chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission: 10/11/2022 Date of Discharge: 11/30/2022  Diagnoses on Admission Order: COVID-19  Hypercapnia  Type 1 respiratory failure     Hospital Principal Problem (Discharge Diagnoses): COVID-19
PT RECEIVED FIRST VACCINE. DEVELOPED LEFT SUPRACAVICULAR LYMPHADENOPATHY IN 2 DAYS. NO OTHER SYMPTOMS OR SIDE EFFECTS.
The pt complained of arm itching, area red and raised where injection given. Had an MD appt. Said to observe and call if it gets bigger. No temp.
Onset of COVID infection - chills, fever (101), diahrrea, nausea,aches, cough, congestion, fatigue, shortness of breath
Severe headaches which I thought may have been sinus, however no relief    Pain started within two weeks after vaccination.     Pain is still present but comes and goes on a daily basis.  Never had this prior until now.
Vaccination error. A non-serious, spontaneous report of FLUMIST administered to a 20 month old has been received from a health care professional concerning a 20 month old male patient. The patient's medical history and concomitant medications was not reported. The patient received FLUMIST on 15 Oct 2009. There was no adverse event associated with this vaccination error; 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.
Had adverse event to the Moderna Vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) in a male patient of an unknown age 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 IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) 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.       Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a spontaneous case concerning a male patient of an unknown age, with no reported medical history, who experienced the unexpected and serious (hospitalization) event of immunisation reaction (reported as Had adverse event to the Moderna Vaccine). The vaccination date with an unspecified dose of mRNA-1273.222 vaccine and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age, with no reported medical history, who experienced the unexpected and serious (hospitalization) event of immunisation reaction (reported as Had adverse event to the Moderna Vaccine). The vaccination date with an unspecified dose of mRNA-1273.222 vaccine and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
8/8/2021: Pt presents with SOB, COVID +. States she was out of town with her fiance and had a known COVID exposure so she got tested outpatient and ended up testing positive with her fiance on 08/3/2021. Reports having symptoms of a cough, nausea, diarrhea, fevers (reaching 103 that she states have been better), chills, myalgias, decreased appetite and headaches. Reports having generalized fatigue and intermittent shortness of breath over the last several days but she SOB started worsening last night with worsening fatigue/weakness this morning. Reports her oxygen saturations at rest were ranging from 90-91% at home and would drop in the 80s with activity or coughing spells.  She states she currently has
On 1/13/21 I had massive head pressure, numbness and tingling of face, fingers and feet. Speech issues My bottom lip shifted to the right when I?d speak. Brain fog Exhaustion Lightheadedness  Currently still have lightheadedness, brain fog, exhaustion
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        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 provided.   This case was linked to (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; Moderna Bivalent; Moderna Bivalent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8735), on 06May2021 as dose 2, single (Lot number: EW0173) and on 06Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 29 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 01Nov2022 as dose 4 (booster), single (Lot number: AS7165B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had asthma as child" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; SUDAFED PE, start date: 26Nov2022, stop date: 26Nov2022; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 26Nov2022, stop date: 27Nov2022; IBUPROFEN, start date: 25Nov2022, stop date: 26Nov2022. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Nov2022, outcome "unknown" and all described as "Moderna Bivalent"; VACCINATION FAILURE (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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks product: Emergen-C Immune+ on 25Nov2022 & stopped on 30Nov2022. Paxlovid received treatment for Covid-19 on 25Nov2022 and stooped on 30Nov2022.
Patient got the injection around 5PM on 05/24/2020, then started feeling nauseous, fatigue and having a headache round 3AM on 05/25/2020. Patient stated that she had been feeling tired with a light headache ad nausea until now (08:42PM 05/27/2020)
Overdosed him with a full shot instead of a half shot.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 02820A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.). On 20-Dec-2021, ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.) had resolved.            No treatment details were reported.
Nausea, body aches and pains, fever. Diarrhea. Swollen, red left arm where shot was given.
Information was received from a consumer in regards to an unknown number of patients who were vaccinated with Gardasil and experienced extreme pain at the injection site. Lot numbers and physician's information was not available. Additional information has been requested. 02/10/2010 In follow-up information received on 28-JAN-2008 the patient did not have an experience with the doctor.  Additional information has beenr equested.
Preg. women given H1N1 FluMist. EDC 1/31/10 at 32 wk gest at vaccination.
