chrisvoncsefalvay/vaers-outcomes huggingface dataset:
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein I Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
At 2:00 AM the next day, I started to violently shake from chills. I took 2 Alieve and within an hour the chills lessened. At around 4:30, my body began to ache. I then got very tired and got a severe headache. Then I ran 101 fever for about 18 hours. Chills, body aches, soreness in the injection spot, and lose of energy remained until the next day. When I the next morning, I didn?t have anymore symptoms. I was a little tired, but much better.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received Moderna vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 4:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 4:58 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
Mild Achiness; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild Achiness) and INFLAMMATION (Inflammation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (Mild Achiness) and INFLAMMATION (Inflammation). At the time of the report, PAIN (Mild Achiness) and INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
his ear got bright red and really really itchy; his ear got bright red and really really itchy; This is a spontaneous report from a contactable Pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The facility type vaccine was clinic. The patient medical history and concomitant medications were not reported. Within 5-10 minutes administering dose, patient ear got bright red and really really itchy and noticeable compared to the other ear. No fever and breathing is fine. The outcome of events was unknown. The pharmacist asked if this a reaction to the vaccine.  Information on the lot/batch number has been requested.
This spontaneous prospective pregnancy report was received from a Licensed Practical Nurse, and refers to a female patient of unknown age. The patient's concurrent conditions, drug reactions/allergies, concomitant medications and historical conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (route of administration, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient had low rubella antibodies, for which it was unknown if she received any treatment. On approximately 07-SEP-2018 (reported as "the patient was 18 weeks pregnant"), the patient became pregnant (last menstrual period was estimated to be on 24-AUG-2018 and date of delivery was calculated to be on 31-MAY-2019). It was unknown if laboratory tests were carried out. The outcome of low rubella antibodies was unknown. Pregnancy outcome was pending. Causality assessment was not provided.
pt recv vax 16JUN97 & on 17JUN97 mom reported lt arm red, swollen, hard-non tender but concerned;mom brought pt in nurse observed local rxn site area 10cm by 10cm red, raised, hard, warm;non tender to touch;
Suspected vaccination failure; Know someone who has Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter knew someone who had shingles at the time of reporting after receiving Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Cold - Chills - 48 hours No sleep  - 48 hours No strength  - 48 hours No Appetite  - 48 hours
Patient was administered the wrong dose of the booster vaccine (Moderna)  Patient was given 0.5 mL (rather than 0.25 mL) No adverse reaction or side effects reported.
A couple days after my first dose, a lump appeared under my clavicle. I got an ultrasound and they told me it is a cyst. The cyst got smaller and smaller. But then I got my second dose yesterday, April 27 and this morning my cyst is bigger than ever before.
MYOCARDITIS; This 44-year-old, male subject (US0070016) was participating in a study.  The subject's medical history, as provided by the investigator, included hypertension, migraines, and anxiety. Concomitant medications reported included paracetamol, benazepril hydrochloride, mirtazapine, and buspirone.   Prior to event onset, the subject received intramuscular mRNA-1273.211 (Dose 1) for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event.  On 07 May 2022, the subject noted chest pain lasting for 30 minutes.   Through week of 08 May 2022, he noted exertional chest pain.   On 13 May 2022, his chest pain returned, and its increased severity prompted medical evaluation in the emergency room and was admitted due to the event.  Laboratory test results indicated that his serial troponin was elevated, while his echocardiogram and cardiac catheterization were with no findings. The subject was given a diagnosis of myocarditis. Treatment for the event included oral colchicine and oral metoprolol tartrate.  On 15 May 2022, the subject was discharged from the hospital.    The subject received the scheduled dose of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.  The event, myocarditis, was reported as not resolved.  The investigator assessed the event, myocarditis, as not related to study drug and not related to study procedure.  Company comment: This case concerns a 44-year-old with male subject whit medical history of hypertension,migraines and anxiety who experienced the serious adverse event of special interest of myocarditis. Prior to event onset, the subject received intramuscular mRNA-1273.211  for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event. The event was considered as not  solved ; as per the SD, the subject noted exertional chest pain which increased severity in the following days. The event was assessed as related to IP in agreement with  the Investigator.; Reporter's Comments: Company comment: This case concerns a 44-year-old with male subject whit medical history of hypertension,migraines and anxiety who experienced the serious adverse event of special interest of myocarditis. Prior to event onset, the subject received intramuscular mRNA-1273.211  for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event. The event was considered as not  solved ; as per the SD, the subject noted exertional chest pain which increased severity in the following days. The event was assessed as related to IP in agreement with  the Investigator.
