chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Dizziness; knots under skin; fell flat on my face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, in the right arm on 17Mar2021(at the age of 63-years-old) as Dose 2, single for COVID-19 immunization. Medical history was not reported. The patient reported that he was not allergic to medication he used every day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620G) via an unspecified route of administration, in the left arm on 24Feb2021(at the age of 63-years-old) as Dose 1, single for COVID-19 immunization and on 24Mar2021 at 16:00 experienced swollen arms and lymph node, arms and wrists hurt. The patient concomitant medication included other unspecified medications in two weeks of vaccination. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced fevers, chills, knots under skin, dizziness when outside and fell flat on his face and he was back in bed. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature:8.74 C , Time frame:35min; This non-serious spontaneous safety report was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35 min." was assessed as not applicable due to the nature of the event.  Further information is expected.
fever; Chills; Headache; fatigue; sore body; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old male patient received second dose BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 14:00 (age at vaccination 32years old) as single dose for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing known allergies: Shellfish. The patient had historical of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 14:00 (age at vaccination 32years old) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Feb2021 the patient experienced fever, chills, headache, fatigue, sore body. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
worsening terrible tinnitus after dose 2 (has been 3 weeks and it has not decreased); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 03Mar2021 15:15 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin, Bactrim, Cipro, Macrobid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (in left arm, at 03:15 PM)), administration date: 10Feb2021, when the patient was 46 years old, for COVID-19 immunisation, reaction(s): "Terrible tinnitus". The following information was reported: TINNITUS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "worsening terrible tinnitus after dose 2 (has been 3 weeks and it has not decreased)". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swelling to vaccination site at the left upper outer arm approx. 3cm x 4cm warm to touch.
8 days post inject pt devel 8cm area of erythema & inc warmth; treated w/Cephalexin 250mg qid x 10 days;
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 4-months patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
got third dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 025L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  No treatment medication was reported.    This case was linked to MOD-2021-352994, MOD-2021-352991, MOD-2021-352994 (Patient Link).
Tasting and smelling rubber after the vaccine; smelling rubber after the vaccine; 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 TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine). At the time of the report, TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
she got sick; she did not feel good; Terrible bruise which was 2inch diameter/stayed with her for a long time; She had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick), FEELING ABNORMAL (she did not feel good), CONTUSION (Terrible bruise which was 2inch diameter/stayed with her for a long time) and FATIGUE (She had fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (she got sick), FEELING ABNORMAL (she did not feel good), CONTUSION (Terrible bruise which was 2inch diameter/stayed with her for a long time) and FATIGUE (She had fatigue). At the time of the report, ILLNESS (she got sick), FEELING ABNORMAL (she did not feel good), CONTUSION (Terrible bruise which was 2inch diameter/stayed with her for a long time) and FATIGUE (She had fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient bruise stayed with her for a long time. Patient had taken Concomitant medication for Blood pressure, cholesterol and something for her stomach.   This case was linked to MOD-2021-265659 (Patient Link).
Tested positive for COVID19 on 6/21/21. Symptoms began on 6/16: fever, body aches, and back pain. Unknown exposure.
Patient developed local swelling immediately following injection which was given on 11/2/2017 at 5:30 pm. Patient was monitored closely for over 30 minutes and given ice pack to apply to site. There was no itching, rash, or shortness of breath. She was advised to contact medical facility if any worsening of symptoms.
PATIENT RECIEVED THE 5-11 YEAR DOSE FOR THE FIRST VACCINE AND THE SECOND. PLEASE LET US KNOW IF THE DOSES RECIEVED ARE ADEQUATE PROTECTION.
tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.
Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hours after receiving the vaccine. On a follow-up call on 1/8/2021, he reported that the symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
elevated/abnormal liver enzymes; epigastric pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in Nov or Dec 2020) in 2020.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) (seriousness criterion hospitalization) and ABDOMINAL PAIN UPPER (epigastric pain) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to ABDOMINAL PAIN UPPER and HEPATIC ENZYME INCREASED. At the time of the report, HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Laboratory test: elevated lver enzymes (High) elevated liver enzymes.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. On 10 Apr 2021, the patient visited a hospital with epigastric pain.  Diagnostic testing revealed elevated liver enzymes.  The patient was transferred to a different medical center due to the abnormal liver enzymes and admitted for more diagnostic testing.  Diagnostic tests at this medical center also revealed elevated liver enzymes. Treatment information was not provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Chest pain and palpitations lasting for at least 15 minutes several times. EKG and lab work done
The next day, Friday January 22, 2021 around midday both of my legs began to ache in my thighs.  Overnight it went away and I was fine Saturday and I worked a 12hr shift 7am to 7pm. Sunday I worked from 7am to 3pm and my legs started to ache when I got home around 4:30pm until 10pm when I went to bed.. I had to take some ibprofen that evening. I was again fine all day Monday. Now today 1/26/2021,my legs began to ache again this morning around 8:30am.
