chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to 8 patients between the ages of 18 to 21 years which was heard on an unspecified television program. On unspecified dates, these patients received vaccination with M-M-R II (dose and route were not reported). These patients developed mumps after being previously vaccinated with M-M-R II (dose and route were not reported). The outcome and causality were not reported. Additional information has been requested.
Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 044A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Additional information was reported as follows: Date the vial was initially stored in the refrigerator was on 26Jan2022 at 8 am. It was reported that vial had not undergone any temperature excursions.
No other AEs or PQC reported. No Additional information available.; received PROQUAD and VARlVAX at same visit; This spontaneous report was received from a medical assistant and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # U006312, expiration date 24-AUG-2022, 0.5 milliliter, subcutaneously (SQ) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # U007471, expiration date 08-MAR-2023, 0.5 ml, SQ (formulations, concentrations, dose numbers and anatomical locations were not reported) for prophylaxis. Both the vaccines were administered at the same visit (overdose). No additional adverse event was reported (no adverse event).
6 days after shot, I got what seemed like an Aura migraine, unable to see well out the front of my eyes, sides of my eyes had lights and line of geometric patterns. No pain in my head at this time.  Lasted for 1-2 hours.  For the next 2 weeks, I had light sensitivity and felt light headed on and off throughout the day with some fatigue.  I had a headache a few times.
Pain, Ecchymosis at injection site-occ. Tingling- (L) middle finger
This spontaneous report was received from a Nurse refers to a 35 week old infant patient. On an unknown date, at 35 week the patient was inadvertently vaccinated with ROTATEQ dose 3, oral. No adverse effects reported. No further information was provided. Additional information has been requested.
indentation in left arm at site of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (indentation in left arm at site of injection) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDENTATION (indentation in left arm at site of injection). At the time of the report, INJECTION SITE INDENTATION (indentation in left arm at site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The follow up received on 25-MAY-2021.It does not contain any new information.
Fever of 105F early afternoon 18MAY90; Developed cough; Seen again 23MAY had developed otitis media;
Fever, fatique, lethergy, weakness, extremely painful right arm (2 days) .   Lethargy, sinus drainage, Loss of sprite, difficulty swallowing, chest pains, headache, fever, chills, soar throat, lymph nodes swelling, extremely painful earache, nose bleed, severe cough, extreme redness , dryness and irritation of eyes and drainage, mucus in both eyes, blurred. Vision. Went to doctors office, 05/27/2022.  Received a steroid injection and ZPack. Covid test negative.  Severe sinus infection.  5/31/2022 contacted medical clinic again- same symptoms.  Except now i have a stomach ache.  Still no appetite
Pain, swelling, erythema and mild induration measuring 13X11 on left arm with cellulitis beginning at 12 hours and lasting for 30 hours.
Presented to ED w/cough, fever, & AMS; admitted for COVID-19 pna; tx w/abx, steroids, remdesivir, O2 therapy; pt weaned from O2/NC to RA; dc'd home
On day 7 I developed significant itching to injection site along with large area of induration, redness and heat. It continues into today. Tender to touch.
axillary, lymphadenopathy  Narrative:  24 hours after receiving the vaccine noted swelling under left arm. Vaccine administered 12/21. Axillary fullness noted on 12/22. Confirmed on my exam in employee health on 12/23. No redness or warmth, but tender to palpation. Enlarged Ln appareciated. Some associated tingling in arm. Symptoms are mild. She will manage with ibuprofen and observe for any worsening / changes. Follow-up next week following holiday closures.
Swelling, redness, heat, and pain at injection site. Headaches unresolved with Tylenol. Fatigue, and general malaise.
sinus infection; sweats; stomach pain; cramping; diarrhea; sore throat; covid-19 infection; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (stomach pain), MUSCLE SPASMS (cramping) and DIARRHOEA (diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SINUSITIS (sinus infection), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (stomach pain), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), HEADACHE (dull headache) and COVID-19 (covid-19 infection). At the time of the report, SINUSITIS (sinus infection), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (stomach pain), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), HEADACHE (dull headache) and COVID-19 (covid-19 infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-072648 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072648:2nd dose case
Headache, Myalgia, Fever, CHILLS; FATIGUES Narrative:
Experienced extreme fatigue beginning in April, 2021. Felt weighted down in chest and throughout body. Had to rest often, felt debilitating exhaustion on and off throughout the day. Continued through May and June. Started to feel less fatigued around mid-July.
