chrisvoncsefalvay/vaers-outcomes huggingface dataset:
starting approx 4 hrs after FluMist administered -sneezing, scratchy throat  Starting approx 8 hrs after FluMist administered through 3 days:  mild sore throat, stuffy nose.  Day 2 mild fever (100 F) and tired.
Nausea, vomiting, diarrhea , headache,  abdominal pain, loss of feelings in toes and fingers
Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, and anatomical location were unknown) first dose with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65  °F degrees Fahrenheit  with an undefined duration in with alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30  °F degrees Fahrenheit  with an undefined duration with the no alarm report . combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA002514: US-009507513-2009USA009583: US-009507513-2009USA009587:
Patient complained of chest pain, throat pain, headache,back pain and pain in in both arms that stared 5/3/19 in the afternoon and lasted for 2-3 days after the vaccines were administered.
Gastrointestinal hemorrhage with melena - Had EGD with Eight small angioectasias with bleeding were found in the gastric body. Coagulation for hemostasis using argon plasma at 0.8 liters/minute and 30 watts was successful. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Covid 19 pcr positive on 9/10/2021. 1st dose pfizer vaccine taken on 8/4/2021. Narrative:
injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 15-Jan-2021, VACCINATION SITE PAIN (injection site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 1/20/21 the staff observed resident to be more restless constantly moving his legs.  He had a decrease in his appetite and fluid intake and required assistance for consumption.  His oxygen sats dropped to 89% on room air and was given oxygen at 2L.  On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed.  VS revealed high BP 147/101.  MD ordered transfer to hospital.  Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.
Malaise, h/a, body ache, sl cough, t99;12OCT95 fever blisters (actually began 11OCT), t101.5;14OCT same sx as 11OCT w/t101.5;able to work 15OCT & 16OCT w/fever in 99's & milder sx;
Breakthrough COVID case. Symptoms of cough and shortness of breath beginning 07/17/2022
The patient developed a fever of 102 degrees. Motrin was given and the fever resolved.  Then, a few hours later another fever developed.  Motrin was administered again. 15 minutes later the patient had a seizure that lasted less than one minute.  Then the patient was limp and unresponsive. Patient was then "moppy" for four days and experienced decreased appetite.   On 5/28/04, the patient was seen in the office with dime-sized, hard, non-tender, fibrous mass on his left deltoid, which is the site of the immunization.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients who on 04-FEB-2013 were vaccinated with doses of GARDASIL (from lot # H017698, expiry on 02-JUL-2015) or M-M-R II (from either lot# 0425AE, expiry on 27-FEB-2014 or from lot# 0367AE, expiry on 15-FEB-2014) that were exposed to an unsupported temperatured excursion. No patient specific information was provided. It was unknown if any patients received both GARDASIL and M-M-R II. No adverse effects were reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
One week and one day after receiving the Moderna vaccine my left arm, the one the vaccine was injected into, became bright red and warm to the touch. It has also become itchy on one or two occasions.  A large portion of my shoulder/arm has swollen up  over the past day and remained swollen for about 12 hours. There has also been an aching pain in my left arm pit. I have not gone into the Dr. regarding this as the symptoms appear minor and related to the vaccine.
A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her arm /rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, approximately 9 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) rash on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on her arm was unknown.
On 2/5/21, started with headache, brain fog which seem to be getting worse rather than better.  This still has continued since it's onset.  Has taken Advil.  Called her provider and they asked her to go to V-safe.   Is scheduled to receive the 2nd vaccine on Thursday, 2/18/21.
This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a adult male patient who received SHINGRIX. On 25th April 2018, the patient received SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site discomfort, joint pain, muscle pain and erythematous rash. On an unknown date, the outcome of the injection site discomfort, joint pain, muscle pain and erythematous rash were unknown. It was unknown if the reporter considered the injection site discomfort, joint pain, muscle pain and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 25th April 2018 (Wednesday afternoon), the received SHINGRIX and the next day, he experienced some discomfort at the injection site as well as muscle aches and joint pain on that same day in the evening the patient noticed what might be a rash on his chest, on both sides, on the day of reporting (in the morning), it was on his back as well. At the time of reporting the patient reported that the rash was not raised at all, it was just redness.
