chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.21 for dose administered on 12-Feb-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 12-Feb-2021. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient came to pharmacy for 3rd dose and pharmacist determined he was eligible. Computer system instructed booster dose as 0.25 mL and that is what was administered.
I had the second Pfizer vaccine in Feb. 2021. At the time I had minimal side affects.  I am 71 and retired. At the end of June, I had a serious eczema outbreak. I have NEVER experienced eczema or other skin problems. I have been seeing a dermatologist since July. The outbreak has been impacting my quality of life.  After following several prescribed treatments, the problem is a minimal problem now. However, there is still discomfort and new areas of outbreaks.  I had had no changes in diet, environment or daily life.  Have there been reports of physical affects months after receiving the Pfizer vaccine?
I started getting cellulitis on both legs from my knees to my ankles which lasted for months. I started having reactions to a Aleve, Volterra, Diclofenac..  Ended up in the ER in anaphylaxis to Aleve which I have been taken with no problem since I was a teenager. The cellulitis did not resolve until I was put on a month long series of prednisone.
fever 102-104, nausea, vomiting, swollen lymph nodes on neck & groin, pain in both areas & lethargy;
This case was reported by a healthcare professional and described a 42 year old female subject who did not respond to immunization to the Engerix B immunization series. The subjects medical history included non smoker and social alcohol drinker (one or two drinks per week. The subject had no known allergies. The subject received a series of 3 doses of Engerix B on 26 July 2005 (lot AHBVB125AA), 29 August 2005 (lot AHBVB125AA), and 22 February 2006 (lot AHBVB135AB). The reporter referred to this series as, the 2nd set of hepatitis B vaccine. On 09 May 2006, 76 days after vaccination with the last dose of Engerix B, a hepatitis B surface antibody titer was again negative. The healthcare professional considered the events were related to vaccination with Engerix B.
Large, hard inflammatory skin response around injection site continued 3 days after injection; size/shape approx that of a slice of cheese, red, hard, warm, painful reported to pharmacy afternoon of 5/16. Patient instructed to use cool compresses, anti-inflammatory med, and diphenhydramine, and she was instructed to follow-up with dr with it continued.
Immediatly after I had the shot, I started to see spots in my eyes and as I was walking out of the doctor's office I felt faint and lost consciousness and fell into a wall. I woke up a few minutes later with several doctors and nurses standing around me they told me that I had fainted and began to convulse. I was brought to a recovery area of the clinic but it was decided it was best if I go to the hospital because of the pain in my head and neck. Life has not been the same since then I have moments of feeling dizzy especially upon standing, permanent derealization, and floaters in my eyes.
pt recv vax 25JUL95 & 25AUG95 & 22FEB96 lab eval revealed a neg varicella antibody;no further details were provided;
The patient is not experiencing any side effects.; administered V ARlV AX intramuscularly vs. subcutaneously; This spontaneous report has been received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  On 03-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T037643, expiration date 06-NOV-2022, 0.5 milliliter, indication: prophylaxis) with sterile diluent (strength, dose, batch/lot # and expiration date were not reported) intramuscularly versus (vs.) subcutaneously (Incorrect route of product administration). The patient was not experiencing any side effects.
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
panic attack; hot flushes; a little lightheaded; dizzy spell; crazy rapid heartbeat/heart rate was 105/heart was tachy; blood pressure in the 150s; tongue and legs began to tingle; tongue and legs began to tingle; sore arm; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell) and HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks (positive for panic attacks). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: inconclusive (Inconclusive) Blood pressure was in 150's.. In February 2021, Electrocardiogram: inconclusive (Inconclusive) EKG showed "heart was tachy" but still in sinus rhythm.. In February 2021, Heart rate: 105 (High) heart rate was 105..         This case was linked to MOD-2021-013265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR with details of second dose AE
Patient received shot around 1pm later that night he started to experience chills, hot/cold, nausea, headache, extreme fatigue, low grade temp (99.1) Associate vomited several times the early the next morning. By the next day, day patient was vomiting less and was able to keep food down. Patient is feeling better the second day, experiencing some nausea.
