chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. No treatment medication was reported.
This spontaneous report as received from a consumer refers to an 11 month old male patient. On an unknown date in April 2013 the patient was vaccinated with ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) orally. On an unknown date approximately in 2013 the patient has missed his 3rd dose with ROTATEQ by 3 months. No adverse events were reported. The action taken with ROTATEQ. The relatedness of the events to the ROTATEQ was unknown. Additional information has been requested.
This case was reported by a pharmacist via sales representative and described the occurrence of injection site reaction in an unknown number of subjects of unspecified ages and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates, the subjects received unspecified dose of ENGERIX B (unknown). At unspecified times after vaccination with ENGERIX B, the subjects experienced injection site reactions. After receiving information from a nurse, a pharmacist inquired with a sales representative about a "difference in the adverse reactions between the vial and TipLock because the subjects are complaining of more injection site reactions with the TipLok". At the time of reporting the outcomes of the event were unspecified. Follow up was received on 02 October 2009 via a nurse, and described the occurrence of burning at injection site during injection in multiple subjects of unspecified ages and genders who were vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, the subjects received unspecified dose of ENGERIX B (40 mcg, intramuscular), and experienced burning at injection site during injection. The nurse reported increased burning on injection with the pre-filled syringe administration of ENGERIX B. The subjects did not complain of burning when previous immunizations were drawn from a vial. All subjects complained of the same signs and symptoms. At the time of reporting the burning at the injection sites during injection were resolved.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 12-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
two days later after the first shot finger gets stiff and has no strength, now involving wrist elbow knee and feet, pain is  persistent, no swelling, unable to drive and in extreme pain; stiffness is major complaint along with pain
Experiencing rashes from her knees down to her feet; This is a spontaneous report from a contactable pharmacist. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on 28Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced experiencing rashes from her knees down to her feet on Jul2021. Outcome of the event was unknown.  Follow-up(30Jul2021):This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of a query.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient states she feels numbness in her left hand and feel like there is a knot in her arm near the injection site.
Developed rash,below site right arm. Rash- antecubital site on left arm-complained of pruitus.
had them twice even with shot before/suspected vaccination failure; Had them twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced vaccination failure (Verbatim: had them twice even with shot before/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had them twice).         The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that it was bad, the patient had Shingles twice even he/she received Shingles vaccine before getting the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt received employee flu vaccine. Within 30 min inj site very red/swollen ice pack applied. 15' later entire upper body red/flushed/widespread itching. Epi 0.30 given IM then BENADRYL 25 mg PO and prednisone 20 mg PO. Symptoms resolved quickly.
developed left side facial weakness and numbness/left sided forehead and mouth weakness; developed left side facial weakness and numbness; loss of left side blink; This is a spontaneous report from a contactable physician.A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0178 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Right on 11Jun2021 11:15 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 13Jun2021 11:15 the patient experienced developed left side facial weakness and numbness/left sided forehead and mouth weakness, loss of left side blink. The patient underwent lab tests and procedures which included physical examination left sided forehead and mouth weakness  on 13Jun2021 His physical exam was notable for left sided forehead and mouth weakness, with loss of left side blink although forced eye closure intact on the left side. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Pt was given wrong vaccine by MA. DTaP given instead of Tdap. Remediation done. State called and recommended right vaccine be given. No interval waiting necessary. Was given same day.
Pt awoke and noticed red raised "sore" area to R lower neck.  Reported it to Manager at worksite. On exam, 2x3/4 inch urticaria noted to R neck, nickel sized are to R ant chest. Pt denies itchiness. Red papular rash noted to posterior mid neck that was reported as itchy.  Advised to contact PCP, who advised Benadryl.  Pt reported improvement following Benadryl and over the next few days.  Note: Pt reports widespread similar episode in 1974 following swine flu vaccine but at no other time since. Reports no similar episode following annual influenza vaccine.
Pt. experienced a near syncopal episode within 5 mins of receiving COVID #1 vaccine. Felt sweaty, light headed and like he might pass out. Cold compress to neck, vitals completed as follows. Vitals as of 12:45 were BP 138/89, P68. O2 98%, @13:03 BP 123/90, P69, O2 99%. Pt had driven 30 mins at ~12:30pm for his appt. Pt ate 2 eggs at ~7:30am. He had an early lunch of turkey sandwich and apple at ~10:30am. Was given 4.6oz apple juice box which he consumed rapidly. Received 2nd juice box and crackers. Pt has history of essential tremor, diagnosed ~ 2yrs prior. Pts father picked him up to drive back, Instructed to rest and report to on clinic, UC or ER if he became symptomatic. 2nd dose on 5/20.
Family members had tested positive for COVID-19, then I did a few days later. Contacted doctor and was given 3 infusions of remdesivir.
Patient called on 10-29 and said that on 10-14 she was unable to lift her arm. She said that while these sx were better, she was now experiencing shooting pains down her arm. I instructed her to call dr.
Arm redness and swelling from shoulder down to elbow. Patient advised to use cold compress, give oral CLARITIN and local anti-itch cream.
Intermittent claudication ICD-10: I73.9: Peripheral Vascular Disease
Slight Headache; Full body joint aches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 12Mar2021 at 2:30 pm (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. Concomitant medications included myfortic (MANUFACTURER UNKNOWN), tacrilomus (MANUFACTURER UNKNOWN), effexor (MANUFACTURER UNKNOWN), calcitrol MANUFACTURER UNKNOWN), contrave (MANUFACTURER UNKNOWN) all for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021, the patient received Tetanus vaccine prior to the COVID-19 vaccination. On 13Mar2021, the patient experienced slight headache that lasted 24-36 hours and full body joint aches. The patient did not receive any treatment for the events. The clinical outcome of the slight headache and full body joint aches was recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
The 48 year old patient was to receive her second Varicella and instead was given a Shingrix.  The nurse giving the shot did not give the injection IM as she should have and nor did she do a double check.  The patient has not had an adverse reaction.  The doctor and patient were notified.
