chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in ears, low fever, nausea, bad headache, achy, tired
breathing problems; sweating; chills; feeling very exhausted; This is a spontaneous report received from a contactable consumer (patient). A 92-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unknown date in Mar2021 at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced breathing problems, sweating, chills and is feeling very exhausted. The events were considered as non-serious. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
The patient received the first dose of RabAvert three weeks ago and coming back on 08-May; Case reference number US-BN-2023-000791 is a spontaneous case report initially received from a physician (reference number: USBAV23-0606) on 03-May-2023 and concerns an adult female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as three weeks ago, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose, route or site of administration, for pre-exposure to rabies (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, that was a problem of pharmacies giving vaccines (*spacing of administration being stage of medication process where the error occurred*) and that the patient would have come back on 08-May-2023 for the second dose.  *Initial dose was administered in a pharmacy prior to patient's coming to travel medicine clinic for evaluation. It was also reported that there was human factor contributing as the patient was not informed by pharmacy that additional doses were needed. The patient went to pharmacy prior to her scheduled visit and requested a number of vaccines many of which were not needed for relocation (Yellow fever, MCV ), as reported.*  *As also reported, the patient did not experienced any adverse event due to RabAvert vaccination and was doing fine.*  Additional information received from Bavarian Nordic on 04-May-2023 included the local case ID.  All follow-up information is blended into the case narrative above, with the latest information pre-sented between asterisks (*).  Follow-up information received from a physician on 26-May-2023: New information included confirmation that the patient did not experience any adverse event due to RabAvert vaccination and additional information regarding error made.; Reporter's Comments: An adult female patient was vaccinated with the second dose of RabAvert approximately three weeks after the first dose for pre-exposure to rabies, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events associated to vaccination. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An adult female patient was vaccinated with the second dose of RabAvert approximately three weeks after the first dose for pre-exposure to rabies, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Breakthrough case admission after 3rd vaccine 3/8/21 Moderna Lot# 040A21a 4/5/21 Moderna Lot# 026B21A 11/8/21 Moderna Lot # 058F21A
sleeping all day; feeling very cold; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever). At the time of the report, SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.
6 hours after injection felt extreme muscle soreness and inflammation of left deltoid that lasted for 36 hours.  Approximately 6 days after injection however, injection site felt itchy, became hot to touch, red inflamed area approximately 3x3 inches located on left arm.  Currently marked area to track if inflammation grows.
Itchy, red rash areas all over back and small area on right side of face--currently taking LYRICA, hydroxyzine, gabapentin and valacyclovir.
Patient came in for Pfizer booster vaccine (age 5-11), but unfortunately received the monovalent instead. Nurse made office manager aware and manager spoke to mom in regard to incident. Patient was monitored for an additional 15 minutes for a total of 30 minutes and discharge home in a stable condition. Follow up call was placed on 12/30/22 at 11:30 AM by RN, CPN and mom states patient is doing well at this time and mom has no concerns. Patient was provided with an appointment for the Pfizer booster Bivalent after two months.
I had severe fatigue. Later on came some upper respitory symptoms. I had sinus congestion, headache and a fever-- 101.2. I had GI symptoms but that may have been from the pacslovid.
The next day I had swelling at injection site, and aches and pains . Yesterday I woke up with hives on both arms between elbows and wrists and legs above the knees.  I haven't eaten anything or been anywhere or changed soaps or detergents.
