chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after more than 1 temperature excursion; Dose 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 (Dose administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose 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.   Patient's age was reported as 71.49  Concomitant products were not provided.  On 03-Nov-2021 Excursion time was 10:00 A.M., temperature was 35 degrees Fahrenheit, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
When flushot was given there was a little muscle twitch upon entry of shot, which sometimes happens if a nerve is touched advised patiet that can happen sometimes. Patient recieved flushot and said she felt lightheaded and dizzy. Her mom was with patient and we had her elvate her legs as she was seated. She proceeded to tense up and was shaking and possibly lost conciousness for 5-10 seconds and when she came  to said " what happened?" as if she didnt remember she fainted. I then left to call paramedics and went back to monitor patient until they arrived. Took BP and HR at 1:04pm was 73/45 Hr:93. She said her mouth was dry asked for some water. Paramedics arrived at 1:15pm and had her lie down on gurney and monitored her vitals and she was taken to the ambulence for further monitoring.
psychotropic effects, emotional changes, sadness and depressed; psychotropic effects, emotional changes, sadness and depressed; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue). On 27-Feb-2021, EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Right Hand and Arm feels tingling numbness ichy and major weakness.  At times feels as though hand and arm are asleep. Lost functionality in hand at times.
Feeling calmly; Injection site is swollen; Injection site is red; Having headaches; Felt tired; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), FATIGUE (Felt tired), PYREXIA (Had fever) and VACCINATION SITE SWELLING (Injection site is swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A0 and 0020B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEADACHE (Having headaches), FATIGUE (Felt tired) and PYREXIA (Had fever). On 30-Apr-2021, the patient experienced FEELING OF RELAXATION (Feeling calmly), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, FATIGUE (Felt tired) had resolved. At the time of the report, FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), PYREXIA (Had fever), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            This case was linked to MOD-2021-100857 (Patient Link).
The morning following administration of vaccines, patient woke up with rash scattered throughout entire body with fever. Fever resolved with Tylenol/ibuprofen. Benadryl for itching.
Patient received shot and believed that technique on vaccination was inappropriate causing patient to develop SSTI (cellulitis). Patient saw red rash that was very warm to touch on arm at injection site.  Patient went to urgent care and given oral antibiotics (Keflex) for infection on arm.
Information has been received from a nurse practitioner concerning a 46 year old female with chronic obstructive pulmonary disease and a sulfonamide allergy, who on 01-FEB-2008 was vaccinated with a first dose of PNEUMOVAX.  On 22-SEP-2008 the patient was vaccinated IM with a 0.5mL second dose of PNEUMOVAX (Lot# 660685/0619X).  Concomitant therapies included ADVAIR, VERAMYST, PROAIR HFA and SYNTHROID.  On 22-SEP-2008 the patient developed a red, warm, painful, swollen area, about 10 centimeters by 18 centimeters on her arm at the injection site post vaccination.  The patient was seen at the office.  No laboratory diagnostics were performed.  At the time of report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
ringing in his ears; amplified sound/ hearing; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in his ears"; HYPERACUSIS (non-serious), outcome "unknown", described as "amplified sound/ hearing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe muscle aches - entire body - started 12 hours after, treated with tylenol#3 (no relief), lasted 12 hours migraine - started 24 hours after, treating with eletriptan nausea - no treatment - avoiding foods diarrhea - no treatment - avoiding foods chills - started 15 hours after injection - treatment with tylenol extra strength - lasted 2 hours fever - started 17 hours after - treating with extra strength tylenol  hypotension - started 20 hours after - drinking liquids  inflammation of abdomen - treating with prednisone increase inflammation of joints - treating with prednisone increase severe fatigue - treating with prednisone increase
DVT in the left peroneal veins.  Symptoms started the same day of vaccine.  Patient seen in urgent care 1 week later.   Started on Xarelto.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Pt reported Fatigue, sore arm, chills, arthralgia, fever, myalgia, headache, nausea day after 2nd dose of covid vaccine. Self treated with ibuprofen.
I have below symptoms starting from 05/18/2021  Fever Nausea Shortness of breath Coughing Pain in body
Stiff neck; Swollen lymph nodes; High fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01Jun2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP). The patient had known allergies to sulfa, fish and seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 11May2021 at 18:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 at 15:00, the patient experienced stiff neck, swollen lymph nodes and high fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stiff neck, swollen lymph nodes and high fever was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 101.3 F Headache Stiff Neck Fatigue Started roughly 24 hours after injection and lasted all day. Woke up on 3/27/2021 with none of the above symptoms. On 3/27/2021 and 3/28/21 had 2 bouts of intense sweating during the day.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: After the first dose of the Pfizer COVID19 vaccine, patient felt faint while sitting. When patient stood up to report dizziness, the patient ended up fainting and falling. Patient reported that he did not hit his head. He regained consciousness quickly after and was able to sit for 30 minutes before leaving the facility.
Reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion ocurred; This spontaneous report was received from a nursing assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, drug reactions/allergies, medical history and historical drugs was not provided.  On 21-AUG-2020, the patient was vaccinated with 1 improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S038698 and expiration date 01-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.2 degree Celsius (°C) for 1 hour and 53 minutes on an unknown date; no previous temperature excursion were reported.  The excursion was called by a digital data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014798:
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of M-M-R-II (lot# as M007279, expiry date: 09-FEB-2018, lot # M004899, expiry date: 27-JAN-2018) (route: subcutaneous) that was exposed to 52.2F for 3.5 hours. No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Red Raised Bumps Around Injection Site; Initial Report Received on 08-DEC-2022  This is a spontaneous report, received from an "LPN"  regarding a 33-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  The patient was reportedly not pregnant.  Concomitant medications were not reported.  On 08-NOV-2022, dose 1 of HEPLISAV B (Lot #937231, expiration date 30-JAN-2023, NDC #43528-003-05), was administered intramuscularly in the left deltoid for hepatitis B immunisation.   On 08-DEC-2022, dose 2 of HEPLISAV B (Lot #937231, expiration date 30-JAN-2023, NDC #43528-003-05), was administered intramuscularly in the right deltoid for hepatitis B immunisation.   On 08-Dec-2022, the same day after having received dose 2 of HEPLISAV B, the patient reported that she developed red raised bumps around the injection site on the right deltoid and on the other arm at the deltoid area, which was the injection site for dose 1.  No other adverse reactions or medical intervention was relayed by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pain from left shoulder to fingers, swollen left lymph node, breast, chest pain left side. Severe hot flashes
Not feeling good; Very light headed/get dizzy; Only want to sleep; Very lethargic; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), DIZZINESS (Very light headed/get dizzy), SOMNOLENCE (Only want to sleep), LETHARGY (Very lethargic) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022BZ1A) for COVID-19 vaccination.     The patient's past medical history included Depression and Anxiety. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), VITAMIN D [VITAMIN D NOS], CLONAZEPAM (KLONOPIN), DEXLANSOPRAZOLE (DEXILANT), GABAPENTIN and MAGNESIUM for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced MALAISE (Not feeling good), DIZZINESS (Very light headed/get dizzy), SOMNOLENCE (Only want to sleep), LETHARGY (Very lethargic) and NAUSEA (Nausea). At the time of the report, MALAISE (Not feeling good), DIZZINESS (Very light headed/get dizzy), SOMNOLENCE (Only want to sleep), LETHARGY (Very lethargic) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: 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.
Had hives on her left side; Felt itchy; Had rash on her left side; weird flush; Felt tingly; her heart was racing; sleepy; Heavy feeling; Could not talk; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy) and LIMB DISCOMFORT (Heavy feeling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling) and APHASIA (Could not talk). On 15-Jan-2021, the patient experienced URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side). The patient was treated with HYDROXYZINE HCL on 14-Jan-2021 at a dose of 25 mg three times a day. At the time of the report, FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling), APHASIA (Could not talk), URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Heart rate: 160 bpm 160 beats per minute.     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.; 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.
Patient received his 2nd dose of Moderna COVID-19 vaccine yesterday. He was found dead at his home today. After speaking with the County Coroner, an autopsy is not planned. Patient had COPD, Type II Diabetes, cardiovascular disease, and a pacemaker. The coroner does not believe vaccination was contributory to his death.
Very sore upper arm for over 2 days especially one area an inch and one-half in diameter.  Outside upper arm red and blotchy an area 4 1/2 inches x 6 inches.  Days 6 & 7 light pink, itchy, big spot tender.  Day 9 tenderness gone.  Day 11 slightly pink.
right bicep has been itching from Sunday through present date and time, 3x4" area 2" above elbow reddened and warm to touch
underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen; underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER8727) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; AMLODIPINE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen".  No follow-up attempts are possible. No further information is expected.
Dizzy, lightheaded, nausea. Blood pressure checked sitting, laying down, standing. Juice given. Temp taken. Patient laid down for 1 hour after injection given.
About a week and a half after my Moderna booster, I started experiencing extreme generalized itching all of my body. About 5 to 10 minutes after itching, I would immediately break out in red, warm to touch, itchy hives/welts that would last about 30 minutes and could last even longer. This continued to occur for about a week straight until I went to my PCP. She prescribed multiple medications. Even after oral corticosterioids, Pepcid for a month, Allegra every day, and Benadryl as needed, I am still experiencing itching and hives when I itch or at random times.
On 1/19/21 I received my SECOND dose of Moderna COVID-19 vaccine. 1/20/21 at around 0300, started with restless leg feeling and headache, nausea (dry heaved). At this time I took two Tylenol & two Advil with a Ketorolac. The restless leg continued into full body aches, head to toe. Headache to migraine (this varied from on the top of my head to my left temple). These symptoms were consistent throughout the day, with severe fatigue. 1000 of 1/20/21 I was feeling chills and again nausea (again dry heaves). I drank ginger ale for the nausea, but I had no appetite till 1400. 1100 I took four more Tylenol. The aches subsided towards evening, however the headache in my left temple remained for the rest of the night. At 0500 on 1/21/21 I took more Tylenol and woke up later without the headache and body aches. However fatigue did linger with some back pain throughout the day. On the morning of 1/21/21 I did notice a lump and redness at injection site, as well as being painful to the touch.
syncope 5min p/vax preceded by dry cough-loss of consciousness x 1min;no sz activity;no rash;no breathing or swallowing diff--syncope is not frequent in a 5yo;nl vs, nl exam;
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown date. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and local swelling. On an unknown date, the outcome of the influenza-like symptoms and local swelling were unknown. It was unknown if the reporter considered the influenza-like symptoms and local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Notice on Saturday 3/22/08 redness, swollen, no fever, hard deltoid and start to increase on Sunday 3/23/08.
pt had first vaccine of moderna on 4/1 2021 and then was found to have an echocardiogram 4/16 and found to have a thrombus of left ventricle. Unclear if related but felt important to submit information
Shot at 12:20. 5-10 minutes later, pt reported feeling very dizzy even while seated. I had the pt sit back down to see if the dizziness improved. She also said her heat was beating fast. She was thirsty and was given water. BP and HR were 172/117 and 94. She eventually began to shake a little and said she was cold. I had her lie down and put her feet on a chair to try to help with her dizziness but even then she said her symptoms weren't improving. I asked if pt would like me to call 911 and she agreed. They arrived and asked if she wanted to go the hospital and she agreed and left around 1:05. I administered no medication.