chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guttate psoriasis; This is a literature report.  A 58-year-old male patient received BNT162b2 (COMIRNATY), as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for COVID-19 immunization. The following information was reported: GUTTATE PSORIASIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event GUTTATE PSORIASIS and BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
mild numbness; ended up getting the flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who experienced mild numbness (hypoaesthesia) and flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included INFLUENZA VACCINE as prophylactic vaccination and patient had reaction to it.  The patient's medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious mild numbness (hypoaesthesia) and flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available on lot number for this case.
body temperature 39.5 - 40 degC (103 - 104degF); severe headache; vomiting; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 18:00 (Lot number: FA7484) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1,, lot number=EY0584,, administration time=05:00 PM,, vaccine location=Left arm), administration date: 15Jul2021, for Covid-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "body temperature 39.5 - 40 degC (103 - 104degF)"; HEADACHE (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "severe headache"; VOMITING (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "vomiting"; MYALGIA (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, headache, vomiting, myalgia.  Additional information- Lab data included body temperature 39.5 - 40 degree C (103-104-degree F) on 05Aug2021. Follow-up attempts are completed. No further information is expected.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Lot number: EP7533) at the age of 38 years as dose 1,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccinations: None. Concomitant Drugs: NA. Patient Medical History:  NA. Pfizer/BioNTech COVID-19 Vaccine Details:Dose: 1st Anatomical site of injection: Left arm. Side effects: First dose: No side effects only sore arm for 1-2 days.   No follow-up attempts are possible. No further information is expected.
Patient became dizzy within 15 minutes of receiving vaccine.  Went home, continued to feel dizzy. Tuesday: patient had black floaters during the whole day with migraine headaches, dizzy with movement.  Patient had ear ache Wednesday, dizzy, pressure in head.  Patient contacted physician Thursday as symptoms became worse - ear drops prescribed to patient.  Patient took 2 doses of ear drops (thursday night and friday morning) with no success in symptom relief.  Patient extremely dizzy - unable to even make small movements without stumbling and/or feeling nauseous d/t dizziness.
Pt. had severe vertigo, nausea and shaking after vaccine. Admitted to ER where BENADRYL was administered. Shaking stopped approximately 1 hour later. Patient also vomited. Symptoms started with 5 minutes of vaccine. She almost passed out.
Patient reported numbness to lips, fingers, bilateral feet . BP 167/87. Fire rescue was dispatch . Patient declined to go to hospital despite Provider strong recommendations.
Admitted on 5/30/07 after a 2 day history of vomiting, associated with low-grade fever and 2 bouts of bloody diarrhea.  Initial impression was acute gastroenteritis with dehydration.  While kept NPO, he still had one episode of emesis and one episode of watery, pinkish-brown stools which was positive for occult blood. An abdominal series showed signs of obstruction; an abdominal ultrasound diagnosed an intussusception.  The patient was transferred to Hospital on 5/31/07 for further management.  A bowel enema was performed, which was able to reduce the intussusception. The patient was discharged 24 hours after the procedure.  07/02/2007 Hospital records received from both admitting and transfer hospitals. Infant was initially seen and admitted for c/o bloody/mucusy stool and vomiting with each breast feed. PE significant for hypoactive BS, otherwise WNL. Infant transfered to another facility for management.     Intussusception was sucessfully reduced via Hypaque enema. Principal DX:  Intussusception.
This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient's concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician's office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.
I did not feel well the two days following the injection.  Was not the same "not feel" as after my first injection.  The following Sunday I started with an itchy rash on the back of my head.  By Sunday evening it was breaking out all over me.  Went to another PA in my PA's office on Monday and he felt it was a pityriasis rosea-like rash and prescribed 10mg  Prednisone on a  5 day plan.  Then this happened:   TUESDAY  I had some swelling and stiffness in the middle finger of my right hand in the am.  In late afternoon my right metacarpal joints swelled as well as some swelling in my fingers WEDNESDAY  when I got up I couldn?t close my right hand enough to grip or hold anything.  My left hand had some swelling.  Was better by afternoon.   At 8:30 pm I was sitting in our recliner and had difficulty getting up.  Shoulders, upper arms, elbows, wrist, hands and knees were all very painful and stiff. A couple hours later I also had some hand tremors and chills after I got out of the chair with the same pain and stiffness issues.  Had difficulty all night with pain and getting in and out of bed to go to bathroom.   Hard to get on and off toilet.   THURSDAY  AM was more of the same as the night before.  Difficult to dress, especially backward arm movements for a shirt because my upper arm muscles would ?lock up?.  Hung out on the couch all am. Was a struggle to rise from it.  By afternoon all symptoms had pretty much subsided.  I think this was the day I noticed the rash appearing on my hands and feet.  FRIDAY  Still some swelling and pain but much improved.  Still some difficulty with upper arm muscles. Slept well that night  SATURDAY     was having a pretty pain free day (and no upper arm muscle issues) until I sat down for supper @ 6:00, then my left hand locked up. . Had taken 8 hr Tylenol @ 2:00.  At 10pm my right hand started swelling and fingers locking up.  Took Tylenol before going to bed. SUNDAY  at 4 am my left hip started becoming painful and stiff.  No improvement in morning until around 9 my hip became more functional and late morning my right hand was a little more useful    The next day I saw my regular PA who was puzzled by my symptoms and concerned about lyme disease.   She did blood work and it all came back okay except a high CRP.   She put me on a 20mg 3 day plan of Prednisone.  They were to also refer me to a rheumatologist, but I've not heard from them.   I am today (Feb 6) much improved but still feel this was caused by the booster.   Not the injection itself, but my body's reaction to the building of antibodies to the antigens.
