chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low-grade fever and chills (99.5 Fahrenheit); Low-grade fever and chills (99.5 Fahrenheit); headache; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received her fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provide), intramuscularly on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT), covid-19 prior vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), rivaroxaban (XARELTO), atenolol, multivitamins. The patient experienced severe headache at 18:00 on 21Dec2020. Low-grade fever and chills (99.5 Fahrenheit) Q (every) 90 mins from 22:00 21Dec2020 till 04:00 22Dec2020. The events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was recovered in Dec2020, the outcome of events chills and low grade fever was recovered at 04:00 on 22Dec2020.  Information on the Lot/Batch number has been requested.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 1:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 29.81.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34 and excursion time was 10 am temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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.
This is an initial report of an AE, received on 06-Oct-2017, for Protein Sciences Flublok. Subject, a 76 year-old male received FLUBLOK Intramuscular on 04-Oct-2017. On 04-Oct-2017, after receiving FLUBLOK and pneumococcal vaccine, the subject experienced cellulitis. It was unknown if any corrective treatment was provided. At the time of the report, it was unknown the outcome of the event. Medical history was not provided. It was unknown if the subject received Flublok in the past. Concomitant medications included an unspecified pneumococcal vaccine.; Sender's Comments: The companys assessment of the causal relationship between cellulitis and FLUBLOK is related. In summary, this case report does not change the known safety profile of FLUBLOK.
Signs of bruising and petechiae in April/May 2008. Petechiae on lower legs and feet.  4/24/2009 MR received for DOS 2/17-19/2009 WITH D/c dx:  Immune Thrombocytopenia.  Pt presented with several month hx of diffuse petechiae.  Platelet counts were low (1,000 range) and pt dx with ITP. Treated as outpt with oral steroids with increase in platelets to 78K.  Pt currently presents with bleeding from the mouth and petechiae. Platelet count 0 on admission for severe thrombocytopenia 2' to ITP. PE (+) for purpuric oral lesions, petechiae and epistaxis. Tx with dexamethasone and Rituximab and d/c for further outpt tx.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Shingrix for prophylaxis. In November 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received the second dose of Shingrix in the left arm. In 2018, the patient experienced pain and soreness at the injection site which lasted for about 3 days. The patient did not consent to follow-up. No further details were provided.
Had slight fever 11/11/2015, Hives on 11/13/2015.
1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
13yr old female who were with her parents.  Patient got her first shot of Pfizer Vaccine and fainted.  Patient's eyes rolled upwards and was in a daze for about a minute.  Patient then returned to her normal self and vomited about 100ml of clear emesis.  Patient denied any chest pain or SOB.  Said that she felt fine after she threw up.  No distress noted after that.  Patients mother said that the patient has a history of passing out with any needle work being done to her.
Initial case received from a literature article on 03 January 2014: A 5-year old female with sickle cell hemoglobin C disease had received a dose of PCV23 (lot number, dose number and route of administration were not reported) in the right arm and had received a dose of MCV4 (lot number, dose number and route of administration were not reported) in the left arm, both vaccines on an unspecified date. On unspecified dates, the patient had received one dose of the PPSV23 two and a half years earlier and a dose of the MCV4 6 months prior to the event. She also had received four doses of the PCV7, one dose of the PCV13, the HepB series, and annual influenza vaccinations and the patient had developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites, and skin test confirmed allergies to dust, mold, mildew and cockroaches. In her previous clinic review, she reported leg pain that sometimes required pain medication and headache pain in the past 4 weeks. On an unspecified date, next day in the early morning after receiving the vaccine, the patient developed pain in her head, neck and arm and a fever of 102.9 DegreeF. Ten hours later, the patient's mother reported a fever of 101.3 Degree F and right arm swelling with edema to the extent that it was difficult to put a shirt sleeve over the arm. The patient was brought to the Hematology clinic. Upon examination, it was noted that the right arm was tender with redness over the lateral aspect and swelling down to the elbow. Blood culture was subsequently negative. The patient was discharged from the clinic. The patient had received Ibuprofen for fever, Ketorolac for pain and Ondansetron for nausea and one dose of IV Ceftriaxone and Morphine for break-through pain. On an unspecified date, the patient had recovered from swelling in the right arm within 24 hours. At the time of this report, the outcome of fever, nausea, pain were unknown. Documents held by sender: None.
developed a task on her arm and torso / rash resolved on its own; This case was reported by a nurse via sales rep and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On 30th August 2020, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix  and developed a task on her arm and torso 3 days later. The patient did not report it or self medicate. The rash resolved on its own after 2 days.
Injection 1 Mild Cellulitis at injection site lasting 3 weeks. Injection 2 Severe Vertigo requiring E.R. intervention Inner Ear fluid requiring antibiotic and steroid intervention lasting months with occasional mild recurrence Exacerbated existing conditions.  Newly acquired  chronic severe sleep disruptions hot flashes and flushing.  Injection 3 above changes remain existent.
felt OK upon awakening 530AM 28OCT94 by 7AM nausea which got worse & h/a started & just felt bad all over; t98 @ noon;
swollen lymph node on my clavicle (on the side of injection); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)). At the time of the report, LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
MILD INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient takes blood pressure medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced mild injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild injection site soreness on 05-JUN-2021. This report was non-serious.
