chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the vaccination after a temperature excursion; received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion).    No concomitant medication were reported.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures At the time of the excursion vaccine was in frozen storage. Unbroken Cartons with vial size of 2.5 mL and 5.5 mL . Maximum or minimum temperatures reached was unknown, only had manual twice a day recording. The Excursion duration was Unknown. The vials were Returned to the freezer at the time of reporting. Upon visual inspection vaccine state change was still frozen. No treatment information was provided by the reporter.
Facial Numbness Left Side; Tingling on left part of forehead; She is very anxious to have her question addressed by USMI; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW1077), via an unspecified route of administration on 19May2021 11:15 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypochondriac (she is probably being a hypochondriac). The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID VACCINE, Lot number: EW0179) on 29Apr2021 for COVID-19 immunization. Patient got the second dose today at 11:15 and was fine as she was driving off. Then she noticed that the left part of her forehead was slightly tingling. Caller states that she went to scratch it and it is not totally numb; bus she is having facial numbness on the left side on 19May2021. Patient states she then searched it and something on the internet told her she would be paralyzed for life. Wants to know if that is true? Patient was very anxious to have her question addressed by contactable consumer on 19May2021. The more questions the call handler asks the more anxious the caller seems to become. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Right after patient blacked-out for a few seconds. He turned pale in face and lips. He felt dizzy. After laying down and resting, patient returned to normal. He verbalized he felt better.
No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster dose.
Chills, sweats, nausea with vomiting, muscle aches, headaches for approx 24 hrs after injection received Fatigue for the following week
Around 2000 patient reported that she developed a bad headache that worsened throughout the evening, at 2240 she lost consciousness at home, her sister was there and she regained consciousness within  1-2 minutes. The patient herself doesn't remember. After that she reports feeling dizzy, and nauseated and almost vomited several times through the night, on 6/6/2020 she reports feeling very dizzy and nauseated, she had to leave work early Saturday due to feeling dizzy. 6/7/2020 she continued to feel dizzy, Tylenol helped. 6/8/2020 she reports feeling great.  The Patient did not go to the doctor.
3-4 days after Flu shot given on 11/2/05, started having "itching" all over (feet first) (805 legs 205 arms). Saw doctor PCP 11/11/05 then saw dermatologist 11/4/05. Tx Erythema Multiforme probably 2 days to flu shot. Treated with soaks and cream.
Patient received covid vaccination.   Became lethargic, diaphoretic and pale in observation. Patient taken to ER for further evaluation. Pt left the ED after only being seen by triage RN; pt did not stay to see a provider.
swollen, red,hot itchy ears; swollen, red,hot itchy ears; swollen, red,hot itchy ears; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on an unknown date in Mar2021 and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included colon cancer, HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome and hemochromatosis. It was unknown whether the patient was pregnant or not. Concomitant medication included daily vitamins (MANUFACTURER UNKNOWN) for an unknown indication and on an unknown date. The patient did not have a history of allergy to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced swollen, red, hot itchy ears and has progressed from there. The patient did not think it had anything to do with the vaccine and since second shot things have gotten much worse. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with steroids and antibiotics. The clinical outcome of the events swollen red, hot itchy ears was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Low grade fever and chills 30 hours after vaccine.  took one advil.  slept through the night.  problems solved.
Pt. received vaccine on 11/17/08; mother called following day.  Stated that pt. left arm was swollen from shoulder to elbow, face and eyes were swollen temp was 102.7.  Recommended to see family physician, try BENADRYL/TYLENOL.  Called to follow up on 11/20/2008.  Mother stated that pt's swelling went down, fever went to 103.4 for 12 hrs; then broke.  Pt. now recovered.  Pt. did not see physician.
August 2021 I started having pain in my left heel and I couldn't put pressure on it or stand up for long periods of time. I started wearing inserts to get relief but it didn't work and 3-4 months in I went to see a podiatrist and he said it was plantar fasciitis. He told me to do certain exercises and to wear cushions in my shoes but it didn't get any better to the point now I have left and right heel and foot pain now. I just have issues standing or walking long periods of time that I've never had before. I did get cortisone injection to alleviate pain but it didn't work. This is still ongoing.
Chills then overheating, severe headache on left side of head from scalp line to below the eye. Took about 18 hours to clear. Treated with tylenol
COVID-19; COVID-19; Dose 1 and Dose 2 Moderna, Dose 3 Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL; IBUPROFEN; PREDNISONE; TIZANIDINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and Dose 2 Moderna, Dose 3 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported fainting "blackout" 1.5hrs after vaccination.  Pt  was driving at the time, resulted in minor car accident.  No injuries reported.
