chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 53-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. On 28Apr2021,16 days after the second dose of vaccination, the patient experienced shingles for the first time. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included treatment with antivirals. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt had local soreness @ inj site;next day p/vax inj area on axilla became swollen & tender to touch for 2 days then swelling subsided;
Moderna Covid vaccine was given, she is 13 years old, it is not approved to be given at this age. No symptoms known at this time.
April 19th 2021 i had taken a spin class. prior to this spin class i started walking and exercising regularly. After the spin class i was quite sore. a few days went by and by thursday i could barely walk. ( i had stopped all exercise after monday) Friday morning i had went to my local urgent care. The doctor there did xrays and ran blood work. By that night they had called me and told me i needed to go to the hospital and i was diagnosed with Rhabdomyolysis. The muscle pain in my legs was so bad and i was exhausted. I was discharged from the hospital the night of april the 25th. no one could figure out why this happened to me at such a young age and for only going to one spin class that i didnt even work to hard at.
pain in arm; Pain moving to other arm and legs (groin/lower back/right hip; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm) and PAIN (Pain moving to other arm and legs (groin/lower back/right hip) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm) and PAIN (Pain moving to other arm and legs (groin/lower back/right hip). At the time of the report, VACCINATION SITE PAIN (pain in arm) and PAIN (Pain moving to other arm and legs (groin/lower back/right hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on breast cancer medication. The treatment taken included acetaminophen, aspirin and ibuprofen.
pt had abn knot on lt leg no bigger than an 1/2in by 1/2in;this was not a nl knot;mom stated it was hot & red for a couple of days;
Received the covid19 vaccine at 11am. Started feeling very cold around 2pm (nail beds were turning purple). By 4pm I had a headache, body aches, upset stomach, tired, fever, and chills. My fever would go up and down, highest was 103.2 reached that temp 3 times. By 2am my mother drove me to the ER. I was diagnosed with a migraine and was given IV fluids and an IV migraine cocktail. After receiving the fluids and meds I felt much better and was released back home. I periodically have pain in the injection site.
p/vax pt slept briefly; then awakened w/gasping breathing & cyanosis; shook about 1 minute; & was limp;slow resolve of normal color & activity; T102 upon arrival at clinic w/pallor;febrile seizure
Malaise; Pyrexia; Rash Macular; Swelling Face; This is a spontaneous report from a contactable other health professional based on the information received by Pfizer from Sanofi-Aventis (reference number: 1-1700051315). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced malaise, pyrexia, rash macular, and swelling face on an unspecified date. The outcome of the events was unknown.
sore like he got run over or beat up; fragile; Pain where his heart; When I first got up I felt out of it; whole body hurts; body had electric current through it; freezing even though the bedroom temperature was 68 degrees F; bad headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEELING COLD (freezing even though the bedroom temperature was 68 degrees F), PAIN (sore like he got run over or beat up), FRAGILE X CARRIER (fragile) and CHEST PAIN (Pain where his heart) in a 63-year-old male 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.     Concomitant products included VITAMINS NOS (MULTIVITAMINUM), COLECALCIFEROL (VITAMIN D 3) and VITAMIN B12 NOS for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced DIZZINESS (dizzy). On 24-Feb-2021, the patient experienced FEELING COLD (freezing even though the bedroom temperature was 68 degrees F), HEADACHE (bad headache) and CHILLS (body had electric current through it). On 25-Feb-2021, the patient experienced PAIN (sore like he got run over or beat up), FRAGILE X CARRIER (fragile), CHEST PAIN (Pain where his heart), FALL (When I first got up I felt out of it) and MYALGIA (whole body hurts). On 25-Feb-2021, FRAGILE X CARRIER (fragile), FALL (When I first got up I felt out of it) and CHILLS (body had electric current through it) had resolved. At the time of the report, DIZZINESS (dizzy) and HEADACHE (bad headache) had resolved and MYALGIA (whole body hurts) outcome was unknown.            Patient have some event like sore arm, dizzy walking around the house.   This case was linked to MOD-2021-026234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
7 DAYS AFTER THE SHOT (APRIL 12TH 2021, THERE ARE HOT TINGLY AND PRICKLY SENSATION ALL OVER (AND STILL HAS THIS SIDE EFFECT ON APRIL 21ST 2021)  2ND AND 3RD DAY, HAD FEVER AND FATIGUE BUT WENT AWAY ON THE 4TH DAY
Upon waking up next am, +facial swelling, +swelling of lips and around mouth, +facial tingling, +dizziness, +burning of lips.  Treated self with acetaminophen and subsequent Benadryl.
01/03/2022 I woke up feeling bad and laid in bed all day. The next morning, I stayed in bed until 12:00 PM, forced myself to stay up and walk around. I had a temperature , the highest it got was 101, and a cough. The next day, I was still feeling, bad, but got up. That afternoon I went for a COVID test, I tested positive. I was prescribed cough medicine. On 1/6/2022, I started going back to normal. I was back to my normal self on 1/7/2022-1/08/2022.