Patient states that after receiving vaccine at about 7pm, he experienced pain in all of his joints/back/and jaw starting around midnight that same day. This lasted for 3 days.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 21-year-old female patient who received BEXSERO. On 10th February 2018, the patient received the 2nd dose of BEXSERO. On 10th February 2018, less than a day after receiving BEXSERO, the patient experienced injection site pain. On 14th February 2018, the patient experienced fever. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the fever was unknown. The reporter considered the injection site pain to be related to BEXSERO. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: Four days after receiving vaccination, the patient's body temperature was recorded as 101.8 degree. The university had an outbreak of meningitis B and each student was required to have the vaccine. The patient experienced soreness at the injection site and was getting better when she went to the doctor on the 14th February 2018. This was all of the information that could be provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, he was treated (by an unspecified healthcare professional) at an urgent care facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Case was hospitalized for Covid 9 months after completing Covid vaccine series . * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Patient compleated vaccination series in 1/2021 She tested positive for Covid on 10/8. Admitted 10/11 but then was transferred to ICU overnight for hypoxic respiratory failure which required HHFNC. CTA chest in icu showed small bilateral PE's and apixaban was started.    While on supplemental oxygen she was treated w/ dexamethasone and remdesivir.    10/16: now off supplemental oxygen.
Blisters on hands and chest (ER); Pain from shingles; Had both doses in 2018, diagnosed with shingles in 2023/Suspected vaccination failure; Diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11-SEP-2018, the patient received the 2nd dose of Shingrix. On 08-MAY-2018, the patient received the 1st dose of Shingrix. On 29-MAR-2023, 1660 days after receiving Shingrix and 1786 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had both doses in 2018, diagnosed with shingles in 2023/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Diagnosed with shingles). On an unknown date, the patient experienced blister (Verbatim: Blisters on hands and chest (ER)) and pain (Verbatim: Pain from shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the blister was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2023 The case was reported by the patient. The patient did not wish to provide his date of birth but provided current age. At 7 am morning on the day of reporting, the patient went to the emergency room because he had blisters on his hands and chest.  The patient was diagnosed with shingles and was given Valacyclovir for shingles treatment. The patient also experienced pain from the shingles.  The patient gave consent to follow up with healthcare professional (pharmacy). This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
On 8/10/09 - 7 pm client taken to ER by ambulance c/o difficulty breathing. Temp 103 degrees. Tx 1000 cc NS IV - ROCEPHIN 1 gram IV piggy back. Lorazepam 0.5mg IV push. TYLENOL 650 mg Po x 1. MOTRIN 800mg Po x1 - Dx influenza - D/c from ER.
The pt experienced severe itching, arthralgia to the hips, right upper extremity myalgia, headache, swollen brain feeling, chills, fatigue, heavy limbs, heart palpitations, inner trembling, nausea, loss of short term memory, numbness and tingling of right arm. Follow up information received on 11/13/2001: In February 2001 a nodule appeared on the knuckle of my left forefinger. Soon thereafter nodes began to appear on the joints of my righ hand along with swelling, stiffness and inflammation. This continues to progress along with my cognitive problems.  Follow up on 01/11/2000: "Lot #'s for vaccination #1: LY120D9, #2: LY120F9, #3: LY130AD."
Vaginal bleeding started day after receiving Gardasil vaccine. Bleeding is persistent (Moderate-severe) and still present LMP 12/28/02 ended 01/02/07. Onset menses 10 year age.
Left upper arm redness and warmth, tenderness the size of a hand developed 2 days after injection. No red streaking, no fluctuance, no abcess. No temperature, no other symptoms.
Throughout the day I had mild chest pains, felt tired, and achy.  A little light headed.  I left work early, and got a good night's rest.  Today (1/6/2010) I feel much better.
Just started having heart palipations which then causes stomach upset a hour later.  I have not seen a doctor yet but I am concerned since what I read is similar to what I am experiencing and will go into the doctor to have it looked into as soon as an appointment is available
Pt fainted to the floor. Woke up was fine after sitting 15 more minutes.  Ems came and checked him out. Pt left with wife
Dose of Vaxelis given to an 11 year patient (out of recommended age range).  This was not noted until approx 6 weeks later. Pt had no adverse events or symptoms reported.
Patient called pharmacy manager at aforementioned location stating that she had been having problems of severe pain in the Left arm near injection site, which continued for 2 weeks. She stated no fever and was unable to pinpoint exact date of onset. The patient called her private prescriber who issued a prescription for Tramadol 50mg. One tablet by mouth every 6 hours pm pain, #20 with 1 refill. Patient reported having no redness or swelling at the injection site and she was feeling much better at time of our discussion.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ITP" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01Apr2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: COVID 19 Treatment; (12Jul2022) Negative, notes: After taking Paxlovid and testing negative on 12Jul2022; (19Jul2022) Positive, notes: tested on 19Jul and was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 06Jul2022 to 10Jul2022 for treatment of covid-19. After taking Paxlovid and tested negative on 12Jul2022, she became symptomatic again on 18Jul. After feeling worse, she tested on 19Jul and was positive again and for which she did not receive any treatment. It was reported that the patient had no known allergies.