Information has been received from a Registered Nurse (RN) concerning a 14 year old white female child with a history of laryngotracheobronchitis, pneumonia, bronchitis and allergic rhinitis who on 22-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up information it was reported that patient's mother called the office to complain that on 23-JAN-2008 her child's arm was hard to touch, warm and tender which lasted couple of days. The child recovered few days after the vaccination. Additional information is not expected.
After 30 minutes of observation, patient started to leave and didn't feel good. Her face complexion turned white and said her chest started to get tight. Staff couldn't get a BP reading. Patient was  lowered to the ground as she passed out. An Epi Pen was administered at  11:02am and she woke up immediately. Patient was slowly transferred her to a stretcher and monitored her vitals until EMS arrived at 11:20am. Patient refused to go to hospital after being observed by EMS and her husband came to pick her up.
Size of injection about a quarter.  Each day the redness has gotten larger and the swelling has increased.  Injection was given on the inside of my left arm.  Today, June 3rd.  Swelling in near elbow and redness is 4 inches.  Used triple antibiotic ointment for itch. A nurse at church today looked at it and said I was having a reaction.  I also had the pharmacist look at my arm on Saturday.  He advised to use Advil/and the ointment for itching.  No longer have itching.  Arm is sore to the touch.
Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination.   No follow up attempts are possible. Information on lot/batch number cannot be obtained.
UPPER LEFT SHOULDER PAIN (MINIMAL); This spontaneous report received from a patient concerned a 63 year old male. 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported.  On 2021, the patient experienced upper left shoulder pain (minimal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper left shoulder pain (minimal) on 2021. This report was non-serious. This case, involving the same patient is linked to 20220735184.
A phamacist reported that a 53 year old female received an injection of Flu Shield on 29-NOV-2001. Within one hour of vaccination, the pt developed paresthesia in her right foot which "traveled up her right side". She was hospitalized where an MRI showed transverse myelitis. No further information was available at the date of this report. The follow up states MRI of her spine showed a 1cm area of plaque at the T2 level. An MRI of the brain was normal. An analysis of her cerebrospinal fluid showed no abnormalities. A diagnosis of transverse myelitis was made. A visual evoked response potential test was normal. Somatosensory evoked potential of the posterior tibial area showed no reproducible cortical activity on the right. As of March 2002, the pt had "nearly complete resolution of symptoms"; however, she still complains of "occasional episodes of tingling in the leg."
Immediately running 30 minutes on treadmill began with itchiness starting with palms of hands and neck. Within ten minutes complete body red warm rash with full body itchiness. Benadryl 50 mg taken at approximately 7:15 pm symptoms started to subside around 7:45pm complete recovery by 9pm. No respiratory symptoms noted. Additional Benadryl 25mg taken by patient at 10:30pm (to be sure)
Right shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), via an unspecified route of administration in the left deltoid on 22Dec2020 at a single dose as preventative and to protect the people around him. The patient had no relevant medical history and no concomitant medications. The patient stated that ever since he got the vaccine, he has had shoulder pain (onset date was on 24Dec2020). He was unsure if it was joint or muscular. When he raises it to a certain level, there was intense pain. This was only his right shoulder, he got the vaccine on his left side. The pain had stayed the same. It goes away every so often and then it comes back, that was with him helping it. He had used heat, taking Advil, and sometimes icing it. It had stayed the same and it has not gone away and it has not improved. The patient thinks his dose was 3mL, if he can recall. He stated that he did have one question. He was about to resume classes at his college and they were requesting that he took a tetanus shot and get a TB skin test. He was trying to figure out if that was okay. He remembers reading something that he should not get another vaccine at this time. If that was true, the patient was inquiring what was the time span. Outcome of the event was not recovered/not resolved.