Information has been received from a physician concerning a 15 month old male who was vaccinated with a dose of Proquad. Subsequently the patient experienced a rash all over. The patient returned to the office after 2 weeks with a rash all over. It appears that it is resolving on it's own. No medications or treatment were given for this experience. Additional information has been requested.
sore throat, fever, chills, body aches within first 24 hours. Developed bells palsy 72 hours after vaccine.
facial & hands edema x 3D, c/o HTN, x 2 days, local edema, dyspnea, h/a;
56 year old F with hx/ of multiple autoimmune conditions and hx/anaphylaxis to multiple agents presented with generalized pruritis 10 minutes after receiving first dose of Pfizer COVID-19 vaccine. Denied lip swelling, tongue swelling, or throat swelling, and had absence of urticaria. Received 50 mg of PO Benadryl with some improvement in her symptoms prior to leaving facility.  Advised of CDC Recommendation to avoid second shot with any allergic reaction to the first dose. Counseled to discuss with her allergy/immunology physician prior to making a decision about whether to return for a second dose.
patient received undiluted dose of pfizer for 6m-4y. No reported adverse reactions as of today
Injection site swollen, hot to touch, painful. Advised patient to take Ibuprofen, Benadryl, and apply ice pack to site, and RTC if worse.  RTC next day, mom states more swollen and fluid filled blisters formed in center of site.  Advised could possible be contagious.  To try to stay away from people.  Iformed to f/u with PCP if gets worse.
RASH AT INJECTION SITE. INJECTION SITE SORENESS. NUMBNESS IN ARM.
Headache, Myalgia, Fever, Swelling and redness at injection site Narrative:
Pain and swelling in joints of left hand making movement difficult. Low level pain in right armpit. Both symptoms are currently present.
This spontaneous report as received from a consumer refers to her daughter of unknown age. The patient was vaccinated with VAQTA (route and strength unknown), vaccination site unknown on an unknown date. Concomitant medications included: H5N1 (manufacturer unknown), Pneumococcal vaccine (manufacturer unknown) and PEDVAXHIB. The patient's mother stated that, while on VAQTA on an unknown date, her daughter began to cry, was ripping her hair out, and her skin became red. She was rocking her body and forth. Her skin was still very sensitive to the sun. All adverse event responses are for VAQTA. The patient sought medical attention via doctor visit. No treatment was given. The outcomes were reported as not recovered/not resolved. Additional information has been requested.
Blood pressure is elevated; dehydrated; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. Medical history included slight chills on an unspecified date. The patient's concomitant medications were not reported. Patient did not have any symptoms on the date of vaccination and the next day too. Patient noticed his blood pressure was elevated on 22Apr2021 and asked if this was a normal symptom. He stated sometimes dehydration could cause an elevated blood pressure and said he might be dehydrated and asked if vaccine could cause this symptom. He reported that chills were not as bad and were a little less and went away and the vaccine must be helping with that. He asked if chills were normal before or after the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Believes the current rash following dose two of Shingrix could be shingles/ Suspected vaccination failure; Could be shingles/ current rash following dose two of Shingrix could be shingles; Rash was flat and red; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash and rash to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a rash prior to receiving dose two of Shingrix but the rash was flat and red and resolved quickly.  The patient believesdthe current rash following dose two of Shingrix could be shingles. No additional details provided. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.
Client received first dose on 2/8/2021 and second dose on 2/24/2021. Second dose was administered out ide of recommended vaccination time.
Approximately 4 days after immunization, pt had nausea that went to fever, chills and extreme diarrhea - went to urgent care about 1 1/2 weeks also had dry cough - treated for pneumonia, gave antibiotic abt 3-4 days. Went to Primary care with all the symptoms - placed on BRAT diet for 2-3 days and went to ER. Admitted - rehydrated and found spot? on lung - diarrhea and other symptoms subsided after 2 days in hospital but they kept her to work up lung condition. Possible valley fever.   3/23/09 MR received for DOS 11/21-12/04/2008 with D/C DX:  Interstitial Lung Disease, newly diagnosed.  Pathology c/w but not confirmatory for UIP (Usual Interstitial Pneumonia).  Hypoxemia 2' to interstitial lung disease.  False (+) coccidiomycosis IgM titre.  HTN.  Hyperlipidemia.  Pleauritic Chest Pain.  SOB and cough.  Antibiotic induced diarrhea.  Gastroenteritis.   Pt presented with several week hx of weakness, fatigue, nausea, vomiting, diarrhea and SOB with cough since receiving Flu shot 11/3/08. Recent worsening of SOB with ambulation precipitated ER visit. Initially dx with PNA at urgent care and placed on abx.  No improvement x1 wk on abx. Admitted for complete w/u. PE (+) for rhonchi and rales. Abx changed. Pt continued to desat w/ ambulation. ? Coccidiomycosis so antifungal added with no response. Thoracoscopy done for bx with chest tube placed. When removed, d/c for outpt f/u with O2 supplementation PRN.