A non-serious spontaneous report of A 52-year-old female who got FLUMIST was received from a registered nurse concerning a 52-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-AUG-2009, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
On 11/6/2021 approximately 22 hours after receiving the shot, my wife passed out in the bathroom. When she came to she began vomiting. and  her eyes rolled back in her head and then her body began shaking violently. I sat her up so that she did not choke on her vomit and she began to come to herself. I put out an emergency call to our personal Physician and he directed me to take my wife to an Immediate Center to have her vitals checked as his office was closed due to it being Saturday. The Doctor there checked her vitals and advised her to stay in bed for the next few days and for her to drink Pedialyte Advance  Care.
Lower portion of my face went numb, nose down. Migraine for 3 days subsequent to vaccines. Tx was benedryl and water. I stayed longer for observation. No further symptoms
Swollen lymph nodes on left side of neck; Lymph node swelling on left side of neck was noticed on 13Jan2021 with some pain; Exposure during breast feeding; Dizziness; Arm pain; This spontaneous case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm pain), LYMPHADENOPATHY (Swollen lymph nodes on left side of neck) and LYMPH NODE PAIN (Lymph node swelling on left side of neck was noticed on 13Jan2021 with some pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Arm pain). On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side of neck) and LYMPH NODE PAIN (Lymph node swelling on left side of neck was noticed on 13Jan2021 with some pain). On 11-Jan-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding) had resolved. On 12-Jan-2021, DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Arm pain) had resolved. On 14-Jan-2021, LYMPH NODE PAIN (Lymph node swelling on left side of neck was noticed on 13Jan2021 with some pain) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on left side of neck) was resolving.        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.   No concomitant medications were reported.   No treatment information was provided.    This case was linked to MOD-2021-013243 (Parent-Child Link).   See case MOD-2021-013243 for details regarding the child case.
Mild nausea beginning 15 minutes after injection and lasting around an hour, some fatigue a few hours later, and mild headache intermittently in first five hours
Resolved suspected Guillain-Barre syndrome (mild). 12/07/2012 Mother is calling in. Pt got her 2nd dose of flu vaccine on Wednesday. Today she woke up "acting strangely". States she was a little fussy this AM but now is calm. She said she seems slow and uncoordinated and doesn't want to stand on legs. Asked mom if there is any local reaction (redness, swelling) or fever, which she denies. Mom wants to know if this is a reaction to the flu vaccine or something else. Please advise. Use TYLENOL or ADVIL for comfort, if not improving in the next 24-48 hours then needs OV. 12/07/2012 PC to mother; she states that patient is acting much more 'normal' after her lunch and nap; she will call if any further concerns. 11 mo healthy infant had received her 2nd flu shot 4 days ago. She has done well with all her vaccinations so far, the following morning, the mother found her acting a bit fussier, no fever, but seeming to not want to stand on her legs and was somewhat wobbling. She already has been crawling, pulling to stand and doing some assisted walking up to this point. She gave her TYLENOL and seemed a bit better that day. 3 days ago, she then refused to get up on her legs at all and drug them while crawling. She did not have fever. Her left thigh was the site of the shot and was not red or swollen. She was not having any obvious bowel or bladder changes (of course in diapers) and could still sit. Over the next 2 days she seemed to slowly improve and today is mostly back to her normal strength, will crawl, get up on her legs to pull to stand an do some assisted walking. Mom was wondering about her ears if they were infected causing her imbalance, or ringing in her ears. She is sleeping better at night as well. Concern after flu vaccination 10/6/12. For 2-3 days, grandparents and parents found her to be clumsier with her hands as well (this wasn't known per her visit in December), even not using her pincer grasp at the time. She also was not able to stand as well as she had been. She was pulling to stand and taking a few steps with assistance before the vaccination. This was her 2nd flu vaccination, she was back to normal strength when I saw her in the ov a few days later. She continues to progress normally with walking unassisted now.
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 10/28/21 and the second dose of Pfizer COVID-19 Vaccine on 11/17/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Patient reported that her arm has been very swollen and the nurse thinks patient had an allergic reaction to the vaccine or the vaccination technique wasn't good.
