chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fresh blood in the stool; Watery stool; Anal bleeding; felt tired; This spontaneous case was reported by a patient and describes the occurrence of HAEMATOCHEZIA (fresh blood in the stool) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced FATIGUE (felt tired). On 14-May-2021, the patient experienced HAEMATOCHEZIA (fresh blood in the stool) (seriousness criterion medically significant), DIARRHOEA (Watery stool) and ANAL HAEMORRHAGE (Anal bleeding). At the time of the report, HAEMATOCHEZIA (fresh blood in the stool), DIARRHOEA (Watery stool) and ANAL HAEMORRHAGE (Anal bleeding) had not resolved and FATIGUE (felt tired) outcome was unknown.            It was reported that the patient was not pregnant and not having her period. SD text:23-year-old female patient is calling to report that she received the SECOND dose of Moderna COVID-19 vaccine on 12MAY2021 (Lot#  023C21A) in the Right Arm. The Next Day on 13MAY2021, she felt Tired.  Today 14MAY2021, She is having Watery Stool and Anal Bleeding. She states that she is not pregnant and she is not having her period. There is fresh blood in the watery stool (Not Coffee ground stool).      Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded
Had High Dose, have taken shot for over 40 years w/ no reaction. Had soreness, hoarseness, cough, headache, fatigue, slight fever, really sick, took ALEVE, with no relief, 24 hrs later symptoms subsided. OK now 10/20.
Pain/hurt all over; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching (serious criteria hospitalization) and pharmaceutical product complaint. On an unknown date, the outcome of the generalized aching and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.  Additional case details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix from different batches (batch number not provided). The patient had increased pain and due to which, the patient had to go to the hospital. The reporter indicated that she was seeing an increase in the number of patients reporting adverse events since GlaxoSmithKline had started to increase production of the Shingrix product. She was wondering if she should continue to administer the product. She believed that there might be something going wrong with the process GlaxoSmithKline was utilizing to manufacture the product more rapidly. The reporter hung up the phone and did not provide any additional details.  It was unknown if the reporter had product to return because she would not continue with the call. The reporter also stated there are 2 more patients who reported adverse events including increased pain and having to go to the hospital, refer linked cases US2019098383 and US2019GSK105628. Additional information regarding event seriousness was requested. However, case is closed conservatively.
Received Shingrix vaccine injection on January 4, 2020. Subsequently, experienced soreness at injection site, insomnia, chills, headache, fever, nausea, dizziness and difficulty breathing. Symptoms subsided 24 hours after injection.
Anaphylactic reaction; Inflammation in eye/ eye swelling; Rash; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included abaloparatide (Tymlos) for senile osteoporosis.   Concurrent medical conditions included senile osteoporosis.   On an unknown date, the patient received the 1st dose of Shingrix. On 30th November 2021, the patient started Tymlos (subcutaneous) 80 ug once daily (80 ug daily). On 28th December 2021, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye swelling and rash. Tymlos was continued with no change. On an unknown date, the outcome of the anaphylactic reaction, eye swelling and rash were unknown.   It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's medical history was not provided.  Relevant surgical, social, or substance-usage history was not provided.  The patient received 1st dose of Shingrix vaccine and experienced eye swelling, rash, and an anaphylactic reaction. The patient was on Tymlos for the treatment of age-related osteoporosis. The patient's eye doctor advised that the eye Inflammation could be due to Shingrix but was unsure if related to Tymlos.  Treatments for the events was not reported. No relevant lab or diagnostic tests were reported. The action taken with Tymlos was did not changed. The outcomes of eye swelling, rash, and an anaphylactic reaction were not reported. It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Tymlos.
Pt. states (R) arm sore last night and noticed redness and swelling this morning.
