chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Appendicitis; administration date 25May2021, dose 1/administration date 06Sep2021, dose 2; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 06Sep2021 14:00 (Lot number was not reported) (at the age of 17-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Concomitant medications within two weeks of vaccination included desvenlafaxine succinate monohydrate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 25May2021 9:00 (at the age of 16-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced appendicitis on 17Sep2021 17:00. The patient was hospitalized for appendicitis on an unspecified date in 2021 for 2 days. The appendicitis resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient underwent appendectomy as treatment for appendicitis. The outcome of the event appendicitis was recovering.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Immediate reactions were slight fuzziness of vision lasting approximately 30 minutes and body fatigue throughout the day (12/22/2020). At 2:30am I suffered from diarrhea and nausea lasting approximately 2 hours. I  woke up at 9:00 am (12/23/2020) with a lowgrade fever of 99.0F.
Informed patient's mom about the improper storage of the Pfizer vaccine and that revaccination is not required. Mom will decide at a later date if she wishes to revaccinate patient.
2 days following the vaccine, I felt like my heart was skipping a beat and it felt like irregular heartbeat but wasn't at the time and only intermittent.
Large area approximately 10 cm on left leg with redness, warmth and swelling. Patient came in for doctor visit to check area. May be related to an arachnoid bite instead of vaccines most likely caused by site according to MD.
4/30/2020 started with fever. 5/1/20  fever up to 102, rash on abdomen and face.  Tele-health appt. 5/1/20 mild spread rash on trunk mostly, not itchy. Approximately 1 dozen vesiculation lesions, Temp 100. 5/4/20 rash drier and fading.  5/7/20 rash now gone, no fever.
Chills, too much dizziness that I can hardly get up, nausea, fatigue
This spontaneous report as received from a nurse refers to a patient of unknown age. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K003422, 06-MSAR-2016. No symptoms were reported. Additional information has been requested.
I tested postive for Covid-19 on 9/19/21. My symptoms included low grade fever, chills, body aches, congestion, and loss of smell. I continue to have loss of smell but all other covid symptoms abated around 9/22.  I am on enoxaparin injections daily to reduce risk of blood clots.   Related to the pregnancy:  On 9/21/21, my blood pressure spiked and I was admitted to the hospital to be induced. I was diagnosed with severe pre-eclampsia. My baby was born at 37+4 weeks gestation was 7 lbs 1oz. I was re-admitted to the hospital 9/26/21 due to continuing/worsening symptoms of pre-eclampsia including severe high blood pressure and elevated liver enzymes.
Within 45 minutes of the vaccine, I started getting a sore throat that was raw feeling. It would come and go. I feel like the vaccine exacerbated my allergy symptoms. I was sick for 2 weeks. I just wanted to sleep. I was very fatigued. I did a telehealth visit and was prescribed Singular. The Singular made me feel more sleepy and fatigued.
p/vax pt exp swelling in lt arm from shoulder to elbow;arm was red from swelling;glands in both arm pits groin & neck began swelling;gland in lt armpit extremely painful;arm began to scale;
Numbness of face-both sides including lips and cheeks. Squeezing of left temple in the head. Body weakness. Went to doctor-had blood work.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid for the adverse events. Patient had no known allergies. Patient did not receive any other medications within 2 weeks to the COVID vaccine  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
injection site redness; arm is red, spreading down arm; arm is hot, spreading down arm; SWELLING IN ARM; ARM DISCOLOURATION; TROBBING IN arm; FLU-LIKE SYMPTOMS; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient called back, to report adverse reactions to the 1st dose of Shingrix but she got into an accident during the call and had to disconnect the call. The patient received dose of shingrix vaccine into unknown arm and experienced her arm was red and hot and the redness seems to be spreading down. Later in the evening/the next day she experienced swelling in arm, redness at injection site, arm discolouration, trobbing in arm, flu-like symptoms and fever. The patient stated that the symptoms were still ongoing. The patient would like to know if she should still get the 2nd dose. The reporter did not consent to follow-up. Additional supportive Information: Since it was not specified, events were at injected arm or not, coded injection site redness and arm redness separately. Since patient had arm related events, car accident (probably consequence) was not coded as event.
Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
swollen heart; Colitis; stomach problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "swollen heart"; COLITIS (non-serious), outcome "unknown", described as "Colitis"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach problem".  Additional information: Caller stated that she was in line the other day at the grocery store and there was an elderly gentleman in front of her that was telling the cashier that he was going to get his 2nd booster of the Covid vaccine. Caller states that she chimed in the conversation, and he told her that he also had stomach problems which he said was a form of colitis, and he also got a swollen heart after receiving the vaccine. Caller has no further information for this patient. No Lot/Expiry date to provide. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Agency called the morning of 08/03/21 and spoke to Representative on the medical team at Pfizer who gave the same information. Representative was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline. No adverse events have been reported by patient.
Approxametly 12 hours after receiving the vaccine I had feelings of nausea, headache, left arm pain and general malaise.  This lasted about 2 hours and then subsided.  For the last week, I've had off and on headaches and feelings of tiredness.  I've also had soreness in left arm at the injection site.  Yesterday, 1/5/2021 I noticed increased redness, warmth and a raised area at the injection site.  It's hard and a little itchy.  I've also had soreness in my neck and arm pitt.  I have reached out to employee health through the hospital that i work at and whom i recieved that vaccine from in regards to my symptoms.  The only invervention I've taken has been taking tylenol for a headache.
This spontaneous report as received from the patient father refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On 14-AUG-2012 the patient was vaccinated with the first dose of GARDASIL. The second dose was received on 15-OCT-2012 and the third on 07-DEC-2012. No concomitant medication was reported. The healthcare professional involved wanted to give a fourth dose of the vaccine. No adverse reactions were reported. No outcome was reported. Additional information has been requested.
Patient received Moderna dose 2 when patient should have received Pfizer dose 2. Patient was monitored to 30 mins with no adverse reactions.
pt notes that a day after receiving the Moderna vaccine he started having body aches, fever, fatigue, and headaches
given 7/20/2019 @ pharmacy had fever that evening, red hard arm @ injection site. sunday 7/21/2019 developed a blister on arm today blisters on hands
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from product quality group. A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 42 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Over Weight" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL taken for blood cholesterol increased, overweight. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome unknown, COVID-19 (medically significant) with onset 29Apr2022, outcome not recovered and all described as "he had three Pfizer vaccine (COVID Vaccine) and then he tested positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: he had three Pfizer vaccine (COVID Vaccine) and then he tested positive and then less than 12 hours had the Paxlovid; (04May2022) Negative; (05May2022) Negative; (06May2022) Negative; (07May2022) Negative; (08May2022) Negative; (09May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: It was reported that, he was started taking Paxlovid on 29Apr2022 at 10 am. He took at 29th to 30th the first the second and one two three four he stopped the last dose was night of 03May (03May2022). The reporter stated, "he started it and then finished his 5 day treatment. On day 5 he was feeling better he tested negative he didn't had any symptom but because he was in high risk they had him to stayed in isolation until today and he was tested for the past 5 days and then negative with no symptoms. Then later before he took his mask off around him and his children because they were high risk he tested one more time and he was positive and then within 30-45 minutes later all the symptoms came back. He had 100 degree fever, drainage came back, cough came back his oxygen levels went to 96 and so everything came back he had negative for 5 days and then later it was positive with all the symptoms which were all gone they all came back. So, he had the Pfizer Vaccine (COVID Vaccine) he had the booster (COVID Vaccine) so he had three Pfizer vaccine (COVID Vaccine) and then he tested positive and then less than 12 hours had the Paxlovid and did 5 days and then was symptom free and negative on rapid test and later was day 11 and he positive and symptoms back. He was not around anyone, he hadn't left house, he slept in the quarantine room. It was reported that, he was given 30 pills to take for 5 days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient called after receiving vaccine, stated he lost hearing in his left ear.  Prescribed predisone taper, referral made to ENT, and performed tympanic and hearing exam.
I started running a  low grade fever immediately after vaccination. Severe head aches and gastro symptoms started 2 weeks later. I still currently have a low grade fever.   I treated with OTC medications.
Very tired, aches, fever of 101 degrees F for 24 hours.  In 48 hours all symptoms were gone.
I now have a severe rash and muscle aches and I have been diagnosed with  Dermatomyositis/ Lupus. I never had this in my life until shortly after the Covid vaccine.
