chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exp 11/3/2021 59267-1000-1 Pfizer COVID-19 Vaccine  Had first Pfizer COVID vaccine 2 weeks ago (9/7/21).  Developed high fevers starting that night and continued for  10 days.  Felt dyspnea, chest pain, weak, fatigued, and body aches.  Went to  ER 2 nights later, tested negative COVID/Flu.  2 days later (9/10/21) started coughing with continued fevers so went to ER 9/14/21 where found to have LLL pneumonia and started on amoxicillin twice a day for 10 days and azithromycin x 5 days.  Fever broke 4 days go (9/17/21).  Chest pain, fatigue x 1 week, Fever/Cough x 10 day
Initial report received from a healthcare professional on 22 September 2014. A 98-year-old female patient had received a dose of FLUZONE HD, (batch number U5022BA, expiry date 29 April 2015, dose number, route and site of vaccination not reported) on 20 September 2014. The patient's illness at the time of vaccination was not reported. The patient had no known allergies and a medical history of hypertension and diabetes. The patient's concomitant medications were not reported. On 20 September 2014, same day after vaccination, the patient experienced hard lump at injection site and red area just below injection site. Complementary investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received from a healthcare professional on 4 May 2015. The patient's identifiers were updated and vaccine provider details were also provided also the name of the reporter was updated. It was reported that the patient had received intramuscular dose of FLUZONE HD in left deltoid. Documents held by sender: none.
She got her vaccine, started with fever, chills, tiredness within 6 hours which lasted for 24 hours.  Within 3 days from that time her chest started feeling very heavy, then she had quite a few heart palpitations throughout the next few days.  She had an APT with her cardiologist on 10/13/21, and he said that she needed a stress test as she hadn't one for a while anyway, and had that on 10/20/21.  She ended up with a heart cath on 11/5/21.  Her FU appointment was on 11/17/21, at that time they increased her Renexa to cut down on her palpitations.  She is taking 1000 mg now instead of 500 mg.  She is still having a few palpitations, the tightness is improving, but she doesn't  know what the future holds.  She was with her husband through his hospitalization and recovery with COVID and COVID pneumonia in January, and did not get COVID herself.  She had not been having additional problems until she got the vaccine.  Her family also had COVID during December/January as well, she was never positive for it.  She had not taken the 2nd vaccine as she is still having problems with her heart.  She has had a lot of tiredness and informed her doctor that she had that and the  chest pressure and palpitations.
Tachycardia, beginning ~24.75 hours after injection, lasting 7 hours including periods of sleep. No treatment, symptoms  abated after 7 approximately 7 hours.
This spontaneous report as received from a pharmacist, via a company representative, refers to a male patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No concomitant medication was reported. 2-3 months following vaccination (unspecified date) the patient developed a vesicular rash (described as: a zoster-like rash). The patient sought unspecified medical attention. The outcome of vesicular rash was reported as recovered on an unknown date. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 1/28/21 and 2/25/21. Recently dx'd w/covid 19 w/delirium on dementia, encephalopathy, and completed paxlovid. Upon assessment pt was with shallow breaths, cold extremities, and weak thready pulse. Nonrebreather mask was placed on pt, and during further examination became unresponsive resulting in a code and CPR. Intubated and transferred to ICU where he expired within minutes. Pt expired on 8/3. Tx'd with azithromycin, vancomycin, and zosyn, ceftriaxone, and paxlovid.
VERY ACHY; CHILLS; 101.6 F FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 51 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 02-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced very achy. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced 101.6 f fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very achy, chills, 101.6 f fever, fatigue, and headaches on 13-APR-2021. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 31st July 2020) for prophylaxis. On 26th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2019, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd dose of SHINGRIX in left deltoid and developed pain, rash, and swelling at the injection site soon after receiving the vaccine. The swelling extended from the site of the injection down to her elbow. The symptoms lasted for a couple of days. The reported batch number (L75Y9) for SHINGRIX did not exist and was updated to L7SY9 as per the sales database.
