chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C/o feeling of tightness around throat and diff. swallowing when drinking a smoothie. Took CLARITIN and legs with intermittent shaking. C/o burning in chest. Eval. in ER on 10/30/12 - observed 4h. Treated w/ normal saline, SOLU-MEDROL, PEPCID, BENADRYL, ZOFRAN, ATIVAN.
began itching approx 3 hrs following 2nd dose of HBV called clinc 330PM next day 23OCT92; still itching no SOB, rash or edema; advised to call MD 26OCT92 TC to pt took DPH on advice of MD & sx relieved;
Felt mild chills and somewhat low energy that night and following morning. Nothing more than that and the muscle soreness.
Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA; 82 patients administered expired moderna vaccine/Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine/Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine/Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine/Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 11-Jan-2022, the vial was initially stored in the refrigerator.  Patient received first dose on 09-May-2022.  The vaccine in question did not experience any temperature excursions. Patient did not reported any adverse reactions.  No treatment medications were provided.
Patient received moderna vaccine on 2/13/21, 3/13/21 and 12/22/21. COVID positive 1/11/22. Presented to ER on 1/14/22. admitted as transfer from hospital on 1/14/22  for encephalopathy . She tested positive to COVID.  Etiology of encephalopathy is presumed to be due to combination of COVID infection and missing dialysis. Patient was managed in the hospital.  She was noted to be in fluid overload on admission whoih has resolved with resumption of routine hemodialysis. She has been followed by Nephrology service. Patient was also followed by Neurology for encephalopathy, and had a noncontrast CT of the head which was unremarkable.  Encephalopathy has now resolved. Patient has no respiratory symptoms of COVID. She is medically stable for discharge, and will go home with HHC. discharged on 1/27/22
Arm started to get sore.  Couldn't lift arm.  Got chills.  Started with nausea. Body aches.  Couldn't walk without hurting. Eyes watered constantly.
Ggot the shot for shingles, still got shingles/suspected vaccination failure; Still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Ggot the shot for shingles, still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient interactive digital media. The patient got the shot for shingles but was still got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
SEVERE HEADACHE/ SPLITTING HEADACHE; This spontaneous report received from a patient 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 was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced severe headache/ splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headache/ splitting headache was not reported. This report was non-serious.
Patient complained of sweaty hands, "unsettled stomach" after vaccination. Patient checked out by EMS, began feeling better shortly thereafter.  Patient advised to call emergency services or go to the nearest emergency room for any additional issues as needed.  Also advised to sign up for v-safe.  Patient left site stating he felt better.
hot to touch; redness around the injection site; hard lump; small lump in the injection site; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (small lump in the injection site), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LD0H) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE MASS (small lump in the injection site) and VACCINATION SITE RASH (rash on the injection site). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump). At the time of the report, VACCINATION SITE MASS (small lump in the injection site), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment information was not provided.
ON THE 24TH OF OCTOBER PATIENT HAD AN EPISODE OF FAINT/WEAK AND STRANGE FEELINGS.  ER VISIT DIAGNOSED AS PANIC ATTACK AND PRESCRIBED XANAX.  SHE SEEMED OK UNTIL 2 WEEKS LATER BEGAN HAVING SEIZURES, NON RESPONSIVE EPISODES, NERVE TWITCHES, CONSTANT FATIGUE, OFTEN WEAK AND LEGS DESCRIBED AS A FUNNY FEELING AS THEY ARENT THERE.
This spontaneous report was received from a medical assistant via company representative referred to a female patient of an unknown age. The patient's pertinent concurrent conditions/drug allergies, medical history and concomitant therapies were not reported. On an unknown date in March 2019 (reported as about 3 weeks ago), the patient sustained a cut to her finger as a result of handling a defective GARDASIL 9 (lot number R011630 and expiration date: 12-DEC-2020) prefilled syringe that broke in her hand. The patient applied a bandage to the cut and it was healed. No patient was administered the dose of GARDASIL 9 from the defective prefilled syringe. The outcome of the product quality issue was unknown. Causality assessment was not provided. Product quality complaint was found and filed.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "hx MV regurgitation" (unspecified if ongoing). Known allergies: NKDA Concomitant medication(s) included: ALFUZOSIN also other medication in 2weeks product. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Negative, notes: Patient's rapid antigen test turned negative in hospital; (30Apr2022) Positive, notes: his rapid antigen test turned positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 20Apr2022, treatment stop date: 24Apr2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
WELT INCREADING IN SIZE, MAX 4" X 4". HIVES WITHIN 6" OF INJECTION SITE. SHORTNESS OF BREATH. DISORIENTATION. PAIN. MALAISE. ONSENT AND END OF SYSTEMIC SYMPTOMS DIRECTLY RELATED TO GROWTH AND DISAPPEARENCE OF LOCALIZED REACTION.
