chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.   Reporter did not allow further contact
Case number PHEH2013US016490 is an initial spontaneous report received from a physician on 01 Aug 2013: This report refers to a male child. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: M12096) intramuscularly on 29 Jul 2013. On 31 Jul 2013, he experienced redness and swelling from the injection site to the elbow. No further information about seriousness, outcome and causality was reported.
Receive SQ injection in left upper arm on 3/24/2013 reported noticing reaction to site of injection 3/26/2013: dark red raised area an inch in diameter with diffuse pink ring was hard and painful.
Started to get fever and red dots on his torso.  Continued to worsen over the next few days.  Had runny nose and sounded congested.  Cleared up by 8/26/14. Having trouble sleeping.
t103.6, swollen glands, joints swollen, red, arthritis type pain started 29APR94;
196 patients received 0.25mL of Moderna Covid-19; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19).    No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up
Injection site bled and immediately swelled up with a bump under the skin, provider informed and warm compress applied per provider. DIPHENHYDRAMINE 25 MG TABS given at 15:41.
After he received first dose of Shingrix all of his joint pain went away; This case was reported by a nurse via sales rep and described the occurrence of unexpected therapeutic effect in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient told the reporter that, after the 1st dose of Shingrix all of his joint pain went away, leading to unexpected therapeutic effect. The patient then received 2nd dose of Shingrix. The reporter consented to follow up.
Information has been received from a pharmacist concerning the pharmacist's 66 year old mother with no pertinent medical history who on 05-MAR-2008 was vaccinated with ZOSTAVAX (Merck) 0.65ml.  There was no concomitant medication. The week later after vaccination, the patient experienced localized reaction like redness, pain and swelling. On an unspecified date, the patient recovered from the events. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
swelling in both legs; swelling in both ankles; Top of feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in both legs), JOINT SWELLING (swelling in both ankles) and PERIPHERAL SWELLING (Top of feet swollen) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZOA) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Joints swelled up.), High cholesterol and Blood pressure high. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterosis, LEVOTHYROXINE, AMLODIPINE and TELMISARTAN for an unknown indication.    On 15-Feb-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in both legs) and PERIPHERAL SWELLING (Top of feet swollen). 08-Mar-2021, the patient experienced JOINT SWELLING (swelling in both ankles). At the time of the report, PERIPHERAL SWELLING (swelling in both legs), JOINT SWELLING (swelling in both ankles) and PERIPHERAL SWELLING (Top of feet swollen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included slept with feet on pillow for 5 nights.   This case was linked to US-MODERNATX, INC.-MOD-2021-079544 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated contact details (address), time of vaccine shot, patient demographic details. Added concomitant products, event (top of feet swelling).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079544:second dose vaccination
The day after my vision got totally screwed up, I also had issues with left shoulder it was sore and I couldn't lift it, had trouble even getting dressed that continued for 3 months. 3 days after my shot my left ear started giving me issues if felt like I was getting an ear infection. It was painful. I also got an UTI and was given antibiotics and that helped the UTI and my ear. A couple weeks later I started spotting and It has not stopped. I was in menopause prior to this. I went to ophthalmologist to get my eyes checked, he said my eye sight has changed could be from getting older. Vison issues lasted for 3 months started to get better than came back but not quite as severe. My dermatologist said I was haying dropping eyelids. She said my eyes were very strained and prescribed me eye drops Apraclonidine Ophthalmic solution .5%, and she also prescribed me another one but my insurance wouldn't cover it since she was not an ophthalmologist. My neurologist did and MRI of my head to rule blood clot, they said it was normal and I had lesions but they are normal. I went back to ophthalmologist about 2 months after first appt and I had to get glasses. My vision was back to where it originally was and he was shocked. I went to my gynecologist since I started bleeding I haven't in years. He said he has had quite a few people come in with the same issue and he doesn't know why.
Leukocytosis/WBC 17.2; This is a spontaneous report from a contactable physician. A 100-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), intramuscular (left arm) on 10Jan2021 12:00, at single dose, for covid-19 immunization. Medical history included chronic kidney disease (CKD) (on Procrit at 14-21 day intervals). The patient has no known allergies. Concomitant medication included epoetin alfa (PROCRIT) for CKD. The patient experienced leukocytosis/WBC 17.2 noted 8 days after the vaccine on 18Jan2021 13:30. The patient underwent lab tests on 18Jan2021 13:30 which includes 81% neutrophils, 8% monos and, 9% lymphs. The outcome of the event was unknown. No treatment was received for the event. The patient had no Covid prior vaccination and had not been Covid-tested post vaccination. It was unknown if the patient had other vaccine in four weeks.  Information on the lot/batch number has been requested.