Localized swelling, induration & tenderness of LUE. Currently hospitalized, outcome not known at this time
Upper abdominal pain started on 4/11/21 and on about night of 4/12/21 left calf pain woke patient up. Patient notified this PCP's office with these symptoms on 4/13/21 at 10:28 at which time patient was referred to the hospital ER due to  6 known cases of women who had received Johnson & Johnson vaccine and developed rare type of blood clots and patient's above symptoms to rule out deep vein thrombus. At the hospital ER provider did physical exam and ordered lab which confirmed patient had no deep vein thrombus. Patient was discharged home with diagnoses of left calf pain and dyspepsia. Patient continues to have abdominal intermittently but left calf pain has been resolved.
ADACEL being administered post excursion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received via health professional. Agency number: 01489354  This case involves 49 years old female patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA051850, 2023SA051621 and 2023SA052675.  It was reported that "Caller reported a temperature excursion involving unopened Adacel, Tenivac and Menquadfi and was requesting stability information. The condition was 48.9F for 7 days due to a refrigerator malfunction on 3-Feb-2023 (not human error). None of the products were supported by the extended stability data. Caller also reports that 4 Adacel doses were administered after the excursion."    On 06-Feb-2023, the patient received booster dose suspect Adacel vaccine at 0.5ml once (lot: U7648AA, expiration: 15-Feb-2025) via intramuscular route in the left deltoid for Immunization being administered post excursion with no reported adverse event (poor quality product administered) at same day latency.  This situation is reported as a medication error due to ADACEL being administered post excursion.   Action taken with ADACEL vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered.    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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
No Adverse effects - patient did receive a second influenza vaccine for the year. Received first on 9/17/21 then again on 12/21/21.
18 days p/vax pt had T102-104;temp for 4mos, rash, stiff neck, joint swelling & pain (ongoing);hosp;pericarditis in AUG w/abn ECHO regarding two valves;dx systemic juvenile enteritis;
Lost most of the vision in left eye; Serious eye infection; This case was reported by a consumer via interactive digital media and described the occurrence of low vision, one eye in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced low vision, one eye (serious criteria GSK medically significant) and eye infection (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the low vision, one eye and eye infection were unknown.   It was unknown if the reporter considered the low vision, one eye and eye infection to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient warned and stated that he/she took the shingles vaccine and it triggered a serious eye infection, lost most of the vision in his/her left eye. The follow-up would not be possible as no contact details were available.
No reaction. This vaccine was administered beyond use by date. It was store in the refrigerator past the 10 weeks recommendation.
Couldn't do anything at all/had to stay in bed 24 hours/had to call off work; Very dizzy/was so dizzy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea). At the time of the report, MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment information was provided.
daughter received HAVRIX 7 days prior 6 month interval; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a child female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received one dose of Havrix on an unknown date).   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The patient's father reported that the patient received her dose of Havrix, 7 days prior of to intended 6 month interval scheduled. The exact date was unknown. The patient was provided with medical advised disclaimer and referred to Healthcare Professional (HCP). The reporter refused to provide mailing address. The reporter did not consent to follow-up. Additional supportive information: The patient received her dose of Havrix (booster) 7 days prior of to intended 6 month interval scheduled, which led to shortening of vaccination schedule.
This spontaneous report as received from a healthcare worker refers to a 17 year old male patient. The patient was vaccinated with GARDASIL (lot # not reported) 0.5 mL on 17-JUL-2012 (dose 1), 16-NOV-2012 (dose 2) and 18-JAN-2013 (dose 3), intramuscularly. No adverse events were reported. Additional information has been requested.
patient was given expired IPOL/ No AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2020SA125068 (same reporter).  This case involves a four years old female patient who on 06-May-2020 received 0.5 mL fifth dose of expired vaccine IPV (VERO) (lot P1A461M and expiry date 03-May-2020) via intramuscular route in the right arm for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event reported.  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 Directive and Module VI of the Practices. 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.
pt recv vax 6JUN95 & 5JAN98 pt devel chicken pox, approx 30 lesions;
No complaints after vaccines, played soccer after school came home and ate dinner and started feeling "horrible" after then...Per mom fever of 101 and patient c/o headache and achey all over. Called mom the following day who states patient felt fine after taking ibuprofen 9/25/2017 and was able to attend school on 9/26/2017 because he woke up feeling fine.
upper respiratory tract sickness; This is a spontaneous report from a contactable consumer. This female consumer reported that she received first dose of BNT162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported) dose 1 via an unspecified route of administration on 19Feb2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On unspecified date she coincidentally has an upper respiratory tract sickness and has been sick for the past 8 days. She will be taking the second dose of the vaccine soon and she was uncomfortable in getting the second dose while sick. She wanted to postpone her appointment to 19Feb2021. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
Erythema, swelling left lateral thigh at injection site, developed about 3 days after injection increased in size, tenderness over next week. Developed pink papular rash over trunk and proximal extremities over past 24 hours.
