chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 19 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious.
Patient received booster dose too early. He received the 2nd dose in September 2021 and the 3rd dose 12/6/21.
Had a 2nd Moderna vaccine on 3/27/21, developed hives all over body on 4/2/21.
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRINE), FUROSEMIDE, SPIRONOLACTONE, RANOLAZINE, RAMIPRIL, ATORVASTATIN, FISH OIL, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), IRON and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Flu like sx: myalgia, fever, sweating, lasted about 2 days.
Information has been received from a registered nurse concerning a 7 year old white female student with no allergies and no medical history who on 01/11/1999 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/19/2004 the patient was diagnosed with varicella by her school nurse.  No medical attention was sought and no diagnostic tests were done.  The varicella all scabbed over and on 05/24/2004 the patient recovered.  On 05/24/2004 the patient was to return to school.  No further information is expected.
2/27-sore, redness 3x3", bruise at injection site-AM rash, itching, burning, hurts, difficulty moving arm, cannot raise arm. 2/28-returned to ER, PA said it was a reaction. In future, may need to avoid shot. That evening fever (102 deg), swelling from shoulder to elbow. Rash grew bubbles. 3/2 felt like bugs running inside and bees stinging.
AFTER RECEIEVING THE VACC FOR HEP A,FLU AND PPD ,PT SAYS SHE FELT PAIN IN HER EYES AND ALSO FELT DIZZY ,FELL STRAIGHT BACK  AND HIT HER HEAD AGAINST THE WALL,SAYS SHE REMEMBERS THE INCIDENCE,NO ITCHING,OR PROBLEM BREATHING,,WHEN EXAMINED ,SHE IS LYING ON THE BED STILL C/O PAIN THE EYES,PT NOTICED TO HAVE OBVIOUS CONJUNTIVAL INJECTIO,PT GIVEN BENEDRYL AND OXYGEN,SEND TO ER
Patient received Adacel after a temperature excursion where the product was not suitable for use with no adverse event; temperature excursion where the product was not suitable for use with no adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 31 years old male patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] where the product was not suitable for use after a temperature excursion with no adverse event .  The patient's past vaccination(s) included diphtheria-2/tetanus/5 ac pertussis vaccine on 09-SEP-1997. The patient's past medical history, medical treatment(s) and family history were not provided.   On 15-Jun-2022, the patient received a 0.5 ml  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine(batch lot U7453AA,Expiry date :29-Jun-2024)(unknown formulation and strength) via intramuscular route in the right deltoid for immunization.  On 15-Jun-2022 (latency :same day) the patient received adacel where the product was not suitable for use with no adverse event (poor quality product administered)  after a temperature excursion (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the events    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 guidelines. 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.
devel rash, face, arms, legs by 28OCT early evening;malaise-rash arms, legs;face: rough macular erythematous;29OCT98 fever 100+, h/a, pharynx + erythema;
This spontaneous report as received via a field representative from a physician refers to a 74 years old male patient. Information regarding the patient's medical history was not provided. In approximately October 2009 (reported as 'three years ago') the patient was vaccinated subcutaneously with ZOSTAVAX, 0.65 ml one shot (dose number and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In 2009 (reported as 'he said 3 years ago') the patient experienced shingles. No treatment information was reported. The outcome of shingles is unknown. A reporter causality for shingles was not provided for ZOSTAVAX. It was unknown if the patient sought medical attention. Additional information is not expected.
Hives (urticaria) within hours of shot, red cheeks, ankles, feet and hands swollen, swollen arm at injection site of DTAP.
really bad stomach ache; abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 047A21A and 006M20A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included ATORVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain). The patient was treated with FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain) outcome was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 57-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 05Apr2021 as dose 1, single (lot number unknown), in left arm; on 26Apr2021 as dose 2, single (lot number unknown), in left arm; on 25Oct2021 as dose 3 (booster), single (lot number unknown), in left arm and; on 30Mar2022 as dose 4 (booster), single (lot number unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". The patient underwent the following laboratory tests and procedures: covid 19: unknown results. Therapeutic measures were taken as a result of drug ineffective and suspected covid-19 which included Paxlovid taken from 13May2022 to 18May2022 for the treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed dizziness, shortness of breath, weakness and headache, that lasted about 2 hours, then subsided.
