chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes were very red; her shoulder to elbow on arm was red and very itchy; her shoulder to elbow on arm was red and very itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (her shoulder to elbow on arm was red and very itchy), ERYTHEMA (her shoulder to elbow on arm was red and very itchy) and OCULAR HYPERAEMIA (Eyes were very red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (her shoulder to elbow on arm was red and very itchy), ERYTHEMA (her shoulder to elbow on arm was red and very itchy) and OCULAR HYPERAEMIA (Eyes were very red). At the time of the report, PRURITUS (her shoulder to elbow on arm was red and very itchy) and ERYTHEMA (her shoulder to elbow on arm was red and very itchy) had resolved and OCULAR HYPERAEMIA (Eyes were very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication were over-the-counter (OTC) anti itching cream and eye drops.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No new information reported.
pt brought to hospital post cardiac arrest; brain anoxia; multi-organ failure; positive for COVID; COVID pneumonia; DIC; admitted to hospital for supportive care; on ventilator; after discussion with family they transitioned pt to DNR; pt became pulseless and ventilation support was stopped; pt passed away in the hospital
Patient turned 12 years of age in December 2021, and was given the pediatric formulation of Pfizer Covid vaccine, for ages 5-11 years
Large red welt around injection site, itchy, swollen and hot to touch. Upper arm muscle very achy and sore.
arm is throbbing; rash is a circle with a red dot inside; bright red dot, elevated, 2in from injection site - small in size 1/4in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is throbbing), VACCINATION SITE RASH (rash is a circle with a red dot inside) and VACCINATION SITE ERYTHEMA (bright red dot, elevated, 2in from injection site - small in size 1/4in) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012120A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm is throbbing), VACCINATION SITE RASH (rash is a circle with a red dot inside) and VACCINATION SITE ERYTHEMA (bright red dot, elevated, 2in from injection site - small in size 1/4in). At the time of the report, VACCINATION SITE PAIN (arm is throbbing), VACCINATION SITE RASH (rash is a circle with a red dot inside) and VACCINATION SITE ERYTHEMA (bright red dot, elevated, 2in from injection site - small in size 1/4in) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=MODERNA US INC/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 15Feb2021 as dose 2, single (Lot number: 022M20A), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm and on 01Feb2022 as dose 4 (booster), single (Lot number: 084021A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "colon cancer" (unspecified if ongoing); "sinus infection" (unspecified if ongoing). Concomitant medication included: CEPHALEXIN [CEFALEXIN], start date: 03Feb2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Vaccine brand other=MODERNA US INC/ vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: initial positive test; (19Feb2023) Positive, notes: tested positive for COVID-19 7 days after completing a round of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Feb2023 to 12Feb2023.
6cm red circle around inj site, warmth, tenderness, 1 red streak x 3 days
pain in lt arm, neck, upper back, h/a, sore eyes;has caused loss of sleep; takes ASA for h/a;
No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, 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 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) 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 ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Body aches, Sore arm can't raise her arm, Could not sleep, nausea, skin is painful, head ache, aching throat. Her work would not allow her to come in.
Received dose Rotateq at 5 months of age.       Informed mother to watch for increased temperature, vomitting or diarrhea and to notify baby's doctor if any of the above for the next 7 days.  Dr. notified of the vaccine administration of Rotateq.
Very sore arm, entire body soreness the next day, nausea, flu like symptoms, arm soreness from left deltoid to wrist lasting for approximately 1 week.
Patient experienced a bruise at the injection site.  There was also pain in the arm.  They also experienced nerve pain done the arm.  They are still experiencing some discomfort in the arm but at a decreasing rate.
pt recv flu & pneumococcal vax combined & given in one inj & exp redness, swelling to elbow, site hard & warm, malaise, pain;told to put heat by ER nurse;
Patient fainted after pharmacist gave immunization within the first few minutes of our in store waiting period post immunization. Pharmacist quickly responded lying patient flat and utilizing cold compress. Patient was breathing and responding and 911 was called. Patient was fine and left store with Mother.
