chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 34 F (1.11 Celsius Degrees) for 224 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Loose, mucousy stools began around 9pm on 1/20/10, on 1/21/10 stools were bright green in color with mucous.
Gave the Moderna Bivalent instead of the Moderna Monovalent - no adverse reaction
Patient experienced reaction at injection site. 10cm swelling, blister, headache, chills, and fever 104 degrees.
Swelling from Elbow to armpit, red, very itchy Large local reaction, bottom of arm swelled up.
pt recv vax & lt arm has been red from shoulder to elbow p/vax on 11FEB97;a knot size of a golf ball & pain when touched;pt brought to pediatrician & on keflex;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown (booster), single (Lot number: GJ3277) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "PCOS" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 21Aug2023 to 25Aug2023.
was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MESALAMINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM, Multicomplete                                                  PO OD and AlgaeCal Plus                                                  PO BID for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (was tired). Not Provided      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.   This case was linked to MOD-2021-098173 (Patient Link).
Painful lump was noted by patient. When seen by provider on 11/23/2010 she had a quarter sized area of induration and slight erythema at the site of injection
Tinnitus. I did not have tinnitus prior to the vaccine. Two days later it started and it has been more than six weeks - it's still going and not showing any signs of improvement.
Fever of 100.4, body aches for a day and a half, head ache for 2 days
feeling sick; could not eat or drink anything; could not eat or drink anything; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything). At the time of the report, VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  On 29-Feb-2021, the patient presented to the Emergency Room due to her symptoms.  No treatment was reported for the events.
her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation.  Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
The pt developed redness and tenderness at injection site treated at urgent care with Keflex.
Developed itching of trunk the same evening after receiving vaccine. Developed rash overnight--awoke the following morning with severe hives.
22MAY94 pt ran temp of 101.5 exp pain & swelling @ site of inject, had genl adenopathy & adenopathy @ inject site; also exp pain in joints; recovered p/5 days
Presented with covid symptoms, having chills, dry cough and nausea, loss of appetite.  Tested positive for Covid-19 on 7/28/2021.  IV steroids was initiated, and Lovenox.  Patient expired on 8/17/2021.
Site: Swelling at Injection Site-Severe, Additional Details: patient reported "covid arm (left arm) - swelling, itchy, hot upper arm lasted for 5 days"
very Fatigue; low fever from 99.4 to 100 /  it is off and on; Clammy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced fatigue, fever and clamminess. On an unknown date, the outcome of the fatigue, fever and clamminess were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever and clamminess to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's spouse. The patient received 1st dose of Shingrix vaccine in his right arm. The patient experienced running low fever from 99.4 to 100 degree F every day and reporter mentioned it as it was off and on. The patient being clammy and very fatigue. Till the time of reporting, the symptoms had not resolved. The reporter consented to follow-up.
Vaccine was administered 76 days after thawed from freezer.  No adverse reaction known.
Swelling pain at injection site. Fever illness that led patient to go to ER. Vaccination PPV23 given 8 yrs after previous PPV23.
pt states he developed ringing in both ears about 15 minutes after getting  2nd dose covid vax.  Pt consulted with his PCP about his condition but was not given any medication or referred to another doctor saying the it may get better over time.  Pt states he still has the Tinitus in both ears that seems to have gotten worse but may have leveled off.  He still has problems with ringing today and will discuss with his PCP again.
Patient presented to the ER with chest pain, he had stents placed to his RCA 3/2/2021
Seizure for 1-2minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (Seizure for 1-2minutes) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizure for 1-2minutes) (seriousness criterion medically significant). On 03-Oct-2021, SEIZURE (Seizure for 1-2minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  The patient had experienced seizure 5 minutes after he got his first dose of the Moderna covid19 vaccine. The patient does not have any known allergies or any history of seizure. The seizure lasted for 1 to 2 minutes.  No treatment medication details was reported.  Company Comment: This case concerns a 23 year-old, male subject whose medical history was not provided, who experienced the serious unexpected event of Seizure. The event occurred approximately 5 minutes after the first dose of mRNA-1273. The rechallenge is unknow, as the events happened immediately after the first dose of mRNA-1273 and since no information from the second dose is provided. The benefit-risk relationship of drug x in not affected by this report.; Sender's Comments: This case concerns a 23 year-old, male subject whose medical history was not provided, who experienced the serious unexpected event of Seizure. The event occurred approximately 5 minutes after the first dose of mRNA-1273. The rechallenge is unknow, as the events happened immediately after the first dose of mRNA-1273 and since no information from the second dose is provided. The benefit-risk relationship of drug x in not affected by this report.
