chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a currently 80 year old male patient. The patient's drug reactions included penicillin allergy and rash caused by TAMIFLU. The patient's medical history was reported as "nothing relevant". Concomitant therapies were reported as "yes". On an unknown date, during the same visit to an unspecified pharmacy, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) (route reported as "injections"; dose, anatomical location, lot number and expiration date were not reported), for shingles and pneumonia prevention, and a dose of PREVNAR 13 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (dose, route, lot number, expiration date and indication were not reported). Later, on the same day at night, the patient experienced sciatica in the right leg, which developed into neuritis of both legs and then progressed to include upper extremity pain of the shoulders. It was also reported that the patient experienced agony in all their muscles and joints and had night sweats. Therefore, the physician treated the patient with tramadol hydrochloride for pain and 2 courses of prednisone (manufacturer unknown). Accordingly, the patient felt much better, but the physician could not keep the patient on the prednisone (manufacturer unknown) forever. No lab diagnostics were performed. At the time of reporting, the outcome of sciatica, night sweats, musculoskeletal disorder and musculoskeletal pain was reported as "gotten worse". The causal relationship between all above mentioned events and the suspect products was not reported. This case was considered as serious because the physician stated that the patient had significant disability.
Had URI, fever, developed respiratory distress, intubated in ER, ARDS ECMO, coded x2 died 12/18/2016.
has not received the second dose yet due to the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 or in early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, due to the pandemic, the patient did not receive 2nd dose of Shingrix, which led to social problem . The reporter did not consent to follow up. This case was linked with case US2021254878, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254878:same reporter, other patient
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 17-DEC-3025, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt presented as cool, pale, diaphoretic, with hypotension  (B/P 72/38) and bradycardic (HR 48). His BGL was 137. He was very lethargic, and was between a GCS-14 and GCS-15. Pt presentation improved to appear pink, warm, and dry. Final BP was 104/87 with a HR of 74 and GCS-15. Pt was AOx4 and his wife said she would drive him to be evaluated at the hospital and refused transport by ambulance.
Chills;   Sore Arm;    Shakes;   Anxiety;  Dizzy
Information has been received from a pharmacist concerning a pt who was vaccinated "last week" with pneumococcal 23v polysaccharide vaccine (lot650457/0973P). Subsequently, the pt developed "what appeared to be cellulitis". Unspecified medical attention was sought. No further information is available.
12/06/21 presents to EC ED for "progressive lower limb weakness". PMHx of "Hypertension, and Primary chronic progressive multiple sclerosis (CMS/HCC)"
Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:
This spontaneous report was received from a pharmacist via a company representative regarding a female patient (age unknown). Medical history included shingles when she was approximately 30 years old. Concomitant medications were not provided. On an unspecified date, the patient received a dose of ZOSTAVAX (route and lot number not provided). She later developed shingles on an unspecified date when she was over 50 years old. The outcome of the shingles was not provided. Additional information has been requested.
GOT SICK RIGHT THERE ON THE SPOT; TREMBLING; COULDN'T GET UP AND WALK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got sick right there on the spot, trembling, and couldn't get up and walk. The action taken with covid-19 vaccine was not applicable. The patient was recovering from got sick right there on the spot, trembling, and couldn't get up and walk. This report was non-serious.
No adverse event; Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter
Patient developed a 10 cm red, indurated, warm area over the left thigh where he received the DTAP/Hib combination.
Itchy red welts appeared on face by next day extremely red, extremely large, extremely large amount of welts were on face including eyebrows, lips, forehead, hairline, and eyelids. The welts were partially on the side of the neck, upper and lower back, and both upper arms. Benadryl did not help. Dr. prescribed prednisone on 12/22/09 and first dose was taken morning of 12/23/09. By evening of 12/23/09 symptoms were lessening immensely.
patient fainted, passed out. did not hit head or get hurt. he was with a friend, who caught him. He was dizzy, light headed, grayish in skin tone, tightness in chest.
On 10/1/10 started c/o pain in Lt. shoulder. On 10/3/10 noted swelling and tenderness involving left supraclavicular fossa and base of neck. Patient referred to hospital emergency department. Evaluation and treatment on 10/5/10.
Breakthrough case admission after 4 vaccines Moderna 1/12/21 Lot# 027L20A;  Moderna 2/9/21 Lot# 010M20A;  Moderna 12/6/21 Lot# 031H21A; 5/5/22 Moderna NO LOT #   NOT IN  VACCINE DATABASE
same day pt slept rest of day; morning of 15MAR93 had congestion, fever of 101, sore throat, rapid heart & resp rate, vomiting; seen by MD;
Client called 06/05/02 and reported rash under arm of injection site. Client reports rash on inside of her legs and between her fingers. She reports that the itching is spreading everywhere.
My left are where shot was give became very sore. As the night went on it became very hard to move or sleep. This vaccine should really not be offered after any serious procedure. In my case after a heart operation. the effect of the shot have really worsened my recovery as the arm is now almost unusable.
