chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.2 C. On 26-MAR-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle pain and fatigue was not reported. This report was non-serious.
Red rash to chheeks and neck; A spontaneous report was received from a nurse concerning a 46-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed red rash to cheeks and neck.    The patient's medical history, as provided by the reporter, included drug allergies to codeine, penicillin, azithromycin and budesomide which cause red facial rash. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 027L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced, rash to cheeks and neck. Emergency medical services (EMS) was called to evaluate. Treatment for the event included EMS started intravenous access and administered 50mg diphenhydramine.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed red rash to cheeks and neck, were considered unknown.; Reporter's Comments: There is not enough information to assess the event as onset from treatment cannot be established and critical details about the case as well as other triggers cannot be established
Left arm extreme sorensss; supraclavicular node swelling; bone and joint pain; bone and joint pain; fever; This is a spontaneous report received from a contactable healthcare professional (patient). A 24-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 26Mar2021 at 11:00 (at the age of 24-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included an allergy to sulfa. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included spironolactone from an unknown date for an unspecified indication and drospirenone, ethinyl estradiol betadex clathrate (YAZ) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On 26Mar2021 at 22:00 the patient experienced left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever. The patient did not receive any treatment for the events. The outcomes of left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
I am in severe pain throughout my arm. It has gone across my chest down my other arm. I got the shot in my left arm and it?s becoming increasingly hard and more painful to use it. I have pain that goes down my arm into my thumb and pinky. I have pain across my collarbone at times. I am kept awake from this pain. I am at my wits end with this pain and doctors are doing tests on me but are not hearing me when I say  I have been injured. I have pain that requires heavy pain medicine that I cannot take. I have been taking only over the counter Tylenol and also flexiril. I feel the need to scratch the inside of my arm as if there?s worms in it. I am so miserable. This cannot be for life. I need help. I don?t know how to make these damn doctors  understand I need help and relief from pain. My latest test was  an  X-ray of my neck just last week. They now say my neck is probably causing my arm pain. No it?s not. The person that injected me with my second dose gave me a serious injury and I need help. Help in the form of answers and ultimately relief.  I did physical therapy for several weeks and was released due to it not helping. The day of my appointment I?d be ok after but the next morning would be more excruciating. I cannot sleep too often due to pain. Help!!! Please!!!!
Fever at 100.2 degrees F; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the arm left on 02Apr2021 at 18:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were reported as N/A. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient had pretty much every symptom except diarrhea (adverse event nos) for 5 days. The patient received approximately 800mg ibuprofen when symptoms occur and would subside. But would continually come back including fever at 100.2 degrees f. After the 5th day, the patient had third episode of fever. Even after 5 days, it seemed that it would not go away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen 800mg (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event Adverse event NOS and Lab data updated for Body temperature.
Information has been received from a physician concerning his 17-month-old male who was vaccinated at 12 months of age with a dose of VARIVAX (Merck). Subsequently, the patient developed chickenpox two times. The patient's father believed that he had possibly developed shingles. No outcome was reported. Additional information has been requested.
?Covid arm? bruised feeling, slightly itchy, 2 inch diameter red raised circular rash
outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial); Off label use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Patients may had received booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial.
Patient developed a fever of 103, lethargy, increased fussiness, pinpoint red rash all over his body, and site became hard and warm to touch. Mom did not seek medical attention - mom called office on 8/8/14 at 10:05 am.
upon inject of vax pt had a breathholding episode followed by cyanosis, apnea, lethargy; remained cyanotic for 15 mins;
redness, itchy, knot, hot to touch.  benadryl and ice.   rednedd, knot, hot to touch next day
Muscle pain, upper and lower back that travels from right  to left. Describe sharp, dull pain. For SHOT #1 Narrative:  Other Relevant History:
had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.; had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PEDIARIX.   On 05-MAY-2015, the patient received the 3rd dose of Pediarix. On 13-MAR-2015, the patient received the 2nd dose of Pediarix. On 13-MAR-2015, not applicable after receiving Pediarix, an unknown time after receiving Pediarix and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short (Verbatim: had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.). On 05-MAY-2015, the patient experienced drug dose administration interval too short (Verbatim: had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.). The outcome of the drug dose administration interval too short and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-MAY-2023 The registered nurse (RN) reported that patient she did not had birth dose of hepatitis B. The reporter stated that it was not counting 3rd dose of hepatitis B on 5th May 2015, tried to figure out why as it says 6 to 8 weeks intervals between shots as this was 7.5 weeks from 2nd to 3rd dose. The patient received 3rd and 2nd dose of Pediarix earlier than recommended interval, which led to shortening of vaccination schedule.