No adverse event; Vaccine was administer five days after the 30 day storage limit; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit).    No concomitant product was reported.  Patient received dose 1 of 0.5 ml on 09-Jan-2021 (Lot: 012L20A, intramuscularly, in right deltoid), dose 2 of 0.5 ml on 06-Feb-2021 (Lot: 031L20A, intramuscularly, in right deltoid), dose 3 of 0.25 ml on 02-Nov-2021 (Lot: 011F21A, intramuscularly, in left deltoid), dose 4 of 0.25 ml on 08-Jul-2021 (Lot: 014B22A, intramuscularly, in right deltoid).  It was unknown whether the patient had allergies to medications, food and other products. It was unknown whether the patient was tested positive for COVID-19. It was unknown whether the patient had acute illness at the time of vaccination.   No treatment information was reported.  This case contains information for the first of two patients who received booster dose on 06-Feb-2023 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708810, US-MODERNATX, INC.-MOD-2023-712471 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2023: Vaccination start date, event onset date and narrative added. On 17-Feb-2023: Follow-up received included updated reporter details, patient demographics, suspect vaccine batch number and I-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708810:Master case_08Feb2023 (one dose) US-MODERNATX, INC.-MOD-2023-712471:Case 1 of 2 patient,06Feb2023
I developed a Chronic Spontaneous Urticaria for the first time, a few days later of getting the booster shot, presenting swelling of my lips , facial area, hands and feet and hives all over my body. Several doses of steroids were administered as well as high doses of antihistamines for more than a week. Symptoms  have been controlled by taking cetirizine  10mg daily. However, symptoms becomes severe if I stop the medication for one day. I have been seen an allergist/immunologist who concludes that based on my health history and evaluation; that my  immune system was over-stimulated by the 3rd booster shot of the Moderna Covid-19 Vaccine, thus causing this chronic condition.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided.  Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2016 the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
SkinRash & Tachycardia Narrative: Seen in er 8/4/21 for rash to chest and neck itching and tingling to finger and feeling palpitations. HR normal in ed, rx medrol diphenhydramine to take at home.
Pt sts noting a slight tightness in her throat.  It has been 23 minutes since her injection at the time that it was reported.  She does not have tongue swelling, difficulty breathing, rash, itching, or any other symptoms, just a "slight throat tightness".  Her vital signs were: HR of 71, BP 126/64, RR 16, Sats 100% on room air, AOX4.  Pt declines all further treatment and evaluation.  She declines ambulance.  She declined to give PCP name and states she doesn't "want to get into all that."  She has a benadryl tablet that she can take on the way home.  She states her symptoms have not progressed and she feels "fine".  She is encouraged to  call 911 if her symptoms worsen and to follow up with her PCP.
Fatigue, severe -6 hours later Chest tightness-24 hours later  Heartburn-24 hours later Arm soreness -6-8 hours later  Back pain( upper)-12 hours later   All symptoms resolved by 72 hours
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 06/10/2022, patient recieved vaccine on 06/13/2022. Patient has not reported any adverse events or symptoms to our facility after recieving the vaccine.
Diarrhea, Vomiting, Fever 100.2 started on 1/13/2021 at 7:00 AM
Headache; Queasy; chills; This is a spontaneous report received from a non-contactable consumer (patient). A 87-year-old non-pregnant-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration in her left arm on 16Mar2021 at 2:45 PM as single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no allergies to medications, food or other products. The patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. On 17Mar2021 at 6:00 AM the patient experienced headache, queasy and chills. The patient did not receive any treatment in response to the events. At the time reporting, the patient was recovering from the events headache, queasy and chills.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient details (Patient's first/middle/last names initial captured in corresponding field, Patient's country captured as US), Historical vaccine added, Concomitant Therapy captured as Yes, Events details (treatment received) and Narrative lead sentence updated.