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 06-APR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Eustachian Tube Dysfunction" (unspecified if ongoing); "sinusitus" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Cipro, reaction(s): "allergies". 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: Negative, notes: Tested negative; Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks product: Acetaminifin and Kirkland. Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 30Jan2023, treatment stop date: 05Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
For the patients second dose, she received undiluted pediatric Pfizer vaccine (0.2 mL of undiluted vaccine). Patient's father was first contacted on the morning of 2/11/22 which is when the incident was discovered, but was unable to be reached. Patient's father was reached on 2/15/22. When asked how the patient was feeling, the father reported she was "doing great" and that she "had a low-grade fever the first night" but was "doing fine." Patient's father appreciated the call and had no concerns at this time. Patient's father was instructed to contact pharmacy with any future questions or concerns related to systemic side effects.
Patient stated that about 2 weeks after getting vaccine, she started to feel some numbing and tingling down left arm and wrist. Patient stated that it happens a lot and she even has tingling and numbness in her left foot and toes. She thought it was blood clots, she did not go see a doctor.
Day after vaccination: fever of 100.8, bad body aches, chills, sore arm, fatigue, redness and slight bump below injection site.  Day 2 &3--feeling better, but arm still very sore, with redness.
I didn't have any reaction to the vaccine, but i did catch covid in May 2022. I had a bad headaches and body aches. All I have been doing is sleeping. I taste everything and I have been eating fine. I just sleep all day. I have been out of work for about 2 weeks. I was prescribed Paxlovid.
Severe sudden diarrhea, nausea.  Subsequently developed headache, reaction at injection site.
This spontaneous report as received from a nurse refers to unspecified patients. The patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the patients was administered with GARDASIL lot # J014219 and expiration date 05-OCT-2015. This is one of several reporters from the same source. Additional information has been requested.
Redness and swelling in the area where 2 vaccines where applied. Mild fever between 100.3 F and 101.5 F were recorded on a 12 hour period.
Patient woke at 2am with swollen throat, and hives & a rash that was very itchy. At first it was just hives on both wrists & rash on elbow, knuckles & knees. As time went on the rash got worse, spreading to ankles & his joints were all swollen. I gave him a Benadryl & that calmed down the itchiness a good bit & the throat was good, but the rash & hives were still bothersome so we went to the clinic near us.  The Nurse gave patient 4 mg prednisone in a Medrol dose pack, more Benadryl for next dosage & a 0.025% cream called Triamcinolone Acetonide. With the Prednisone steroid & Benadryl plus cream - the rash & hives went away by that evening. We kept up the Prednisone & Benadryl for the duration of the Steroid. Cream was not needed again. He is totally fine now - really was fine by day 2 of treatment.
colds; on and off fever; chills; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (colds), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (on and off fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (colds), PYREXIA (on and off fever) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (colds), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (on and off fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Swollen sore lymph nodes undwr left arm that then spread over through neck and shoulders and under right arm.  Headache from swollen lymph nodes in back of neck.  Started on Friday to Saturday on left. By next Wednesday was equal under both arms with bunches of lymph nodes palpable and sore.  Headache and soreness continues today, thursday the 21st of january.  Site of injection initially sore, worsened day 2, then ended with pain of swollen lymph nodes.  On Wed the 20th, site grew a hard 2 inch diameter lump and began to itch when previously there had been no issue.