According to patient, he felt tingling, weakness in the feet/hands and unable to get up hours following vaccination.
Left arm soreness; significant aching, raised welt at site of vaccination to half way down the upper arm; headache and fatigue.
Approx 15 min after 1 mms given, child dev. hives near injection site, L leg. variable hives on trunk back & face.  Pt given diphenhydramine 10 mg in clinic.  Mother cont med after 4-6 h at home over 48 hrs, as Sx resolved.  Pt also initially had some airway congestion but no wheezing, cyonisis or other changes.  Resolved with benadryl
Low immune system; Feeling very tired; Fever; Vaccine arm was very sore; This is a spontaneous report based on information received by Pfizer from Corporation (Reference ID: NVSC2021US203163) via a non-contactable consumer (patient's daughter). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced low immune system, was feeling very tired, had fever, and vaccine arm was very sore on an unspecified date. The patient was hospitalized for low immune system for 2 days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fell; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Apr2021 11:50 (Lot number: EP7533) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing); "COPD" (ongoing); "Diabetes" (unspecified if ongoing); "Heart attack", start date: Feb2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single (NDC number of Covid-19 vaccine: 59267-1000-01, lot number: EL3302, Expiry Date: Jul2021, right arm), administration date: 27Jan2021, when the patient was 87 years old, for COVID-19 Immunisation, reaction(s): "Sore arm", "Heart attack". The following information was reported: FALL (non-serious) with onset 13Apr2021, outcome "unknown", described as "Fell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility type was pharmacy and not military facility. The patient was not overweight and probably 5'8 inch or 5'9 inch. The reporter guessed the patient was around 160 pounds. No family medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Within an hour, patient developed injection site reaction with redness, swelling and pain. She also reported to the local emergency room with an episode of hypertension and extreme nausea. Hypertension and nausea subsided within 24 hours, but injection site is still inflamed and painful 2 days after immunization
Amenorrhea. First time I can ever remember missing a period. I am not on birth control or sexually active. I have month over month tracking of all my mensuration cycles.   There have been no other life changes aside from me receiving the vaccine booster on November 20, 2021.
covid like symptoms and tested positive on  22Apr2021; sick; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient's wife) via medical information team. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021, the patient got sick. On22Apr2021, patient had COVID like symptoms and was tested positive for COVID-19. The reporter wanted reassurance that having COVID and getting the vaccine will not affect the vaccine and wants to know if they should wait for a certain period of time before getting the 2nd dose. The outcome of the events was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right arm feel kind of numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on an unspecified date reported as 'on the 16' (Lot Number: EP7534; Expiration Date: Jul2021) at the age of 54-year-old as dose 1, single for covid-19 immunization. The vaccine was administered at doctor's office. Medical history included diabetes from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient did not receive any prior vaccination. The patient had unspecified lab test on an unspecified date. The patient experienced in right arm feel kind of numb on an unspecified date. The outcome of the event was unknown. The patient did not receive any treatment for the event.
pt recvd vax & 1hr post vax devel welts all over body,swollen lt arm;MD treated sx w/DPH & atarax;sx resolved
A dose at age 11 and an accidental 2nd dose at age 12 with no AE; Initial information received on 19-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 12 year old patient who received a dose at age 11 and an accidental second dose at age 12 (Extra dose administered), while patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection [lot number and expiry date no reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  This was a case of actual medication error due to extra dose administered (latency was on same day).  It was reported that, patient received previous shot at age 11. It was advised her to call -800-vaccine to find out what needs to be done but patient also wanted to report this information here. It was unknown if patient's physician provided consent to be contacted.  At the time of report, no adverse event reported (It was unknown if the patient experienced any additional symptoms/events).  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.  There will be no information available on the batch number for this case.
