chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 1:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 1:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 28.32. Concomitant products were not provided. On 29-Apr-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-Apr-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Redness & itch around injection site wt based BENADRYL given ice pack applied - 30 mg BENADRYL.
Patient began having pain in her right arm 3-4 days after receiving the vaccine. She states it is a nagging pain that is worse at times. She states she also has a tingling sensation that goes down her arm into her had and little finger. She is still having these issues as of 5/17/21. Referred patient to her PCP.
Lightheadedness when she gets up and walk around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness when she gets up and walk around".  Additional information: It was also reported that patient was asking for how long does side effects from bivalent COVID booster for adults would last. She said that she wanted to know specifically about lightheadedness when she gets up and walk around.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Back pain - was waking up several times a night in pain. I went to Hospital ER on Saturday (it started on a Tuesday or Wednesday). They gave me muscle relaxers, Lidocaine patches and hydrocodone. After I started taking the relaxers, I was better after another day or two. Follow up check - with doctor.
Skin disorder/ Spots on middle of back; had really high fevers after second covid vaccine.; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (Skin disorder/ Spots on middle of back) and PYREXIA (had really high fevers after second covid vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's relevant medical history was not reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (had really high fevers after second covid vaccine.). On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/ Spots on middle of back). In 2021, PYREXIA (had really high fevers after second covid vaccine.) had resolved. At the time of the report, SKIN DISORDER (Skin disorder/ Spots on middle of back) had not resolved.            Concomitant Drugs were not reported.  The patient had reported that she had really high fevers after second COVID vaccine. She had spot in middle of her back.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna
Injection site warmth; Allergic to preservatives; Vaccination site erythema; Vaccination site swelling; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives (Allergy to Preservatives). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced FATIGUE (fatigue). On 28-May-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue) 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 treatment information was provided.  On 28MAY2021, Patient experienced an allergic reaction at injection site which has turned to red, swollen, warm with a diameter of 2.5 inches. Patient also experienced fatigue.
INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 200 pounds, and height was 182 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies (food vaccine and drug). No history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:30 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness on 11-MAR-2021. This report was non-serious.  Additional information was received from reporter on follow up 23-MAR-2021 following information was amended into case:  The patient details (height, weight, sex and age), concurrent conditions (alcohol use, non-smoker), vaccination time, route and vaccination site.
Hives, raised red rash on the face, neck, and upper chest with a  burning/ itching sensation at times
At about 1am the same night, I started to feel really nauseous and thought I might throw up, then I realized my hands and arms were numb and I was getting cold. Within 10 minutes my entire body was shaking violently and my teeth chattering so badly I bit my tongue and couldn't walk or put more cloth on. I buried myself under 2 blankets and was incredibly cold and told myself if it didn't get better in 20mins I would do something else. 20mins later, it had gotten worse and I managed to put several additional layers of clothes on and 8 more blankets. I stayed completely under them and about an hour later things were still bad but my hands worked well enough to look up side effects on my phone. I figured that this is what "chills" are and just stayed under the blankets for about 3 hours. Eventually, I stopped shaking and then I woke up sweating and had to take everything off. Since then I've been incredibly warm. Now, the next day, I have a terrible headache and my entire body is very sore and sensitive. I took some pain meds which helped some, but I had to take the day off work.
Swelling, red, tender left upper arm with pain, fever, seen in ER on 10.12.8 & Dx: Cellulitis Tx: KEFLEX 500 BID X 10 days. With unremarkable recovery
This spontaneous report was received from a registered nurse and refers to a currently 14 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # L033549, expiration date 05-JUN-2017, for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013280; US-009507513-1802USA003852.
MAKING THIS REPORT BECAUSE THE PATIENT HAD THE INITIAL  VACCINATION IN JANUARY 2021 AND IS NOW RECEIVING THE 2ND VACCINATION IN AUGUST 2021.
some fatigue; some chills; arm got red and prickly and super itchy; arm Very itchy and prickly after booster; covid arm (left arm) after booster dose; itchy prickly rash 2 inches lower than the injection site; arm started itchin/super itchy/ Very itchy after booster; had a little discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm (left arm) after booster dose), RASH PRURITIC (itchy prickly rash 2 inches lower than the injection site), PRURITUS (arm started itchin/super itchy/ Very itchy after booster), LIMB DISCOMFORT (had a little discomfort) and ERYTHEMA (arm got red and prickly and super itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 023M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included RIVAROXABAN (XARELTO), METFORMIN, METOPROLOL SUCCINATE and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PRURITUS (arm started itchin/super itchy/ Very itchy after booster) and LIMB DISCOMFORT (had a little discomfort). On 05-Nov-2021, the patient experienced VACCINATION SITE REACTION (covid arm (left arm) after booster dose), RASH PRURITIC (itchy prickly rash 2 inches lower than the injection site), ERYTHEMA (arm got red and prickly and super itchy) and PARAESTHESIA (arm Very itchy and prickly after booster). On an unknown date, the patient experienced FATIGUE (some fatigue) and CHILLS (some chills). At the time of the report, VACCINATION SITE REACTION (covid arm (left arm) after booster dose), PRURITUS (arm started itchin/super itchy/ Very itchy after booster), LIMB DISCOMFORT (had a little discomfort), ERYTHEMA (arm got red and prickly and super itchy), PARAESTHESIA (arm Very itchy and prickly after booster), FATIGUE (some fatigue) and CHILLS (some chills) outcome was unknown and RASH PRURITIC (itchy prickly rash 2 inches lower than the injection site) had not resolved.            No treatment were reported.   This case was linked to MOD-2021-377069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow up document received included newevent added and outcome of event rash updated.