Patient experienced vomiting, fever and Asthma exacerbation. Vomiting began approx. 6 hours after vaccination.
Greater than 12 hours after initial vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  It was reported that, patient received punctured vial that was 5 hours past the 12 hour temperature rule.
Per mom had swelling, redness, and small bumps on thigh around injection sight for a week.
Patient had soreness and redness after injection. Swelling is now only slight at time of report but patient say it is still red and sore
Patient report in the past day she had a very itchy feeling in the left arm.  Patient report had a very strong dizziness  in May 18, 2021. No medication at the moment.
About 20 minutes after vaccine my tongue swelled about 1 and 1/2 times it?s normal size. My eyes became slightly swollen, I developed a (non-itchy) rash on my cheeks and across my nose, and a fever. My tongue also was partially numb. After about 1 hour, the tongue swelling significantly decreased and the rash began to calm. About 3 hours after the vaccine I developed severe nausea (no vomiting), body aches, and a headache. My face was also partially numb. Today I woke up with severe body aches, fever, headache, nausea, diarrhea, very sore arm.
SECOND DOSE OF COVID VACCINE KICKED BUTTOCKS AND WAS IN BED FOR 24 HOURS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (SECOND DOSE OF COVID VACCINE KICKED BUTTOCKS AND WAS IN BED FOR 24 HOURS) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (SECOND DOSE OF COVID VACCINE KICKED BUTTOCKS AND WAS IN BED FOR 24 HOURS). At the time of the report, VACCINATION COMPLICATION (SECOND DOSE OF COVID VACCINE KICKED BUTTOCKS AND WAS IN BED FOR 24 HOURS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
says she had anaphylaxis; itching eyeballs,itching beneath the lids,itching near the lashes; throat did not close; it felt weird when swallowing; itching internally all her body for 7 hours; swelling; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (says she had anaphylaxis) in a 38-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.     Concomitant products included VITAMINS NOS and CETIRIZINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (says she had anaphylaxis) (seriousness criterion medically significant), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close), DYSPHAGIA (it felt weird when swallowing), PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling). At the time of the report, ANAPHYLACTIC REACTION (says she had anaphylaxis), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close) and DYSPHAGIA (it felt weird when swallowing) outcome was unknown and PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Cetirizine 10mg took it earlier than usual, but it did not help to relieve the symptoms.  Company comment : This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Patient was given flu shot 10/30/2005.  Said he had muscle tenderness for approximately 3 weeks.  No redness or swelling, just sore.  On 11/23/2005 told him to contact his doctor just to check it out.  On 11/26/2005 he said the pain had disappeared.  Patient went to doctor for regular check up and was told he had an adverse reaction to the flu shot, that spread to rotator cuff.  Doctor told him to use Aleve for 3 weeks and come in to get cortisone shot.
Information has been received from a patient who was vaccinated with ZOSTAVAX. The patient reported that she was supposed to receive VARIVAX, but was accidentally given ZOSTAVAX. Patient never had chicken pox. There was no product quality complaint. Additional information is not expected.
Initial (expected) soreness at injection site that went away by day 2, post vaxx#1. However, on 2/10/2021 (7 days after injection) my arm started to feel sore again, got swollen, hot, stiff and red at injection sight and lymph nodes in armpit are swollen and painful. Otherwise, I feel fine.   On a side note, because I'm not sure if it's relevant, my husband got his second shot of Moderns on 2/9/21. He had expected side effects (fever, chills, headache and body aches). Not sure if it has any connection but wanted to report that I am in close contact with him.