Homebound visit complete 4/14/21 around 1230-1300, monitored for 15 minutes, left attended with home health nurse. Patient was found dead per EMS and had passed sometime during the night.
Irregular menstrual cycle. I started menstruation a week early. Blood was light in volume and dark in color, as if it had already clotted. I have been on birth control since 2017, and always have my period during my placebo week. This time it started while I was on week 3 of my birth control.
Fever 102.4 degrees F sweats, chills, body aches, loss of energy, loss of appetite. 72 hours.
This spontaneous report was received from a pharmacist referring to a 21 years old female patient. Information about the patient's concurrent condition, medical history and concomitant therapy was not reported. Approximately on an unknown date in 2011, when the patient was 14 years, 5 months old, she was vaccinated with the first dose of  hepatitis a vaccine, inactivated (manufacturer unknown) (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis. On an unspecified date one year later, when the patient was 15 years, 5 months old, she was  vaccinated with the second dose of  hepatitis a vaccine, inactivated (manufacturer unknown) (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis. On an unknown date in 2018, reported as recently, the currently 21 years old patient received an adult dose of VAQTA (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis, due to international travel. No adverse effect was provided. The outcome of the event was not reported.
SORE THROAT; VERY SICK; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore throat, very sick, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, chills, fever, and headache, and the outcome of very sick was not reported. This report was non-serious.
Patient developed a rash 7 days after first dose.  Rash present on stomach, back groin, anus, hands
Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022; Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that he thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. Caller stated 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022 Date the vial was initially stored in refrigerator- 04-Apr-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information to add.
This spontaneous report as received from a pharmacist refers to a 73 years old female patient with no known relevant medical history or drug allergies. The patient was vaccinated with lot # (0172AE, Exp. 18-APR-2013), 0.65 ml live ZOSTAVAX subcutaneously on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-NOV-2012 ("a month later") the patient developed cold sore, which has reoccurred at least once a month on unspecified dates since receiving ZOSTAVAX vaccination. The pharmacist noted that the patient showed her the location of the healed cold sores and that there was an indentation where the cold sore had healed. No treatment was given for the event. The patient contacted pharmacist for medical attention. No lab test was performed. Final outcome of patient's cold sores is unknown. The relatedness for cold sores is unknown for live ZOSTAVAX. Additional information is not expected.
Increased crying, running temp>101 off and on, even though receiving Tylenol and now has spots on her arms, legs and mouth has blisters.
UPON GETTING PREPARED TO ADMINISTER THE 2ND DOSE OF THE HEP B VACCINE ON 10/17/2022, PATIENT REPORTED THAT ON THE FIRST DOSE GIVEN (ON 09/15/2022) HE FELT LIGHTHEADED BUT DID NOT REPORT TO NURSE UPON THE NURSE CHECKING ON THE PATIENT AFTER VACCINE WAS GIVEN. PATIENT STATED HE DID NOT REPORT DUE TO BEING AN EMPLOYEE AT THE SITE BECAUSE HE DID NOT WISH TO BE SENT HOME EARLY. PATIENT STAYED THE REMAINDER OF HIS 8 HOUR SHIFT.
In addition to achiness, I have experienced a numb sensation at the injection site and the entire deltoid muscle that extended towards the elbow. The numbness lasted at least an hour after the injection and a couple of times over the past three days. I have experienced a mild fever (99.8 F) each day since the vaccination, but only in the mornings or late at night. I treated this by taking Tylenol.
Itching all over. Rash on arms. Fever for 3 days. Fatigue.
ACUTE RESPIRATORY FAILURE 1/25/2022  --  RECURRENCE OF SAME SYMPTOMS
1st dose in 2022 never received the 2nd; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2022 never received the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The pharmacist had a patient who never got the second dose of Shingrix. The lot number was not available at the moment of the call. The follow-up accepted by mailing. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Left arm axillary pain with feeling of knot or lump there. Parasthesia down entire right arm to wrist and hand. It started the day after the vaccine and still present 2 days later (today).
No Dilution and Expired Product. Injection of 0.2 mL was given with first diluting the vial.  NDC 59267-1055-04.  Exp:  09/30/2022.
This case was reported by a nurse via sales rep and described the occurrence of faint in a 16-year-old female patient who received BEXSERO. Co-suspect products included Hepatitis A vaccine and MENACTRA. On 1st September 2016, the patient received BEXSERO (intramuscular), Hepatitis A vaccine and MENACTRA. On 1st September 2016, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced faint. On an unknown date, the outcome of the faint was not recovered/not resolved. It was unknown if the reporter considered the faint to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: the patient received BEXSERO and Hepatitis A vaccines on her arm. the patient also received a dose of MENACTRA concomitantly on her arm. the manufacturer of co-suspect vaccine Hepatitis A was unknown. the lot number and expiration date of the vaccines were unknown. the sales representative noted that the office had filed a VAERS report. This case has been linked with US2016128112 (twin's case), reported by the same reporter.