chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Jul2023 to 19Jul2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea, vomiting, diarrhea, low-grade fever (99.9 degrees Fahrenheit) intense migraine, extreme muscle pain, brain fog, going back and forth between insomnia and exhaustion, intermittent neuropathy primarily in feet/toes
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with an unintended extra dose of M-M-R II (exact dose, therapy type, route of administration, lot number and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire.  It quickly spread over entire body.  I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb.  PCP office told me to hang up and go to the nearest emergency room.
Every time I have gotten my Covid vaccine within 12 hours my asthma flares typically day two I?m already at an urgent care or somewhere being taken care of and receiving oral steroids. I have to use my albuterol rescue inhaler more which is every four hours. I started the prednisone yesterday and had to call out of work today cause I was coughing too much
Pericarditis, started 2:10 am 11/2/21 with severe chest pain. Diagnosis and treatment at Cardiology emergent walk-in care
Pt woke from a nap on 5/17/01 with 10-15 water blisters on abdomen, gradually increased spots until 5/19/01 with a total of 50-60 spots. Now all gone. Afebrile.
States she developed leg pain 6 days after shot and didn't think it was anything to worry about until she saw the J&J blood clot news and decided to get checked. Had appt and ultrasound on 4/19/2021 with NP.  Found to have two non-occlusive, small blood clots in the right leg.
Case previously recorded as MA2009-4553. Initial case report received from a nurse via agency, on 18 NOV 2009. A patient 06-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use is unexpected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008426.
bad reactions to the Moderna vaccine; she was so itchy; She felt like she was going to die; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die) in a female patient of an unknown age 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 VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die). At the time of the report, VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications are provided by the reporter. patient stated that after the first dose, the caregiver was in the hospital.   This case was linked to MOD-2021-387480 (Patient Link).
1 yo received Varivax vaccine on 11/23/04 came in 12/9/04 with 3 days h/o small vesicles at area of vaccine administration, seen 12/23/04 healing lesion no problem.
Mom stated 14MAR93 appt, pt had screaming episode p/immun given on 11JAN94; mom unable to console pt, took to ER; ER MD told mom it was a react to DTP; gave pt med to calm down;
Chills, body aches, headache, itchy arm at injection site - lasting 24 hours
Myalgia, Fever, Shaking for several hours, lightheadedness Narrative:
Red at the injection site; Minimally warm at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site) in a female patient of an unknown age 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 VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site) outcome was unknown.        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 relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client developed anaphylactic rxn within 10 min. of receiving vaccines-AEB hives, flushed skin, blood shot eyes, bronchospasm, cough and tightness in throat. ER protocols initiated per health dept policy as well as doctor and immunization supervisor notified. At 11:30 AM 0-8 ml of Benadryl given at 11:45 am 0.4 ml of Epi given by RN. CT discharged to hosp in good condition for further follow-up. 8L of O2 per NC was initiated at 11:35 am. Vitals monitored throughout.
Tested Positive for Covid19 after receiving the Covid vaccine.; little bump and a little redness on the left arm; little bump and a little redness on the left arm; Tested Positive for Covid19 after receiving the Covid vaccine.; This is a spontaneous report received from a contactable consumer.   A 64-years-old female patient (consumer) received first dose of BNT162B2 (Solution for injection), (Batch/Lot Number: LOT:ER8727), on 23MAR2021 at 10:40 (24 hour clock) and second dose (Batch/Lot Number: LOT: EP7533.) on 13Apr2021 at 09:00 via an unspecified route of administration as a single dose for covid-19 immunisation. The medical history of patient included Hypothyroid (ongoing), Cholesterol (ongoing). The Concomitant medications included Hypothyroid Pill (ongoing). The patient reported little bump and a little redness on the left arm from 13 Apr2021 (ongoing). The seriousness for little bump and a little redness on the left arm was unspecified. Patient further explained she had 4 negative tests for Covid19 after that, this past Tuesday, 13APR2021, she had her second shot. At same time, she had a test done for Covid19 on that day. Patient received the results and they said she was positive for Covid19 (13APR2021). Patient was wondering if because she had the virus in her system [from the vaccine] if that is what caused her to test positive? patient stated she had no fe-ver, no headache, or any symptoms. She just had a little bump and a little redness on the arm and got the vaccine, no pains or nothing. patient was wondering if because she already had the first vaccine, if when they did the test at same time as she got the second shot, did that cause her to test positive? Patient wants to know what she should do?  Patient reported usually sleeps on that arm and maybe she was pressing to hard on it. Patient did not received any treatment. Also patient did not require any visit to emergency Room and Physician Office. Patient further reported description of productcom-plaint: Patient stated she tested positive for Covid19 on 13APR2021, the same day she received her second dose of the vaccine. The outcome of the event was unknown.  Follow up attempts are required. Further information was expected.
Myalgias, maculopapular rash on thighs. Treatment: BENADRYL, TYLENOL, Ibuprofen.
Nausea following administration of vaccine; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 17Mar2021, at 10:45 as single dose for covid-19 immunization when the patient was 54-yeasr-old.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications  included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took BNT162B2 for covid-19 immunization as dose 1 on 23Feb2021. The patient experienced nausea following administration of vaccine on 17Mar2021, at 11:00.  No  treatment was received for the adverse event.The outcome of event was recovering.
Administered 1mL doses instead of 0.5mL dose; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered 1mL dose instead of 0.5mL dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, after vaccine administration, the nurse called to report that the patient had been administered a 1mL dose instead of 0.5mL dose of the vaccine. No side effects were reported due to the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered 1mL dose instead of 0.5mL dose, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose of vaccine administered (1ml instead of recommended 0.5ml).  The event occurred on 29 Dec 2020 during the administration of first dose of mRNA-1273. The patient did not have any side effects. The sponsor considered the event as not related to mRNA-1273.
On 11/18 patient received the bivalent booster instead of the initial dose for Pfizer. Patient was scheduled today for 2nd dose which it is how we found out patient was given the  wrong vaccine. Patient was scheduled with Dr., speaking to mom at patients visit today, mom stated that patient did not get  an adverse reaction after receiving vaccine and patient was fine.  Dr. asked mom that if she would like her son to start the series and mother declined.
administration of an expired vaccination with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA295989(CLUSTER).  This case involves a 100 years old male patient where reporter reported administration of an expired influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received 0.7 ml TOTAL dose of suspect influenza quadrival a-b high dose hv vaccine (lot- UT7733CA and expiration date- 30-Jun-2023) via intramuscular route in the left arm (formulation, strength: not provided) for Immunisation (expired product administered) (latency- same day).  Reporting expired doses of FLUZONE HIGH DOSE QIV were administered to 2 patients, husband and wife. Caller reporting she didn't think they even had any doses left from last year in stock but a new MA administered the doses.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
STROKE; This spontaneous report received from a social media 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, route of admin not reported, batch number: Unknown) dose, frequency one total ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. no concomitant medications were reported. The consumer reported that, patient experienced stroke 4 weeks ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504221-covid-19 vaccine ad26.cov2.s-stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
8 hours after the second vaccine dose, I suddenly experienced body aches, chills, and a fever. This lasted throughout the night (lasted 24 hours after vaccine administration). I had a lot of trouble sleeping due to the pain and temperature fluctuations (I would wake up hot and sweating, then an hour later cold and shivering, multiple times throughout the night). I treated the symptoms with Acetaminophen 500mg throughout the evening and the day after. The day after (24 hours later), I was fatigued and had stomach pains, with not much of an appetite.
Developed cellulitis at injection site. Inflamation (size of palm), redness and warmth to the touch were noted day 8 after the injection.
Patient returned 2days after Iz's given. Presented with fever & bulging fontanal. Sent to hospital to R/O meningitis, MD stated reaction to vaccine.
This spontaneous report as received from a Registered Nurse, refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. The reporting nurse stated that she was informed by some of her friends and colleagues, that an unspecified number of their children developed beginning signs of autism (some of them noted differences with eye contact and smiling with their children), on unknown dates after receiving M-M-R II (dose, route, lot numbers and expiration dates were not provided). No concomitant medications were reported. The reporter stated that some of her friends and colleagues decided not to continue with a second dose of M-M-R II, and that some of those parents noticed that their children "snapped right back". This is one of several reports from the same reporter. Additional information has been requested.
Noticeable swelling, warmth, and pain localized to injection site.   Naproxen and ice pack.
I dropped a considerable amount of weight; headaches; weakness; diarrhea; experience stomach pains; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 10:00 AM (Lot Number: ER8735) as dose 2, single (at age of 18-years-old) for covid-19 immunisation. No pregnancy at time of vaccination. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0179) on 04May2021 11:00 (at age of 17-years-old) in Arm Right for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced Drug allergy. On 27May2021 07:00, the second day after receiving the shot, she began to experience stomach pains. On 28May2021 (the third day after the shot) the that symptom increased in strength and transitioned into severe diarrhea. In addition, she also began to suffer from headaches and weakness. She dropped a considerable amount of weight, approximately 10 pounds well experiencing the diarrhea. The events were not received treatment. Since the vaccination, the patient had been tested for COVID-19 included rapid test: negative (nasal Swab) on 28May2021. No Hospitalization Prolonged. Outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Parents (mom & dad) came to the clinic 10/9/09, reported & was concern that child had possibly a flu vaccine reaction with on & off slight nose spot bleed 3 days post vaccine & up to now. Moved from elsewhere 9/2/09. Advised to go to PMP. States no previous reaction on flu vaccine from that region.
My doctor said I have shingles; I had pain around the side of my back. It woke me up out of my sleep. It was right around the corner from the rash under my boob; I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them; I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them.; horrible sore throat, didn't feel good for several days; horrible sore throat, didn't feel good for several days; very bad neck ache; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (very bad neck ache), FATIGUE (extreme fatigue), OROPHARYNGEAL PAIN (horrible sore throat, didn't feel good for several days), FEELING ABNORMAL (horrible sore throat, didn't feel good for several days) and RASH (I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them) in a 73-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.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced NECK PAIN (very bad neck ache) and FATIGUE (extreme fatigue). On 03-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (horrible sore throat, didn't feel good for several days) and FEELING ABNORMAL (horrible sore throat, didn't feel good for several days). On 04-Feb-2021, the patient experienced RASH (I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them) and BLISTER (I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them.). On 05-Feb-2021, the patient experienced BACK PAIN (I had pain around the side of my back. It woke me up out of my sleep. It was right around the corner from the rash under my boob). On 08-Feb-2021, the patient experienced HERPES ZOSTER (My doctor said I have shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency. On 24-Jan-2021, NECK PAIN (very bad neck ache) and FATIGUE (extreme fatigue) had resolved. In March 2021, BACK PAIN (I had pain around the side of my back. It woke me up out of my sleep. It was right around the corner from the rash under my boob) had resolved. At the time of the report, OROPHARYNGEAL PAIN (horrible sore throat, didn't feel good for several days) and BLISTER (I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them.) was resolving and FEELING ABNORMAL (horrible sore throat, didn't feel good for several days), RASH (I first noticed the rash under my left breast. It was 2 or 3 circles with a blister in each of them) and HERPES ZOSTER (My doctor said I have shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
left deltoid became red, warm, swollen, hard to touch around localized area of injection site about 2 hours after vaccination. Ice/cold pack applied. approx. 3 hours later, entire left upper arm was red, hot, swollen, hard to touch with itching present. employee stated like her arm was becoming tighter and felt hot and started intensely itching. employee took a Benadryl 25mg and APAP 650mg PO. several hours into reaction the swelling, redness, warmth, hardness spread to her left forearm. this caused moderate-severe pain/discomfort. on the next day, this nurse checked in with employee. left upper arm/forearm remains swollen, not as red/swollen. but reaction is still present.
It began with sudden fatigue around 5:15. By the evening I felt ?high? for lack of a better word. I was feeling odd. I woke up in the middle of the night with a fever, major chills, and a strong headache. I spent all of today dealing with what feels like the flu and that I was punched in my arm all the way to the bone.    I think it is getting a little better but right now I?m lying in bed in the dark with a winter coat.
Extremely sore arm at the injection site, ice applied, minimal relief. Took ibuprofen x 2 days. The 3rd day, my arm was fine, but I experienced extreme fatigue, no energy, and actually had to take a nap!! By day 4, I was fine.
pt recvd vax; pt vomited & was irritable; devel t102.3 lasting 24 hrs