1. within 20 minutes my vision became blurry and that lasted about 5 minutes and stopped,  2. 36 hours after the shot all my joints became very sore and it was very painful to touch my right arm far below the shot site along with pain in the right hand (shot arm) these were gone within 12 hours after they started.    2. Two weeks later on 3/20/2021 I had a scheduled blood draw results: PTH Intact 151 pg/mL 18 - 84 HIGH, BUN 34 mg/dL 7 - 31 HIGH   Creatinine 1.72 mg/dL 0.50 - 1.40 HIGH   eGFR non-African Am 29 mL/Min/1.73M2 Greater Than60 LOW    There were higher than any other blood work done prior to the shot, last was 9/2020
Patient currently inpatient admission at (4) days. Acute hypoxemic respiratory failure due to COVID pneumonia: Symptom onset 11/17, started with sinus congestion. She was found to be COVID positive 11/19. She started having fevers 11/24. o Trend appropriate labs daily o Prone patient TID for 1 hour if they can tolerate o Dexamethasone for 10 day course o Continuous pulse oximetry. Goal SpO2 >92%.   Dehydration:  Likely due to poor PO intake o LR at 100 mL an hour o Hold home HCTZ   Anxiety/depression Seasonal allergic rhinitis Morbidity obesity HTN Asthma GERD o Continue essential home medications unless otherwise stated above o     VTE Prophylaxis:   This patient is high risk per the VTE risk assessment tool, pharmacologic prophylaxis is indicated. Lovenox has been ordered.    Diet: General Code Status: Full     HPI    CHIEF COMPLAINT: SHORTNESS OF BREATH (Covid + 11/19 worsening cough the last 3 days. persistent dry cough was found hypoxic when fire arrived. patient reports 86% on home pulse ox. chest pain with movement and cough. )    HISTORY OF PRESENT ILLNESS: Patient is a 50 y.o. female with a pertinent past medical history for anxiety, depression, asthma, HTN, GERD who presented to the ED primarily with shortness of breath.  She denies a history of tobacco or alcohol abuse.  She states that she started having symptoms of 11/17 with congestion similar to previous episodes of sinusitis, she was found to be positive 11/19, she started having fevers 11/24, last few days she has been dealing with increased cough and shortness of breath. She has also been having chest pains with cough, mostly dry cough.  In the emergency department she desatted to 81% on room air, with improvement in saturations with 2 L of oxygen.  Her blood pressure was soft in the emergency department and she received 1 L of IV fluids with improvement in her blood pressure.  She was given Decadron 6 mg IV. Chest x-ray showed ?prominent diffuse airspace disease consistent with COVID pneumonia.?
brother and sister took the Pfizer Vaccine shot and are both dead now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). This case refers to reporters sister.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "brother and sister took the Pfizer Vaccine shot and are both dead now". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036809 Same drug, same event, different patient;; Reported Cause(s) of Death: brother and sister took the Pfizer Vaccine shot and are both dead now
Headache, Myalgia, fatigue, chills, burning eyes, nasal congestion Narrative:
No adverse event; Received expired Moderna Covid-19 vaccine for his second Primary Series dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.).    No concomitant medications was provided.  The vial size was 5.5ml. The vial did not undergo any temperature excursions. It was reported that, no other adverse reactions reported after the first dose and second dose. Reporter does not know the date the vial was initially stored in the refrigerator as it came from the County Jails supply. Expiration date of the second dose vaccine was on 07 Apr 2022.  No treatment medications was provided.
Fever ranging from 101-104 beginning on ninth day after vaccine and lasting 5 days.  Tylenol given to reduce fever.
Pt came to ER c/o severe abdominal pain  for several days after receiving Moderna vaccination.  Pt given pain medication and d/c home.
Patient presented with chest pain that was exertional and intermittent - The workup revealed STEMI and the patient was given 180mg Brilinta and transferred to facility. He underwent LHC and balloon pump was placed. LHC revealed severe LM with multivessel CAD. CT Surgery was consulted for CABG. Balloon pump was removed 11/26/21 per cardiology. After brilinta washout, on November 30 the patient underwent CABG.
devel rash & fever 106 r; fever remained for at least 48 hrs but was brought down w/antipyretics;
Was given a Tdap booster to immunize against tetanus after a deep knee wound/running accident. I immediately had a sore arm, muscle spasms and aches and felt sick. I got my period the next day approximately 5 days earlier than normal.
Severe generalized hives everyday since 2/18. Have had to see allergist and dermatologist.
Tested positive for COVID-19 virus; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19 virus) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus). At the time of the report, COVID-19 (Tested positive for COVID-19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, COVID-19: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to safety for Follow-up.
Pt had Her Johnson and Johnson COVID shot on April 1.  three days after this have coughing,  and this was followed by  a steady decline in her mental status and functioning.   She was walking , talking , feeding self prior to time she go the shot. She could shortly not do any of these.