chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a itching red rash all over; I have a itching red rash all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 (Lot number: EN6200) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Nope just the covid vaccine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Lot No: EN5318, Location of injection: m Left), administration date: 27Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "I have a itching red rash all over". The event "i have a itching red rash all over" and "i have a itching red rash all over" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pruritus, rash erythematous.  Additional information: Patient had a itching red rash all over that does not go away or heal and have see several doctors and dermatologists, nothing helps and treatment medication included prescription meds, cream and pills. Patient had not received other vaccine in four weeks. Patient had received blood pressure medications in two weeks. Patient had no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Dizziness & NauseaVomiting Narrative:  vaccine adm 1348 (2nd dose) @1350, pt reports "feeling of going to pass out" and nausea, placed in supine positive VSS 125/84 RR 18 HR 96 O2 100% on RA T36.5. re-eval q5mins w/stable VS. @1407, symptoms improving (nausea/dizziness), gave grape juice; Vitals remain stable w/HR resolving to low 70s BP 115/79; @ 1426 reports ache in L shoulder in vaccine admin site, site w/o signs of swelling or redness (2/10 pain), denies any further symptoms. RN's helped pt to standing position, no signs of dizziness, reports feeling comfortable to leave @ 1430. No meds given
pt recv vax 1JUL97 & the next day pt exp a large local rxn described as red, swollen, warm & raised;
Felt hot, got sweaty, breathing rapidly, got very pale and felt like she would throw up. Gave an ice pack and monitored. She sat until 4:00 PM (25-30 minutes). Left feeling relatively well.
Patient presented to ED with AMS, GCS 8, elevated troponin within 48hrs of receiving vaccination. Initial dx NSTEMI
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 152, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
SEVERE FLU LIKE BODY PAIN IN ALL PARTS, SEVERE HEADACHE, SEVERE NECK PAIN, SEVERE CHILLS, FEVER, SENSITIVITY TO LIGHT/ SOUNDS/ SMELLS/ twitching/ shakey, extreme fatigue
a large rash on my stomach, back and front of thighs.; chills; body aches; tired; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in right arm on 04Feb2021 (Batch/Lot Number: EL9265) as single dose (at the age of 51-year-old) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history was not reported. No known allergies. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN). The patient previously took first dose of BNT162B2 in right arm, lot EL3248, administration date: 15Jan2021, time: 05:45 PM, for covid-19 immunisation. The patient has not been diagnosed with Covid prior to vaccination and has not tested positive since the vaccination. As of 24Feb2021, patient still had a large rash on stomach, back and front of thighs. This rash appeared on day 2, following the 2nd injection, on 06Feb2021. It was post day 18 and it was still a severe rash. Following 2nd injection, she also had chills, body aches and was tired for 2 days. No treatment was received. Outcome of the event rash was not recovered and for other event was recovered on feb2021.
One week after injection a raised red itchy hive like bump appeared in the injection site. A little warm to touch. Not painful.
Vaccine administered without proper thawing; Vaccine administered after being shaken; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered without proper thawing) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after being shaken) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047b21a) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered without proper thawing) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after being shaken). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered without proper thawing) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after being shaken) 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.
AREA IS WITH REDNESS AND SWELLING. REDNESS STARTED ON THE NIGHT OF 08/16/2011. NO ITCHING PRESENT. AREA MEASURES 5 BY 4.
Pain in arm, numbness in hand and numbness that radiated to chest. Saw an orthopedic MD 2 weeks after shot and is in physical therapy. Called pharmacy day after shot to inquire about discomfort in arm but never called back until today 11/19 to report issue.
I thought I had a cold for about a week started effecting my breathing. The same day I had extreme headache, fatigue, right ear, breathing issues cause me to prop myself up. I went to the neighborhood clinic was diagnosed with Bronchitis. After I got home needed assistance to the restroom due to the weakness. My symptoms felt worse than the flu lasting for about 3 1/2 weeks and I'm still having breathing issues.
throat is dry; cannot fall asleep at night; Throat is itchy; fatigued; when I lay down at night it feels like I'm drowning; really dry cough; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night) and THROAT IRRITATION (Throat is itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (really bad headache). On 22-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (really dry cough). On an unknown date, the patient experienced FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 17-Aug-2021, HEADACHE (really bad headache) had resolved. At the time of the report, FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  The patient took other treatment medication include cough drops, cough syrup to relieve the symptoms.  It was reported that the day after receiving the vaccine she had a really bad headache which lasted for 2 days. Seven  days after receiving the vaccine she started to have a really dry cough that she could not get rid of. When she laid down at night it felt like she was drowning. Her throat was itchy and dry. She also felt fatigued and cannot sleep the whole night through.
while injecting  the vaccine into her left arm. it came shooting out of the arm. This was a small petite woman. she did not  complain of any discomfort. Re vaccinated on the right arm without incidents. monitored pt for 20 mins. counseled her to monitor for any issues outside of pain  on the injection site.
