chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the same problem as her after taking the Moderna Covid19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 Vaccine). At the time of the report, UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD21-125467 (Linked Report).; Sender's Comments:  MOD21-125467:
I experienced pain within areas of injection, caused me to lose approximately 50% use of my arm. I also had small splotches develop, red in color dime size.
Pt had overall body rash after vaccination which he went to the ED for. Treated with oral steroid taper and hydroxyzine. Referred to dermatology and was given topical steroids. Came to practice today still complaining of rash and spreading. Asked for him to report to the ED once more because PCP was not available.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a mother (WAES# 0907USA03355) who on 13-JAN-2009 was vaccinated with her second dose of GARDASIL (lot # not provided), 0.5 ml. On 21-JUL-2009, the mother was 6 and half months pregnant after getting the 2nd dose of GARDASIL. On 18-OCT-2009 she delivered a normal male infant. Apgar score 1/11, the baby had no congenital abnormalities. On an unspecified date, the infant experienced fetal sepsis. The patient recovered with antibiotic treatment. No further information is available.
Numbness in left leg, dry mouth, headache 4/10 pain on chest, throat dryness. Reports runny nose since first dose. After further monitoring, patient reports numbness and chest pain subsided. Dry mouth persists. Vital signs assessed and found within normmal limits. 12:20pm: BP 129/85, HR 68 bpm, O2 sat 100%, RR 12, Temperature 96.1 F. 12:35pm: BP 133/84, HR 64 bpm, O2 sat 100%, RR 12, Temperature 96.8 F. Lungs clear.
The evening of receiving the vaccine, I began having extreme chest pain on the left side of my chest, significant pain when breathing, and eventually to urgent care and ER from there. They performed a CT scan and discovered three embolisms in my chest. They put me on blood thinners. I was admitted in the hospital for 36 hours before being discharged, and they prescribed me ELIQUIS for the time being for blood thinners and prevent clotting. I have a follow-up with a cardiologist in February to perform another CT scan to ensure the clots have resolved themselves and a genetic testing to see how the clots formed.
10-16-21 Admitted to Hospital via ER, complaining of numbness from the waist down, difficulty walking and balancing. given muscle relaxer and oral steroids' 10-20-21 Admitted to Hospital per Dr. Given blood thinner, IV Steroids' treated for Transverse Myelitis
This spontaneous report was received from a medical assissance concerning a 3 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 18-SEP-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # R008164 as reported, expiry date 12-NOV-2020, for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided) (drug administered to patient of inappropriate age). No adverse effect reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 11Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Received flu vaccine on 10/7/14 at 100 pm. she states shortly thereafter developed sore throat then redness on neck which progressed to hives-treated in ED at 500 pm for allergic reaction-disch meds: prednisone/famotidine/BENADRYL/albuterol/epipen.
Pharmacist came to observation area noticed MD  and EMT with client. Client reportedly per OBservation Lead was complaining of not feeling well, feeling dizzy and having blurred vision. Client was intially refusing to provide us with his information. Per EMT clients BP 202/127 oxygenation 97% HR 85, client declined Blood Sugar check. MD advised client to go to ER due to BP,  EMT called paramedics at approx 350pm.  Paramedics arrived at 4pm repeat BP 200/130  agreed to transport to hospital. TRansferred to doctors hospital at 0405pm
Information has been received from a nurse concerning a 24 year old female with no medical history and no known drug allergies who on 08-APR-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL. There was no concomitant medication. On 08-APR-2008 the patient developed a fever in the evening that lasted through the next day. When the fever broke on 09-APR-2008 or 10-APR-2008 the patient developed a rash. The rash was not at the injection site, but on the right forearm, left side of the face and left forehead. The patient sought medical attention on 11-APR-2008 in the office and was told to take BENADRYL. On 14-APR-2008 the office contacted the patient by phone and the patient indicated that the rash was getting better. No product quality complaint was involved. Additional information has been requested.  07/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a nurse concerning a 24 year old female with no medical history and no known drug allergies who on 08-APR-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL. There was no concomitant medication. On 08-APR-2008 the patient developed a fever in the evening that lasted through the next day. When the fever broke on 09-APR-2008 or 10-APR-2008 the patient developed a rash. The rash was not at the injection site, but on the right forearm, left side of the face and left forehead. The patient sought medical attention on 11-APR-2008 in the office and was told to take BENADRYL 50 mg. On 14-APR-2008 the office contacted the patient by phone and the patient indicated that the rash was getting better. Followup indicated that patient outcome was recovered. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Started out and described as a headache on Friday, the day injection was taken.  By Saturday headache turned into right side neck and shoulder pain.  By Monday coughing, and wheezing sounds in all quadrant lobes of both lungs.  Coughing up clear phlegm, has not run a fever.
Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue. Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMIN D NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Feb-2021, the patient experienced LETHARGY (Lethargic). At the time of the report, LETHARGY (Lethargic) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-079719 (Patient Link).
Suspected vaccination failure/I have had it 5 times, even got the vaccine twice; Shingles (mild)/I have had it 5 times, even got the vaccine twice; still burned, itched and felt awful just not as bad as before; still burned, itched and felt awful just not as bad as before; still burned, itched and felt awful just not as bad as before; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first case of shingles when the patient was 7).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation, pruritus and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and feels awful to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received from the patient via (Facebook) interactive digital media. The patient have had them 5 times now and even got the vaccine twice. Each time they were getting worse, except for the last time it was more mild.  The patient stated that they were still burned, itched and felt awful just not as bad as before. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per the reported verbatim,' it still burned, itched and felt awful just not as bad as before', outcome for all adverse events were captured as not recovered.
pt recvd vax & the next day exp rash on side, back, chest, arms, & leg; addtl pt exp a sore throat; these  sx were treated on 3UG94 w/ Amoxil & 5AUG94 w/Atarax; 6AUG94 rash is more pronounced;
headache, fever, muscle aches, joint pain, chills, sore throat; from 2/16/21 - 2/18/21
Patient experienced extensive bruising the day of the vaccination. Then 1 week later, experienced redness below the injection site. No pain. Just uncomfortable. Much better today.
J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/2/2023 SHORTNESS OF BREATH
Swelling like a large muscle (like men) Red fever to elbow - hurting (stinging).
Statement from patient: "Numbness in face when I left here Friday but it got much worse. I had all the normal  fever, chills, headache, fatigue. The one thing I had that was not so normal  as it started almost right away and  My face and jaw, cheek went numb so much so that it felt like someone punched me in the face on the left side. Also, I am unable to chew anything without a reaction of cracking, extreme pain and it causes me to scream out loud.  It also happens it I yawn."
Disabling muscle spasms in right to center neck and upper shoulder/back; This is a spontaneous report from a contactable consumer (patient).   A 96-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 96-year-old via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included High blood pressure.  No known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. Concomitant drug included unspecified other medications in two weeks. The patient experienced disabling muscle spasms in right to center neck and upper shoulder/back on unspecified date, resulted in Emergency room/department or urgent care, hospitalization and disability. Treatment was included OTC pain reliever. The outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29APR97 has a fine raised pink rash on stomach, cranky, rash still present but also on back & sides;no other places affected w/rash;
Fever between 100.4 and 102.1 for 24 hrs. Rash and skin tightness surrounding the injection site for 5 days (lessening after day 4).
3" x 3" area of erythema and swelling at site of Influenza vaccine administration. Influenza Vaccine was administered in the lateral thigh of the left leg.
