chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started getting a headache / on the left side of my head / still feel a pulsing pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received Shingrix. On 11th July 2021, 2 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received shingrix vaccine on friday and experienced headache on sunday evening on the left side of my head and felt a pulsing pain on and off till tuesday. The patient asked if this was a side effect from vaccine because he/she normally do not get headches. No further details provided.
After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to use her Epi-Pen.  Did a telemed appointment with her physician who told her to take one dose of the Epi-Pen, Benadryl, Prednisone, Ventolin, and Singulair.  These medications have worn off, and wants her to take even more doses of the Prednisone, Benadryl and the inhaler.  She is still having symptoms, but improving.  She does not itch as badly.  Her arm is sore.
Child received vaccines noted below, observed her sibling. Faint, then fainted as well, falling to her anterior abdomen; pale and diaphoretic, pupils equal dram -RN
Within an hour my blood pressure peaked and stayed that way for three hours.  Normaly 140/ 80's and went to 199/ 85
Started as slight itching,   eventually, 2-Days, broke out in hives over arms, legs and torso.  Extreme itching.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022).    No concomitant medications were provided by the reporter.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
TINGLING THROAT; RASH ON FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced rash on face, and tingling throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on face and tingling throat was not reported. This report was non-serious.
Generalize ditching, sense of doom, tightness in chest/neck (no dyspnea, no wheeze). Chills. Cold intolerance. Oral Beandryl, SQ epinephrine x 2 doses. Prednisone taper for 8 days.
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (batch/lot number: GL0448) at the age of 58 years for covid-19 immunization; BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (batch/lot number: FJ4991) 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 included: "chronic migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid on 27Feb2023.
Pain in foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuroma (pain in the bottom of the foot, something to do with ligament, has the issue for last 6 years.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in foot). At the time of the report, PAIN IN EXTREMITY (Pain in foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Patient received cortisone shot in foot 06Apr2021. No concomitant medications were provided.
The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing.
Sore muscles; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscles) and PYREXIA (Fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MYALGIA (Sore muscles) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 UNK. At the time of the report, MYALGIA (Sore muscles) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included Flonase.   This case was linked to MOD-2021-046419 (Patient Link).
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 128 hours. The highest recorded temperature was 49 (9.444444444 Celsius) F. No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Classic measles rash with coryza, mild conjunctivitis.  Treatment: Observation, isolate from unvaccinated people.
p/vax pt devel low grade fever & extensive maculopapular rash-purple red on arms chest, legs & very thick raised arms & legs
Panic attacks that started several days after administration. Required prescription medication to manage panic symptoms (Citalopram).
having no energy; fatigued/extreme tiredness; Not sure if she will get second dose of the vaccine; Sleeping 13-14 hours a day; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0151), dose 1 via an unspecified route of administration on 07Apr2021 17:30 (at the age of 30-years-old) as single dose for covid-19 immunisation . Medical history included breast cancer and urinary bladder haemorrhage. The patients concomitant medications were not reported. On 08Apr2021 the patient experienced fatigued/extreme tiredness. On an unspecified date in Apr2021 the patient was not sure if she will get second dose of the vaccine, sleeping 13-14 hours a day and having no energy. She was sleeping 13-14 hours a day and that was not normal for her. She was not sure if she would take the second dose because she was tired all of the time. For extreme tiredness patient visited physician office. Patient did not receive any other vaccine prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included pregnancy test negative: negative, sars-cov-2 test negative: negative. The outcome of event experienced fatigued/extreme tiredness was not recovered and outcome of rest of event was unknown.  No follow-up attempts are needed. No further information is expected.
My left arm at the injection site is extremely itchy and my arm hurts and does not feel right.
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268362, 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358 and 2019SA268359 (same reporter).  This case involves a 84 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were 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 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.  List of documents held by sender: none.