Right arm at 530am bright red 2 spots hot to touch swelling spots getting larger. Reported to me agreed yes to use ice watch for itching or not going away. At 1110am school nurse called to say patient vomited once but had three spells of vomiting. School nurse suggested reporting to md and to report to vaccine info personnel this info since he received these 3 shots at once. Left message at md and received message back unknown if from shots can bring patient in if we want. I opted to let him rest. He has not thrust up again.
HYPERtension, Tachycardia & pain at injection site, chills
Extreme fatigue,  was unable to go to work day after vaccination. Lasted  12 hours.
I administered patient's second Moderna vaccine and after about 5 minutes in my vaccine observation area she stated that she felt dizzy. She did feel dizzy after the first shot as well but at the time she was fasting for religious reasons and her dizzy spell resolved after she broke her fast and drank orange soda. The patient was concerned that would happen again and I made sure that she had eaten today.   Her breathing became rapid and she was sweaty. I gave her a wet washcloth to put on her head and neck. I monitored her vital signs and encouraged her to try to take deep breaths and put her head in between her knees. After a little while she said she was cold and was shivering I gave her her jacket. She asked my staff to call 9-1-1 and was panicked.   I kept encouraging her to try to take deep breaths and slow down her breathing including meditation techniques and breathing techniques as I thought it was a panic attack as she had no other signs of allergic reaction. No hives no difficulty breathing other than rapid rate.  The paramedics came and surmised the same that the patient was having a panic attack and asked if she wanted to be transported to the hospital in which she responded "yes". She was then taken in the ambulance to the hospital.
Body Aches Low Grade Fever Soreness / Swelling at Injection Site Redness at Injection Site
chills @ 1st noc;chills am & noc 2nd noc;sore throat & runny nose;
This spontaneous report was received from a medical assistant, concerning a 5 months old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N022972 with expiration date on 19-FEB-2019 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was considered as a drug administered to patient of inappropriate age. No adverse were effects reported.
Arm soreness and was unable to lift arm (paresthesia) vertigo, chills.
SORE THROAT; MUCUS BUILDING UP; TERRIBLE AFTER EFFECTS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced sore throat, mucus building up, terrible after effects, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, sore throat, mucus building up and terrible after effects was not reported. This report was non-serious.
Patient stated she had a fever for one day. Crying spells and severe body aches since recieving immunization.
Pt received shot at 10:49 am. She had warned us of a history to anaphylaxis with penicillin and cephalosporins and we counseled her to be observed for 30 minutes at the pharmacy. Between 10 and 15 minutes after her immunization she had a panicked look on her face and said her throat felt extremely dry and scratchy. We immediately called 911 due to the history of anaphylaxis and they instructed us to not let her have any water to drink.  She continued to be alert and breathing/talking through the entire episode and never had any other complaints besides extremely dry mouth, sore throat, and scratchy voice. The paramedics arrived approximately 20-25 minutes after the immunization and observed her in the pharmacy for approximately 5 minutes. They then walked with her to the ambulance where she just sat and talked to them for another 10 minutes and they cleared her to drive home. No medications were administered. A couple hours later I spoke to the patient and she said her throat was still a little sore and dry but nothing else had happened.
Post vax, the pt experienced chickenpox consisting of 50 pruritic vesicles, (25 on back and the remaining 25 scattered on the rest of the body) and fever. He received vaccine on 4/30/98 and experienced the chickenpox on 3/8/99. Follow-up information received from a physician indicated that the pt had recovered from all symptoms.
