chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sickness; Hot flashes; Flu; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HOT FLUSH (Hot flashes) and INFLUENZA (Flu) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes) and INFLUENZA (Flu). At the time of the report, ILLNESS (Sickness) and INFLUENZA (Flu) outcome was unknown and HOT FLUSH (Hot flashes) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drugs not reported. No treatment medication information provided.
took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.) 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 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.) had resolved.            Relevant concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Non-significant follow up added.
Blisters, rash, burning sensation, itchiness all over body except face. Blood pressure at 240.  Started off with little red dots all over body after the first shot.  Went into a urgent care to see if it was safe to get the second shot.  Was told ?yes?.  After second shot?it attacked the body.  Went to ER and was hospitalized.
This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, and rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.The patient was recovering from injection site pain. This report was non-serious.
pt recv vax;devel severe d; was tx w/ sulfamethozole-trimethoprim;also devel dehydration & poss going to be hosp;f/u info indicated that pharmacist felt report to be a personal question, not an adverse exp report;
brain fog; couldn't do anything; fever subsided; 102°F fever; chills; tired; light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), PYREXIA (102°F fever), CHILLS (chills), FATIGUE (tired) and DISCOMFORT (couldn't do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (light headed) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (102°F fever), CHILLS (chills), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog). At the time of the report, DIZZINESS (light headed), FATIGUE (tired), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
around midnight patient experienced a "sharp pain in left arm", "whoosh over her brain", ringing in the ears, facial numbness, felt like she was drugged with a sort of "brain fog" Significant swelling in left arm.   Patient called 4-11-22 to report to pharmacist - she had called her physician and they instructed her to also call pharmacy.  Dr made her an appointment for next week. Patient still experiencing "brain fog" and trouble concentrating, ringing in the ears continues which is affecting sleep.
Developed Fever, chills, body aches, cough, sore throat and ear pain on 4/21. Started on Amoxicillin following telephone visit.  Fever persisted and was seen for cough/fever on 4/26 at which time work up was initiated for persistent fever and antibiotic changed to Augmentin.  Returned 4/30 due to continued fever, negative cause identified on previous blood tests. At visit had low BP with tachycardia and fever. New onset that day of conjunctivitis. Cough and L sided wheezing improved with albuterol.  Lab eval and ED referral initiated for fluid resuscitation in consultation with pediatric infectious disease.
This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
8-10 cm ovoid well demarcated raised red welt like reaction at site of Meningococcal injection site.
Patient inadvertently given DTaP instead of Tdap. Mom said patient had a little pain in her arm where shot was given, but arm is ok now. Mom notified of the error.
Started with chills during the night following vaccine. By the next morning (4-2-21) I had fever, dizziness, headache and nausea (some dry heaving). These symptoms continued most of they day. I took Tylenol for fever and headache.  Headache continued through the night into next morning (4-3-21).  Started feeling  better around 1:00pm (4-3-21)
Patient had a red, raised rash. Complained of itching, stiffness, and soreness. She also stated she had fever, chills, and a headache.
Patient began to experience breathlessness after receiving vaccine. His SOB continued to worsen. On the 13th, the patient reported to the ER.  The patient was discharged from the hospital with a diagnosis of CHF exacerbation
Death Narrative:  80 yr old metastatic lung cancer, had stopped eating, still wanted vaccine, Died on hospice service. no vaccine complications reported.
6 hours after I had vaccine I developed A fib which lasted for 3 hours before I converted. I haven?t had an episode of a fib in over a year.
My son received Varicella vaccination on Monday,June 2, 2008. The medical assistant administered it sub-cutaneously left UE. Within 24 hours proximal to the injection site, he developed a raised reddened area measuring 2.25 inches by 1.75 inches with a bright red center, warm to touch. The area was painless, and did not itch. Over the next 48 hours the area increased to measurements of 3.5 inches by2.75 inches raised with a bright red center measuring 0.75 inches by0.75 inches. The entire area was warm to touch.
pain of the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 19-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 09:15 (Lot number: EW0162) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2021, outcome "recovered" (2021), described as "pain of the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination and was not tested for COVID since the vaccination. No treatment was received for adverse event.  No follow-up attempts are possible. No further information is expected.
After injection, there was bleeding and it stopped after pressing a cotton. The patient fainted when she saw blood on cotton ball
Developed folliculitis on opposite axillary area - not an accidental inoculation. Developed 1+ pitting edema, rash (possible vasculitis or erythema multiforme) on both lower extremities. Flattening of T waves on EKG - new EKG 6/26/03, old EKG 2/27/03 - no other cardiac symptoms - no shortness of breath or chest pain.
Subsequently post vax, the vaccinee experienced a severe itchy maculopapular rash all over his body. Additionally, he experienced a mild headache, and five episodes of abdominal pain which passed each time with a bowel movement. The vaccinee's symptoms were treated with Medrol Dosepak and Zyrtec.
Pt recvd a series of 3 Hep B vax given 12JUN89, 12JUL89, 13DEC89 respectively; 1st & 2nd doses were w/? Heptavax; 3rd dose was w/Engerix-B; Did not develop HBSAB; 4th dose given 27NOV90 & did develop antibodies;
The first two weeks after the vaccine I got severe muscle spasms that were pretty much all over my body but they were mostly in my back, I could not even stand up straight. I was 50/60 degrees, could not stand up straight. Also for like 3 days straight I just slept. The back spasms were the worst, they have gradually gotten better but not completely better. It progressively gets better, but is going very slow. I talked to my DR and my Rheumatologist several times  throughout this time and I saw my DR at least once every six weeks since this began and Rheumatologist once since this has happened. This started on 2/19/2021 and it is now 7/19/2021. My Internist put me on Prednisone and Valium and muscle relaxer. The Prednisone helped, I was given those medications at different times, about a month apart.
TEMP OF 104; SHAKING; WEAKNESS; BODY FELT ON FIRE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested  No concomitant medications were reported. On 08-MAR-2021, the patient experienced temp of 104. On 08-MAR-2021, the patient experienced shaking. On 08-MAR-2021, the patient experienced weakness. On 08-MAR-2021, the patient experienced body felt on fire. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp of 104, shaking, weakness and body felt on fire was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Dizziness for 10 minutes after shot. Generalized pain left side of her body from head to arm and back.
I did a home test on Monday morning. I couldn't tell if I had cold or flu or what. I had runny nose, sore ears, drainage, coughing a lot, I typically felt terrible. I called the internist after getting the positive test. He called in a script for PAXLOVID. My doctor had me to stop taking the immune suppressant until after I was over the illness. I started PAXLOVID on that Tuesday. I had immediate improvement. The PAXLOVID was wonderful. I am still dealing with fatigue, some cough and slightly tender ears. I ran a low-grade fever of around 101 which lasted until Thursday.
30 Mins after injection felt like I had consumed caffine, heart was racing.   1 week after the injection I still had migrains.  2 weeks after injection, injection site is still painful and the site has a bright red rash.
Tingling on face and arm on same side as injection site that started about 30 min after vaccination; Muscular twitch on face and arm on same side as injection site that started about 30 min after vaccination; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021(at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to medications, food, or other products. On 23Mar2021, 30 minutes after vaccination, the patient experienced tingling and muscular twitch on face and arm on same side as injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling and muscular twitch on face and arm on same side as injection site was recovered on 23Mar2021, on the same day.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
12/28/22 I started getting a cough and it got much worse. I went to the doctor a couple of times and ended up in the Emergency Room on 1/25/2023. I had bloodwork done and my eosinophils were very high. I had CT and MRI of my lungs and there was fluid in my lungs. I was hospitalized for two days and was treated. Two weeks later, I had an allergic reaction. My throat and tongue were swollen. I went back to the hospital on 2/9/23. I stayed overnight and was sent home with EPIPENs. We still have no idea what caused the allergic reaction.
not feeling well; headache; nausea; joint pain; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not a healthcare professional (HCP), but she works in a healthcare facility. She had received the COVID-19 vaccine on 07Jan2021 and she was not feeling well on an unspecified date. The patient was also asking what could she take for the headache, nausea, and joint pain on an unspecified date. She also asked if her regular doctor would answer her concerns considering she had been given the vaccine at the hospital. The outcome of the events "not feeling well, headache, nausea, and joint pain" was unknown.  Information on the lot/batch number has been requested.
