chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
hot flashes; bone pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache) had not resolved.            No concomitant medications provided. The patient experienced hot flashes, chills, headaches, and bones aching.  The symptoms are ongoing.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date (exact date was not provided by the reporter), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously injection, intramuscular (dose, series, anatomical location, batch/lot # and expiration date were not reported). This was coded as "incorrect route of drug administration" (reported as "a patient was administered ZOSTAVAX intramuscularly instead of subcutaneously"). Concomitant therapies were not reported. On an unknown date the patient experienced injection site pain. The patient did not seek medical attention, and it was not specified by the reporter if the patient received treatment for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Patient was administered the flu vaccine. Pt had some bleeding at injection site. Pressured applied to injection site. She then stated she didn't feel well and that vision was distorted. 911 was called and pt was taken away via EMT.
Headache, Myalgia & Fever Narrative: missed work due to the above symptoms following the second dose
Afib; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a female 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 15-Jun-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 an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL at an unspecified dose and frequency and DOFETILIDE (TIKOSYN) at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Afib) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2023, Heart rate: 138, 153 and 150.         Concomitant medication was not reported.  After booster shot, patient was sick for four days. Patient got call from cardiologist, where her pacemaker monitored and was told that patient had Afib for four days straight. Since then, patient had been hospitalized a couple of times for the high pulse rate, chest pains and irregular heartbeat. Last hospitalization was 01-Aug-2023 to 04-Aug-2023. Patient was taken off Metoprolol and was given Tikosyn instead. For a little while after patient returned home her numbers were getting better. Prior getting COVID booster, patient had normal heart rate in the 60's, 70's and 80's.    Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant and Hospitalization) unexpected AESI of Atrial fibrillation. The event occurred on an unknown date after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). Clinical course and supportive diagnostic procedures were not provided. The patient was treated with metoprolol and dofetilide, at an unspecified dose and frequency. The outcome of the event was reported as recovering. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.
I experienced a fever of 103.3, body aches, weakness in my legs, brain fog, nausea, and fatigue. I was advised to treat my symptoms with over the counter medication. The symptoms began to resolve after 3 days. It took me 7 days to fully recover from the booster.
Excessive pain during period. This was not the case before vaccination. I spoke to my gynecologist about it. She said it might not be related to the vaccine and prescribed birth control pills. I did experience cramps/ pain before taking the vaccine. But the pain I experienced after the vaccination was unbearable.
slept the entire day; wiped out; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the entire day) and FATIGUE (wiped out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised since an unknown date.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SOMNOLENCE (slept the entire day) and FATIGUE (wiped out). At the time of the report, SOMNOLENCE (slept the entire day) and FATIGUE (wiped out) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided
First Shingrix / on March 2020 / second / in February 2021, late due to Covid delays /second dose of Shingrix in March of 2021, not February 2021; patient was injected with recalled Shingrix, Lot 9LH3Y / given after the recall notice; patient was injected with recalled Shingrix, Lot 9LH3Y / given after the recall notice; Upset stomach; fever; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (received 1st dose in March 2020 and experienced upset stomach and fever, refer case-US2021062776).   In February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced upset stomach, fever and social problem. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach and fever were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the upset stomach and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 12 hours after vaccination, patient experienced upset stomach and fever which lasted for 2 days. The reporter did not consent to follow up. This case has been linked with US2021062776, reported by same reporter.   Follow up information was provided by consumer on 5th April 2021: The patient stated that, she received her 2nd dose in March 2021 and not in February 2021. The patient was injected with recalled Shingrix, which was given after the recall notice, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062776:Same reporter.
Swollen painful little ball in the armpit; Swollen painful little ball in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Swollen painful little ball in the armpit) and LYMPHADENOPATHY (Swollen painful little ball in the armpit) 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 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced AXILLARY PAIN (Swollen painful little ball in the armpit) and LYMPHADENOPATHY (Swollen painful little ball in the armpit). At the time of the report, AXILLARY PAIN (Swollen painful little ball in the armpit) and LYMPHADENOPATHY (Swollen painful little ball in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-239690 (Patient Link).