second dose: really high fevers; She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 001C21A), via an unspecified route of administration on 21Apr2021 as dose 2, single for COVID-19 immunization. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273), Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COVID-19 from on an unspecified date in Nov2020 to an unknown date (patient got the COVID virus from her brother in Nov2020). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 046A21A), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced second dose: really high fevers on 21Apr2021, She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable on an unspecified date in 2021. Reporter is calling about the COVID 19 vaccine. She calling on behalf of her brother. While patient is reporting on her brother's experience with the Pfizer COVID 19 vaccine, caller states, it maybe be helpful. She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable but she was she was sick, only for the common 48-72 hours, she had really high fevers with both vaccine doses. Primary Care: She says the primary care doctor's information is the same for her as she provided for her brother. She did not go see him related to this but Pfizer would be welcome to contact him. Event details: Her first dose was given on 24Mar2021. Second dose given on 21Apr2021. With the first dose her fever started on 24Mar2021 and it has recovered completely at this point. She also got the COVID virus from her brother in Nov2020. She says the fever with her first dose went away on the third day, so it went away 27Mar2021. The second dose was 21Apr2021 and the fever began that night same day and lasted until 23Apr. It was high like 104 at multiple occasions. She confirm she has recovered completely from that fever. Product details: She reports lot number from her first dose 046A21A. Lot number from her second dose 001C21A. She does not see NDC or expiration dates. The patient underwent lab tests and procedures which included fever was 104 (high like 104 at multiple occasions) on 21Apr2021. Outcome of the event was recovered on 23Apr2021.  Follow-up (PRD/SRD 29Jul2021): No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021560230 similar report from same reporter
A 2 year old female patient experienced increased tremors, uncoordinated movements, drowsiness and a strong heart beat after receiving RabAvert for post exposure prophylaxis. The patient received RabAvert intramuscularly, 1 ml in the left thigh. Medical history included intermittent mild tremors of th hands upon awakening. Family history included mild epilepsy and benign tumors in the mother. Concomitant medication included Poly-Vi-Sol with iron and Zantac. The patient received a flu vaccination on 10/06/04. On 10/08/04 her mother reported "something grey flew out of the bushes at the stroller", and that upon arriving home noted the patient had scratches on her lower extremities; later that day the patient received RabAvert and human immunoglobulin (IGG). Subsequently the mother noticed that the patient was trembling prior to going to sleep. The next day she was still trembling, had uncoordinated movements, was drowsy and her heart was "going really strongly." The events were all resolved without treatment on 10/11/04. She was seen in the pediatrician's office for the second dose of RabAvert, which was not given. On 10/14/04 the patient was seen by another pediatrician and a neurologist, who stated the patient was "perfectly healthy and just had a day of involuntary movement."
The day of the shot I had a headache,  swollen lymph nodes about 6 hours after.   Next day arm at injection site was sore.   Following day arm at I jection site was very tender,  hot to the touche and hard lump.   That lasted for 3 days.   6 days after shoy the red mark came back just below I jection site,  became hot again,  was about 4" in diameter and itched/hurt.   Day 10 redness has go e down,  still itches/hurts and a little hard lump.
Sore arm below injection site, redness, swelling.  Sore shoulders and lower back.  100.7 fever for 12-24 hrs after shot.  Slight feeling of nausea.  Fatigue for 48 hrs.
dizzy; headache; nausea; vomiting; diarrhea; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) mRNA-1273. On 23-Feb-2021, the patient experienced FATIGUE (tired). On 01-Mar-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). On 28-Feb-2021, FATIGUE (tired) outcome was unknown. On 01-Mar-2021, HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown. On 03-Mar-2021, DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol
Hospitalized with fever, chills, worsening dyspnea and a severe dry cough Covid Pneumonia
Information has been received from a physician, via a company representative, concerning a 14 year old female patient, was vaccinated with a dose of Gardasil.  "Almost immediately." the patient experienced a severe headache, tingling in her extremities, and severe injection site pain.  While she was checking out, she fainted and hit her head on the counter.  Later that evening, she continued to "feel ill," and her mother took her to the ER, where a computed tomography (CT) was performed (results not provided).  The following day, the patient reported feeling better, but still had a headache and nausea.  Additional information has been requested.
Developed frequent heart palpitations beginning approximately 24 hours after my second dose (received second dose March 9, 2021). Developed an episode of atrial fibrillation on Thursday April 8 , which lasted for approximately 3 hours. My heart rate was in the 110s-120s for approximately 20 minutes, and then decreased to the 80s-100s for the duration of the episode. I am a physician and was able to self-diagnose. My wife is also a physician who confirmed that I was in atrial fibrillation and monitored me during the episode. Given that I did not have additional symptoms to suggest decreased cardiac output during the event, I did not seek medical care at the time of the event. In addition, since I had recently had a normal echocardiogram, I did not pursue additional testing. The frequency of my palpitations decreased over the  subsequent months and I had an apparent return to baseline cardiac function in July 2021.
The patient was inadvertently administered with a dose of Pneumovax23 which expired on 26-MAR-2020; No adverse effect reported; This spontaneous report was received from a Nurse Practitioner reporting about a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions or concomitant medications was not reported.     On 02-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R017900 that expired on 26-MAR-2020 (dose number, dose, route of administration or anatomical location were not reported). No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R017900; expirationdate: 26-MAR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability