chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RED RASH THAT COVERED ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced red rash that covered arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red rash that covered arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220924450.
98-83-18 150/104 VS on adm. Pt arrived in ER with complaints of sunburn Left shoulder pain/itching with yellow exudate inside blistered areas. Physician ordered tetanus vaccine. Nurse administered Adacel and then recalled pt stated childhood allergy to pertussis. Called poison control and followed recommendations per doctor order. No reaction. Pt observed x 2 hrs with cont O2 sat x 1. VS dismissed 97.8-68-18 122/48 O2 Sat 100%.
Patient received Pfizer Covid vaccine 2nd dose (LOT#: EW0171 EXP: 8/21) at 1453 on 4/20/21. Patient alerted PHN that he was done with his 15 minute observation. PHN asked patient if he felt fine. Patient stated he felt a little dizzy. PHN asked patient when it started and patient stated as soon as he got up. PHN asked patient to stay an extra 30 minutes for observation. Patient agreed to stay. Patient was given water. Patient finished water. After 5 minutes patient stated that he wanted to leave and no longer felt dizzy. PHN advised patient to stay the recommended 30 minute. Patient insisted that he no longer felt any symptoms and wanted to go. PHN stated that he was now agreeing to leave against medical advice. PHN educated patient on worsening signs and symptoms of covid vaccine and when to call EMS or go to ED/urgent care. Patient verbalized understanding. Patient left vaccination site at 1525 unassisted and with a steady gait.
Redness and swelling at he injection site with itching. Area swelled and became very red and painful per pt. Swelling was decreased when I saw it on 8/16/00.
Patient received Pfizer vaccine on 2/11/21 and 3/4/21. COVID positive on 1/11/22. Presented to ER on 1/12/2022. Admitted on 1/12/22. presented to the emergency department after having been diagnosed with COVID-19 and having increased symptoms at home namely shortness of breath and some nausea.  Was moderately hypoxic in the emergency department and admitted on 3 L of oxygen via nasal cannula.  He was started on remdesivir and Decadron.  Had at some diarrhea as well prior to coming in and subsequent volume depletion resulted in acute kidney injury that by the time of discharge had resolved.  Activity was increased carefully.  By the date of discharge he was no longer requiring supplemental oxygen with activity or at rest. Dicharged on 1/17/22
Information has been received from a medical assistant concerning a 16 year old female patient with no pertinent medical history who on 23-MAY-1996 was vaccinated subcutaneously with the first dose of VARIVAX. On 15-FEB-2010 the patient was vaccinated subcutaneously with the second dose of VARIVAX (lot # 665644/1205Y). There was no concomitant medication. Subsequently the patient developed red itchy areas at the injection site. The patient sought medical attention via phone call. No laboratory diagnostics studies were performed. At the time of the report, the patient had not recovered from these events. This is one of several reports received from the same source. The office request a lot check. A lot check had been initiated. Additional information has been requested.
Abscess blister to right thigh, we are culturing drainage had lump since injection but 01/05/04 when drainage started.
Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was provided. Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.   No treatment information was provided. This case was related to patient number 23 out of 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-DEC-2015 at 01:27 the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.5 (22 hours and 55 minutes) and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning his 54 year old wife who on 18-APR-2011 ("yesterday at noon") was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into left arm. The reporter stated that now ("on 19-APR-2011") the patient had a localized reaction below the injection sit eof her left arm, rash which was raised, red and hard. At the time of reporting, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
1008: Upon  being seated in the post vaccination area, c/o feeling slightly flushed in the face.  No other symptoms. By 1011, reports feeling better, flushed feeling has resolved. Will continue to remain in observation area until 15 minute observaton period is complete.
Following day,  (3/18/2021) SEVERE flu like symptoms. 75% loss of equilibrium.  Left wrist in pain, left knuckles in pain, teeth in pain. Impossible to sleep. Considered admission to local hospital. Impossible to speak.  (3/19/2021)...50% decrease in above symptoms. (3/20/2021)...25% decrease in above symptoms. (3/21/2021)...slight percentage of symptoms exist. (3/22/2021)...most symptoms evaporate. Slight dizziness still exists. IN GREAT FEAR OF RECIEVING 2nd VACCINE DOSE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Initial report was received from a health care professional on 18 June 2012. This reporter reported another adverse event which was captured in case number 2012-06239. A 58-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4105 (corresponding sanofi pasteur Inc. lot number U4325AA), on 24 April 2012. On 26 April 2012, the patient experienced a headache and site reaction of redness, swelling and heat. The doctor diagnosed the patient with cellulitis without any confirmed culture being obtained. The patient was treated with KEFLEX 500 mg three times a day (TID) for seven days. The patient had no illness at the time of vaccination with a past medical history of hypothyroidism, depression and gastroesophageal reflux disease (GERD). No additional information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Pain in left arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:00 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: After the first dose: Pain in left arm.   No follow-up attempts are possible. No further information is expected.