Pharmacist did not discuss prior vaccine reaction reported on my form; or check on me after vaccine, just told me to wait 15 minutes. I did not realize what was happening was an allergic reaction: Headache within 3 minutes - lasted about 10 days; severe violent stomach pains (not menstrual or intestinal) became manageable after 3-4 days but still present; tightness in chest, difficulty breathing - still experiencing sensitivity to chemicals or strong scents, & getting winded after simple activities; immediate exhaustion; intense nausea occurred when drinking or eating (even water) - still experiencing waves of nausea; cystic facial pimples in unusual locations began within 3 hours , continued for next 3-5 days; severe joint pain all over, particularly left side of neck began with 24 hours - still experiencing aches at specific locations; Sleeplessness began that night, lasted about 10 days; tiredness began around 24 hours later; pain in arm radiating, not at injection site - began within 6 hours lasted a few days; loss of appetite began that day;  digestion significantly and noticeably slowed began within 48 hours - still experiencing; itchy scalp began within 48-72 hours - still happening
Pt states she experienced severe pain and stiffness in her arm and up her neck on the left side. It was so bad she saw her MD who said her lymph nodes were swollen. It has nearly resolved now, pain far less
I got COVID-19 on January 23, 2023. My first symptoms were up in my nose my sinuses and a tingling in the back of my throat. It was all very sudden that was in the afternoon. My wife was positive two days before I did. When increased drainage appeared it was after I tested on day 3. I was developing fatigue and increase sinus pressure and achiness. I began treatment with Paxlovid after calling my PCP. I began it that afternoon, within the week of taking it the sinus symptoms cleared up, but the fatigue did not let up. I finished the medication and %5days later I started developing more sinus symptoms and intensified fatigue. I tested positive again on January 30th. I was very low in energy again, I called again to my PCP and they suggested just that I did Isolation for 5 Days and tested after and I was negative. I got out and soon after developed a sinus infection. I had discolored mucus, pressure in my face, a lot drainage fatigue and congestion. I was given some medications to treat the infection and pain. I also with diagnosed with a upper respiratory virus. I was having tightness in my chest and a lot of coughing. This was for about two weeks, I think. I fell better now. I still have problems with low energy, but that could be due to my reoccurrence of prostate cancer.
Muscle soreness Joint pain Fever Vomiting Diarrhea  Pain at injection site
she had felt she had more local reactions with Flublok and more each year she's received it; Initial information was received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced she had felt she had more local reactions with flublok and more each year she's received it after receiving influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrivalent recombinant vaccine (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(Immunization). The information on batch number was requested.  On an unknown date the patient developed a non-serious event of she had felt she had more local reactions with flublok and more each year she's received it (local reaction) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok) was not applicable.  It was not reported if the patient received a corrective treatment for the event (she had felt she had more local reactions with Flublok and more each year she's received it).  At time of reporting, the outcome was Unknown for the event she had felt she had more local reactions with flublok and more each year she's received it.
Fever, fatigue, congestion, headache, chills, body aches. Tested at home for 2 days to recover.  Slowly recovering.
Patient received Pfizer vaccine in 8/2021. In 9/2021 she began to have some vague complaints of upper back pain. Patient ultimately diagnosed with epitheliod sarcoma. Parents requested that this information be sent to VAERS in case her cancer was related to Vaccine. Physicians caring for the child do not feel her death or her cancer was related to the covid vaccine. Presented to the local Medical Center on 10/30/21 after having received care closer to home. Pt is a 13 y.o. female with no past medical history who presents with fever, chest pain, and diarrhea. About two weeks PTA, she began complaining of sternal chest pain. She had fatigue and sore throat so was taken to an urgent care where she was negative for strep, flu, and COVID. She was prescribed bromfed. She then progressed to a dry mild that started about 10 days PTA. On Tuesday, 10/26, she was seen at an outside ER and was diagnosed with pneumonia. She was started on azithromycin and augmentin. She has continued to have chest pain, SOB, and fatigue. The day of presentation, she stayed home from school. She developed nonbloody diarrhea, tachycardia, and weakness so she was taken back to the ER for evaluation. Found to have a pericardial friction rub. Admitted to hospitalist service.
Multiple seizures on hospitalization; found to be hyponatremia. Hospitalized in PICU.  Discharge Summary received stated patient experienced RSV bronchiolitis, respiratory distress, wheezing, congestion, cyanosis and fever.
approx 10% of the 95 pts who recvd 2nd dose of Engerix-B c/o sore arms; arm swelled up to neck; some rxn occurred immed & some had delayed rxns; c/o muscle soreness @ inject site;
PT STATED THAT HE EXPERIENCED A RASH AND ITCHINESS SINCE THE VACCINE
on 7-4-07 the next day after the Tetanus shot pt stated: "I felt chills, muscle pain, headache, tiredness.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
pt has gastroesophageal reflux, s/p prematurity (32wk);10SEP96 recv vax also started on med;4-5hr p/vax pt had ?sz-dystonic rxn;pt febrile to touch;t100R p/APAP in office;pt adm for observation;no further problems;
I have been in excruating pain since receiving the 2nd boost shot. I am unable to walk without using a walker,  which I not had to use since 2007. I was experiencing pain in my whole body, until the June, then the pain began moving down to my hips, thighs and legs. There is burning sensation, muscle cramps and sharp pain.
Pain & Edema in upper left are from elbow to shoulder extending down under arm pit & side of breast.  No fever or redness.  Hard edematous area present at injection site.
10 minutes after administration of Flublok, patient experienced  rash on torso and back. No shortness of breath or difficulty breathing.