Arms hurt; Neck hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arms hurt) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-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 PAIN IN EXTREMITY (Arms hurt) and NECK PAIN (Neck hurts). At the time of the report, PAIN IN EXTREMITY (Arms hurt) and NECK PAIN (Neck hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
HEARING LOSS; CHILLS; VISION LOSS TO BOTH EYES; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polyethylene glycol (peg) allergy, and propylene glycol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 11-MAR-2021, patient experienced vision loss that lasted for an hour. Subject attributed it to the PEG and propylene glycol allergy. Later on the same day, she experienced chills that lasted until 14-MAR-2021. The subject also began having some hearing loss and further probing reveals she was referring to her ears feeling "stopped up" and it "sounded like she was in a deep well". She had not sought medical care at this time. Subject was encouraged to seek medical treatment for issues that won't resolve, would seem serious, or, would be bothersome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision loss to both eyes on 11-MAR-2021, and chills on 14-MAR-2021, and the outcome of hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210328836-Covid-19 vaccine ad26.cov2.s-Vision loss to both eyes, Hearing loss. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Pt. received 6 mo. well baby checkup on 2/23/09.  Vaccines listed below given.  Pt. came in to see MD on 2/28/09.  Vomiting began on 2/25 with Diarrhea.  Diarrhea continued over 5 days post vaccination.
Patient did not have any adverse reactions to the vaccine that was given. Dr. ordered DTaP and I gave the patient DTaP; however, for children over the age of 7 they are supposed to get Tdap
Headache; Muscle aches; Fever; This is a spontaneous report from a contactable consumer (patient) who reported in response to consumer letter sent via follow-up letter. A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via intramuscular on 21Jan2021 at 11:00 in left arm as a single dose for covid-19 immunization. The patient's medical history, concomitant medications and prior vaccinations were reported as none. The patient experienced fever on 22Jan2021 at 06:00, headache and muscle aches on 22Jan2021 at 10:00. The events were reported as non-serious. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via intramuscular on 12Feb2021 at 10.50 in left arm as a single dose for covid-19 immunization. Relevant tests were reported as none. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received PREVENAR 13) Lot Number: N16560, Expiration Date: Sep2017), intramuscular as a single dose in the left arm on 10Oct2016 for immunization. The patient's medical history and concomitant medications were not provided. In Oct2016, a couple of day after the patient received pneumococcal 13-valent conjugate vaccine, her arm became really red and swollen around the injection area. It was elaborated that the swelling and redness was the size of her hand on the left arm. There was no laboratory data provided. The clinical outcome of the events, red and swollen around the injection area, was not recovered.
PT PRESENTED TO ED WITH VOMITING AND DIARRHEA AND BLOOD IN STOOL  PT DEVELOPED INTUSSUSCEPTION ON  10/10/2020, HAD REDUCTION WITH BARIUM ENEMA, RETURNED TO HOSPITAL ON 10/14/2020 ATTEMPTED REDUCTION TO RELIEVE AGAIN, FAILED HAD SURGICAL INTERVENTION ON 10/15/2020.  PLANNED DISCHARGE ON 10/16
Blood pressure dropped to 90/65 with a heart rate of 90; Blood pressure dropped to 90/65 with a heart rate of 90; Dose Number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 14:00 as dose 1, single (Lot number: Gh9694) at the age of 74 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Bad back" (unspecified if ongoing), notes: Other medical history :  Bad back; "heart murmur" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 24Sep2022 at 14:00, outcome "unknown", described as "Dose Number: 1"; BLOOD PRESSURE DECREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Sep2022 at 08:00, outcome "not recovered" and all described as "Blood pressure dropped to 90/65 with a heart rate of 90". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure decreased, heart rate increased.  Additional information: Blood pressure dropped to 90/65 with a heart rate of 90. My normal blood pressure is about 135/75 with a heart rate of about 63  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Upon administration of Kinrix in left deltoid, patient experienced a syncopal episode. This was the fourth and final vaccine administered at this visit. Patient collapsed backwards onto exam table. Dr. was called in to examine. Dr. determined this to be a syncopal episode. Patient was not postictal and was not presenting with signs of anaphylactic reaction. Pt was alert and conscious after approximately 30 seconds from time of syncopal episode. Patient reported experiencing dizziness and light-headedness. Patient was positioned supine for 30 minutes. Patient drank juice box and reported resolution of symptoms. Patient was monitored for a total of 40 minutes from time of episode. Patient was able to ambulate normally and went home.
