chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stated that she is as sick as a dog; Fever; Chills; Nauseated; body aches; stated that she cannot get warm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 at 05:00 PM as an unspecified dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that she got Pfizer COVID vaccine yesterday. Stated that she is as sick as a dog. Stated has fever, chills, nauseated and body aches. Stated that she cannot get warm and has blankets all around. on an unspecified date in Jan2021. Wanted to know what to do. Stated that they let her get the vaccine early because she has a bad heart. Stated that she is only 65. Stated that she got it at 5:00PM. The outcome of the events was reported as unknown.  Information on Lot/Batch has been requested.
Nausea and shivers for 2 days starting day of vaccination. Redness, swelling, hives, fatigue, headache starting the next morning then rash covering most of the torso the next day lasting for 4+ days.
12/05/20 Nausea, headache, fever--- next day 12/06/20 diarrhea, shivering, dizziness, rapid heart beat, arm soreness/pain. 12/07/20 relief from all symptoms
Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Additional information: Concern, consumer stated, I get the vaccine yesterday, the  (Comirnaty) and I feel dizzy, is that because of it, I read this is some of the side effects."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I was diagnosed with Covid on 09Nov2022; I was diagnosed with Covid on 09Nov2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0187), on 22Jul2021 as dose 2, single (Lot number: EW0187) and on 09Feb2022 as dose 3 (booster), single (Lot number: 084J21A) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar II disorder" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL, start date: 27Sep2021; LAMOTRIGINE, start date: 12Apr2021; LEVOTHYROXINE, start date: 12Jul2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022, outcome "unknown" and all described as "I was diagnosed with Covid on 09Nov2022". The event "i was diagnosed with covid on 09nov2022" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (14Sep2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
pt recvd vax on 10oct94; w/in 12 hrs arm became edematous & deep purple in color from inject site to below the elbow; lasted approx 1 wk accompanied by myalgia of arm;
tested positive twice using the Covid home test kits; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive twice using the Covid home test kits) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Cardiovascular disorder. Concurrent medical conditions included Type 2 diabetes mellitus and Allergic reaction to drug (name of drug is not reported).   On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 11-May-2022, the patient experienced COVID-19 (tested positive twice using the Covid home test kits). At the time of the report, COVID-19 (tested positive twice using the Covid home test kits) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive twice. On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for 4 consecutive days.         No concomitant medication were provided  Patient tested negative for 4 consecutive days with  COVID home test kits. Patient had very slight symptoms at night and early morning a bit of mucus and slight cough.  No Treatment medication were provided  Company comment- This spontaneous case concerns a 63-year-old male patient with relevant medical history of Type 2 Diabetes and Cardiovascular disease, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 3 weeks after receiving a fourth dose of mRNA-1273 Vaccine.  After completing the Paxlovid regimen, the patient tested negative for 4 consecutive days with Covid home test kits. Since then, he has tested positive twice using the Covid home test kits.  He had very slight symptoms, at night or early morning, with a bit of mucous and slight cough. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old male patient with relevant medical history of Type 2 Diabetes and Cardiovascular disease, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 3 weeks after receiving a fourth dose of mRNA-1273 Vaccine.  After completing the Paxlovid regimen, the patient tested negative for 4 consecutive days with Covid home test kits. Since then, he has tested positive twice using the Covid home test kits.  He had very slight symptoms, at night or early morning, with a bit of mucous and slight cough. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Loss of appetite; Short of breath; Little tired; Shivering; Body aches; Balance problems; Didn't feel good; Feeling of fogginess; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), FEELING ABNORMAL (Feeling of fogginess), DECREASED APPETITE (Loss of appetite), BALANCE DISORDER (Balance problems) and DYSPNOEA (Short of breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 22-Aug-2020. Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (Didn't feel good), FEELING ABNORMAL (Feeling of fogginess), BALANCE DISORDER (Balance problems), CHILLS (Shivering) and PAIN (Body aches). On 06-Feb-2021, the patient experienced FATIGUE (Little tired). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and DYSPNOEA (Short of breath). At the time of the report, MALAISE (Didn't feel good), FEELING ABNORMAL (Feeling of fogginess), DECREASED APPETITE (Loss of appetite), BALANCE DISORDER (Balance problems), CHILLS (Shivering) and PAIN (Body aches) was resolving and DYSPNOEA (Short of breath) and FATIGUE (Little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was reported.