Called Public Health (where treatment was authorized) 8/21 and c/o numbness, tingling, feeling "on fire" since "earlier" in the day. Advised PCP, who advised ED. Presented c/o light-headedness, SOB, Nausea, tingling and syncope. Responded to IVF and Zofran, discharged later in day. Denied similar Sx w/subsequent doses, and has since complete Rabies PEP series.
Case number PHEH2013US002664 is an initial spontaneous report received from a nurse practitioner on 28 Jan 2013, and with a follow up received on 15 Feb 2013. This case refers to a 40-year-old female patient. She was vaccinated only with Men CYW-135 component of MENVEO vaccine (batch number: M11042) at a dose of 0.5 ml intramuscularly into the left deltoid on 14 Jan 2013. No adverse event was reported following this drug administration error. Follow up report received on 15 Feb 2013. Updated patient initials, vaccination details.
During administration, patient jumped away from the needle, she felt like fainting.  Proceeded to black out.  Patient was warm to touch, sweating, eyes dilated.  After about 30 minutes of laying on her side on the floor she started to feel better.  She was capable of walking out to the car by herself.
I was felling a bit dizzy upon awakening the day after the vaccination. Once in the bathroom I became very dizzy and started sweating profusely. I tried to walk back to the bedroom but fainted. I came to sitting on the floor. My husband brought me some water and stayed with me. It took quite a while for those symptoms to subside enough that I could get up and go back to bed.  For the next 7 or 8 hours I felt chilly and somewhat tired. Normal by late afternoon and evening.
shortly p/vax mom was driving car home & pt was reading MMR booklet; suddenly dropped booklet head went back, face was pale, did not respond for a few minutes; mom able to drive to aunt's house where rested; c/o nausea;
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt came in to receive vaccine around 3pm on 4/27/21, Pharm.D. verifed  pt has had a rxn in the past to flu vaccine, which resulted in itching. Patient did not have any difficulty breathing or anaphylaxis from flu vaccine and did not require any extra treatment.  Pharm.D. req Patient  to stay for 30 minutes per protocol. At 3:15 rash appeared, Pharm.D. gave benadryl. stayed 30 mins from the benadryl dose. Developed anaphylaxis. required epipen at 3:53. ems arriv @4:10
Possible administration of vaccines that are past 'use by date'.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 31-Jan-2021, PAIN IN EXTREMITY (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by reporter.  No treatment information was provided.
Very bad headache; A little bit nauseous; the doctor that lives with her has Corona; stated that she has sore throat; has an eye doctor appointment; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date in 2021, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore throat; a little bit nauseous, she also stated that the doctor that lives with her had corona. On 31Mar2021, she had very bad headache. It was also reported that the patient has an eye doctor appointment on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the incorrect vaccine.  He received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and he received the correct Moderna Spikevax vaccine later the same day at 7:10pm.  No adverse effects were reported by patient.
The pharmacist administered the Pfizer covid 19 vaccine 2nd dose yesterday at 6:55 pm to this patient which the vaccine was about 1 hour 15 min passed its expiration time (should  be used within 6hours after diluted at room temp). I was reported  by  our technicians  about the incidence and  called Pfizer customer service today .  Per Pfizer customer service person they did not intend to recommend us to give the shot that was expired or had outside recommended temperature/time. However, she said according to their stability test, the efficacy won't be affected since it could be used within 24hours at room temp in a diluted vial after mixing.  I have tried to contact patient but she did not answered so I left message for patient to call us back. Patient does not have primary MD.