chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of erythema in a 71-year-old patient who received SHINGRIX (batch number 32GR4, expiry date 7th April 2020) for prophylaxis.  On 31st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, swelling and skin warm. On an unknown date, the outcome of the erythema, swelling and skin warm were not recovered/not resolved.  It was unknown if the reporter considered the erythema, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: After receiving Shingrix, the patient experienced redness, swelling and heat.
Flu shot was received on monday nov.5th, on tues evening tristan was feeling very tired. On wed. he complained of being very tired and late evening began to vomit.  Thurs, he slept all day not eating anything and had not had an appetite up to this day.  Fri, he woke up vomitting, and continued throughout the day. He had finally eaten 1/2 a sandwhich on fri. afternoon.  He woke up vomitting early sat. morning and I took him to the er to make sure that he was okay.  They took chest xrays because as of Wed. he had developed a cough.  Chest xrays were clear and we were released.  Sat. afternoon and evening he continued to vomit and at this time has now developed diarrehea
Acid reflux; Burning in feet extending upwards; Burning in chest; Burning in lips and tongue; Elevated Blood pressure; Elevated pulse; Feeling Aweful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure), HEART RATE INCREASED (Elevated pulse) and FEELING ABNORMAL (Feeling Aweful). On 09-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, SIMETICONE (ANTACID [ALUMINIUM HYDROXIDE GEL;MAGNESIUM HYDROXIDE;SIMETICONE]) at an unspecified dose and frequency. On 11-Jan-2021, BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) had resolved. At the time of the report, FEELING ABNORMAL (Feeling Aweful) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) 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.   Concomitant products include Beta blockers for blood pressure
symptoms were severe headache, chills, muscle weakness, nausea . I was really sick for about 24 hours. I have never had a reaction like this with any other shot or medication. I slept almost all the next day. Im afraid to get my second one.
Post vax, the pt developed a fever of 101, achy all over, pharyngitis, nausea, and headache.
I had extreme diarrhea and extreme abdominal pain. I went to the ER, and they did a CAT scan and blood work. I was diagnosed with diverticulitis. They prescribed me Amoxicillin and Flagyl.  I started to feel better and it hit me again on 01/08/2023. I went to the doctor the next day and she gave me another antibiotic. I ended up having to go back to the ER 01/13/2023 and they said I had still had an infection left over in my abdominal.
pt recvd vax 31AUG95 & went to ER w/3 days of fever of 103.6;pt hospitalized; lab eval revealed WBC 2400, segmented neutrophils 33 & bands 33;LP was clear;no signs of infection;no further details were provided;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient sat down after vaccine and became dizzy. He laid down and fainted but regained conciousness. He was sweating profusely and could not speak well. This lasted about 10 minutes. BP was measured at 150/71 with a pulse of 71. He drank some gatorade and was monitored for 30 minutes and was able to leave.
almost killed my fiance; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported: "The vaccine almost killed my Fiance I assume you need to know things like that please contact so we can have a dialog. Others know I have contacted you in case something happens to me." The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
my blood pressure is really really low; I know you get tired and I am trying to sleep through it; my arms going to hurt; feeling a little dizzy and light headed; I start to get nervous when I start feeling this way; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "my blood used to be high" (unspecified if ongoing), notes: I mean and normally for the good time was my blood used to be high, I was on my medication (Name not specified hence, suspect captured as unspecified medication conservatively). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "my blood pressure is really really low"; FATIGUE (non-serious), outcome "unknown", described as "I know you get tired and I am trying to sleep through it"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arms going to hurt"; DIZZINESS (non-serious), outcome "unknown", described as "feeling a little dizzy and light headed"; NERVOUSNESS (non-serious), outcome "unknown", described as "I start to get nervous when I start feeling this way". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical information: : Consumer stated, "I am just calling because I have gotten the second booster shot (Clarified as Pfizer COVID-19 Vaccine Bivalent) yesterday and my blood pressure is really really low, It is, I mean and normally for the good time was my blood used to be high, I was on my medication (Name not specified hence, suspect captured as unspecified medication conservatively) few years ago, its been pretty normal but I Just, I mean I know I am going to get tired after this and you know my arms going to hurt and all that kind of stuff but its different feeling a little dizzy and light headed. And my blood pressure like, Last time I just took it about 20 minutes ago. It was 91 over 56 and it seems 11 Approx. is 98 over 69 last night, I mean, I start to get nervous when I start feeling this way, 102 over 62 was the high that was 11 O'clock last night and then it started dropping. I just wanted to know that, Is that part of the, I know you get tired and I am trying to sleep through it this time a little bit but may be I am, but I think my blood pressure be up not down." When paraphrased the vaccine name as Pfizer COVID-19 Vaccine: Consumer stated, "Yesterday yes, October 20. It was the second booster shot the (Clarified as Pfizer COVID-19 Vaccine Bivalent). Pfizer, Yes."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for COVID after vaccination; trouble breathing; cough; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.