feeling sick; inability to get warm; monster headache; mild nausea; fatigue; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm), CHILLS (chills) and HEADACHE (monster headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04132A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, ALPRAZOLAM for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced FEELING COLD (inability to get warm), HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (body aches) and CHILLS (chills). At the time of the report, MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm) and CHILLS (chills) outcome was unknown and HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue) had not resolved.            Treatment medications included Ibuprofen, aspirin, Zofran and ginger ale beverage.  Concomitant medication included albuterol inhaler and alprazolam 0.5 mg takes half a tablet daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-078362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR received however it is reporting on the first dose, not this second dose, therefore NNI.; Sender's Comments:  MOD-2021-078362:
administered with a third dose; 1st dose of shingrix on Feb 2019, and 2nd dose on August 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in February 2019).   On 4th April 2022, the patient received the 3rd dose of Shingrix. In August 2021, the patient received the 2nd dose of Shingrix. In August 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th April 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: The patient was administered with a third dose of Shingrix on the day of reporting. The reporter explained that, after getting medical history of patient's vaccination, they got that the patient received only one dose. Then, he administered what he believed was the 2nd dose of Shingrix on the day of reporting. During the day, the pharmacist received new information and was that the patient was administered with 1st dose of shingrix on February 2019 and 2nd dose on August 2021. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. On the day of reporting, patient received 3rd dose of Shingrix, which led to extra dose administered.
8/4/08 emp c/o redness and swelling in left deltoid since receiving Tdap vaccine.  Also experienced a fever of up to 103 for 3 days.  Tylenol would relieve fever.  Redness size 2"x3" in size.
Severe muscle aches all over body for 24 hours, nothing helped.  Now I have swollen lymph nodes in the neck and arm pit.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: This case was not previously reported to anyone. The reporter described that he received the first dose of Shingrix (right arm) in May or June of 2018. The reporter stated that he had symptoms to include achiness, pain and flu-like symptoms that resolved within 4 days. The reporter gave permission for his physician (cardiologist) to be contacted. The reporter was not able to provide full address of the physician. For tolerance to next dose, refer case US2018GSK168383.
raw/ tongue/ feeling like when you burn your mouth; raw /palette/ feeling like when you burn your mouth; This case was reported by a consumer via call center representative and described the occurrence of raw tongue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2021 12:00, the patient received the 1st dose of Shingrix (intramuscular). In August 2021, less than a week after receiving Shingrix, the patient experienced raw tongue and raw mouth. On an unknown date, the outcome of the raw tongue and raw mouth were not recovered/not resolved.   It was unknown if the reporter considered the raw tongue and raw mouth to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and on 3rd or 4th August 2021 felt a raw sensation on her tongue and palette. The caller described the feeling like when we burn our mouth after eating something too hot. The caller reported her dentist said that it might be related to the Shingrix vaccine. The reporter did not gave permission to contact health care professional. The reporter did not consent to follow-up.
Pfizer lot number fw1330 expired on 12/31/2022 but given on 1/12/2023
Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated; Joint pain; arthritis; stomach issue; her legs felt heavy, it was difficult to walk; she could not concentrate; Leg pain; hard to keep balance; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer-sponsored program COVAX US Support.   A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis, abdominal pain and Joint pain. The patient's concomitant medications were not reported. It was reported that the patient received the Pfizer Covid-19 vaccine on 05Mar2021. Caller stated she has a history of arthritis and stomach issues. However, caller reported 5 days later on 10Mar2021 after receiving the vaccine her stomach pain and joint pain got worse. Caller also reported that her legs felt heavy, it was difficult to walk, and she could not concentrate. Caller asked could you experience an reaction 5 days after receiving the vaccine. Caller asked was it safer to get the second dose of the Pfizer COVID-19 vaccine. Caller asked would her side effects be worse after the second dose. Caller clarified 5 days later she started having side effects like stomach issue, leg pain, hard to keep balance and could not concentrate. Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated. Caller wants to know if side effects can happen 5 days after first dose of COVID-19 vaccine. The outcome of all the events was unknown.  No follow-up attempts are possible.Information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable other HCP reporting on behalf of a physician. An 83-year-old male patient received PREVNAR 13 (Lot# H017759, Expiration Date 07Jul2014) on 17Oct2013 at 2:09pm, on left arm. Relevant medical history included diabetes, asthma and chronic obstructive pulmonary disease (COPD) and these conditions were ongoing at the time of events. Relevant concomitant medication included DALIRESP and unspecified medications and he was taking these medications at the time of events. Vaccine administered on the same day included Influenza Vaccine on right arm. Vaccine taken within the last four weeks was unknown. On 21Oct2013 the patient experienced cellulitis that was going down the left arm and erythema that was going down the left arm. At the time of the report the clinical outcome of the events was unknown.