Doses both given in LEFT arm, but my RIGHT arm has been achy / sore since my first dose.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F8839) via an unspecified route of administration in the left arm on 01Oct2021 at 10:30(at the age of 25-years-old)  as a single dose for COVID-19 immunisation. The medical history included Crohn's disease, allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The concomitant medications included adalimumab (HUMIRA) and azathioprine (MANUFACTURER UNKNOWN), both from unknown dates for unknown indications and unknown if ongoing. On 01Oct2021 at 12:00, since the first dose, the patient's right arm had been achy / sore. The patient reported that both doses were given in the left arm. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm achy / sore was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 24Oct2021 at 12:30 (at the age 25-years-old) as single doses for COVID-19 immunisation.
Swelling, redness, discomfort, itching at injection site. Induration was approx 10 cm circle on upper arm with depth of approx 4 cm  (raised area on arm felt like half of golf ball) It lasted for a full 3 weeks.  After reading about "Moderna arm" in some of the news releases I did start using Hydrocortisone Oint 2.5% topically, largely for the itching, with desired effect. Had 2nd shot on 3/27 (lot 044A21A) to R arm with essentially the same response.  I did start Hydrocortisone when induration appeared on day 2.   Size, redness, induration essentially the same but seems to be resolving sooner with use of Hydrocortisone.  Offered information on my experience with first shot when I went for second.  No one there was interested so I hope info will add to your data.  I have had vaccines before and have never had any response to them so this was a new experience for me.                                               (I am a retired RN)
Died of cardiac arrest; Inflammation on his heart; This is a spontaneous report from a contactable consumer or other non-HCP (patient friend) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient died recently and he was a bigger man. He experienced inflammation on his heart and died of cardiac arrest. It was unknown if an autopsy was done. The outcome of the event inflammation on his heart was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Died of cardiac arrest
irritability, low grade fever day of immun 3DEC93; fever of 103 on 4DEC93 not controlled by APAP; 5DEC93 fever 101-102; 6DEC93 MD visit, placed on antiviral med; 7DEC93 fever gone;
headache; fatigue; cough; vertigo; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, administered in right arm on 07Mar2021 at 09:45 hours as dose 2, single (at the age of 41-year-old) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, administered in right arm on 14Feb2021 at 10: 30 hours as dose 1, single (at the age of 41-year-old) for COVID-19 immunisation. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Concomitant medication(s) included thyroid (Armour Thyroid) taken for an unspecified indication, start and stop date were not reported. On 07Mar2021, patient experienced headache, fatigue, cough and vertigo. Patient received no treatment for the events. The outcome of all the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child was given initial dose of Varicella on 05-21-03 was seen in office on 06-01-11 and diagnosed with chicken pox. Child had vesicular rash on face, arms and legs. Pt. has not had booster dose of Varicella yet.
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
Allergic reaction from elbow to shoulder. Red, Hot , Swollen, Itchy. Took benedryl for symptoms. Lasted 48 hours.
Myalgia of bilateral lower extremities, dark urine, hematuria, severely elevated liver enzyme
+ COVID July 8, 2020.  Next day inj site was big knot on arm. Chills, 101.6 fever, h/a. Lasted 24hrs. Couldn't eat, no energy. Red knot on arm about a week.
First night at home work up with chills and had trouble getting to sleep had bad tummy pains and had some diarrhea. Woke up next day feeling cold, lethargic, chills, and lack of appetite. Second day still the same. Noticed I was breathing harder after completing anything. Third day just feel hot behind the eyes, lethargic, very congested.