No Adverse Event; Moderna Covid-19 Bivalent was administered to patient after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD) and NO ADVERSE EVENT (No Adverse Event) in an 81-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, 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 20-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD).    Concomitant medication list was not provided. It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423, US-MODERNATX, INC.-MOD-2022-692429, US-MODERNATX, INC.-MOD-2022-692430, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-692432 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-692429:same reporter US-MODERNATX, INC.-MOD-2022-692430:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-692432:same reporter
Pt revcvd DTP/OPV/MMR/HIB & pt held breath, then had petite mal type sz while being held by mom who had expected some type of immediate rxn; pt recovered p/10 seconds;
pain in his eye; diarrhea; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in his eye), DIARRHOEA (diarrhea) and HEADACHE (really bad headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Diabetes), Hypertension, Blindness, Hearing loss and Eye abnormality (Ischemic neuropathy of bilateral eyes). Concomitant products included CLONIDINE, LISINOPRIL, AMLODIPINE BESILATE (NORVASC) and CARVEDILOL (COREG) for an unknown indication.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EYE PAIN (pain in his eye), DIARRHOEA (diarrhea) and HEADACHE (really bad headache). On 22-Apr-2021, EYE PAIN (pain in his eye) and DIARRHOEA (diarrhea) had resolved. At the time of the report, HEADACHE (really bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure measurement: 225/92 (High) 225/92 Blood pressure increased.         Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Non-Significant Follow Up received contains NNI.
04/20/2021 - none   04/21/2021 - slightly sore arm.   04/22/2021 - Starts  achy, lymph nodes swollen. left armpit (Lymph node) untouchable due to pain.  04/26/2021 - lightheaded low grade fever, and tired. Overall aches going away, armpit still swollen and sore.    05/06/021 - sandpaper bumps all over arms and legs. Still lightheaded.    05/28/2021 -  overall swelling going down, armpit still sore, now "dizzy".   06/10/2021 - Doctor visit, for issues, was prescribed steroid.   06/13/2021 - Arm pit Lymph node, and injection site stil sore, rash going away, now have mild vertigo.   07/21/2021 - Seeing neuro and spine specialist for vertigo from the inflamation.  08/02/2021 - Still sore with vertigo. Testing continues
Pt developed a stomach ache and nausea about 4 hours after vaccine, dry heaves without vomit, and diarrhea. This continued all through the night and into the next day 8/2/2017 until she was seen by me, so far 22 hours of symptoms.
Red patch around injection area one week later. Saw MD diagnosed as infection-prescribed antibiotic.
The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023; No adverse event; Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD) and PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023).    No concomitant medications were reported.  No adverse event was reported and a dose of the Moderna vaccine was given to the patient beyond the use by date of 13-Apr-2023.  The dose details of the fourth dose of Moderna vaccine was reported as 0.5.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722205 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
No additional AE reported; two lots of the vaccine have been administered to two different patients; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. No information regarding the patients pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-JUL-2020, the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), lot # S007811, expiration date 14-MAR-2021 (dose and route of administration were not reported) given for prophylaxis, experienced temperature excursion of -15 Celsius degrees (C) for 48 minutes. On 28-JUL-2020, the patient was vaccinated with improperly stored dose of the suspect vaccine. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2008USA000403:
Severe Headache Chills Fatigue Gastrointestinal 101 degree fever Chills  Symptoms lasted about 30 hours
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer and a contactable nurse. A 41-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), dose 1 intramuscular on 26Jan2021 at 06:15 AM (Lot Number: EL3248) as single dose, dose 2 intramuscular, administered in arm right on 16Feb2021 at 05:45 PM (Lot Number: EL3248) as single dose, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced COVID-19 virus test positive (medically significant) on 05Apr2021 with outcome of recovering. Patient became ill on 04Apr2021 with symptoms of runny nose, sore throat, cough. The patient underwent lab tests and procedures which included COVID-19 PRC test (nasal swab): positive on 05Apr2021. The event required physician office visit. It was unknown if treatment was administered.  Follow-up attempts completed. No further information expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded in the development of event drug ineffective. The event COVID 19 is assessed as unrelated to the suspect product. The general population is at increased risk for acquiring this infection in light of the current global pandemic, and provides the more likely explanation.
METAL TASTE IN MOUTH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metal taste in mouth. This report was non-serious.
Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Unknown if any recent change in status such as improvement or worsening.).    On 27-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jul-2022, the patient experienced UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap). At the time of the report, UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. The reporter stated that the patient was administered with a volume of 0.25 ml of Moderna COVID-19 Vaccine booster dose only presentation (vial with blue cap) for a second booster dose. The reporter was not aware of any adverse events after the vaccine was administered for the patient and did not know if any treatment was given, or if the patient was under any regular medication. Treatment details was not reported by the reporter.   This case was linked.; Sender's Comments:Other patient (Same Reporter)
After the first shot a few hours later I broke into hives bad all over my body I have pictures. Then when it came for my second I told the nurse I had a reaction to the first she still gave me the second one and man I?ve been sick ever since but the second shot took longer for the side affect to hit me but when they did it is so much servere then the first and still ongoing.
Color drained from patient's face/skin and she became dizzy. Did not lose consciousness. Gave her support, moved her to floor, ice pack, and water until her color returned and she felt well enough to get up and move around.
p/vax pt exp severe diarrhea, explosive in nature, lasted 3-4 days.
Patient woke up the following morning with swollen eyelids and took 24-hour Allegra.