BREATHING PROBLEMS, COUGH, FEVER, FATIGUE, DECREASED APPETITE, SORE THROAT, DIARRHEA
In patient's words: 2-3 inches below injection site there was swelling, hard as a rock, hot, palm size area with redness and itching. Experienced headache all day long.
she got the shingles; This spontaneous report was received from a currently 79 years old female patient referring to herself. The patient's concurrent conditions, concomitant medications and historical drugs were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, strength, route, lot# and expiration date were not reported) for prophylaxis.         On an unknown date, the patient stated she got the shingles.  The outcome of the shingles was unknown. The causality between the shingles and zoster vaccine live (manufacturer unknown) was not provided.
Severe chills Vomiting  Diarrhea  Pain at injection site for 7 days Fatigue
Severe myalgia legs & back. Most  significant in the thighs.  Temp 99.3-100 F
arm really hurts; muscles really hurts; little upset tummy; tired; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, muscle pain, upset stomach and tiredness. On an unknown date, the outcome of the pain in arm, muscle pain, upset stomach and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient reported pain in arm and muscle really hurts and a little upset tummy and tired.
For a day and a half I was about as sick as I was at the peak of having covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (For a day and a half I was about as sick as I was at the peak of having covid) 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 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced ILLNESS (For a day and a half I was about as sick as I was at the peak of having covid). On 28-May-2021, ILLNESS (For a day and a half I was about as sick as I was at the peak of having covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
Nausea and headache at 12:00 Dizzy,headache,shaky, itchy,difficulty breathing, pain in the chest, and out of body feeling starting at 3:00 PM
I had intense shocking all over my body, a fever of 109 degrees, headache and muscle aches, and I took two Tylenols. It started at about 06:00PM and then at 3:00AM in the morning I was fine.
24 hours later: arm and axillary area with edema, redness and pain. 72 hours later: flu-like symptoms and abdominal rash. Seen at our office 8/6/03; symptomatic treatment.
pt recvd vax;approx 2 wks later,exp a 2 1/2"x1 1/2" area which was red,& had a blister & broken skin;subsequently recvd 2 addl doses;did not mention event until just a/ dose 3;hlth dept decided to give dose 3 anyway;still present 31aug94
Rash on his arm; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported) via an unspecified route of administration on Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced rash on his arm on Jul2021. The patient unsure if this has something to do with the vaccine or not and want to clarify if rashes on the arm is a common side effect. Patient also wanted to know, is still safe to get a second dose of BNT162B2. The outcome of the events was unknown.   No follow-up attempts are possible; No further information is expected.
A serious spontaneous report of seizures has been received from a non-health professional concerning a seven-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Nov-2011. Two days after receiving FLUMIST, on 30-Nov-2011, the patient had seizures and then two weeks later he experienced seizures again. The outcome of the event seizures was unknown.
one week following vaccination was unable to respond, unable to move, life flighted to hospital intubated and treated for blood infection
Patient has a lump in the area where the injection was given.  He noticed it after the immunization but it has not went down since the immunization 12 days ago.
FEVER NORTH OF 102, AND RIGHT ARM AND ARMPIT SWELLING. I HAD TO USE MY LEFT HAND TO PICK UP MY RIGHT ARM.
EXTREME vertigo in April, May, and August (recorded episodes). No treatment, other than rest.
no adverse effects. patient received a bivalent 0.2ml dose instead of a monovalent 0.2ml dose. The vials look almost identical - both orange, both same size, both same dilution, and both same dose. Pharmacist did not notice the labeling difference. Correct age vaccine administered, but bivalent instead of monovalent.
extreme tiredness; medium grade headache; pain throughout the whole body; High fever (102F); Strong shaking throughout the whole body; pain down the left arm; Tenderness at the injection site; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The concomitant medications included cetirizine (ZYRTEC) for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) for unknown indications on unknown dates and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Mar2021 at 03:45, the patient experienced strong shaking throughout the whole body and pain down the left arm for approximately 30 min at 03:55, the following day after the shot. Pain reduced in severity, but changed to the pain throughout the whole body. High fever (102F) throughout the day, medium grade pain especially on the left side of the body, medium grade headache. On the 2nd day pain and headache subsided but experienced Tenderness at the injection site, Nausea and extreme tiredness throughout the day. On third day most symptoms were gone and had slight tiredness. Therapeutic measures were taken for the events and shaking subsided after 2 (200mg/each) Ibuprofen pills. Pain reduced in severity, but changed to the pain throughout the whole body. Headache, body pain and fever was better controlled with Tylenol (500mg). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shaking, pain down the left arm, high fever, headache, body pain, Tenderness at the injection site, Nausea and tiredness was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and DIZZINESS (Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event. Concomitant products included LORAZEPAM (ATIVAN) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced NAUSEA (nausea) and DIZZINESS (Dizziness). At the time of the report, NAUSEA (nausea) and DIZZINESS (Dizziness) 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 information was provided.
Moderna booster vaccine administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected between 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in the database lookup tool is 12/31/2069. Patient contacted on 12/4/2021. No adverse effects reported.