Second shot  made me feel fatigue hot/cold flashes on March 23  but subsided  March 25. On March 27 started to hear strange whistling sound from my right ear. Would fade  at times but now its continuous, having trouble sleeping without white noise like a fan.
Day 1 / Wed.: Headache, slight dizziness (starting at 4 PM) Day 2 / Thurs: Headache (All day / night) Day 3 / Fri: Light headache (All day / night) Day 4 / Sat: Very bad body aches, muscle soreness, (All day / night) Day 5 / Sun: Extreme diarrhea, light body and muscle soreness (All day / night) Day 6 / Mon: Extreme diarrhea, light  body aches / Stomach gurgling  (All day / night) Day7 / Tues: Diarrhea stopped at AM. Stomach gurgling / cloudy mind (All day / night) Day 8 / Wed:  Stomach still gurgling / cloudy mind.  Still happening at time I write this.
Woke up with c/o general malaise and enlarged lymph nodes in left axilla and left neck. Felt somewhat better on 10/10/10, but still had enlarged lymph nodes. Lymph node swelling resolved by 10/12/10 and able to resume daily activities.
Severe Alopecia requiring steroid injection; Elevated ANA; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2020 (Lot number: EH9899) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ALOPECIA (medically significant) with onset 31Dec2020, outcome "recovering", described as "Severe Alopecia requiring steroid injection"; ANTINUCLEAR ANTIBODY INCREASED (non-serious) with onset 31Dec2020, outcome "recovering", described as "Elevated ANA". The events "severe alopecia requiring steroid injection" and "elevated ana" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antinuclear antibody: (31Dec2020) elevated. Therapeutic measures were taken as a result of alopecia, antinuclear antibody increased. It was reported that patient received treatment with Steroid injection every 4 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications within 2 weeks of vaccination. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event Alopecia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Severe shortness of breath. RR 50. Severe chest pain unable to take deep breath severe back pain unable to move.
Pt presented to the ER with abdominal pain; workup demonstrated appendicitis. Pt had covid last month, which was complicated by pna and was on azithromycin. Pt had worsening leukocytosis and pain and was taken to OR for lap appendectomy 8/4 with perforated appendicitis and drainage of abscess. Post-op pt had a T of 100.2 which resolved with tylenol. She also was not able to have a BM post-op. She also wanted to be seen by ID to evaluate her due to her concerns for pna and her appendectomy. ID saw pt and recommended for her to have ciprofloxacin 500mg BID and metronidazole 500 mg TID till 8/18. Pt did not have any more fevers and was able to have BM. well.  She received half dose of Neulasta after chemotherapy. Physical examination was only remarkable for in injected pharynx. Labs on presentation showed WBC of 0.2, RBC 2.69, Hct 25.2, RDW 16, Platelets 45, neutrophil 0.1, Hb 8.8 and CMP was within normal limits. Afterwards, blood culture were sent from doctor, normal saline fluid bolus initiated in clinic,  and patient received first dose of cefepime at 14: 30 in clinic. And patient was started on Paxlovid (nirmatrelevir & ritonavir)1 dose orally twice per day. Patient was diagnosed with febrile neutropenia and was admitted to the inpatient ward to continue IV antibiotics, fluids and for monitoring. On 08/04 at midnight, patient developed a fever of 100.7 and was started on Tylenol. Aftwerwards, her congestion and sore throat improved and patient has been afebrile since. On 08/05, patient was doing well with no fevers, chills or night sweats. However, patient's platelet count decreased to 27 and was given 1 dose of platelet transfusion and no transfusions reactions occured. Furthermore, blood cultures showed no growth at 1 day. Patient was deemed stable for discharge on 08/05 to home.
vaccination site red, swollen and very itchy. I used Cortisone cream to alleviate the itch and ice pack to calm the swelling. Taking Extra-Strength Tylenol every 6 hours and still experiencing the same adverse signs....will continue self-treatment.