Patient claims they had a mild anaphylactic response to vaccine.  Patient reported swelling of tongue/lips, and mild difficulty breathing.  Patient contacted physician and was directed to take Benadryl which stopped anaphylactic reaction.  Patient reports being fine after dose of Benadryl.
Hair falling out , my hair has been falling out so much since I had the vaccine. I?m extremely worried. I?ve never had this before.
This case was reported by a consumer and described the occurrence of an injection site reaction in a 44 year old female patient who received hepatitis B vaccine recombinant (Engerix B). The reporter is the patient. A physician or other health care professional has not verified this report. The patients past medical history included allergy to norflex, codeine and bismuth subsalicylate. On 2/25/2005, the patient received the first dose of Engerix B. On 3/23/2005, the patient received the second dose of Engerix B in the arm. At an unspecified time following the second administration of Engerix B, on 3/23/2005, the patient experienced an injection site reaction characterized as pain at the spot where the needle was inserted. The patient was seen at a physicians office. The injection site reaction was ongoing as of 3/23/2005. Report received via manufacturer.
pt recv vax & devel an inj site rxn characterized by redness, soreness & induration;reporter indicated that 60 out of 90 staff residents vaccinated exp this event;however they are not presently identifiable;
PATIENT HAD NEVER HAD A FLU SHOT. NURSE HAD HER WAIT 20 MINUTES , AT 20 MINUTES SHE CAME TO NURSE SAYING ARM WAS HOT,TINGLING,AND TICKLE IN THROAT. GIVEN BENADRYL-10 ML. SHE BECAME HOT AND DIZZY. NO RELIEF FROM BENADRYL. VITALS STABLE. 911 CALLED. SENT TO ER. EKG AND OBSERVATION FOR 1 HOUR. SENT HOME. SJEHE WAS CALLED 10/08/20 TO CHECK ON HER STATUS. HEADING TO WORK AND DOING FINE.
Moderna on 3/3 and 3/31. Positive on 11/30
arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is a little sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-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 PAIN IN EXTREMITY (arm is a little sore). At the time of the report, PAIN IN EXTREMITY (arm is a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated event outcome from unknown to recovered/resolved.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ABDOMINAL PAIN UPPER (Stomach pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Ankylosing spondylitis. Concurrent medical conditions included Rheumatoid arthritis and Ankylosing spondylitis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced COVID-19 (COVID-19). On 03-Jun-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). In 2022, COVID-19 (COVID-19) and ABDOMINAL PAIN UPPER (Stomach pain) had resolved. No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of COVID-19, stomach pain was not reported for co-suspect Humira. No treatment medications were reported. Company comment: This spontaneous case concerns a 20 year old female patient with concurrent rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving the booster dose of mRNA1273. Further details regarding the clinical course, additional diagnostic or imaging test done and treatment were not provided. The patient's compromised immune system due to concurrent rheumatoid arthritis and use of co-suspect drug adalimumab (Humira) may be considered as risk factors for COVID-19. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 20 year old female patient with concurrent rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving the booster dose of mRNA1273. Further details regarding the clinical course, additional diagnostic or imaging test done and treatment were not provided. The patient's compromised immune system due to concurrent rheumatoid arthritis and use of co-suspect drug adalimumab (Humira) may be considered as risk factors for COVID-19. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches.  Felt like every bone in my body was broken (4 days)
Three days post vax, the infant developed a fever of 102, abdominal cramping, and persistent vomiting. The fever abated on 7/19/99. The vomiting reportedly wakes the infant up in the middle of the night twice weekly. The infant was seen by a physician who started him on antibiotics. This is one of two pts from this facility who had an adverse experience following receipt of vax.
Immediate itching at injection site.  Later swelling occured from site to elbow. Patient complained of worsening asthma symptoms over the next four days.
Tingling Sensation in back of neck and base of head that comes and goes randomly. Feelings of fatigue, when they do occur, feel more prevalent in this area of the neck. Was most noticeable in first few days after vaccine but still has not fully gone away.  Lowered sex drive.  Mild pain/soreness in testicles that comes and goes randomly. Started on 3rd day after shot, now seems to come up more regularly.  Difficulty falling asleep. Was really bad the first few days after the shot but still has not fully gone back to normal.
Caller is HCP who reports administered dose of PROQUAD that experienced temperature excursion. No additional details available. No further adverse events. No product quality complaints.; Caller is HCP who reports administered dose of PROQUAD that experienced temperature excursion. No additional details available. No further adverse events. No product quality complaints.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # T035410 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 14-APR-2022) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were not provided. If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.