Sedation, Myalgia, Fever, Pain, redness, swelling at injection site, Chills Narrative:
Pt typically has an adverse reaction to needles, with the most common reaction being syncope. The Pt was vaccinated on a bed to be proactive about the Pt fainting during vaccination. Pt was fine during and after vaccination, speaking with EMT before, during, and after the vaccination. No action was needed by EMT.
Hives on both sides all over body; Extremely itchy; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called on how to proceed with 2nd dose of Shingrix after 1st dose reaction. The patient broke out with hives. It was reported that, 8 out of 10 on both sides all over the body and extremely itchy. The health care professional (HCP) was unable to provide full details. The reporter did not consent to follow-up.
Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 29-MAY-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 28-APR-2016, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
Rash, fever-sib with chicken pox, skin itchy. Approximately 20 red papules scattered with clear vesicles on trunk.
Fatigue, chills, myalgia, arthralgia, nausea, headache, soreness at injection site
Patient had a 2 seizures lasting 1 minute each approximately 2 hours and 4 and 1/2 hours post vaccination.
Patient lived independently in own home and was driving independently prior to getting the 4th dose of the Moderna covid19 vaccine. Received vaccine 6/3/22. The following day started with confusion, which progressed in severity. Taken to a local ED on 6/5/22. After evaluation in the ED was admitted to ICU, where she stayed in ICU for several weeks. During hospitalization, she was found to have suffered a severe stroke. After several weeks in the hospital, she was directly transferred to a local rehab center on 7/13/22. While at the rehab center, she was taken to another hospital locally on 8/18. Was inpatient at that facility until 8/31, where she was transferred back to the rehab center. Transferred back to the hospital on 9/7/22 and then to a local hospice center on 9/8/22 and passed away on 9/22/23.
Nausea, headache, pain of the left arm, pain of the left leg (behind the knee), Severe itchy rash on arms, legs, belly and face , blisters.
He was having breathing problems, bronchitis and developed influenza on 11/17/00, 1 month, post vax. Still sick but doing better as of 3/27/01. 60 day follow-up states the pt still has a slight cough and bronchitis.  Follow up:  MD's office had no further information.
24 days after vaccine ringing in both ears.  No treatment, still having ringing in both ears
Patient contacted our team at 1709. Patient had covid vaccine at 1630 (Moderna lot# 025J20-2A) and complained he had elevated heart rate since the vaccine.  Patient states has history of AFib, high blood pressure and takes multiple meds. 3-lead ekg placed on patient. Patient stated he was supposed to see MD today but didn't want to miss his vaccine. Patient has allergies to Iodine, Haldol. Home Medications: Lasix, Niacin, Xaralto, Oxybutyroin (BP), Coreg (BP), Zolpidem. Vitals @ 1710: BP 162/92, HR 84, RR 20, SP02 97 Vitals @ 1720: 160/113, HR 98, RR 20, SP02 97 Patient released home.
Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620.
pt recv vax; swelling rt arm, c/o redness, soreness; swelling and redness at inject site; applied heat to area and soreness and swelling resolved;
Patient stated that she was light headed immediately after receiving the vaccine.  She responded well to a cold compress.
She also received TdaP and menactra and felt dizzy and like she was going to faint yesterday.  Still feels "terrible" today.  Some headache but she already had headache with URI
A report was received on 1/2/02 concerning a 72 year old male patient who experienced COPD exacerbation 7 days after receiving Fluvirin vaccine on 10/23/98. The event was considered serious (OMIC).