Not Serious. Just unusual as it started 7 days after, at shot site on rt arm, became red and itching. Now 10 days later still itchy and red. Not hot to touch, no fever. Just itchy and red on arm. No ther pain now or other symptoms.
allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00535257) and transmitted to Sanofi on 25-Mar-2021.  This case involves a female patient (age not reported) who had allergic reaction (allergy to vaccine) while receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past vaccination(s) included Influenza vaccine in 1970 and DTP VACCINE for prophylactic vaccination and experienced itching after receiving DTP VACCINE.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.   On 20-Sep-2012, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UH714AA and expiry date: 30-Jun-2013) via an unknown route in an unknown administration site for prophylactic vaccination.  On 20-Sep-2012 the patient developed a non-serious allergic reaction (allergy to vaccine) same day following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  The caller had a known allergy to thimerosal. She had an allergic reaction to a flu vaccine but does not know which manufacturer's vaccine it was that caused the reaction. At the time, it was thought her allergic reaction happened due to her thimerosal allergy because even though the outer package of the vaccine she received indicated "thimerosal free", it was later found in the package insert that the product contained a millimicron of thimerosal. She did not have information about what presentation but thinks it was possible that it was from a single dose vial. She summarized that she had only reacted to two types of vaccines in her lifetime. She had reacted mildly with itching to DTP vaccines. She did not receive any more flu vaccines until in 2007 and at that time went into the hospital. She avoided reactions because that entire time she thought it was thimerosal she was allergic to, and as long as she would avoid thimerosal, she thought she was okay. But she did note that her allergist did not believe that thimerosal causes allergic reactions of the type that she experienced.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Patient given immunization of Meningococcal and not PREVNAR Pneumococcal.
Temp. 98.8, redness at the site of immunization shot given anterolateral thigh.
The patient experienced swelling of the right arm from the shoulder to the wrist. The area was red and hot to the touch, with itchiness that began 24 hours after the vax and persisted for 5 days after.
Pain in right arm, redness in right arm with a palpable nodule in the right axilla.
Headache described as what felt like the back of her head was bruised, concerns that she hit her head with no recollection of a trauma. Tender to the touch.  One dose 400mg ibuprofen. Lasted intermittently for 24-48 hours.  Pain score of 6-7/10.
pt has had sz type activity since vax in JUN; pt seen by MD put on anticonvuls meds; pt seems to be doing better; MD relatively unclear as to cause; poss vax related;
From mom 101.6 fever noon. Noticed rash to both arms. Fingers are white and cold forearms are gray cream color rash. 'Big polka dots' mom states. Child was not seen for this. Spoke to the provider and mom to go to ER if further concern and mom to call and update.
Pt recvd a series of 3 doses of Engerix-B exp no adverse exp however did not convert; plan to revax;
Ear was hurting; throat hurting too.; This is a spontaneous report from a Pfizer-sponsored program via a non-contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included she was a little hoarse and acid reflux problems for the past year. The patient's concomitant medications were not reported.  Called before having her first vaccine and had another question. Caller was a little hoarse. Had acid reflux problems for the past year, but she woke up this morning (on 18Jan2021) and her ear was hurting and throat hurting too. Inquiring if she could take the vaccine with those symptoms. Caller indicated that this is not related to the vaccine. It was reported that she was hoarse today (on 18Jan2021), plus her ear and throat were both hurting as well.  The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.   There is limited information provided in this report.  This case will be reassessed once additional information is available.
inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was inadvertently given expired product with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7378MA, expiration date: 30-Jun-2022 via intramuscular route in the thigh nos (not other wise specified) (vastus lateralis) as Immunization  On 07-OCT-2022 the patient was inadvertently given expired product with no reported adverse event (expired product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently given expired product with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   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.
Early, heavy and prolonged menstruation.; Early, heavy and prolonged menstruation.; This is a spontaneous report from a contactable consumer. A 43-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955, Batch no: CCBH 7957), via an unspecified route of administration, administered in Arm Right on 21Mar2021 01:15 PM as single dose for covid-19 immunization. Medical history included Latex Allergy. Concomitant medication included escitalopram oxalate (LEXAPRO) and Vitamin D. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines with 4 weeks prior to COVID vaccine. On 03Apr2021 13:00 the patient experienced early, heavy and prolonged menstruation. Patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
herpes zoster with ophthalmic complications; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster with ophthalmic complications. As a result of these symptoms, the pt had been seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered the event of herpes zoster with ophthalmic complications to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster with ophthalmic complications was considered to be disabling. Upon internal review, the event of herpes zoster with ophthalmic complications was determined to be medically significant.
pt recv vax 24OCT95 p/inj pt devel h/a & cough which had reportedly not resolved;
Narrative:  64 y/o male presented to ER on 1/16 with progressive shortness of breath over 3 - 4 days and productive sputum. Home nebulizers not improving symptoms. Dx with COVID infection, admitted and treated with IV remdesivir 01/16- 01/20/2022, dexamethasone (1/16 - 1/17) which was changed to methylprednisolone (better effect for associated COPD exacerbation) tapering dose. Discharged on 1/20/2022/ PMH of TIA, pulmonary embolism, hypertension, hyperlipidemia coronary disease status post graft, and on 2 L home O2 for COPD.
ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Patient complains of a painful and burning rash on her upper, center back. The rash is comprised of six small, round, red bumps. Her skin appears irritated around the bumps. Patient reports pain from touch and clothing at the site of rash. Patient denies pruritis. Her primary care physician's office was closed for the day when she presented to the pharmacy. We were able to get ahold of Dr. on his personal number. He prescribed Valacyclovir 1g 3 times per day for 7 days. She is to be examined at his office tomorrow (8/10/18). I also recommended, and she purchased, OTC Lidocaine 4% cream. Patient reports that she has been immunized with ZOSTAVAX in the past, but I do not have the date recorded at the pharmacy. She told me that she was planning to babysit her four-month-old grandchild this week, and I advised against it.
administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial  did not undergo any temperature excursions. All vials were removed from freezer just prior to administration times. No concomitant medications information was reported.   This case was linked to MOD-2022-570980, MOD-2022-570985, MOD-2022-571139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Significant follow-up appended- Lot number added.
EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (EXPOSURE DURING PREGNANCY) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Jun-2020 and the estimated date of delivery was 20-Mar-2021. On 08-Jul-2020, the patient experienced EXPOSURE DURING PREGNANCY (EXPOSURE DURING PREGNANCY). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (EXPOSURE DURING PREGNANCY) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33 year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.