chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came to clinic this morning c/o pain redness and swelling at injection site. It was warm to the touch. Reports she felt "flu-like symptoms" and had had a small  episode of nausea, vomiting and diarrhea last night.
This spontaneous report as received from a registered nurse refers to three unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (lot # M013639, expiration date: 15-SEP-2017) (dose and route of administration were not provided). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 22-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
11/10/2023 evening arm soreness. next day 11/11-chills,nausea,backache took tylenol, sunday 11/12 nausea, backache muscle cramps, arm still sore and red monday 11/13 still having nausea, arm red and swollen at injection site general itching both arms, stomach and back-taking benadryl
Diagnosed with Strep Throat; Feeling bad; Lost sense of taste; Lost sense of smell; Sluggish feeling; Tested positive for COVID19 Virus; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad) and AGEUSIA (Lost sense of taste) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacterial infection.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus) and SINUSITIS (Sinus infection). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell). On 27-Apr-2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat). The patient was treated with AZITHROMYCIN (Z-PAK) on 17-Apr-2021 for COVID-19 and Sinus infection, at a dose of UNK dosage form and PENICILLIN NOS for Streptococcal pharyngitis, at a dose of UNK dosage form. At the time of the report, SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  It was also reported that the patient went to receive 2nd vaccination but was turned down because of previous COVID19 diagnosis and 2 bacterial infections.
Shooting aches and pains in joints, general malaise, headache, shivers, fever, dizzy, stomach upset. Felt very bad all night the first night, all day the second day.  Worse than a flu feeling.
Comes in with spots right upper chest, right chest, right arm and spot on upper nose between eyes with itching. Dx: varicella.
Started having heart irregular heart palpations that came and went over the course of 3 months which became quite severe beginning 30 March 2022 and was actually arrhythmia that became AT/AFib with the culprit being synapse misfiring at the pulmonary vein at the left atrium entry.  Radiation ablation was required, accomplished 4 April 2022, and  ceased the AFib with no following issues at this point nearly 90-days post procedure.
extreme fatigue; low grade fever and body aches.; body aches; Experienced a headache; Stated that she feels the headache was due to dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever and body aches."; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "Experienced a headache"; DEHYDRATION (non-serious), outcome "unknown", described as "Stated that she feels the headache was due to dehydration". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the shot in my left arm. Two things happened upon injection (1) I immediately began to bleed from the injection site. I have been told the provider may have hit a capillary; it bled for about 45 seconds. (2) within 20 seconds of injection I felt faint and began to sweat; this was rather short and subsided within 2-3 minutes. I was concerned that because I began to bleed immediately after injection that the vaccine may have also been expelled, too. But given the following reaction just described and the soreness I continue to feel in my arm, I assume the vaccine was successfully injected. The shot provider was surprised at the bleeding, as was I, but unsure of the exact reasoning behind it.
A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
This spontaneous report as received from a nurse refers to 13 patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with doses of improperly stored of GARDASIL (strength, dosage, route, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right leg was swollen, whelpy rash, 2 days with IZ. Also, ate corn/wheat with possible allergy. ER MD dx'd as "allergy" and RX'd Benadryl and prelone syrup.
3 YEAR OLD MALE SEEN IN THE EMERGENCY ROOM FOR RASH IN A DERMATOMAL DISTRIBUTION IN THE LEFT SCAPULAR REGION EXTENDING TO LEFT DELTOID, ELBOW AND FOREARM. CHILD WAS IN PAIN, COULD NOT ELEVATE ARM 90 DEGREES. RASH BEGAN NIGHT PRIOR TO VISITING EMERGENCY ROOM.
Acute cor pulmonale; problems breathing; experienced heart strongest beat; dizziness; Saddle embolism pulmonary art; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Saddle embolism pulmonary art), COR PULMONALE ACUTE (Acute cor pulmonale), DYSPNOEA (problems breathing), PALPITATIONS (experienced heart strongest beat) and DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ERENUMAB (AIMOVIG [ERENUMAB]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PULMONARY EMBOLISM (Saddle embolism pulmonary art) (seriousness criteria hospitalization and life threatening), DYSPNOEA (problems breathing) (seriousness criterion hospitalization), PALPITATIONS (experienced heart strongest beat) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced COR PULMONALE ACUTE (Acute cor pulmonale) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to COR PULMONALE ACUTE, DIZZINESS, DYSPNOEA, PALPITATIONS and PULMONARY EMBOLISM. On 31-Mar-2021, PULMONARY EMBOLISM (Saddle embolism pulmonary art) outcome was unknown. At the time of the report, COR PULMONALE ACUTE (Acute cor pulmonale), DYSPNOEA (problems breathing), PALPITATIONS (experienced heart strongest beat) and DIZZINESS (dizziness) 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.   After 2 weeks of vaccination, the patient started to experienced heart strongest beat, problems to breathing and dizziness. On 28 MAR 2021 she felt this symptom and she thought "something is going bad" and has to be hospitalized on intensive care unit (ICU)  from 28MAR2021 to 31MAR2021 (4 days). They diagnosticated "saddle embolism pulmonary art with acute cor pulmonale". They found several clots in both lungs and one big clot/ one large clot in the pulmonary artery. Pulmonary embolism between lungs.  Treatment information was not provided. Vaccination second dose was recommended.  Based on the current available information and temporal association between the use of the product and the start date of 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 start date of the events, a causal relationship cannot be excluded.