pt recv vax 23OCT97 & later that same day pt exp "2 inches hives", itching, redness & warmth @ inj site;pt also exp some wheezing;wheezing relieve by proventil inhaler;hives relieved by DPH;itching & 2" lump remained x 3 days a/resolving;
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date of administration of vaccine 26-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date of administration of vaccine 26-Jul-2022) and NO ADVERSE EVENT (No Adverse event) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date of administration of vaccine 26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date of administration of vaccine 26-Jul-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date of administration of vaccine 26-Jul-2022).    Concomitant medication was not provided.   Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13-Jul-2022 Date(s) of administration of vaccine were 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose).  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Patient came in the day after vaccination reporting difficulty being able to completely raise their left arm. Patient reports a good deal of pain in the shoulder area, and had mentioned to the pharmacy that she thought the vaccination may have been administered too high on the arm. Patient stated that left shoulder-area pain started a few hours after receiving Spikevax, which was administered on Tuesday, October 17th around 11:30am.
Arm was red and swollen from the side of the DTaP to about 2/3 of way from elbow to wrist and proximally over the entire shoulder and extending anteriorally to about 1" from nipple.
Moderna COVID-19 Vaccine EUA  Since receiving my second shot of the Moderna vaccine, my tinnitus has been louder and more intense.
fever, chills, shakes, hallucinations, dizzy, light headed, headaches. arm pit and left breast were very tender, trouble negotiating from one room to another, loss of appetite and tired very easily.
Per hospital event reporting system " Patient received COVID Moderna Booster on 11/18/22, called into the office today to report an adverse effect from vaccine. Patient reported a rash to both arms and legs starting on Saturday 11/19/22, after receiving the Moderna Booster."
Sore throat chest congestion head congestion and a headache fatigue body aches and chills no fever.
hard time seeing, eyes get dry and get blurry due to her allergies; eyes get itchy; eyes get dry; sore left arm that only hurt when she put her hand on the arm just where they put in the injection; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy), DRY EYE (eyes get dry) and VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic sinusitis (eyes get dry and itchy due to her sinus allergies).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection). On 15-Apr-2021, the patient experienced VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy) and DRY EYE (eyes get dry). On 31-Mar-2021, VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection) had resolved. At the time of the report, VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy) and DRY EYE (eyes get dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included eye drops she uses when her eyes get dry and itchy due to her sinus allergies.
Patient received above vaccination at 2:48 PM, then began crying and screaming at 6:10 pm, parents gave tylenol at about 8:30 pm, patient fell asleep and rhythmic gasping while asleep noted, at first thought it was residual from crying, but it continued for 20min, they called me and I referred to ER. The rhythmic gasping type breaths continued for another 4-5 hours, and whenever she awoke during that time she went back to screaming, when she would fall asleep she begin the rhythmic gasps again. Seen at hospital by Dr., who by the time she examined her found the breathing had normalized. She spoke with me and said the episode seemed most consistent with irritability and screaming/crying which during sleep would present as gasping. After it resolved, awoke, became alert, ate well, smiled, observed for 2 hours and discharged to home. Mother describes infant as back to herself this am. She only notes mild bruising at site of pentacel injection.
Information has been received from a physician concerning a patient who was vaccinated with an oral first dose of Rotateq. Subsequently the patient developed a salmonella infection. The patient was seen in the emergency room and was admitted to the hospital for observation. The patient was reported to have blood in the stools as a result of the salmonella infection. The patient was due to receive the second dose of Rotateq, but at the time of the report had not yet received it. It was reported that the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Every time patient ever got flu shot ,still got the flu.Rarely when patient didnt; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (unknown demography) who every time ever got flu (influenza),after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient every time had non-serious flu (influenza, unknown latency) after getting INFLUENZA VACCINE. Also reported that the patient had it rarely when he/she did not (As reported in the source by the reporter: "Every time I ever got flu shot I still got the flu...Rarely when I didn't").   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the reported event.  There will be no information on  the batch number for this case.
Inflammation; Pain; On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced INFLAMMATION (Inflammation), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose). At the time of the report, INFLAMMATION (Inflammation) and PAIN (Pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Next morning: severe joint and muscle pain in arms and legs. Continues till today (two months)
103 fever,body aches,headaches two days,fever sores on mouth 5 days. one week after shot still have headaches
subconjunctival hemorrhage in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient was healthy.     On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Company comment: This spontaneous case concerns an elderly female patient (unknown age), with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Conjunctival haemorrhage. The event occurred approximately 2 days after a dose of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula; no information about prior immunisation schedule was provided. The report stated that the patient experienced subconjunctival hemorrhage in the left eye. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741885:Different patient same reporter (Neighbours case)
Development of superficial vein tromboses in the right lower extremity great saphenous vein with propagation of thrombus.