Patient returned to pharmacy on 12-22-15 stating she had to visit her doctor because she cannot raise her arm since she received the Influenza vaccine.
pt recv vax & devel a measles like rash, sore throat & urticaria;pt sought unspecified medical attention & is being treated by MD as contagious;pt recovered;
patient was vaccinated COVID bivalent which was discontinued by the facility. Spoke to mother Patient is stable no Adverse effect. Denies fever, chill, nausea, or vomiting.
suspected vaccination failure/1st and 2nd doses in 2019 / had Shingles in 2020; Shingles; received Shingrix when she was 48 / prior to approval of Shingrixfor patients under 50; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a 48-year-old female 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, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided are as follows: The case was reported by patient's husband. The patient received 2 doses of Shingrix in an unknown arm in summer of 2019 (exact dates were unknown) and had first outbreak of shingles in 2020. The patient received both doses when she was 48 years old prior to the FDA approval Shingrix for immunocompromised patients under 50 years of age, which led inappropriate age at vaccine administration. The reporter was not asked for lot, expiration date and arm administered. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The case has been linked with case US2021AMR255952, reported by same reporter for same patient for shingles experienced in 2021.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR255952:Same reporter, same product, same patient, case created for event that happened in another point in time
pt recvd vax & 24 hrs p/vax pt exp a red dot rash from waist to neck;
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (batch/lot number: Gh9702) at the age of 39 years, in left arm for covid-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
2/3 days after patient arm swelled and turned red for 2 weeks. Pt states she had felt tired and has had nausea/vomiting since then.
Patient has a solid nodule formed at site of injection. Redness and edema to site. Patient denies pain. Hard nodule size of a pen cap around in size. Pt noticed this the day of the immunization and brought it to my attention on 08/22/2005.
This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, nausea and headache. On an unknown date, the outcome of the pain, nausea and headache were unknown. It was unknown if the reporter considered the pain, nausea and headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by GlaxoSmithKline representative to Medical Information on behalf of the healthcare professional. The patient experienced severe soreness, headache and nausea. No additional information was provided. The physician did not want to be contacted. This case was linked with case US2017130642, reported by the same reporter.
Information has been received from a 70 year old male consumer with no known allergies or pertinent medical history who on 09-JUL-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included verapamil, hydrochlorothiazide (manufacturer unknown), diuretic (unspecified), terazosin hydrochloride, lisoprinil (manufacturer unknown), simvastatin (manufacturer unknown) and finasteride (manufacturer unknown).  "Around 17-JUL-2007" the patient developed a slight case of the shingles.  The breakout was about the size of a silver dollar on his left shoulder.  There was no itching or pain.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.
I have been suffering from constant pain in my dominant left arm, since I received the shot. At first the pain was manageable with some Tylenol. but the last two weeks, the pain has been excruciating and unbearable. I have taken Tylenol, Advill, Alleve. to help with the pain. Then my pain medication was upped to Tylenol 3 with codiene and also Ibruprofen 600. That also did not relieve my pain. I can hardly get out of bed now. I have tried using, rest, ice, compression, and elevation. I have an appoint to see my general practioner to see what can be done.
On Sept. 28, 2021 after my first dose at 12:30 pm my Heart rate 130's, Blood Pressure 211/100, lightheaded, weakness began at 12:48 pm. By around 1:35 pm Heart rate down from 130.s and sustained 100's to mid 80's, Blood Pressure was still elevated at 150's-160's/80's-90's and less lightheaded. 6:00pm fever of 100.5 and severe body aches and pins and needles to both hands. Pins and needles to both hands resolved next morning on Sept 29, 2021, fever on and off and severe body aches continue throughout Sept 29, 2021. Headache on Sept 29, 2021 continued all day until Sept 30, 2021
Pain, swelling, slight discoloration and marble size lump at injection site. Swelling and lump dissipated within 1-2 weeks. Pain at injection site still persists and painful when moving the arm.