tiredness this morning; He also has a 99.9 degrees fever and is slowly going away now; he has a very congested runny nose; general fatigue; This is a spontaneous report from a Pfizer Sponsored Program. A spontaneous report from a contactable consumer or other non hcp (Patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on 11Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced a very congested runny nose, general fatigue, he also had a 99.9 degrees fever and is slowly going away now. The patient experienced tiredness on 14Apr2021. The patient underwent lab tests and procedures which included body temperature was 99.9 degrees on 13Apr2021. The outcome of the events was unknown except in the event he also had a 99.9 degrees fever and is slowly going away now was recovered on 14Apr2021.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Laid around all day yesterday; arm much sorer; 2-3 hours of chills during the night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Laid around all day yesterday), AXILLARY PAIN (arm much sorer) and CHILLS (2-3 hours of chills during the night) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Feb-2021, the patient experienced AXILLARY PAIN (arm much sorer) and CHILLS (2-3 hours of chills during the night).   On 21-Feb-2021, the patient experienced HYPERSOMNIA (Laid around all day yesterday).   On 20-Feb-2021, CHILLS (2-3 hours of chills during the night) had resolved. On 21-Feb-2021, HYPERSOMNIA (Laid around all day yesterday) had resolved.   At the time of the report, AXILLARY PAIN (arm much sorer) was resolving.      No relevant concomitant medications were reported. Treatment information was not provided.
Injection site: red, hot, itchy and painful. Influenza and pneumonia vaccine given in same syringe.
urticaria & periorbital edema p/4th dose in series; being treated w/Atarax; Provoked bite of a opossum that had a nest under hood of old car; when person tried to chase away; animal bite pt; series started on 3JAN93, 2nd dose 6JAN, 3rd 11JA
Hospitalized;  COVID-19 positive (8.28.21); fully vaccinated  Admission Date: 8/28/2021 Discharge Date: 8/31/2021 PRESENTING PROBLEM: COVID-19 virus detected [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 44-year-old female with past medical history significant for GERD, status post Nissen and a recent diagnosis of hypocellular bone marrow/myelofibrosis and thrombocythemia (was following with benign Hematology, yet to follow-up with heme Onc) presents to the hospital on 08/28 due to dyspnea and chest pain.  Patient was vaccinated in January.  7 days PTA, patient started to notice productive cough, sinus congestion, chills and then went on to develop dyspnea on exertion.  In ER she was noted to be 98% on room air but desaturated at 84% with ambulation.  Chest x-ray was clear CTA was negative for PE or infiltrates.   COVID-19 infection:  No evidence of pulmonary infiltrates/pneumonia however patient with exertional hypoxia and dyspnea.  Remdesivir has been initiated but  can be discontinued when patient discharges irrespective of completion of course.  Pulmonary rehab as already  arranged home oxygen. Chest pain is felt to be musculoskeletal versus pleurisy.  Evaluation negative with EKG/troponins and PE. Patient was diagnosed to have hypocellular bone marrow and was told to have thrombocythemia and myelofibrosis and has an upcoming appointment to see Heme-Onc.  She had been seeing benign Hematology so far.  Patient was supposed to have a ultrasound of the spleen scheduled as outpatient , this was completed inpatient and was unremarkable . She will follow up with hematology and her PCP as outpatient , she was discharged in stable condition.  Consultations: None  Procedures: CT angiogram thorax negative for PE or pulmonary infiltrates.
Immunized on 4/2/21 and 4/23/21.  sinus pressure, loss of taste and smell since 7/26/21. Covid test positive on 7/27/21
Went home fron work with a sore neck/shoulder. Iced my neck. 1 hour later started feeling ho/cold flashes. Felt feverish. Started icing me head. Within 5 minute my heart starts racing and and start beathing heavy. I try to take big deep slow breaths. I cant. I call my friend.  10 minutes of talking and and it gets worse. He comes to picking me up 15 minutes later im fully hyperventilating enroute to hospital  5 minutea later my body is shaking and i have pins and needles on my extremities. 1 minute later i feel im about to passout and my brain is going to shut off. 2 minutes later i get to the hospital. Hyperventilating and hands cramped i cant get my health card out. My friend pulls it out for me. I sit waitinf to be attended for 10-15 minutes still hyperventilating and still heart racing. Eventually i get in for tests. About at the 2.5 hour mark is when my heart and breathing start getting a bit better. 3.5 hrs in is where i started feeling (though exhausted) normalish