The following day I get very disoriented and brain fog, severe difficulty paying attention, it?s almost a week later and I still feel off
Red itchy rash at injection site 1.5 inches wide and 2.5 inches long.  I took one Benadryl tablet and the itching has stopped.
No additional AE; VARIVAX was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a 23-month-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 11-APR-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U015688 has been verified to be valid, expiration date reported and established as 18-MAY-2023) as prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of 12.95 degrees Fahrenheit (F), during a time frame of 21 hours and 15 minutes before it was administered to the patient (product storage error). No additional adverse event was reported (no adverse event). No previous temperature excursion was reported.
Pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist called to report that the patient was complaining of pain in arm of injection for one month after receiving Shingrix.
Pt states was "out of it" for three days post flu vaccine. States was tired and not up to par. Started after that had thick throat with swollen glands, back and neck pain, dry membranes x 1 month. Has not been to MD. Pt states has had previous flu vaccines without any problems.
sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-386518 (Patient Link).
vomiting abdo pain, joint aches 10PM; no treatment; felt better a/24 hrs;
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: patient also complained of sore throat, muscle aches, fever and chills which started on Sunday 08/22/21.  On Saturday 08/21; she reported initial signs of rash on both arms and chest area which still has not cleared up.  currently taking Benadryl OTC orally and topically for rash on arms and chest area.
pt recv vax & later that evening pt devel SOB, cough, chest burning w/flu like sx, achy joints, chilling;no fever-resolved in 24hr;
Pt reported to PCP office on 04/15/21 with itchy and painful red lesions to L elbow, L hand, L neck, and face x1 week - 10 days. Onset around 04/05/21. She reported a  sudden onset of sharp pain to face lesions the day before while at work. She has been using creams for that she had at home including Triamcinelone and Desonide cream to no relief. Pt reports some swelling to L elbow and blood when she scratched. PCP diagnosed her with Herpes Zoster and prescribed valACYclovir 1 GM Tab Take 1 Tab 3 times Daily for 7 days on 04/15/21.
Pain radiates form right arm to hand; (arm) area is kind of warm; cannot move her arm as well as she used to (bending elbow and lifting arm); soreness in her arm; knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot at the injection site), VACCINATION SITE WARMTH ((arm) area is kind of warm), LIMB DISCOMFORT (cannot move her arm as well as she used to (bending elbow and lifting arm)), PAIN IN EXTREMITY (soreness in her arm) and PAIN (Pain radiates form right arm to hand) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Stable) since 2009. Concomitant products included LISINOPRIL from 12-Aug-2020 to an unknown date for Hypertension.    On 24-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 VACCINATION SITE NODULE (knot at the injection site) and PAIN IN EXTREMITY (soreness in her arm). On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH ((arm) area is kind of warm) and LIMB DISCOMFORT (cannot move her arm as well as she used to (bending elbow and lifting arm)). On 14-Apr-2021, the patient experienced PAIN (Pain radiates form right arm to hand). At the time of the report, VACCINATION SITE NODULE (knot at the injection site), VACCINATION SITE WARMTH ((arm) area is kind of warm), LIMB DISCOMFORT (cannot move her arm as well as she used to (bending elbow and lifting arm)), PAIN IN EXTREMITY (soreness in her arm) and PAIN (Pain radiates form right arm to hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient tried to massage his arm and heating for his symptoms. Patient weight 216 Patient race was black.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added event,  Updated patient demographics relevant history, concomitant medication, outcome of the added event.
After the vaccine at 9:30, went home about an hour or so later started feeling an itch, and thought it would go away.  A few days later the itch was still there, drinking a lot of water.  She did take Tylenol when she got home.  Felt nothing else.  A couple of days later the itch was there and she noticed a few days ago and noticed that there was a rash on her arm, her stomach and her side, and turning red in certain spots.  She started using Calamine lotion because it was "driving her crazy'.  She did before that rub herself down with 90% Alcohol, and then proceeded to the calamine as the alcohol did not work.  She is scheduled to see her doctor today at 4:00 PM.  She did have soreness in the arm for a couple of days for a couple of days but that has gone away.   She looked at her thigh today and she is starting to get very small blotches on there as well.
Lethagy, malaise, fluid on lungs, CHF, ICU = 6 days, heart floor 3 days Rehab Center admit day = 10/7/19, outcome remains to be seen, potential date to be released is 11/7/19
On Tuesday May 9th 2022 I had increased cold symptoms in the morning on May 10th 2022 tested positive foe Covid and began to take Paxlovid for five days. Outcome was feeling well by Thursday May 11th. I did run a low grade fever of 99.6 during this same time period.