Left arm sore day after vaccination increasing soreness 10/24 and 10/25 "so sore cannot life up". 10-26-10 same (no worse), no fever no other sore areas, no redness, no swelling.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI986AA, expiration date: 30-Jun-2019, site of administration: right deltoid and route was not reported) on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (vaccine was exposed to 31.5F for 1 hour and 40 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On Saturday, April 17 at some point overnight I developed hives. The hives started  on my right thigh and left knee area lower back an buttocks.  On Sunday, April 18 the hives continued to spread throughout my kegs, then  in the evening at about 10PM worked their way to my arms and hands. I woke up with hives on my lower legs and feet face, and stomach. The hives remained until Monday, April 19 and Tuesday, April 20 but continued to lessen as the days progressed. The hives were gone by Wednesday, April 21. I took Benadryl to relieve symptoms.
moderate to sever muscle and joint aches, fever and chills with some nausea starting about 2 hours after shot, worsening for next 2 hours, lasting about 24 hours.  Moderate fatigue another 24 hr.
In the mornings I have my protein shake and without physical activity I noticed I was having heart palpitations, like the butterflies and intermittent and fairly consistent.  I went to Urgent Care and they took some reads and saw what was going on.  I have Complete Right Branch Bundle Block that is benign.  They didn't have enough/right equipment and sent me to ER.  They observed me for 2-3 hours and they saw what was going on.  They released me and recommended I follow up with cardiologist.  I saw the cardiologist and he did another EKG.  He put me on a monitor for one week and I turned it in this morning.  I will get the results on the 31st.
redness & swelling of entire limb, warmth @ inj site, DPH relieved the swelling & warmth, but petechiae presented w/in 2hr;over 24hr all sx resolved;
Headache, body ache, fever, cough, nausea, Muscle weakness, fatigue, loss of appetite.
Redness of injection site; Raised at the injection site; hot to the touch sensation; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   On 16th June 2020, the patient received Shingrix. On 18th June 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The batch number was updated as G7274 to G72Z4, as per sales data sheet. The suspect vaccine lot number provided by the reporter did not pull up in database. The patient received the Shingrix and experienced an injection site reaction that included redness, hot to the touch sensation, and a raised injection site. The injection site reaction was 2 inches in diameter, with no associated drainage or change in sensation. The reporter consented to follow up. The reporter provided limited information at time of call.
Redness and swelling  at injection site; 3.5 hr after shot, feeling ?in a fog?; nausea; body malaise the day after
3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022; immunocompromised patient received a 0.25ml 3rd Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose) and PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 042j21a, 007m20a and 025j21-2a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose). On 28-Feb-2022, the patient experienced PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022). On 11-Nov-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose) outcome was unknown. At the time of the report, PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow up received on 28-Feb-2022 includes no new information
Patient reported experiencing tingling in fingers of hand of same arm of Fluzone immunization around 45 minutes after administered. Her fingers continued to tingle for the remainder of the day, but when she woke up the next morning she was fine.
Two hospitalizations for adverse events:  12/31/2010 and 01/13/2011. First hospitalization required intubation and ICU stay as patient went into respiratory failure. Second hospitalization was when association with vaccination discovered. Steroids, supportive care.
pt recvd vax & 1-3 days p/vax devel serum sickness (rash); exp arthritis type sx (swelling) 2-3 wks later; 5MAR93 swelling almost gone; pt has core antibody for hepatitis;
Patient was born on 11/1/22. Patient is a 6 month old who received the incorrect COVID vaccine at her initial visit on 5/2/23 (she received 0.2mL of Moderna bivalent booster for 6mo-5yo). This was caught after receiving her second vaccine on 5/30/23 when she received correct 0.25mL of Moderna bivalent for 6mo-11yo. This is reported as a medication error, no adverse reaction occurred.