3 days p/immun given mom says could feel mass @ inject site, which was red & hot to touch, looked bruised; Pt taken to clinic on 30APR91 marble-sized mass could be palpated @ DTP inject site, had browish discoloration, looked like contusion
Pfizer-BioNTech Covid 19 vaccine EUA-   Severe chills, HA, fever 100.6 , dizziness and muscle pain in legs
At 3 weeks post injection had 3 days of overwhelming fatigue. At 6 weeks outbreak of Cranial Nerve 5 Shingles with cankers inside the mouth, fever, sore throat, gum irritation and hypersensitivity (unable to eat X 2 days) skin rash, blisters and hypersensitivity along left jaw line and behind ear.
My wife took the COVID-19 vaccine at the same time than me and had mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.It was reported that the patient had mild soreness at the injection site on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021099121 same reporter/drug/event, different patient
working in a Family Practice been so busy and having multiple well child visits a wrong vaccine was given. Provider order DTAP and was given Pentacel. Per provider patient will not be harm and provider will communicate with parents.
patient died after receiving the 1st dose of the vaccine; This is a spontaneous report from a non-contactable consumer (patient's sister) via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient died after receiving the 1st dose of the vaccine on an unspecified date. The patient underwent lab tests and procedures which included blood grouping: AB negative on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient died after receiving the 1st dose of the vaccine
Feels slightly nauseous when she eats; legs are week and wobbly; Arm hurts; Shivering; Tired; Dizzy; Not been feeling well; Migraine for 2 days; This case was reported by a consumer via call center representative and described the occurrence of nauseous in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2022, the patient received the 1st dose of Shingrix (injection). On an unknown date, less than a week after receiving Shingrix, the patient experienced nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell. On an unknown date, the outcome of the nauseous and pain in arm were not recovered/not resolved and the outcome of the lower extremities weakness of and feeling unwell were unknown and the outcome of the shivering, tiredness, dizzy and migraine were recovered/resolved.   It was unknown if the reporter considered the nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was unknown. Since receiving vaccine patient had not been feeling well. In January 2022, patient recovered from the events shivering, tiredness, dizzy and migraine. She had a migraine for 2 continuous days and at the time to reporting that had resolved. She felt dizzy, tired, shivering that had resolved at the time to reporting, arm was still hurting, legs were week and wobbly, and felt slightly nauseous when she eat. The reporter would like to know how long symptoms last.  Reporter did not want to provide full address and HCP information. Reporter refused to provide HCP details and full address. The outcome for tiredness and dizzy was reported as not recovered in source document, however it was updated to recovered as per information provided in the narrative.
Fever blisters in mouth and lips; Fever blisters in mouth and lips; Fever blisters in mouth and lips; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever blister, blistering of mouth and lip blister. On an unknown date, the outcome of the fever blister, blistering of mouth and lip blister were unknown.   It was unknown if the reporter considered the fever blister, blistering of mouth and lip blister to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient broke out in fever blisters after receiving a dose of Shingrix. The pharmacist described breaking out in fever blisters as fever blisters on the roof of the patients mouth and on the lips.  Shingrix was administered at another location, so the health care professional did not have lot number and expiration date.
flushing, heart palpitations, shortness of breath within minutes of injection. started resolved within about 10 min . gave 25 mg benadryl PO
Day after vaccine patient had chills and muscle aches.  They started to go away and then in the past couple of days they have come back and gotten worse
did not receive 2nd dose/ late 2nd dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose/ late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-OCT-2023 The sales representative submitted the query via system for a nurse practitioner. The physician was inquired that if a patient only received the first series of the Shingrix vaccine ad it was been over a year or 2, did the patient need to restart the Shingrix series over. The medical information specialist did not speak with the health care provider. The consented to follow up granted.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; Bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 017C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided Patient reported that  they are using allergy medication to help with events.
slight pain in left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain in left injection site arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slight pain in left injection site arm). At the time of the report, VACCINATION SITE PAIN (slight pain in left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided. The patient reports no Adverse Reactions after his second Moderna Covid-19 vaccine.
Headache, Myalgia, Arthralgia, NauseaVomiting, Localized swelling, pain; chills, fatigue Narrative:  Other Relevant History:
Patient was given 2nd Moderna dose on 4/22.  The vaccinator felt that > 1/2 of volume of the leaked from the needle. As per CDC Interim Clinical Considerations, a another dose was immediately repeated.  The patient was contacted on 4/23. She reported fever to 102, fatigue, muscle aches and headaches but no unexpected side effects
I developed Tinnitus is my right ear the day after my first dose of the Moderna vaccine.
Patient started having left breast pain at 5 pm on 05/09/2018 the following day after receiving the vaccination (9:30A on 05/08/2018) in her left arm. She went to the doctor on 05/10/2018 who said she had a breast infection. She was prescribed KEFLEX 500 mg #30 1TID x 10 days. She followed up with the MD 5-7 days later and finished her antibiotics. Infection was gone. Doctor said she looked good.