Extreme pain in legs, back of knees, thighs, hips, low-grade fever.
inconsolable crying-several hrs, shrill cry; no treatment-event not reported until 2 minutes later;
Initial report was received from a health care professional on 21 September 2010 which involved a cluster of five patients (same lot number, same reporter) which consisted of one male and four female patients. This case has captured four female patients, and the fifth male patient has been captured in case number 2010-05251. A cluster of four female patients with an unreported past medical history, had received FLUZONE HIGH DOSE, lot number U3617AA (date, route and site of administration not reported) and an unspecified amount of time later, experienced nausea, vomiting and "green discharge from the eyes". No further information was available at the time of this report. The patient's outcomes were not reported. Follow-up information was received on 04 October 2010 and 25 October 2010 from a health care professional who stated they were unaware of the four unidentified female patients previously referenced in this case. The reporter stated they had not been informed about these patients by any of the doctors at their clinic and they had no further information to provide. The reporter of this case is the same as for case 2010-05251. Documents held by sender: none.
Only chest pains. He was uncomfortable and unable to sleep due to the pain. Pain went away the next morning but returned again in the afternoon. Now, the following day, he says the pain is gone.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, dose route and frequency unknown. On 26-APR-2013, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 2, lot # 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 21st September 2022, the patient received Engerix B adult. On 21st September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The registered nurse reported that a dose of Engerix B adult given to the patient in their facility and it was already expired. The reporter asked how to proceed.  The reporter did not consent to follow up. Additional Supportive Information: The use of Engerix B adult dose, which was already expired on 11th September 2022, which led to expired vaccine used.
Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No treatment information was provided.  Patient got vaccine two days before reporting and had blood in stool.  Company comment: Very limited information regarding this event has been provided at this time. Further information is not expected as reporter refused to be contacted.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as reporter refused to be contacted.
16 11/12 yr old male reports body ache, leg/arm ache after visit on 10/22/13 for routine exam 1 day after visit. Hx asthma. Hx tick bite 2 wks prev myalgia.
pt recvd vax;cough,difficulty breathing in, lungs sounds dec;BP 130/100;P 80, R 24;md notified & pt having asthma;meds given; BP 110/70,P 80's;R 20's;lung sounds clear; pt tired; local rxn to adrenalin site with vaso constriction;
1) Received flu shot on left arm. 2) Localized pain was immediate. Pain was not consistent with prior flu shot administrations. 3) At approx. 5:40 PM on the day of the shot, I began to have a throbbing pain in the area surrounding the joint and severe pain & stiffness in the joint itself. 4) The morning of 09/25/14, my left arm was in severe pain, along with stiffness and the inability to move my left arm to any appreciable degree. 5) As of 09/26/14, the pain and lack of motion in my left arm has not subsided and is the same as it was on 09/25/14.
Two days after injection, noticed palm and stiffness radiating to shoulder and neck on left arm.  Complained of limited movement to arm-unable to lift arm above head or reach back without pain.  Discomfort noticed above elbow.  Report hand pain.  Strength and grip normal.
Arm hurts bad, red rash in area, feels like a big lump in my arm
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received TRUMENBA, intramuscular, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain and redness at the injection site, stiffness in the neck and nausea all on unspecified date with outcome of unknown.
102 temp, feeling sick, swelling in arm. Sought doctor and got steroids and antibiotic.