chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in my heart; A spontaneous report was received from an 81 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in heart.  The patient's medical history included heart problem and concomitant medications included Metoprolol.   On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced pain in her heart and went to emergency care. The patient said the doctor asked for stress test but the patient could not walk on the treadmill so she was given a shot instead of walking. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, pain in my heart, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (Lot # not reported) that were exposed to unsupported temperatures. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
My entire body is shaking. Feels like muscle spasm over my entire body. Slight chills no fever yet. Very sore arm and clenching of stomach, arm, back and shoulders. I took 500 mil of Advil. Shaking starting to stop after 41 min. May be feeling warm I have to check.
Information has been received from a physician assistant concerning a patient (age and gender not reported) who on an unknown date, was vaccinated intramuscular with a 0.mL of Pneumovax 23 (Lot# 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Menstrual cycle changes started shortly after the first COVID19 vaccination. Prior to vaccination, my menstrual cycle occurred every 28 days and lasted 3-4 days. Since vaccination and over the last 6 months, menstrual cycle has been every 18.7 days on average and lasted 7 days on average.  Menstrual cycle start dates:  March 19, 2021 April 11, 2021 April 27, 2021 May 18, 2021 June 6, 2021 June 19, 2021 July 1, 2021 July 29, 2021 August 13, 2021 August 28, 2021 September 22, 2021
School nurse called on patients behalf to report patient had a 4x4 area on the bicep of the arm they had received the vaccine (in the deltoid) - red area - warm to touch MD advised probable allergic reaction and not to take flu shot again. Resolving on its own.
Patient complained about having blood pressure over 200/90 and went to urgent care and was referred to the ER. Patient was given Metoprolol  and the systolic blood pressure decreased to 170 and has been in the 170 ever since. Patient's normally systolic blood pressure is normally between 130-140 while on anti-hypertensive medications and has jumped up to 170-200 since getting vaccinated. She is currently in contact with her cardiologist to manage her blood pressure.
Filler reactions/Seen lots of filler reactions; Foreign body reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions) 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 VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions). At the time of the report, VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   Reporter did not allow further contact
Arm became red; Arm became swollen; Arm became warm; Arm became itchy; A little soreness around the injection site; Lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection site), ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Hypothyroidism (mild hypothyroidism). Concomitant products included SOTALOL (SOTALOL AF [SOTALOL]), LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LORAZEPAM (ATIVAN) and PRAVASTATIN for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection site) and VACCINATION SITE PAIN (A little soreness around the injection site). On 17-Jan-2021, the patient experienced ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy). On 10-Jan-2021, VACCINATION SITE PAIN (A little soreness around the injection site) had resolved. On 17-Jan-2021, VACCINATION SITE MASS (Lump at the injection site) had resolved. At the time of the report, ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  No adverse event reported.   This case was linked to MOD-2021-395985 (Patient Link).
Mother of patient phoned the clinic and told me that her daughter received her 4 year old shots on Friday (02/02/2007). She noticed Monday (2-5-07) that her daughter developed a rash on her face. Today, Tuesday (2/6/07) she noticed a rash developing on her arms and legs.
Received MMR #1 on 1/31/13 - developed fever within 24 hours then had febrile seizure within 48 hours. Fever 101.
her age did not fit with the Vaccine Schedule/Kinrix maladministration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Nurse reported that a patient received her first Kinrix dose by error as her age did not fit with the vaccine schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Body Aches, chills, diarrhea, fever, headache, arm soreness, redness, swelling
Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Crohn's disease.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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) at an unspecified dose. On 22-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            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.  Concomitant Medication use information was not provided by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment Medication use information was not provided by reporter.  Company Comment: This is a spontaneous case concerning a 24-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the second dose of mRNA-1273 vaccine. Drug ineffective was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 24-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the second dose of mRNA-1273 vaccine. Drug ineffective was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history drug allergies or reactions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursions. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Caller received the first Covid vaccine on 03Apr2021 and tested positive for the Covid virus a week later; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he received the first dose of Covid vaccine on 03Apr2021 and tested positive for the Covid virus a week later (Apr2021). He stated that he was out of isolation and has no symptoms. He asked if he should be able to receive the second dose on 24Apr2021. The patient underwent lab tests and procedures which included COVID-19: positive on Apr2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
The night of first dose I had a fast heart beat all night I couldn?t sleep The second day a terrible headache and nausea  Now I have bad cramps and am spotting as if I am going to start my period which I already finished my cycle last week I never had break thru bleeding or spotting like this a few days after my period finished. I am having symptoms again
low-grade fever/100.6 fever; swollen lymph node; swollen lower lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lower lip), PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced LIP SWELLING (swollen lower lip). On 28-Dec-2021, the patient experienced PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swollen lips, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swollen lower lip), PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) Body temperature increased 100.6.         Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-435201 (Patient Link).
