistant stated, the physician had instructed the mother to treat the patient's area with cool compresses. On 17-Apr-2003 the patient's mother called the physician office and reported the patient's fever had resolved. the patient could now walk on his right leg, and the "site reaction" was improving. It was noted there were no laboratory tests performed and the patient had not had adverse events following prior vaccination. The certified medical assistant reported the patient has since recovered from all of the adverse events reported. Unspecified medical attention was sought. Additional information is not expected.
No A/E.   Vaccine  was   stored  in  freezer  for  30 days
No additional adverse effects reported; a patient was administered improperly stored M-M-R II; Information has been received from a immunization official who was also a nurse referring to a 4 years old patient of unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not provided.       On 27-JAN-2020, the patient was administered improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose, frequency and route were unknown;  lot # S004118 and expiration date 11-FEB-2021) for prophylaxis. The vaccine was exposed to temperature excursion above 9 degrees Celsius (10.9 degrees Celsius) for 8 hours and 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with sterile diluent, which was unknown if there was previous temperature excursions. No additional adverse effects were reported.
about 10 mins after the vaccine I had  hot flashes started in my feet and went through my whole body ,  dull headache. It didn't last but a few seconds.  the headache lasted a couple hours. I went to the ER for further monitoring and checked blood pressure and vitals for two hours and released me.
17 year old patient received the first dose of Moderna COVID-19 vaccine; Slight arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt attempted to stand up a minute after the shot, lost consciousness, and fell over sideways onto the floor.  I yelled for my technician to call 911, grabbed my emergency kit and ran over to him, checked his breathing and pulse and pulled him onto his side.  He opened his eyes during this time and began to apologize for falling.  He continued to lie down for about 5 minutes, then was helped to a chair.  At that point paramedics arrived and began to ask him questions and check him out.  He walked out of the store a few minutes later with the paramedics.
Initial report received on 03/Jan/2006 from a consumer. A 71 year old male who received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1773AA, expiration date 30/Jun/2006, in the arm (site not specified) in October, 2005. Approximately six weeks later, the patient developed a loss of feeling in his hands and tingling in his feet. At an unspecified time later, he was admitted to the hospital for eight days and diagnosed with GBS (Guillain-Barre Syndrome). Per the reporter, the patient had recovered from this event at the time of this report. Follow-up information received from a health care professional on 24/Jan/2006. It was reported that the patient received the FLUZONE vaccination on 25/Oct/2005 at 1:35 PM. It is unknown whether the patient had any relevant diagnostic or laboratory testing. As per the reporter, the name of the responsible physician that was provided by the patient's wife is unknown at that facility. No other information was provided at this time.
felt little bit achy; temperature elevated; numbness at the chin; heart beat raising; weakness in the legs; tightness in the throat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr viraemia, Pericarditis, Allergy (Allergy to boric acid), Allergy (Allergy to Tagamet) and Dizziness since 22-Jan-2021.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature elevated). On 23-Jan-2021, the patient experienced PAIN (felt little bit achy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea), PAIN (felt little bit achy) and BODY TEMPERATURE INCREASED (temperature elevated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a medical assistant refers to a 17 year old female patient. On 21-JUN-2013 the patient was vaccinated with GARDASIL dose 1 (route, site and lot number not provided). Concomitant therapies included PPD tine test and MENACTRA. On 21-JUN-2013, the patient had a seizure, fell and hit her head, also fainted and fell and subsequently hit her head. The patient sought unspecified medical attention. It was unknown if this patient had received any further doses of GARDASIL. The outcome of the events was unknown. The causal relationship was not reported. Upon internal review, seizure was considered medically significant. Additional information has been requested.
Pt felt dizziness after receiving her first dose of immunization. Pt denied any other associated S/S of an anaphylactic reaction.