A little over a week after receiving Moderna booster, I developed dermatographia. 6 months later, this has not resolved.
Moderna vaccine administered to individual under age 18. No adverse signs/symptoms to report. Patient will be over 18 years of age for 2nd dose.
DOS/12/18. Rash, joint pain and swelling, color change, erythema. Tx: Methylprednisolone; ZANTAC.
Pt while standing at Counter with mother and sister for discharge paper, fainted and hurt his mouth and head with edge of the door frame. LOC (few second). According to mother pt had twisting of hands no eye rolling, no drooling. Pt was pale, blood in mouth.
blistering rash all over stomach and below ribs all the way to the back of the patient. patient went to PCP and PCP prescribed an rx itching cream and benadrl. pt says the medication helped, but still not resolved. pcp said for pt to go to ER if the rash gets worse or if experiences any breathing problems or etc.
Patient developed chills, fever 24 hours after administration. Patient went to the doctor 72 hour after administration and had a diagnosis of cellulitis - Pt received IV antibiotics for 2 consecutives.
Patient was accidentally given a Hiberix in addition to a Pentacel during the same visit.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Shortness of breath, itching about 20 minutes after flu shot. Patient has asthma and used inhaler which helped. Blood pressure and pulse were normal (120/80 and 77bpm), but paramedics took to hospital just in case.
PATIENT COMPLAINED OF FEELING A LITTLE OFF.  PATIENT DRANK WATER . OBSERVED.
pt recv vax & 10 to 14 days p/vax pt devel chicken pox like pustules & 1 red spot on abd;no further details were provided;
Chronic Urticaria (flat, itchy red patches that last about one hour and then appear in a different location on the body) developed two weeks after vaccine dose #4 and lasted three months. Treated with high doses of antihistamines Urticaria also developed two weeks  after vaccine dose #5 - Moderna Bivalent; urticaria ongoing for four days at time of report and still unresolved. Dose 5 was administered on 11/12/22 and urticaria developed on 11/25/22; symptoms similar to those reported after dose 4.
"high fever, muscle aches everywhere, joint pains, numbness in arms. weak in left arm" by history. Examined on 1/15/2010: Afebrile. Neuro exam normal. No joint swelling. Still has subjective dysesthesias.
Headache, Myalgia,  chills, arm soreness, right axilla had a lump Narrative: States her headache has been the most intense, has been afebrile. Right axilla became swollen with a lump. Taking Tylenol and Benadryl OTC.
This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 07 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
20 minutes after vaccination pat left arm started itching, nothing around injection site. Pt didn't have any other adverse reaction. Pt left clinic after 40 minutes.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 21-JAN-2016 the patient was administered with a dose of improperly stored GARDASIL 9 (lot # L004014 and expiration date 04-MAR-2016, dose, dose # and route not reported). No adverse effects reported. This is one of several reports received from the same source, Additional information it not expected since there was no consent for follow up contact.
jolt in the arm when the injection was done; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (jolt in the arm when the injection was done) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-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 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (jolt in the arm when the injection was done). At the time of the report, VACCINATION SITE PAIN (jolt in the arm when the injection was done) outcome was unknown.            Half an hour later, her arm started to hurt more than ever. It hurt so bad that she had tears in her eyes and she couldn't even lift her arm. She states "I was in a terrible amount of pain."  Concomitant medications were not reported. Treatment details not provided
Next morning after receiving Pneumococcal - had swelling in affected arm pit and a "red line" moving across deltoid. Pt was seen by a MD and placed on PO Atox. Pt states that she is back to normal now. This is all from pt's recollection of events.
