chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Stuffy nose; Low grade fever; This case was reported by a consumer and described the occurrence of fatigue in a 57-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced fatigue, nasal stuffiness and low grade fever. On an unknown date, the outcome of the fatigue, nasal stuffiness and low grade fever were unknown.   It was unknown if the reporter considered the fatigue, nasal stuffiness and low grade fever to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received a dose of Flulaval vaccine on Friday and experienced a low grade fever, a stuffy nose and fatigue. The patient inquired about the ingredients of the Flulaval vaccine and the type of vaccine was it. The caller was provided with medical advice disclaimer. No additional details were provided by the reporter. The reporter provided permission to contact health care professional. The reporter consented to follow-up.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 28-JUN-2016, the patient was inadvertently vaccinated with first dose of ROTATEQ (lot # K023534) that was expired on 22-MAY-2016. No adverse effects were reported. Additional information has been requested.
patient was administered a vaccine that was left at room temprature for >12; left out past 12 hours and an expired dose administered/patient was administered a vaccine that was left at room temprature for >12; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (left out past 12 hours and an expired dose administered/patient was administered a vaccine that was left at room temprature for >12) and PRODUCT STORAGE ERROR (patient was administered a vaccine that was left at room temprature for >12) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091B21A and 09021A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (left out past 12 hours and an expired dose administered/patient was administered a vaccine that was left at room temprature for >12). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient was administered a vaccine that was left at room temprature for >12). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (left out past 12 hours and an expired dose administered/patient was administered a vaccine that was left at room temprature for >12) had resolved. At the time of the report, PRODUCT STORAGE ERROR (patient was administered a vaccine that was left at room temprature for >12) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: Event added.
Initial report received from a consumer on 30 October 2013. A male patient (date of birth 07 August 1942), had received FLUZONE HD, batch number: unknown, route and site of administration was not reported) for first time last year 2012 (date was not reported). The patient had received numerous intramuscular flue vaccines (lot number, dose, route and site of vaccine administration was not reported and had allergies to Penicillin and Allergies to Eggs. The patient's concomitant medications were not reported.  It was reported that after vaccination experienced to 6 days of "explosive diarrhea". Relevant diagnostic tests and laboratory data were not reported. As of 30 October 2013, the outcome of the event was not reported. Documents held by sender: none
negative for antibodies ~3 weeks after she got the vaccine; Therapy non-responder; A spontaneous report was received from a Healthcare Professional concerning a 22-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events negative for antibodies ~3 weeks after she got the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date the patient experienced event negative for antibodies ~3 weeks after she got the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, negative for antibodies ~3 weeks after she got the vaccine and therapy non- responder was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Fever with chills and headache  for atleast 4 days after 7 days of 2nd shot of Pfizer vaccine. No aches and pains or malaise or any respiratory symptoms. No immediate sideeefects at all. Negative for Covid  and all labs except inflammatory markers like C-reactive protein and ESR elevated. Tested negative for the flu also. ESR 90, C-reactive protein 6.4.
Assmnt: No visible swelling over the left outer arm. Area of presumed vaccination well below AC joint and in upper deltoid. No echymosis. There is pain approx one inch below ac joint to palpation, pain worsened with active movement of arm upward. No skin induration, no warmth. A/P: Pt is a 13 yrs. old male with myalgia s/p immunization with HPV. Greater than one week s/p immunization, history and exam raises possibility of bursitis as well. Recommend advil 400mg bid x 3-5 days, if not getting better in 3 days will refer to ortho as may benefit from intra-articular steroids vs oral steroids. Discussed with father.
(02/08/2021)(102)Fever, Bone rattling chills, aches, nausea, 3-5in of major swelling at the injection site, Tylenol for fever, light clothing, bed rest and fluids. took about 4-5 days to come to normal
Approximately 12 hours after recieving the vaccine I broke out in hives. Benadryl 25mg. Taken at that time and every 4-6 hours after.Hives lasted for 2 days.
DEATH; This spontaneous report received from a consumer (social media) via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "vaccine killed my brother". The patient died from an unknown cause of death. It was unknown if an autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death This report was serious (Death).; Sender's Comments: V0 20211031250-COVID-19 VACCINE AD26.COV2.S-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Redness and swelling at inj site 2" x 1" within 24 hrs. Resolved within 48 hrs.
24 hr after injection, started to run a temp of 102,rash on all extremities. both feet became swollen. fingernail and toenail became bright red. the next day temp 101 abd scream when touched. today 7/16 afrible. still has rash on legs and arms.
Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.
large lower extremity DVT; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 82-year-old male patient received BNT162b2 (COMIRNATY), in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "poor mobility" (unspecified if ongoing), notes: has poor mobility due to that and his age. The patient's concomitant medications were not reported.  The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "large lower extremity DVT". Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: Unclear if the vaccine caused the DVT but he had no prior history of thrombotic events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Photophobia & red, gritty & painful eyes post inject; Local rxn characterized by moderate pain & inc warmth;
Upper shoulder pain; Weakness, Feels like she has no energy; Fatigue; Epigastric pain; Pain in legs; Severe lower back pain going into hips and; A spontaneous report was received from a 56 year old  nurse who experienced severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Dec 2020, approximately 16 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient reports that she received the Moderna COVID-19 vaccine on 29 Dec 2020 at 08:00. By 24:00 that night she experienced severe lower back pain going into hips and knees. She also reported experiencing some upper shoulder pain, weakness, fatigue, epigastric pain, pain in lower back and legs, and feels like she has no energy.   Treatment for the event included paracetamol, naproxen sodium, and ibuprofen.  Action taken with mRNA-1273 in response to the event(s) was not provided.    The outcome of the events, severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy were not reported.; Reporter'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
No adverse effects; Patient received improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. Concomitant therapies  included a properly stored sterile diluent to reconstitute the vaccine.  On 26-SEP-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# R018142 and expiration date 25-JUN-2020,  for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -12.7Centigrade degrees (°C), during 36 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Shot received 9/26/2015. Patient says arm has hurt ever since, almost 5 months has trouble sleeping at night because of pain.
Upper and lower lip swelling, redness, burning and itching that started approximately 24 hours after the Moderna Bivalent Booster (Saturday Sept 24th) and worsened over the course of 3 days before I contacted my provider on Tuesday September 27th. Treatment was first applied at home and included ice packs, Lysine lip treatment, Aspirin and Benadryl 50 mg on Tuesday morning, with no improvement noted. My NP prescribed a Steroid Injection that I received on Wednesday morning Sept 28th. Symptoms gradually improved that day and this morning the 29th the swelling is gone but my lips are still tender and slightly itchy.
Moderately severe gum bleeding around each  tooth.  I drooled blood at night onto a towel.  "Signs and symptoms" gradually ended.
Weak after booster; Pain after booster; Felt  worst again after booster; Super sick again after booster; Chills after booster; Headache after booster/Headache on 27OCT2021; Body Aches after booster; Fever 102.8F after booster/Fever 102.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), ASTHENIA (Weak after booster), PAIN (Pain after booster) and PYREXIA (Fever 102.8F after booster/Fever 102.2F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 102.8F after booster/Fever 102.2F). On 03-Oct-2021, the patient experienced HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster). On 27-Oct-2021, the patient experienced FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster). On 28-Oct-2021, the patient experienced ASTHENIA (Weak after booster). On 03-Oct-2021, PYREXIA (Fever 102.8F after booster/Fever 102.2F) had resolved. On 17-Oct-2021, HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster) had resolved. On 28-Oct-2021, FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster) had resolved. At the time of the report, ASTHENIA (Weak after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 102.8f (High) Fever 102.8F for a couple of days. On 27-Oct-2021, Body temperature: 102.2f (High) Fever 102.2F.         No Concomitant product use was reported. No treatment information was provided.  The patient reported that after the third dose they had Fever of 102.8F for a couple of days and on 03-Oct-2021, they began to have a headache and Body Aches for 2 weeks. On 27-Oct-2021, the patient felt worst and super sick again with Fever of 102.2F and Chills and also developed aches, pain, and headache again. On 28-Oct-2021 they felt better but was weak but no more fever since then.   This case was linked to MOD-2021-373647, MOD-2021-373656, MOD-2021-373647 (Patient Link).
Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021 and administered on 01-Nov-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021 and administered on 01-Nov-2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021 and administered on 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021 and administered on 01-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Date the vial was placed in refrigerator was on 26-Oct-2021. Temperature excursion was not reported. The patient did not experience any adverse event. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The patient developed shingles on their back and head at an unspecified time. On 21-AUG-2013, the patient went to an Immediate Care Center. The patient saw a doctor at the center who prescribed valacyclovir hydrochloride. Pharmacist stated the patient's "condition was good". The outcome of event was unknown. Additional information has been requested.
headache; dizziness; nausea; Chills; sleepiness; This is a spontaneous report received from a contactable consumer. A 54-year-old non-pregnant female patient received BNT162B2 (BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 07Apr2021 at 07:30 (at the age of 54-year-old) as 1st dose, single dose, in left arm for COVID-19 immunization. The patient's medical history included Ehlers Danlos Syndrome, Lyme Disease, Epstein Barr Virus. Patient had allergies to penicillin. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 at 08:00, about 30 minutes after vaccination, the patient experienced dizziness, nausea, chills, sleepiness and headache. Even after 5 days, the headache and sleepiness was not resolved. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events headache and sleepiness was not resolved and outcome of all other events was unknown.  No follow-up attempts needed. No further information expected.
BODY ACHES; CHILLS; EXTREME TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced extreme tiredness. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body aches, extreme tiredness and headache was not reported. This report was non-serious.
Pain in right arm with a slight raised mass noted at injection site about the size of a dime.
Approximately 4 days after my vaccination I experienced the following symptoms: Brain fog and Memory problem - I have brought it up to my Doctor and I can't really remember what she said or advised and I was not prescribed with anything. Up to this day I still experience the same symptoms with no improvement since I got vaccinated.