About a week after my shot, I started getting very, very light-headed and extremely lethargic.  As I've grown older, tinnitus has been a problem but nothing compared to the on-going problem I now deal with after having received the vaccine.  I have spent a tremendous amount of time in bed and this is NOT who I am.  I constantly deal with a pressure in my head, light-headedness and, at times, low-level headaches.
This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever). At the time of the report, COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had trouble walking and was taken to emergency room and was discharged with antibiotics (unspecified antibiotics). Concomitant product use was not provided.  The nurse reported that it was never actually confirmed that the patient had contracted COVID-19 through a test or lab result.   This case was linked to MOD-2021-344054 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a 86-year-old, male patient with no listed medical history, who experienced the unexpected events of COVID-19, Feeling abnormal, Gait disturbance and listed event Pyrexia. The events  occurred approximately 3 months after the second dose of Covid19 Moderna. This is a case of lack of effect assuming the patient had 2 doses of Moderna vaccine in the correct interval. The rechallenge was unknown since no event after the first dose was disclosed. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
On 15th of December 2009, two months old patient got Rocephin 350 mg I'M after seeing Dr.
1 hour after receiving Moderna booster, eyelids swelled. Great pain in eyes when moving eyes. Pain and eyelid edema persisting after 48 hours
Patient received Ixiaro, Rabavert and Typhim Vi injections upon admin of final shot, Typhim, patient felt faint and dizzy which persisted for 20 minutes. Patient recovered and taken home by a friend
patient received an expired Quadracel on 14-Nov-2019/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2020SA010008, 2020SA010010 and 2020SA010011(same reporter).  This case involves a 4 years old male patient who received an expired DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [Quadracel] on 14-NOV-2019 (expired product administered) ( lot C5325BA, other dosing details, route and administration site not reported)  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error case due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
died ather shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient just died after Shingles shot.  The reporter asked was this coincidence and there were immediate and profound symptoms. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Exactly three weeks after receiving the second dose of the vaccine, I developed scleritis in my left eye (diagnosed by my ophthalmologist, ). After the first dose of the vaccine (so six weeks before developing scleritis), my left eyelid became swollen within two hours. The swelling went away after a day, and I did not have any issues with my left eye until three weeks after the second dose of the vaccine, when the scleritis presented in this eye.
patient should have received second dose Moderna; physician and patient notified; patient monitored for 30 minutes; no adverse events noted
Information has been received from a physician concerning  a 22 year old female patient who on 05-OCT-2009 was vaccinated with the third 0.5 ml dose of GARDASIL. There was no concomitant medication. On 05-OCT-2009 the patient had a fever for over 24 hours. There was no information provided on first and second dose. There was no lot number provided. The patient had sought unknown medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
Intense generalized itching that began 30+ minutes following rabies vaccine. Was given Benadryl 50mg IM with marked improvement in symptoms.
On 11/20/2003 developed oval about 3 1/2 x 1" red, indurated, raised, itchy, tender mild, right antero lat upper arm proximal well-circumscribed lesion. Skin unbroken around injection site (Also about 2" x 1" red tender itchy lesion right mid dorsal forearm per pt. Today this lesion 1" x 2" scaly, tender mild area only.
sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) 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: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: The reporter was the patient's mother. The patient received the dose 1 at home but cannot go to the office where the vaccine was to receive the second dose because he was sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.