Patient was sitting in the waiting room alert and responsive after his vaccine. Suddenly while he was sitting in the waiting room His eyes began to roll back into his head, his head dropped and his body tensed up and he began to shake. The event lasted approximately 30 and then the patient became alert and oriented again. When he became alert again he seemed very sweaty and pale. Nurse Practitioner took blood pressure and it was 100/58. Paramedics arrived on scene approximately 5 minutes after and transported him to the hospital.
Patient received entire vial of vaccine undiluted as single dose  ED 10/01/2021 Other ED 10/02/2021  Patient presented on 10/02/2021 with fever, aches and fatigue . No treatment given, instructed to monitor patient and return if any adverse events noted.
Information has been received from a physician concerning a 19 year old female with no known allergies and no reported medical history who in December 2007, was vaccinated with her second dose of 0.5 ml GARDASIL intramuscularly. There was no concomitant medication. The patient experienced pain in her arm at the injection site. The patient couldn't sleep following the injection due to the numbness and tenderness in her arm. The patient experienced the conditions after the first and second dose of GARDASIL. The second was given in DEC-2007. There was no lot number provided. No additional information was provided. This is one several reports received from the same source. Additional information has been requested. 02/10/2010 Follow up information was received from the physician. It was reported that it's been approimately 6 months and the patient still gets sharp pains on the area that she received the shots. The pain usually lasts for about 2-3 minutes, but they occur often, 2-3 times per day. The patient has recovered from the soreness, tenderness, redness and numbness, the outcoome of sharp pain the in the arm is unknown.  This is one of several reports received from the same source. No additional information is expected.
Working 7 hours 10pm I had fever of 101.6 Right arm is swollen and sore to the point I can not move it without wincing  Extreme fatigue Body Ans joint aches could not get out of bed  Migraine like headache  Sore throat
Mental status changes - confusion lasting 2-3 days after first COVID vaccine and 24-48 hrs post second vaccine on 3-19-21
Approx in early morning with few vague rashes on back, chest, and stomach. More rashes developed am about 30 rashes. Developed blisters. No fever.
Swelling of lower eyelids and slight swelling of cheeks, which resolved with Benadryl (12.5mg/5ml) 9ml po x 1.  No swelling of lips or tongue no stridor no breathing difficulties.  Local swelling of right upper arm noted.
Symptoms: left side of lips numbing, throat and tongue swelling Treatment:  Sent to Urgent Care and was moved from there to the hospital by ambulance. Given EPI Pen and Benadryl intervenosly, Admitted to the Summit ER Outcome: Stayed in ER for 4-1/2 hours, symptoms went away then sent home
vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reaction.
Patient reported to the pharmacy the morning after receiving her vaccine in the right deltoid. Her arm was visibly swollen from the injection site down to her right hand. The arm was also warm to the touch. I called a local urgent care to she if she could be seen there and recommended that she go right away.
She was vaccinated and boosted and she contracted Covid; She was vaccinated and boosted and she contracted Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 53-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bacterial vaginosis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "She is allergic to generics of Flagyl.", notes: She is allergic to generics of Flagyl. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She was vaccinated and boosted and she contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: Patient was vaccinated and boosted and she contracted Covid. Patient had J&J and then she got one booster and she will probably get another today.  3 months since she had Covid and now she can have a booster and the doctor said wait 3 months and she will get the Bivalent booster. Patient does not have her vaccine card handy. She is allergic all forms of generic and if she can't take the generic what is she supposed to do and she requires the brand. Name, NDC, Lot and expiration are unknown for all generics that she is allergic too.  She took all of the brand she had. She was done with the brand and discarded it and she only has rest of one gel and she only took one tube of it and the next day she noticed she was sick again and she didn't think something not taken by mouth would make her sick and she was surprised.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Within 3-5 minutes of receiving the vaccine, patient stated they felt lightheaded and dizzy. Patient lost consciousness shortly after for approximately 30 seconds and their face became pale. Patient was brought to a supine position with legs elevated until color returned and she regained consciousness.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
~5 hours after falling asleep, woke up with a fever of 100.7°F, hands tingling, and heart rate at 125. Took 1x Propranolol 10mg for it. HR rapidly rose to a peak of 186, took second Propranolol 10mg. HR remained around 140-160 for the next hour, took around 6 hours to fall back into the 80s and for tingling and fever to subside.
patient received vaccination and moved to post vaccination waiting area.  shortly after taking  a seat he felt light headed and started sweating profusely.  He placed himself on the ground took his mask off and rested.  He never lost consciousness and stated he ate only a granola bar.  I gave him water and continued to conversate with the patient.  He remained stable and after 15 minutes was able to sit in chair.  He stayed for an additional 10 minutes/drank water and was able to walk/leave the pharmacy.