12 hours after vaccine vomiting; fever; body aches; tremors; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female Non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration, administered in Arm Left on 06Jun2021 at 10:45 (at the age of 15-years-old) as a DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: Ew0177), dose 1 via an unspecified route of administration, administered in Arm Left on 16May2021 at 12:00 PM, (at the age of 15-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient did not have Known allergies. No other vaccine was received in four weeks prior to vaccination. Other medications received in two weeks were none. Patient did not have COVID prior vaccination and not tested for COVID post vaccination. On 06Jun2021 23:00, 12 hours after vaccine patient had vomiting, fever, body aches and tremors. No treatment was received for the events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Red, itchy rash started around chest/upper torso, spread to entire body, head, and face.  Swelling of face and body.  Nausea and vomiting.  Difficulty breathing.    Took Tylenol for pain.  Antihistamine (Benadryl) and Calamine lotion for the itching.  Symptoms lasted about 20 hours
Mom reported pt was very fussy p/prev vax for approx 3 days; had fever, high pitched crying;
Patient presented to hospital on 3/2/21 with decreased appetite, nausea and generalized weakness. Cardiac workup showed mildly elevated troponin (~ 0.260, 0.240, 0.200). Patient underwent an echocardiogram which showed preserved ejection fraction but regional wall motion abnormalities were present, mild to moderate aortic regurgitation, mild mitral regurgitation and dilated aortic root and ascending aorta. Patient underwent a CT coronary angiogram which showed a calcium score of 63 with moderate LAD stenosis (FFR 0.94), RCA 50% stenosis noted. Diagnosis presumed to be takotsubo cardiomyopathy and patient was treated with medical therapy. Repeat echo on 4/15/21 after discharge showed resolution of wall motion abnormalities.
1st dose on 04Oct2022, shingles appeared on 09Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Shingrix. On 9th October 2022, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received first of two shingrix shots on 4th October 2022, shingles appeared on 9th October 2022 PM and diagnosed 13th October 2022 was only on his/her left thigh.  The patient was realised it could have been much, much worse. The patient finished Rx on this morning of day of reporting. The patients second shot approximately on 4th December 2022. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Patient was under 18 and was given the booster dose of the Pfizer vaccination, which is not yet approved for those under 18 years old. No adverse events were reported by the patient or their mom upon talking to them after the incident was realized and addressed. His mother stated that he had a fever and a sore arm when I talked to her yesterday, which she said was similar to the first two vaccinations.
During a vaccine clinic, a 10-year-old girl was inadvertently given a 2nd dose of Pfizer for ages 12+ when she should have received the dose for 5 to 11 years old.  Patient was observed for the required 15 min post vaccination; no adverse events observed.
10/12/02 Swelling began in left arm where Pneumovax was given. Local swelling in left upper arm from shoulder to elbow. No redness or fever. 10/13/02 Spread to proximal upper forearm on left. Seen in urgent care. Given Meclizine. Also started on prednisone. 10/15/02 Seen at provider's office. Swelling down per patient, at its worst swelling was about 6" diameter in upper arm. Usual is 2.5". Redness developed in left cheek. Continue prednisone until 17th.
PT C/O TIGHTNESS IN HIS THROAT, DIZZINESS, AND TINGLING IN HIS ARMS AND LEGS. PT STATED THAT HE HAS HISTORY OF TRYPANOPHOBIA WITH VACCINATIONS. HE WAS ENCOURAGED TO BREATHE, LIE BACK IN THE DRIVER SEAT, AND TO ELEVATE HIS FEET.  VS @ 5:00 PM BP 158/127 (POSSIBLE BP MACHINE ERROR) HR 93 SpO2 100%  VS @ 5:07 PM (FOR VERIFICATION) BP 100/61  HR 87  REPEAT VS @ 5:22 PM BP 111/61  HR 64 SpO2 100%  5:49 PM  AFTER CLOSE OBSERVATION, PT STATED HE IS FEELING BETTER. HE CALLED HIS SPOUSE TO THE OBSERVATION SITE, WHOM DROVE HIM HOME. PT WAS INSTRUCTED TO GO TO THE ER OR CALL EMS IF SYMPTOMS BECOME WORSE.
Mother called office on 10/1/04 to report seen at pt first evening of immunizations for difficulty breathing and throat constriction. Reports given IM Benadryl w/resolution of symptoms.
I got both doses and did not have any adverse events except feeling tired for a few days (dose 1- Lot EN9810 on 2/11/2021 IMLA and  dose 2-lot  EN6206 on 3/4/2021 IMLA).  Then around May  30, 2021,  my blood pressure at home  that day 117/112.  I decided to go the the ER.   I was diagnosed with A-fib and was hospitalized for 2 days.   They gave me medications amiodarone and furosemide.  Once I was stablized, I was discharged.  I was given new medications- Eliquis and Entresto and to follow up with my cardiologist.  I did get a new replacement of my IAD in my chest.