Starting that night i had usual flu like symptoms, pain in hip that is continuing, shooting pains and pressures, episodes of pains where i cannot even keep my eyes open. Shooting pains in head that extend to eyes, achy hands and a dead weight feeling in feet. Back aches and pains. Constant pains in hips and breasts. Doctor has said this is neurological pains. Shakes, tremor in right arm, twist that happens in the forearm and upper arm shakes. Sensitivity to light and sound, I cannot listen to music. I cannot work, on my back all day lying down. Test scheduled this week with neurologists.
pt recv 1 dose varivax 4/20/98 & next day pt devel rash described as a bump  not action was taken
achey; cold-like symptoms; worn out; unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out), MALAISE (unwell) and PAIN (achey) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient was otherwise healthy.     On 31-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out) and MALAISE (unwell). On an unknown date, the patient experienced PAIN (achey). At the time of the report, NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out) and MALAISE (unwell) had not resolved and PAIN (achey) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that advised reporter to refer to mother's health care professional for treatment options.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to DTPa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned that the patient nearly lost to the DTPa shot.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-OCT-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route unknown). The total cumulative excursion time was 1392 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patent under 16 at time of vaccination.  Contacted parents - patient had not issue with vaccination.
left hand numbness, itchy eyes, asthma attack, flu-like symptoms like body aches and chills.
Experienced SVT  at 4:45 AM the day after 2nd  vaccination (heart rate =219 bpm. SpO2=99%). Took25 mg metoprolol  tartrate. Rythm broke at 5:20 AM, when heart rate returned to 98 bpm, SpO2=98%.
Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45.  Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
allergic rash; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from a physician in the   This case involves adult patient of unknown demographics who experienced allergic rash, while he/she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose and dose in series not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergic rash (dermatitis allergic) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was allergic rash.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for allergic rash.  Documents held by the sender: none.
Patient is an 82 y/o male h/o prostate cancer, CAD s/p CABG 2003, DM, dementia who presents for positive COVID test and generalized weakness/fatigue. No SOB, chest pain, or other complaints at this time. He remained on room air throughout hospitalization. Inflammatory markers mildly elevated as expected. Evaluated by ID team and due to risk factors for severe disease (advanced age) he completed 3 days of remdesivir. He remained on room air with no SOB or cough. Arranged with his daughters and his 24/7 home care for discharge. DC in stable condition, pt is agreeable w plan.
My son started sweating profusely few seconds after the vaccine injection was administered. He felt intense heat all over his body and his vision blurred. The symptoms lasted for about 20 minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with MMR II (one dose, 0.5ml, lot# and expiry date were not reported) that was administered intramuscularly. No adverse effect was reported. Follow up information as received from the registered nurse refers to the 45 year old female patient. The patient had no pre-existing allergies, birth defects or medical conditions. On an unknown date, the patient was vaccinated with the second dose of MMR II (lot number, dose, route, strength and indication were not reported). On 10-JUN-2014 the patient was vaccinated with the second dose of MMR II (lot # H017027, expired date 14-SEP-2014) (0.5 ml, in the left arm) intramuscularly instead of subcutaneously (S.Q.). The patient had no illness at time of vaccination. There was no relevant diagnostic tests or lab data reported. The outcome was reported as recovered by the reporter. Additional information is not expected.
PATIENT FIRST RECEIVED MODERNA BOOSTER SHOT, THEN GOT FLU SHOT NEXT AND PASSED OUT ABOUT 1-2 MINUTES AFTER FLU SHOT FOR A TOTAL OF ABOUT 5 SECONDS.  PT WAS SUPPORTED IN A CHAIR AND DID NOT INJURE HERSELF.
h/a, muscle aches (generalized), arthralgia, swollen hand, eyes ached alot; chest pressure, fever (temp not taken), arm ached;
Mother called office @2:45 pm. Mom was changing diaper after nap, child was very pale and blue around nose and lips.  Baby was breathing, but "out of it" per mom.  Did pink up with stimulation & cry - episode lasted 1 - 2 minutes. Mom called primary care physician office and was sent to Emergency room. After evaluation at emergency room admitted to Hospital, admitting diagnosis apparent life threatening event.
Pain and induration at site of injection ((R) deltoid M). Also heat and tingling (in (R) shoulder).
Initial expected side effects of hard mildly painful lump at injection site; mild elevated temp approx 1 degree 1st 24 hours; slight fatigue resolved in 48 hours. Noticed itching on day 8, by day 9 had 14cm warm to the touch red and painful swelling distal to injection site which grew to 21cm over next three days. No fever, headache, or joint pain. Saw urgent care physician on day 11, and am currently on a course of 500mg keflex for 7 days. Arm is still itchy, but less painful, and rednesss seems to be resolving medially. Entire site still warm, but less puffy and painful to pressure. Instructed to follow up with physician if not significantly improved in 48 hours.