LARGE (4 INCH DIAMETER) RED, SWOLLEN AREA STARTING 1-2 INCHES BELOW INTECTION SITE.  WARM TO THE TOUCH.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014 the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2010, the patient was treated at a family medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
severe muscle spasms in back and shoulder on right side, severe pain in right arm, shooting pain and numbness in right arm finger pins and needles numb.  Unable to stand without pain and spasms.  symptoms started 2 days after first shot, went to urgent care since have seen 8 doctors, 2 trips to the ER,  2 MRI,  CT scan and back and neck xrays..  Presently seeing a spine specialist and received a cortizone shot.  Still can not stand witout pain and numb arm and hand.
Information had been received on 13-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 11-NOV-2010 by a physician, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-FEB-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient had been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Cardiac arrest, pt revived but EEG revealed no cortical, only brainstem functioning; (pt died 3 days after being placed in hospice)
today she has a little bit of a headache; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 29Apr2021, outcome "unknown", described as "today she has a little bit of a headache"; MALAISE (non-serious) with onset 29Apr2021, outcome "unknown", described as "Not feeling well". Therapeutic measures were taken as a result of headache, malaise.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction; allergic reaction that progressed over a few days; wheezing; trouble breathing; rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included PANTOPRAZOLE and GABAPENTIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body). The patient was treated with PREDNISONE for Allergic reaction, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Per report, the patient developed an allergic reaction that progressed over the next few day and felt better after treatment. The patient reported that his antibody level  was 70, as informed by his doctor who advised the patient against receiving the second dose of Moderna Covid-19 vaccine.
SUDDEN ONSET IN NIGHT OF SEVERE BACK PAIN, KNEE PAIN AND SWELLING WITH NO PROVOCATION IN THE NIGHT OF 11/1/2021. WOKE UP FROM SLEEP UNABLE TO FIND ANY POSITION THAT WASN'T PAINFUL.  UNABLE TO SLEEP. LEFT KNEE SWELLED SO I COULD NOT COMPLETELY STRAIGHTEN OR FLEX. HAD NO SYMPOTMS 11/1/2021 - NORMAL WORK DAY BAD ENOUGH THAT I COULD NOT WALK - MISSED 2 DAYS OF WORK DUE TO SEVERITY. CONTINUED WITH SYMPTOMS UNTIL THEY COMPLETELY RESOLVED 11/15.   SAW MY ORTHOPEDIST 11/4/2021 - HAD 40 CC FLUID TAKEN OFF MY KNEE AND COMPLETED MY VISCOSUP INJECTION SERIES.
She was able to move her arm which was paralyzed for four years; after being vaccinated she was able to move her arm/I got it wave up over my head right now; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program CO. A 72-year-old female patient received first dose of BNT162B2 via an unspecified route of administration in arm left on 15Apr2021 (Lot Number: EW015P, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included allergy. Her arm was paralyzed for four years. It was not, really paralyzed it was just in the muscle in it are deteriorated so bad that she had unable to use it. She had unable to do this for four years and unable to put her arm up over her head for four years. She was reaching to the feeling on moving all around. Concomitant medications included multi-vitamins and antihistamine for her allergy. She went to get my first COVID shot on 15Apr2021. She got it in her left arm. She just stuck holy grab around my husband, she can now work. She had unable to do this for four years and unable to put her arm up over her head for four years. She was reaching to the feeling on moving all around and she had not unable to do it, so BNT162B2, whatever in it helped her shoulder tremendously. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered pharmacist refers to a 76 years old female patient with no pertinent medical history and no drug reactions or allergies who on 28-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 671779/0169AE, Exp. Date: 06-MAR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and methotrexate. The pharmacist reported that a patient developed a reaction at the injection site consisted of red, swollen and warm area after receiving ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient developed a reaction at the injection site consisted of red, swollen and warm area warm unknown for ZOSTAVAX. Additional information has been requested.
Woke up 1/8/11 c/o R > L leg pain. Had trouble sitting up & walking. MOTRIN helped some. 1/9/11 - a little better & less pain. 1/10/11 - better.