Patient came to off-site COVID test & flu shot clinic on 12/3/20.  Per patient's boss's email on 12/4/20: "When he was coming back to work, he passed out while driving, running into a Construction trailer, a stop sign, and damaging the van. (All on our Property)  He woke up and walked into the school where we called the police and filed a police report.  He is fine, I drove him down to the Hospital, on the way we called his Dr. and the nurse said not to come in unless he was feeling Nausea, or other symptoms.  She stated that "He probably just had a reaction to the Flu shot."  I drove him back home last night, and he is at work today."
redness; swelling; itching at injection site; site is warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch). At the time of the report, INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch). At the time of the report, INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
initially erythema at injection site for # 1. " muscle twitch & aches " near injection site , diffuse ongoing fatigue, not activity limiting . Muscle " twitching" persisted x 2 weeks after first shot - then resolved. Received second vaccine on 1/28/21 with similar reaction of erythema & muscle twitching' near injection site . Intermittent fatigue.   No other neurologic or MSK symptoms.
A consumer report has been received from a health professional, concerning a female patient. The relevant history, concomitant disease and concomitant medications of the patient were not reported. The patient had received nasal FLUMIST. It was reported that the patient experienced breakthrough infections of influenza and also tested positive for Flu B, on 19-Dec-2012. Action taken with influenza vaccine was not applicable. The outcome of the event of breakthrough infection of influenza was unknown and the patient recovered from the even of tested positive for Flu B on an unspecified date. The reporter assessed the events of breakthrough infection of influenza B to be non-serous. The event of tested positive for Flu B has been identified by the company physician from the source documents and added as adverse event and considered to be non-serious. Summary of follow-up information received 06-Mar-2013 from health professional: form completed date updated. Non serious event of tested positive for Flu B added. patient details updated. Start date added for event of breakthrough infections of influenza added. Corrected report 18-Mar-2013. Action taken for FLUMIST changed form unknown to not applicable. Vaccinated and vaccine purchased with added as other/unknown.
Irritable, red swelling around left eye, fever of 103.2 Fahrenheit.
Information has been received from a pharmacist concerning a 59 years old female patient, who was hospitalized when on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). On an unknown date the patient experienced swelling of the whole arm and shoulder. No other co-suspects were reported. No concomitant medications were reported. The outcome of swelling of the whole arm and shoulder was reported as recovered. The relatedness for swelling of the whole arm and shoulder was unknown for PNEUMOVAX 23. The patient sought unspecified medical attention. Additional information is not expected.
First dose in January and a week later she got COVID; 91 days since the first shot; It has been 91 days since the first shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot). At the time of the report, COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
feels weak the bone that connect the arm with the body; shoulder aches; pain in the knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20K) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
had fevers and aches for about a week up to now; temperature of 101 on and off intermittently through the day/ had fevers and aches for about a week up to now; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non-HCP) from medical information team. A female patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "had fevers and aches for about a week up to now"; PYREXIA (non-serious) with onset Oct2021, outcome "not recovered", described as "temperature of 101 on and off intermittently through the day/ had fevers and aches for about a week up to now". Relevant laboratory tests and procedures are available in the appropriate section. Additional information This physician (Patient's husband) reported for a female patient (reporter's wife). Patient History was not Provided. Investigation Assessment was not Provided. Reaction/event as reported by primary source had fevers and aches for about a week up to now and temperature of 101 on and off intermittently through the day. Dates for had fevers and aches for about a week up to now and temperature of 101 on and off intermittently through the day was (From: Unspecified To: Unspecified). Reporter seriousness for temperature of 101 on and off intermittently through the day and had fevers and aches for about a week up to now was Unspecified. Tylenol a Pfizer product was Unspecified, Tylenol manufacturer: Unspecified, Dates for Tylenol: (Start: Unspecified Stop: Unspecified) UPC number of Tylenol: Not Provided, Reason for no lot number: of Tylenol-Caller unwilling to complete the report, Expiry Date of Tylenol was not Provided. Additional Context: Caller states he has a question about possible reactions. His wife got a shot 10 days ago and from Day 4-5 she had fevers and aches for about a week up to now and a temperature of 101 on and off intermittently through the day. Other people are getting reactions and localized redness, this, and that. Is trying to speak to someone to get an idea on what to do or report it. Is asking because they simply can give Tylenol for 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.