He got PNEUMOVAX vaccine (SC) on his left upper arm. After 2-3 days, mom called here and told he got swelling (L) arm and diagnosed with cellulitis.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # M035385 and expiration date on 08-APR-2018, oral for prophylaxis. No adverse effects reported.
Shoulder drop approximately 2-3 hours after administration. I had a similar event occur after the second dose in May
Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 16 hours. Insomnia the first night after receiving the vaccination.
Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseated".  Additional Information: The patient have been nauseated for like 30 minutes yesterday evening.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
double and blurred vision. Began to improve 24 hours after onset. 48hours after onset, it is continuing to improve.
feeling tired; achy; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing (Takes Vyndaqel (tafamidis) for cardiac amyloidosis, otherwise healthy and active. Concomitant medication(s) included tafamidis meglumine (VYNDAQEL) taken for a cardiac amyloidosis, start and stop date were not reported. On an unspecified date the patient experienced feeling tired, achy and chills. Outcome of all events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Within 5 minutes of giving vaccine Patient stated he felt dizzy, sweaty, and not feeling well with ringing in his ears. Mom went with patient to bathroom.  About 5-10 minutes later they returned to exam room. Mom stated her son threw up a small amount. Patient stated he felt much better though ringing in ears still present. Denied difficulty breathing. Blood pressure taken with adult cuff  120/69 and pulse was 62. Discussed with mom adverse effects of vaccine. Told to call 911 if difficulty with breathing developed and to call Dr if patient continued to have ringing in the ears or felt dizzy or nausea again. They left the office about 5 minutes later ---1330-1335. Follow up call to mom's phone at 1645. No answer. Left text message on phone.
NIGHT AFTER VACCINATION : WOKE UP WITH CHILLS AND HOT SWEATS DAY AFTER: SEVERE FATGIUE , EYES WERE RED
100 degrees fever, productive cough, headache, body aches, "bloodshot" eyes, fever blisters x 2, minor head congestion, rash on (R) foot with pruritis, malaise, fatigue.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Since 06-NOV-2014 the patients were vaccinated with doses of ROTATEQ (lot #, expiration date and dose unspecified, oral) that were improperly stored. No adverse effects were known. This is one of several reports received from same source. Additional information has been requested.
HCW presented for COVID Booster Dose #2.  HCW reported approx. 5 days after 1st COVID-19 Vaccine dose (12/18/2020)  having experience swelling  (Nodule) over the left clavicular area. Per HCW, the raised area appears to have decreased in size but is still visibly evident.   Denies pain to touch or movement. Denies numbness or tingling.  Denies numbness/tingling to left arm.  Denies Chest pain or breast pain.
THE PATIENT RECEIVED A DOSE OF VARIVAX WHICH WAS IMPROPERLY STORED; No adverse event; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. Concomitant medications included sterile diluent (lot# and expiry date unknown). On 25-FEB-2020, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S024369, expiration date 08-JUN-2021 (strength, dose, route, anatomical location were unknown) for prophylaxis. The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of minus 13.8 degrees Celsius for a time frame of 13 minutes. The previous temperature excursion was 3.4 degree Celsius for 1 hour 30 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
She began to develop spots on her neck and torso on a Sat. afternoon.  By the following morning (Sun.) the spots turned to a huge rash from her face her feet.  They got redder and bigger and her face began to swell.  She screamed and was miserable! We took her to the hospital and they recommended oatmeal Aveeno baths. The next morning I took her to her pediatrician and they told us it was a reaction to the vaccine. We were then sent for blood work to rule out if she really had the Measles, Mumps or Rubella. If took almost 2 weeks before the entire rash went away.
Fever up to 100.5º, muscle aches, nausea, exhaustion, strong headache over a 32-hour period.
BODY ACHES; CONGESTION; LABORED BREATHING; MIGRAINE SYMPTOMS; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced congestion. On APR-2021, the subject experienced labored breathing. On APR-2021, the subject experienced migraine symptoms. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills, congestion, labored breathing, fatigue and migraine symptoms was not reported. This report was non-serious.
In office with varicella 9 days s/p vaccine. No known exposure previously. Acyclovir.
pt recv vax; lt arm at site of injection; swelling & erythema at inject site; lt arm tender;
First exhaustion and mild headache, then stomach upset, then freezing and shaking with chills. At 10 hours post I noticed red blotchy rash at administration site.