Felt neck ache and back ache the morning after as well as headache and fatigue. That Monday had a pounding headache, nausea, vomiting, light headed, weak. Was prescribed Zofran. Nausea subsided but dizziness, pulsing headache, fatigue and light headed continued all week. That Friday I almost fainted and my head felt like there was liquid wooshing around and kept pulsating. Went to walk in and was sent to ER. Was prescribed Promethazine at ER. Here I am a week and two days after the second dose feeling constant dizziness and light headed.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: shortly after administration, pt stated feeling light-headed and asked for water, gave bottle of water, pt took sip then shortly lost conciousness for a minute then regained conciousness. attempted to have pt lay down but pt requested to stay seated. Due to continuous complaints of not feeling well, visual changes, confusion/disorientation, an epipen was administered. pt refused ambulance, monitored bp for 30min, counseled pt to followup with dr or go to ER and pt left pharmacy.
CRYING; NOT FEELING GOOD; CHILLS; SEVERE HEADACHE; FEVER; This spontaneous report received from a parent concerned a 24 year old female. 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, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced crying, not feeling good, chills, severe headache, and fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, severe headache, and fever, and the outcome of crying and not feeling good was not reported. This report was non-serious.
This spontaneous report as received from a Pharmacist refers to a 72 years old patient with unknown demographics. On 22-SEP-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were unspecified). Pertinent medical history, drug reactions and allergies were unspecified. Concomitant medications were unspecified. On 22-SEP-2012 within hours after receiving ZOSTAVAX, the patient experienced red rash and arm became swollen. The patient was treated with ice pack and a topical ointment ARNICA. The outcome of arm became swollen and red rash was reported as recovering/resolving. Additional information is not expected.
Baby developed fever and vomiting approx. 12 hours after immunizations.  Taken to ER. Blood work and urinalysis done. Mother reported event to Health dept at time of 2nd set of shots. Follow up with mother reveals no problems with 2nd set of immunizations.
8/26/2022 hypotension: vitals checked on 8/26/22 at 1PM - BP was 57/43 w/ MAP 48 - given midodrine 10 mg x 1 at 2PM - vitals rechecked at 2:30 PM - BP was 92/56 MAP 68 - vitals rechecked at 3PM - BP was 83/58 MAP 66.
1.) Extreme arm soreness at site of injection. . .so sore I couldn't life my arm above my head - lasted 2 days.  Started within a few hours of receiving the injection. 2.) Migraine headache which started the evening injection was received & lasted 2 days. 3.) Sensation & tenderness  in my left underarm & left breast (same side of injection) noticed within the first hour of receiving the vaccine.  2 weeks post injection, I can still feel the sensation &this am worried about receiving the second vaccine this week.
COVID-19; COVID-19; This is a literature report for the following literature source(s).  This study involved individuals aged hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: vaccination failure (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient.
Hospice nurse fully vaccinated as above on 1/5/21 and 1/26/21 tested positive on 3/30/21 utilizing the Laboratory PCR anterior nasal swab test.
24 hours after vaccination, patient developed erythema around injection site. Patient saw physician assistant who diagnosed cellulitis and treated with oral BENADRYL and cleared.
devel fever of 103.8 about 600 to 630AM taken to ER 7PM started on 02-APAP suppositories-adm 720PM to be watched given cool bath to lower temp; disch 9AM to mom w/temp of 101.6;
A 36 year old female patient developed SOB with exertion and diaphoresis in the evening of the day she received the intramuscular injection of Adacel on 08/23/05 in the left deltoid. The patient has a history of asthma for 1.5 years and is on Albuternol inhaler and Maxeron. The patient received a Hapatitis B injection 2-3 weeks ago. The patient experienced pain at injection site half a hour after immunization. Two hours later she complained of entire left arm pain, numbness and was unable to lift a jar. At the time of report the symptoms were persisting but were less than at 24 hours post immunization. The evening of the vaccination the patient also developed SOB with exertion and diaphoresis episodes which are continuing. The patient has not seen a doctor for symptoms. As per reporter the patient has not recovered. Follow up information received on 10/13/05. As per reporter, the patient was seen by a physician in an emergency room. After the symptoms, she was back to work, returned to full duty within a few days. The patient had received prior hepatitis B vaccinations on 10/20/99 in right deltoid, on 11/05/99 in left deltoid, on 12/13/02 in left deltoid, on 08/01/05 in left deltoid and on 09/08/05 in right deltoid. The patient has not experienced similar reactions post previous vaccinations. No further information is available. The case is closed.
Breakthrough Case of COVID 19: I had a mild case of COVID 19, no treatment was given. I called my doctor and was told to isolate for six days. I was achy, had chills, headache, fatigue, and a cough. I did not have a fever, by the fifth day my symptoms had resided and I only have a cough.