After administration and counseling when the patient went to stand up to get out of the room, about 2-3 minutes after injection, she felt lightheaded and dizzy. She sat back down and started visibly shaking. She was not having any breathing distress or closure of passage ways. Her blood pressure was 140/89 and HR was 88. She stayed sitting with her feet up on another chair and we had an epi-pen ready to administer. I offered to call EMS, but she was hesitant as she wasn't experience her normal allergic reaction symptoms. We got her some water and Benadryl. After about 10 minutes the shaking had stopped and she only felt a little bit of lightheadedness. Her BP was down to 118/78 and HR was 66. At that point she was able to stand and start making her way home with her husband. They bought some Benadryl on the way out and were counseled that if she started to develop any further symptoms to alert EMS.
This retrospective pregnancy case was reported in a literature article and described the occurrence of a stillbirth in a 27-year-old female subject who was vaccinated with DTPa (with small D & P), manufacturer unspecified. On an unspecified date, the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at just between the 1st and the 2nd trimester (46 days prior 22 weeks of gestation). 46 days after vaccination with DTPa (with small D & P), the subject experienced stillbirth without other pregnancy complications. No congenital anomaly was reported. The subject was hospitalised.
One week after vaccination started feeling feverish and achy, was around somebody with COVID-19. Took a Home COVID-19 test and it was positive. Decided not to take Paxlovid.
Patient had just received covid vaccine.  She was still seated in immunization room and said she felt dizzy and then passed out.  She then started having a seizure a few seconds later.  She seized for about 2 minutes.  Patient was breathing but unconscious.
outbreak of genital herpes/second outbreak of genital herpes; injection site reaction on her right arm. It was sore; injection site reaction on her right arm,. It was sore and itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes. Concomitant products included valaciclovir hydrochloride (Valacyclovir) and ethanol (Alcohol).   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site itching. On 17th October 2020, the patient experienced genital herpes. On an unknown date, the outcome of the injection site pain and injection site itching were recovered/resolved and the outcome of the genital herpes was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching and genital herpes to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site reaction on her right arm, it was sore and itching and had resolved.  On 17th October 2020, the patient had an outbreak of genital herpes.  The first outbreak of genital herpes resolved but on 26th October 2020 second outbreak occurred and was not resolved. The reporter did not consent to follow up.
Severe joint pain in hand and feet - arthritic, painful swelling at base of big toes, tops of feet and finger joints
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Rash on the arm; This case was reported by a nurse via sales rep and described the occurrence of rash in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 4 days after receiving Bexsero, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix on an unknown arm. Four to five days after vaccination, the patient experienced a rash on the arm, not in the area of the injection, but same arm. The event was resolved without treatment. The reporter did not agree to follow up.
No adverse events other than the FLUZONE that was given expired 6/22/2014.
Headache, Arthralgia, Fever,  chills, weakness, injection arm pain  Narrative:   Other Relevant History:
covid arm which is severe after effect; 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 PAIN IN EXTREMITY (covid arm which is severe after effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN IN EXTREMITY (covid arm which is severe after effect). At the time of the report, PAIN IN EXTREMITY (covid arm which is severe after effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Tingling and numbness in lips, discomfort in throat, dizziness. No treatment.  Tingling, numbness, and dizziness subsided within 35 minutes of the vaccine.  Discomfort in throat still constant over 9 hours later.
Significant hearing loss and tinnitus in right ear.  Treated with prednisone and acyclovir once diagnosed on 5/25/21.  Hearing has improved considerably, but is still reduced in right ear.
Much information is stated from patient and what was presented to pharmacist who administered the vaccination. Patient said they had gone to dermatologist on 11/07/2016 having fever and dermatologist diagnosed as cellulitis in right lower leg. Dermatologist told patient after counseling that could come from contaminated vial or technique. Patient stated that they visited the hospital. Patient showed injection site to pharmacist and no swelling or redness detected. Patient said had mild inflammation after injection. Upon visual inspection none noticed. Patient then saw dermatologist on 11/7/2016 for treatment and obtained 3 prescription medications which were filled at same location. Patient stated developed allergic reaction from one medication and contacted prescriber and was changed to another antibiotic on 11/08/2016.
1st dose Pfizer given 4/6/21, patient received Moderna for 2nd dose on 5/3/21
Pt. states that after receiving the 3rd Booster of Moderna 11/01/2021, started experiencing symptoms of fever (101.3), chills, and fatigue. No noted Primary visit /communications. Symptoms have subsided 11/03/2021.