48 hrs p/shot, had episode of jerking lasting 15-20 seconds; (no fever) 13MAR95 tc to RN; high fever & sz;
vaccination site erythema; right arm hurt.; "a feeling of a rapid heartbeat"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (vaccination site erythema), PALPITATIONS ("a feeling of a rapid heartbeat") and PAIN IN EXTREMITY (right arm hurt.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date, Hypertension since an unknown date, Migraine since an unknown date, Burning mouth syndrome since an unknown date, Sore throat since an unknown date, Coronary stent placement in 2016 and Coronary stent placement in February 2020. Concomitant products included PROPRANOLOL for Migraine, CLINDAMYCIN, DULOXETINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), OLMESARTAN, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), MONTELUKAST, VITAMIN D3, CALCIUM, VITAMIN C [ASCORBIC ACID] and VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PALPITATIONS ("a feeling of a rapid heartbeat"). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm hurt.). On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema), PALPITATIONS ("a feeling of a rapid heartbeat") and PAIN IN EXTREMITY (right arm hurt.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, Chili?s, headache and feeling of vomiting. It?s been 24hrs and still symptoms don?t subside.   Taking Tynelol every 6hrs.
This spontaneous report was received from the patient's mother refers to her daughter a 4 year old female patient. Patient with no drug reactions or allergies. Patient has Down's Syndrome. On an unknown date (several years ago) the patient was vaccinated with the first dose of MMR II (route, lot number and expiration date not reported). There was no concomitant medication reported. Patient's mother reported that when the patient received MMR II she experienced fever and was lethargic on an unknown date. Patient sought for medical attention: unspecified contact. No lab diagnostic studies were performed. These symptoms lasted for about a week and then recovered on an unknown date. It was reported that events occurred several years ago when family was living in another city. It was also reported that the patient had not received dose 2 of MMR II. This is one of two reports from the same source (sibling MARRS # 1406USA003598). Additional information is not expected.
Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When touching the area there is a lump that measures between an inch and two; Speech is weird; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 04:00 PM in the left arm at 2nd dose, single for COVID-19 immunisation. The patient age at vaccination was 57 Years. Medical history included IBS (inflammatory bowel disease) and recently the patient was developed a sensitivity to shrimp that results in hives. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL9282) received in left arm on 10Feb2021 05:00 PM for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and after the vaccination. On 05Mar2021 7:15 AM, the patient had swelling occurred in the area between my mouth and chin on the left side of my face up and my speech is weird. It almost feels like I went to the dentist and got a shot of novocaine in that area. When touching the area there is a lump that measures between an inch and two. I took two Benadryl at 7:35 or so and the swelling has started to decrease but is still there, as well as the numbness. Therapeutic measures were taken as a result of numbness (hypoaesthesia), swelling occurred in the area between my mouth and chin on the left side of my face (swelling face), when touching the area there is a lump that measures between an inch and two (mass) with Benadryl and novocaine. The patient reported that she do not know if this was happened before but potentially having a reaction to the vaccine that she got on Wednesday part of face has swelled up. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
achy arm from first dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy arm from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy arm from first dose). At the time of the report, PAIN (achy arm from first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
PNEUMOVAX .5 CC GIVEN R DELTOID IM APPROX 10 A.M..   PT STATES THAT EVENING ARM TENDER, SOME SWELLING, WARMNESS AT SITE,C/O FEVER. STATES HE CALLED AN ER AND THEY TOLD HIM TO COME IN IF BREATHING DIFFICULTY.  PT DENIED SOB.  STATES ARM SORENESS LASTED 48-60 HOURS.
ACUTE ONSET OF DIURNAL ENURESIS AND ENCOPRESIS. OCCURRED SIMULTANEOUSLY IN PATIENT AND HIS BROTHER WHO ALSO GOT VACCINE AT SAME TIME AND DOES NOT HAVE PREEXISTING CONDITIONS. TIME OF ONSET UNKNOWN AND N/A. MOM SAID OCCURRENCE WITHIN "SEVERAL DAYS" OF VACCINATION. SHE IS CONVINCED THIS IS A VACCINE ASSOCIATED EVENT. SHE STATES IT REMINDS HER OF "REGRESSIONS SEEN WITH PREVIOUS INFLUENZA IMMUNIZATIONS". SHE VACCINATED HIM BECAUSE HE IS ASTHMATIC AND BROTHER HAD TO BE VACCINATED TO STAY IN A AIR FORCE BASE LOCATED DAY CARE CENTER. SHE VACCINATED THEM BY HER CHOICE AFTER HAVING REFUSED VACCINATION PREVIOUSLY. SHE STILL REFUSED SEASONAL INFLUENZA VACCINE.
Pt respresently called to say pt felt sick and having hard time getting out of bed. Was told to call MD if pt Sx were severe. MD then called And stated they administered Flu and Boostrix earlier that day. MD stated the were working with pt and to fill out VAERS. Pt dosed twice on Flu + TDP in same day.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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.   No concomitant medications were reported.  The vial was initially stored in the fridge on 05-Jan-2021, moved to clinic on 08-Jan-2021 and proposed beyond use date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M, the temperature recorded was 34 degree Fahrenheit and at 02:00 P.M, the temperature recorded was 35 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
I received the Pneumonia 23 vaccine about 1 PM on 8/25/2021, and that night my arm was sore (expected), but around midnight, I had severe chills, and fever for about 8 hours, to the point that my entire body was shaking.  Twenty four hours after the injection, I feel abouit 80% normal, and continuing to get better.
MA misread orders and gave Tdap along with other vaccines. Tdap, Lot: AC52B018AB, Site: Right leg
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 05-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.