This spontaneous report was received from a medical assistant and refers to an 80 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
numbness of face; tingling of face; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of face), PARAESTHESIA (tingling of face) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and MELOXICAM for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (numbness of face), PARAESTHESIA (tingling of face) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA (numbness of face), PARAESTHESIA (tingling of face) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
He received anthrax #2 on 24 Jan '03 and #3 on 8 Feb '03. No other vaccines were given simultaneously. He does not recall similar immediate adverse events after these doses. However, he does recall developing new onset headaches during the 4 week period when he received these vaccines. He states he sought treatment several times at the clinic and "lived on ibuprofen". He continues to work even though the headaches were severe and occurred daily for the next year. They interfered with sleep and were "the worse pain I ever experienced." Although there are no medical records for review from this time period there are documented ibuprofen and oxycodone prescriptions from 27 Mar '03. The patient received anthrax #4 on 26 July '04. He doesn't recall any increase in headaches with this dose but he was taking NAPROXYN prescribed on 24 July '04 for continued head and neck pain. He has had for headache prophylaxis which was ineffective. He does recall that the anthrax vaccination he received on 10 Sep '09 triggered worsening headaches for 4-5 weeks, beginning on the day he received the shot.
vision changes in her left eye/ vision changes in the right eye; spider web in the field of vision; This case was reported by a other health professional via call center representative and described the occurrence of visual disturbance in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix. On 2nd March 2020, 1 days after receiving Shingrix, the patient experienced visual disturbance and eye floaters. On an unknown date, the outcome of the visual disturbance was not recovered/not resolved and the outcome of the eye floaters was unknown.   It was unknown if the reporter considered the visual disturbance and eye floaters to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and the patient had vision changes in her left eye on next day 2nd March 2020 where the patient saw a spider web in the field of vision.  These vision changed in the left eye were still ongoing at the time of reporting. It was reported that the patient recently developed vision changes in the right eye where the patient saw a spider web in her field of vision and this was still ongoing at the time of reporting. The reporter did not consent to follow-up.
Patient went to the doctor on 5/11/21 due to adverse reaction to vaccine .The patient had a swollen arm (lump) for two weeks after vaccine. The area was hot, hard, and red. She experienced a fever, chills, and body ache for three days. Her bloodwork showed a 2.7 titer of antibodies therefore Doctor is suggesting not to take second dose of vaccine.
Expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        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.   No concomitant medications were reported. No treatment medications were provided.
fever; numbness in fingertips; soreness at injection site; induration at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced numbness in fingers. On 19th September 2019, the patient experienced injection site pain and injection site induration. On 20th September 2019, the patient experienced fever. On an unknown date, the outcome of the injection site pain, injection site induration, fever and numbness in fingers were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site induration, fever and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: Twenty four hours after receiving the vaccine, the patient developed a fever of 101 degree F.  Approximately 36 hours after receiving the vaccine, she developed numbness in the fingertips on her left hand that lasted for a few hours before resolving. In September 2019, soreness at the injection site resolved after lasting for 4 days and induration at the injection site resolved after lasting for 5 days. The reporter did not consent to follow up. The caller did not provide any additional information. There is discrepancy between the outcome reported in the structured field of database (recovered) and the outcome reported in the source document (recovered with sequel).
Initial unsolicited report received from a consumer on 28-Dec-2017. This case involves an 80-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE in right deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, 3 weeks following the vaccination, the patient developed injection site reaction, developed a scab that was elevated. Initial size was 1.5cm, each time the scab falls off, the site is smaller, and currently it is 3mm. There was also redness at the site. Initially the reaction became larger and larger, then became smaller and has not yet healed. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was not recovered from events. List of documents held by sender: none.
Pt received a  Moderna  covid 19 vaccine and started having numbness and tingling in her lips, mouth ,gums ,throat with rapid heart rate vital signs assessed Pt  given .3mg epinephrine IM  via epi pen in left vastus lateralis and 50 mg Benadryl IM in right deltoid .EMS called. Pt's vital signs reassessed ,Pt now asymptomatic .EMS arrived  and transport to Local emergency room  via ambulance for further evaluation .
Swollen lymph node near right clavicle appeared 3 days after vaccination. Slowly reduced to normal size after 2 weeks.
High fever, malaise, unresponsive, loss of speech and motor coordination. Fever-1wk off and on. Malaise-1wk. Unresponsiveness-~2wks. Loss of speech-~12 mos. taking speech therapy now. Motor coordination-~6 mos. Diagnosed mild autistic. Patient is exhibiting diminished mental capacity and has been diagnosed as austistic. However, her physical capabilities have returned to normal.  Annual follow up on 12/16/03: "Vaccine recipient has not recovered from the adverse events that was provided for this vaccination.  A lowered function of mental faculties.  Due to the above, pt has been deemed as disabled by the social security board."