severe local reaction few days after vaccine. pruritis 2 weeks after vaccine, jaundice 6/17.  secondary foot infection from scratching. given few dose of doxycycline and Bactrim. On 7/1 bilirubin 4.9, sl increased AST/ALT. Hepatitis panel negative
pt under age. true age 16 y/o.  Originally registered D.O.B
Abrupt onset of feeling faint(passed out briefly according to husband while sitting in chair), moderate rigors(chills).  Pulse was weak but regular with low rate.  Initial blood pressure was barely detectable but appeared to be 90/60, but could have been due to heavy sweat shirt.  Subsequent bP in 10-15 minutes was normal at 122/60 with normal rate and rhythm.  High degree of lethargy that persisted for 3 hours with a lower degree of lethargy persisting for 24 hours.  An initial observation of abrupt onset and degree of symptoms were similar to some symptoms of anaphylaxis but breathing appeared normal.
Left arm redness and itchiness at site of injection four hours after she received 3rd hep B dose.
Severe asthma, severe cough , severe shortness of breath requiring oxygen for the first time.  Severe muscle spasm in rib cage and chest wall
FEVER ; TEMP OF 105 DEGREE FAHRENHEIT ( TEMPORAL ARTERY THERMOMETER )
Menveo reconstituted with sterile water instead of the supplied CYW liquid conjugat; Nurse administered a dose that was reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: Nurse reports that a fellow nurse administered dose of Menveo that was reconstituted with sterile water instead of the supplied CYW liquid conjugate. At the time of reporting, the dose was not repeated. The reporter did not have any patient details aside from gender. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received dose of Menveo reconstituted with sterile water instead of the supplied CYW liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was older but healthy men. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "My father in law died from sudden blood clots after they got vaxxed. Older but healthy men." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220108012.; Sender's Comments: V0: 20220107619 - Covid-19 vaccine ad26.cov2.s- Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in September 2018). On 22nd January 2019, the patient received the 2nd dose of SHINGRIX. On 24th January 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient complained to pharmacist at pharmacy where she got immunized that she has redness swelling and pain at the injection site. The pharmacist informed her that if her symptoms worsened then contact her doctor.
From telephone contact received at manufacturer on 06/21/2002, it was reported that a 38-year-old female received dose one of Imovax Rabies vaccine in the left deltoid on 06/15/02 and dose two in the right deltoid on 06/18/02 for post exposure prophylaxis. Pt had superficial bite in right arm, RIG administered at wound site. On 06/20/02, pt developed complete paralysis from right elbow down to fingers with slight sensation in finger tips present. No sensation in forearm at all. No other signs and symptoms at this time. This case is closed.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Date of refrigeration of vial is 19-AUG-2021.   This case was linked to MOD-2021-364610 (Patient Link).
fever of 100.2F; bad headache; tiredness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PYREXIA (fever of 100.2F), HEADACHE (bad headache) and FATIGUE (tiredness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (achiness). 14-Apr-2021, the patient experienced FATIGUE (tiredness). On 15-Apr-2021, the patient experienced PYREXIA (fever of 100.2F). 15-Apr-2021, the patient experienced HEADACHE (bad headache). At the time of the report, PAIN (achiness) and FATIGUE (tiredness) outcome was unknown and PYREXIA (fever of 100.2F) and HEADACHE (bad headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication provided.  No treatment drugs were provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     This case was linked to US-MODERNATX, INC.-MOD-2021-077705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077705:1st dose
Swollen Right Arm; Fever; Red Injection Site on the Right Arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Right Arm), PYREXIA (Fever) and INJECTION SITE ERYTHEMA (Red Injection Site on the Right Arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen Right Arm), PYREXIA (Fever) and INJECTION SITE ERYTHEMA (Red Injection Site on the Right Arm). On 15-Mar-2021, PERIPHERAL SWELLING (Swollen Right Arm), PYREXIA (Fever) and INJECTION SITE ERYTHEMA (Red Injection Site on the Right Arm) had resolved.            No concomitant medications were reported. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-022177 (Patient Link).