I contracted COVID-19; I contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 14:45 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 18Feb2021 14:45 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 27Jan2021 14:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "recovering" and all described as "I contracted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.
peripheral neuropathy diagnosis of hands and feet; arm swelling; ankle swelled up 3 weeks to a month later; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet) (seriousness criterion medically significant), PERIPHERAL SWELLING (arm swelling) and JOINT SWELLING (ankle swelled up 3 weeks to a month later). The patient was treated with CANNABIDIOL (CBD OIL) for Adverse event, at a dose of 1 dosage form; GABAPENTIN for Peripheral neuropathy, at a dose of 1 dosage form and MARIJUANA at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet), PERIPHERAL SWELLING (arm swelling) and JOINT SWELLING (ankle swelled up 3 weeks to a month later) outcome was unknown.            Concomitant products were not provided.  After administration of second dose of moderna vaccine patient experienced ankle swelling for more than 3 weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected   This case was linked to MOD-2021-281227 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected
PAIN ALL OVER THE BODY; TINGLING ALL OVER THE BODY; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included caller states she has no medical problems and takes no medications., and other pre-existing medical conditions included the patient had no medical problems and took no medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced pain all over the body. On 15-APR-2021, the subject experienced tingling all over the body. On 15-APR-2021, the subject experienced couldn't sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over the body, and tingling all over the body, and the outcome of couldn't sleep was not reported. This report was non-serious.
Received the second dose of COVID 19 on Feb. 24, 2021, at 2:20 pm.  After the injection, I sat for 15 minutes, felt fine, then left, went home.  The next morning at 5 am, woke with right arm throbbing and a huge swelling where the vaccine was injected.  I got up, felt dizzy, and went the the bathroom, took my temperature, which was 101 F, then got the chills and had chest pains across my entire chest. Tried to go back to bed but the symptoms got worse.  Called my neighbor and asked him to take me to the ER.  He took me to the ER and I was checked for fever, had a chest x-ray, urine test, blood pressure checked and at 5 PM was admitted.
Per mother, patient developed rash, spreading over body. Pt presented with scattered erythematous papules, few vesicles treatment symptomatic.
Narrative: day 1 - headache; day 3 sneeze and stuffy nose; no further symptoms noted Headache headache, sneezes, stuffy nose
2/2/2021 vaccination . About 6pm cold chills, fever, vomiting, HA. Still experiencing fever and migraine.  Really 'shaky'. Did not experience this with the first vaccine.
Information has been received from a registered nurse concerning a 74 year old female with no medical hx of allergies who on 30OCT2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide. Concomitant therapy included unnamed medications for the stomach. The reporter indicated that the patient was seen in the office on 31OCT2003 and her whole arm was inflamed from the wrist to the shoulder. It was unknown if treatment was required for the event. The reporter also noted that she was concerned about the lot number and has pulled the remaining vials in this lot form the stock. . The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The RN also indicated that two other female patient's had similar reactions after therapy with pneumococcal 23v polysaccharide vaccine and developed injection site redness, swelling and pain. Additional information has been requested.
Nothing major just fussy, no temperature.  She ate somewhat normal, was a little fussy at the breast at times.  Didn't want to be put down.
Information has been received from a registered pharmacist (R.PH.) concerning a number of patients who on unknown dates were vaccinated with PNEUMOVAX 23 (lot # not reported). The reporter stated that the hospital had to quarantine a lot of PNEUMOVAX 23 because it was thought to be causing cellulitis in a number of patients who had received the vaccination. It was unknown if the patient sought medical attention. Follow-up information has been received which reported the patient was a 59 years old female. The patient might have been given Tdap (manufacturer unknown). The lot number for PNEUMOVAX 23 may have been 667692/1110Z. The patient was given an antibiotic. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023; No adverse event; Administered within 5 days of the expiration of the beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-May-2023, 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 03-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) 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 (Administered within 5 days of the expiration of the beyond-use-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023).    No concomitant medications were provided. It was administered within 5 days of the expiration of the beyond-use-date, which was 29-Apr-2023. The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 30-Mar-2023.  No treatment medication was provided.
Product Complaint; not full dose was given; part fell off from arm of patient; part fell off from arm of patient; syringe issue; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 49R79, expiry date 2nd April 2022) for prophylaxis. This case was associated with a product complaint.   On 1st February 2022, the patient received Boostrix. On 1st February 2022, unknown after receiving Boostrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows: Registered nurse reported that Boostrix's little white attachment had a malfunction during administration so not full dose was given, white part fell off and needle came out from the arm of the patient, which led to incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact, syringe issue and pharmaceutical product complaint. No further information reported. The reporter consented to follow-up.
Red and warm-to-the-touch arm; Red and warm-to-the-touch arm; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) and STEROIDS for an unknown indication.   On 19-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MIGRAINE (Migraine). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm). In February 2021, MIGRAINE (Migraine) had resolved. At the time of the report, VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product also included supplements.  Treatment information was not provided.
Patient began with a rash to trunk 20 minutes after vaccine    Benadryl IM given as no other symptoms.  Within 5 minutes he stated his throat itched and was sractchy  Epinephrine 0.3 mg given IM  then sent to ER as he needed monitored
Temperature, felt very weak, food repulsive: following morning, lasted all day. Felt slightly better next day.