Pt recvd vax on 23NOV93 & 2 days later devel myalgia & a mild fever (100-101);
On 1/10/22 patient did not receive COVID-19 Moderna booster as requested and was injected with empty syringe in error.  Unable to contact patient for follow up. Certified letter sent to patient address on file.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 4 years old male patient who received IPOL and TDAP vaccine twice. The patients past medical history, concomitant medication and family history were not provided. On 25-Jul-2018, the patient received injection of suspect IPV (VERO) lot number, expiry date and dose not reported not reported via unknown route in left leg. On 27-Jul-2018 he also received injection of the same vaccine with an unknown batch number via unknown route in the right arm. On 25-Jul-2018, the patient received injection of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in left leg. On 27-Jul-2018 he also received injection of the same vaccine with an unknown batch number via unknown route in the right arm. It was an actual medication error due to extra dose administered. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Patient arrives with complaints of chest tightness and fever after receiving his second dose of pfeizer Covid vaccine yesterday around 1100.  Mother administered 600 Ibuprofen two hours prior to presentation.  Tmax 99.9f, lung clear on triage.  Patient endorses body aches when his fever is up.  Mother states temp at home was 102.8.  Mother and patient endorses no known sick contacts.
I got the second shot at 3 pm and by 2 am I had a temp of 100 and body aches and felt like I had the flu.  It is now 8 pm- 29 hours after the injection and I still have a fever and a migraine.  Haven?t gotten out of bed
Itchy rash presented itself on torso, back, arms, and legs accompanied by dizziness, nausea, and vomiting. After vomiting, dizziness subsided and rash resolved within a few hours.
Extremely high temperature, projectile vomiting, diarrhea, fainting, full body pain. Over the next few months I experienced chronic fatigue, daily headaches, loss of appetite, increased feeling of SOB, since vaccinations I have had a herpes flare up monthly with swelling of lymph nodes in my left groin
Patient received his first dose of Pfizer vaccine at around 10:15am on Friday April 2, 2021. His family reports he waited 15 minutes after vaccination and then proceeded home and reported no other issues. Patient collapsed at his home on Saturday April 3, 2021 around 11am. Family did CPR and called 911. Upon arrival of EMS they determined he was deceased and did not  do anything further.
intense itching/burning in throat within one hour of vaccination causing incessant coughing; lasting 2 days wheezing and shortness of breath beginning 8 hours after vaccination and lasting at least through Monday Mar1. conjunctivitis and light-sensitivity beginning Saturday (24 hours after vaccination) lasting at least through Mar 1 fatigue commensurate with what others describe as having and worse than many have reported lasting at least through mar 1
No response to PPSV23; Pneumococcal titers: 0/14 protective after vaccination; This literature marketed report was received from the authors in a published article concerning a 34-month-old female patient with Immunodeficiency, centromeric instability and facial anomalies (ICF) syndrome.  The patient presented with fever and respiratory distress at age 3 months. After brief hospitalization for presumed bronchiolitis, she returned with new fever, worsening of respiratory symptoms, hepatosplenomegaly, leukopenia, and diffuse hazy infiltrates on chest radiograph. Further evaluation revealed a whole-blood cytomegalovirus (CMV) PCR (polymerase chain reaction) of 125,257 copies/mL and she was diagnosed with CMV pneumonitis.  She was born full-term and newborn screen was normal, including T-cell receptor excision circles. She had received her 2-month vaccinations including live oral rotavirus vaccine without issue, was formula-fed, and had no allergies. Her parents are first cousins, and she had a healthy older brother. Her family history was significant for "blood cancers" in 2 female cousins and a maternal aunt.  She received intravenous immunoglobulin and valganciclovir. She was discharged on hospital day 32 after CMV PCR was undetectable and continued valganciclovir prophylaxis as an outpatient.  Continued evaluation at age 32 months was significant for low NK (natural killer) cells, low memory B cells, and low pneumococcal titers (0/14 protective). Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was administered shortly thereafter. At age 34 months, she developed fever and respiratory distress. Initial evaluation revealed bilateral infiltrates on chest radiograph respiratory viral panel positive for rhinovirus/enterovirus, and elevated whole-blood EBV PCR of 6500 copies/mL CMV PCR was negative. Immunologic evaluation showed loss of previously protective tetanus and diphtheria titers, no response to PPSV23 (0/14 protective) (therapy non-responder and antibody test negative), low IgG, and additional abnormalities in lymphocyte subsets.  A copy of the published article is attached as further documentation of the patient's experience.