CUSTOMER CAME TODAY ( 9/25/21 ) AT 4:30 PM SAYING THAT HER ARM JUST BELOW THE INJECTION SITE IS RED AND HAS BLISTERS. SHE SAID THAT IT STARTED AT 8 PM YESTERDAY 9 9/24/21)  SHE RECEIVED THE VACCINATION AT 3;05PM ON 9/25/21.  SHE DOES NOT HAVE ANY PAIN OR ANY OTHER SYMPTOMS.  SHE IS USING ICE PACK AT THE SITE.
2 inch red indurated area right upper back arm. where Varicella vaccine given 2 days ago. No c/o, does not itch. Did not notice the area, mother pointed out to her it was red.
diarrhea for 2 weeks.  Tested for infection.  There was none.
This spontaneous report as received from a registered nurse refers to a 52 year old female patient with attention deficit disorder and allergy to BIAXIN, morphine and penicillin. On 20-NOV-2013, the patient was vaccinated with ZOSTAVAX in the right arm, (dose, route and lot number were not reported). Concomitant therapies included acyclovir (the patient might be taking acyclovir periodically), STRATTERA, lorazepam and CELEBREX. Approximately on 20-NOV-2013, after receiving ZOSTAVAX, the patient developed a puff, red area on her right arm at the injection site. Treatment was not given for the adverse events. Lab studies were not performed. The patient visited office to seek medical attention. The outcome of puffy, red area at the injection site was reported as not recovered. Causality was not reported. Additional information has been requested.
Administered additional dose of Pfizer vaccine, resident was eligible for additional dose. No negative outcomes observed (no signs or symptoms of adverse event).
1/19/21:  ER visit for evaluation 1/20/21:  Hospital admit due to increased confusion and possible sepsis. Principle Problem listed: Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction; Acute encephalopathy SIRS likely due to COVID-19 vaccine but no current evidence of acute infection. Her acute encephalopathy is likely due to her SIRS response in the elderly and does not require acute intervention other than support.
Rash on palm of hands.  Small watery blisters that are uncomfortable, they dry up and skin flakes off a bit.   Both hands, outer edges and down towards the wrist area/middle.  Not in the center of my palm.  This has been continual since April.   It goes away, kind of,  then comes back.  This has been ongoing ever since shot#2.   Fresh blisters weekly or every two to three weeks.  Came down with Shingles as well in mid August.  Got a prescription for that 5 days into it. I had not had my Shingles vaccine yet.
Patient experienced severe acid reflux exactly 4 days following her first dose of Moderna vaccine.  She has never experienced that in the past and is currently not on any other medications.  She also tried to alleviate the problem with over the counter Tums and Pepcid, but neither worked.  The reflux went away a day or two later, but then she again had severe acid reflux/heartburn exactly four days after her 2nd vaccination.  Both time it occured exactly four days after her vaccine of Moderna, and never before had she had this issue.
Patient received vaccination at CVS, felt nauseous, dizzy, chest pressure, palpitations for 1 hr. Patient brought to ED reports similar symptoms, but improved.
pt recvd vax & was transferred to a hosp for observation; No further details were provided; It was felt that this report should be included in periodic submission becuase the pt was hospitalized for observation
Lost consciousness approximately 3 minutes after receiving first dose of vaccine. was feeling fine after vaccine until they stood up.; This is a spontaneous report received from a contactable consumer (patient). A 17-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153, expiration date unknown), via unspecified route of administration in left arm on 05Apr2021 at 11:30 AM at a single dose for COVID-19 immunization. The medical history was not reported. Patient did not receive any other vaccine in four weeks. No allergies to medications, food, or other products No known allergies. Concomitant medications included birth control pills (other medications in two weeks). On 05Apr2021 at 11:30 AM, the patient lost consciousness approximately 3 minutes after receiving first dose of vaccine and was feeling fine after vaccine until they stood up. Treatment included the emergency room/department or urgent care, treatment was EKG, concussion test. No covid prior vaccination. There was no covid test performed post vaccination. The patient considered the event as non-serious. The patient recovered from the event on 05Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.