Pain in right arm injection site, it is painful; Injection site swelling on right arm; Injection site red on right arm; Injection site bruising on right arm; Anxious; Feel very sick; Restless; Ankles aching; Muscles aching; Felt hot, feverish but no fever; Flushed; Could not sleep; Shakiness; Body tired; Chills have resolved; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID 19 VACCINE with an associated reaction of injection site pain.   On 10-APR-2023 10:00, the patient received the 1st dose of Shingrix (right arm). On 10-APR-2023 19:00, 9 hrs after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in right arm injection site, it is painful), injection site swelling (Verbatim: Injection site swelling on right arm), injection site erythema (Verbatim: Injection site red on right arm), injection site bruising (Verbatim: Injection site bruising on right arm), anxiety (Verbatim: Anxious), sickness (Verbatim: Feel very sick), restlessness (Verbatim: Restless), pain ankle (Verbatim: Ankles aching), muscle pain (Verbatim: Muscles aching), feeling hot (Verbatim: Felt hot, feverish but no fever), flushing (Verbatim: Flushed), sleeplessness (Verbatim: Could not sleep), tremor (Verbatim: Shakiness), tiredness (Verbatim: Body tired) and chills (Verbatim: Chills have resolved). The outcome of the injection site pain, injection site swelling, injection site erythema, injection site bruising, anxiety, sickness, restlessness, pain ankle, muscle pain, feeling hot, flushing, sleeplessness, tremor and tiredness were resolving and the outcome of the chills was resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site bruising, anxiety, sickness, restlessness, pain ankle, muscle pain, feeling hot, flushing, sleeplessness, tremor, tiredness and chills to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, injection site bruising, anxiety, sickness, restlessness, pain ankle, muscle pain, feeling hot, flushing, sleeplessness, tremor, tiredness and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 The patient stated that she had her 1st Shingrix vaccine day before reporting around 10AM and around 7PM at night she felt restless, anxious and her ankles and muscles were aching. She felt hot, flushed, feverish but had no fever and stated that the pain was worst than Covid vaccines  The patient suffered from in right arm injection site redness, injection site swelling, bruising on right arm, which she was used to but stated that it was painful. The patient could not sleep had shakiness and body was tired.  The patient had not called her physician yet.  She was feeling better now and stated that chills had resolved. The reporter consented to follow up.
Chills with fever after 2nd vaccine -  3 days  Site of injection site red/swollen/painful-2 weeks Tightness/numbing in  left arm-ongoing chest pain when bending forward and shortness of breath on the 4th day-1.5 days light headed-day 4
A day or 2 after the first dose EVERYTHING I started eating/drinking had a metallic taste to it.  I can taste things still but the metallic taste overtakes most flavors/scents.  It has lasted over a month and I assumed maybe I had bad batches of the food in my house.  I have since replaced the food in my house and the metallic taste is there no matter what I eat or drink and has not dulled yet which is concerning to me.
This is one case out of a cumulative total of 14 pertussis cases received during the surveillance period from 01 January 2010 to 10 March 2011. Initial report received on 10 March 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included four doses of DAPTACEL, lot number C2799AA received on 14 March 2008, lot number C2933AB received on 15 May 2008, lot number C2934AA received on 16 July 2008 and lot number C2956AA received on 30 April 2009 (routes and site of administration not reported). On 17 February 2011, approximately 21 months after the last dose, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 March 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Amoxicillin starting on 17 February 2011 for 10 days. The subject was not hospitalized. At the time of final contact on 03 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Left arm sore; This is a spontaneous report from a contactable consumer (Patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm sore. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.