Intense left arm pain in joints and muscles began on 11/20/2022. Swollen armpit and red swollen and hard injection site area also on left.
pt recv vax & bedtime that day arm OK;next morning lt arm red, swollen, hot & sensitive to touch;also had sl fever, T98.9 remained this way 3 days;woke up on 4th day fever OK, arm less swollen rash appearing to disappear slowly;
A non-serious, spontaneous report of FLUMIST given to a child taking aspirin, in a two year-old male patient was received from a consumer. There was no adverse event associated with this medication error as of seventeen days after administration; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
This spontaneous report as received from a consumer refers to a 68 year old female patient. The patient's medical history included shingles and drug reactions/allergies to steroids. It was also reproted that the female had a medical history of thyroid (not further specified). In November 2012 the patient was vaccinated with ZOSTAVAX (1 time vaccine). Dosing information, route of administration and lot number were not provided. On 29-OCT-2013 the patient experienced shingles again on her left side of her forehead, with pain in her left eye. Lab diagnostics studies were not performed. The outcome of shingles on her left side of her forehead, with pain in her left eye was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from a Healthcare Worker (Medical Assistant) and refers to a 4 months old male patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. The reporter stated that the patent was vaccinate with an expired 2 ml dose of ROTATEQ oral (lot # H016251, expiration date 26-MAR-2014) today (on 06-MAY-2014). No adverse effects were reported at this time. Additional information is not expected.
according to mom child became lethargic, pale w/in 3hr of vax;child then devel T103, chills & c/o h/a x 3 days;mom stated had not taken child to MD;
pt recvd vax; high pitch screaming, started at 10:30am on way home from immun clinic;crying lasted 2 hrs; slept for 2 1/2 hrs & awoke screaming again; doing much better today; MD said crying episodes due to colic;
Patient had first dose of Moderna COVID-19 VACCINE ON 3/12/21. When she returned to pharmacy for her second dose on 4/9/21, she said She has had rash on her lower back, neck, and stomach and increased blood pressure about one week after the first dose.  Pharmacists held off second dose and recommended her to let her doctor know as soon as possible then follow-up with pharmacy for second dose decisions as soon as possible.
Instant sharp pain right away, couldnt breath,, had to remove my mask right away put hands in the air, the I got very HOT and lightheaded,, then within 5 minutes or less passed out hit the ground, was passed out over 10 minutes. Having extreme headaches, pain in my shoulder arm, numbness in my hands and feet. I could feel the shot go in it was cold. I am feeling tired and like my right ear is plugged.
Fever; Chills; Nausea; Joint pain; Skin sensitivity; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on an unknown date (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date, the patient experienced fever, chills, nausea, joint pain, skin sensitivity. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, joint pain, skin sensitivity were resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Was bedridden for 48 hours after receiving vaccine. Fever, chills, extreme muscle and joint pain, rash on legs and left foot.
pt recvd vax & devel neck stiffness & pain in arm of inject; sx lasted 3 days;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site tenderness and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site tenderness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that her patient received SHINGRIX 7 days before the reporting date and her arm was still red, swollen, and tender around the injection site.
Day 9 post vaccine started with local vaccine reaction. Itching, redness and swelling at site of immunization. 5.0 cm of erythema and induration.
I been having heavy and weak legs. I been having weak hands and my arms feel heavy sometimes. My left arm has gone numb. My lower feet and legs on my left leg, I get nerve pain. My face feels heavy. My mouth feels like pin and needles. I sometimes get patchy numbness in my lower legs. I have had low blood pressure. I had burning in my mouth. I several doctors about this. They had done an EMG, normal results. I had blood work, normal results. I had a MRI, normal results. They want to do a small fiber neuropathy test in the next few months.
Erythema, edema and warmth of left upper arm. Treated with Keflex 250mg TID X 7 days.
It was given to 2 people beyond the 12 hr mark.; No adverse event; There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022 at 10:15 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.) and PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.).    No concomitant medications were reported. There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster. It was given to 2 people beyond the 12 hr mark.  Vial size was reported as 2.5 mL On 04-Nov-2022, the vial was initially stored in the refrigerator.  On 08Nov2022, Vial was first punctured.  The vial stored post puncture in Refrigerator.  The vial did not undergo any temperature excursions. Vial was remained refrigerated within range. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-672851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672851:MOD-2022-672851 (IB patient)