Upper arm became red, swollen, warm itchy and sore progressively over 2 days redness and induration 10x16 Left upper arm treated with oral prednisone.
Hospitalization for SIRS likely due to COVID-19 on dates 6/27/2023 to 7/6/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
The next day I had a mild headache fatigue fever of 101 symptoms resolved within 36 hours
Rash is itchy; Rash near the injection site which is size of a softball; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itchy) and VACCINATION SITE RASH (Rash near the injection site which is size of a softball) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RASH PRURITIC (Rash is itchy) and VACCINATION SITE RASH (Rash near the injection site which is size of a softball). At the time of the report, RASH PRURITIC (Rash is itchy) and VACCINATION SITE RASH (Rash near the injection site which is size of a softball) outcome was unknown.            No concomitant medications were used by patient.  No treatment medications. were used by patient.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021, had updated address.
Daughter calls to report severe seizure like reaction after tdap.  Reports was seen by PCP, Dr. today and diagnosed as mild klonic jerking. Reports this may have also happened with regular TD when previous vaccinated after cat bite, but was diagnosed with cat scratch fever. Reports had seizure like activity then also.
This spontaneous report was received from a health professional referring to herself, a 61 year old female patient without any pertinent medical history or any drug reaction or allergies. On 11-NOV-2008, the patient was vaccinated with a dose of ZOSTAVAX (Lot# AKABB132AC; expiration date was not reported) dose and route of administration were not reported. Concomitant therapies included methimazole 5mg (manufacturer unknown) and montelukast sodium (manufacturer unknown). On an unspecified date in February 2013, the patient experienced shingles and "blisters" on "the right side of her lip". She was seen by the physician on an unspecified date in February 2013, who then prescribed valacyclovir hydrochloride tablets and ZOVIRAX ointment. The reporter stated that "it took one week to heal up" after starting the prescribed medications. The reporter stated that she again was seen by the same physician on an unspecified date in October 2015 after experiencing "a sharp shooting pain in my lip and a couple of blisters". The reporter stated that the physician told her she was "having a flare up of shingles", and the physician prescribed "a one day treatment of valacyclovir hydrochloride tablets" and that "within 2 days I was cleared of it". There were no lab diagnostic studies performed. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
-PFIZER COVID 12 plus VACCINE, HE IS 9 YEARS OLD. -PARENT NOTIFIED -NO REACTIONS/ NO ADVERSE EVENTS
has not received 6-month Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 12th September 2019.) and Twinrix (received 2nd dose on 19th October 2019.).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 3rd dose which led to incomplete course of vaccination. The reporter mentioned that, patient had not received the 6-month Twinrix dose. The reporter consented to follow up
pfizer booster administered to 15 year old.  1st dose 6-21-21, 2nd dose 6-10-21.  Nothing in Database.  Mom was not aware of age limitation when she presented.  Mom got booster same day.  Age missed on screening. currently experienced Side effects are  typical vaccination reactions
Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dose was administered to the patient after 30-day use by date or after manufacturer date of expiry.  The date on which the vial was initially stored in the refrigerator was unknown.  Number of doses/vials that were administered from that lot was reported as 173 doses.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contain non significant information
1 case study involving another transplant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Leaking blood" (ongoing), notes: P still leaking blood and can't find source.; "diarrhea" (unspecified if ongoing), notes: diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: TRANSPLANT (medically significant), outcome "unknown", described as "1 case study involving another transplant". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present or tumor found, notes: o marker present or tumor found for liver CA; Hepatic cirrhosis: Confirmed cirrhosis, notes: Confirmed cirrhosis of liver w no cause of onset determined; Hepatitis viral test: No hepatitis, notes: No hepatitis; Liver disorder: No infection, notes: No infection in liver fluid; Oesophageal varices haemorrhage: No bleeding of varicose veins, notes: No bleeding of varicose veins in esophagus; Stool analysis: No detected blood, notes: No detected blood in diarrhea.  Clinical course: Reporter (sister) and Mom (withheld) 54 year old kidney transplant patient's (withheld) (brother's)medical care team at withheld still leaking blood and can't find source. (withheld) has received 2 units of blood, 4/30 & 5/10 and will receive more today. Confirmed cirrhosis of liver w no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver CA. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again. Sister did internet search of possible liver injury from Covid vaccine. She found 1 case study involving another transplant (withheld) who received Pfizer vaccine. 54 year old kidney transplant patient Name of Product: 3 doses of Comirnaty vaccine. Reporter has dates & lot numbers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.