upset stomach; worst diarrhea of his life, pouring liquids; Felt like crap; headaches; fatigue; Muscle pain; Felt achy,arm was sore for a couple of days; very nauseous; flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap) and NAUSEA (very nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and NAUSEA (very nauseous). On 20-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days). On 20-Jan-2021, NAUSEA (very nauseous) had resolved. On 21-Jan-2021, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (worst diarrhea of his life, pouring liquids) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Arm soreness; injection has been bothering arm when moves; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who experienced arm soreness (pain in extremity) and injection had been bothering arm when moved (vaccination site movement impairment), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. Patient had no other vaccines.    On 28-Aug-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AA and expiry date 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm soreness (pain in extremity) and injection had been bothering arm when moved (vaccination site movement impairment) on an unknown latency (after a 2-3 days) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Reporter stated that the injection of suspect vaccine had not bothered patient for a couple of days, but then it got sore and has been bothering him when he moves it for the last couple of days. Patient stated that there was no warmth or redness to the site, just soreness.  Details of laboratory data were not reported.   The patient was treated with IBUPROFEN (IBUPRO [IBUPROFEN]) and applied ice for pain in extremity and vaccination site movement impairment.  The outcome was unknown for both the events.
Pt had fever, red and swollen deltoid on 7/30/99. Fever was gone on 7/31/99 and swelling less.
Injection arm has tingly feeling like its fallen asleep or like carpal tunnel.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 09:00, the patient's injection arm had tingly feeling like it was fallen asleep or like carpal tunnel. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event injection arm has tingly feeling like its fallen asleep or like carpal tunnel was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
A non-serious report of tachycardia, lightheadedness and tremors was received from a physician in concerning a 31-year-old female. The patient had a medical history of neutropenia. Concomitant medications were not reported. The patient received FluMist vaccine on 24-Oct-2007. Seven hours after receiving FluMist vaccine, the patient became lightheaded, became tachycardic and had tremors. The patient went to the emergency room and the symptoms subsided shortly. The patient recovered from all events, is now asymptomic with no problems. The patient did experience a rechallenge after receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
pt recv vax 13MAY96 & 18JAN97 pt devel varicella;
Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; This is a spontaneous report from a non-contactable consumer (the patient). A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- Ew0161) via an unspecified route of administration, in the left arm, on 20Apr2021 at 13:30 (at the age of 37-year-old), as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on and unspecified date, as single dose, for COVID-19 immunization. On 20Apr2021 at 14:00, patient experienced adverse event Numbness and Tingling in hands feet and face. Patient did not receive any treatment for events. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Pt was being vaccinated for COVID-19 by facility.  Pt was doing 15 min post-vaccination observation and nurse and accompanying staff was informed by mate that pt was reporting a numb tongue but did not "want to make a scene."  Staff asked pt to accompany them to sit nearby where pt stated that her tip of tongue went numb, then her lips went numb, then her chin started to go numb.  VS taken at 15:13 where O2 was 98-99%, HR 104-105, temp 98.4 F, BP 140/80.  Pt then stated that she was having chest tightness, slight shortness of breath, and pt appeared to staff to be slightly diaphoretic.  This PHN had officer contact nursing staff and contacted on-call physician Dr. to explain pt symptoms.  Dr. instructed to give epinepherine, contact jail nursing staff and to call 911.  Auto injector epinepherine 0.3 mg was given to pt at 1523.  Pt reported feeling some ease from chest tightness and shortness of breath, although still present. Nursing staff arrived and were instructed to call 911; VS taken again at 1523: O2 99%, HR 89, RR 20, temp 98.3F, BP 120/80 and pt continued to be monitored.  At 1530 pt reported throat tightness, and autoinjector of epinepherine 0.3 mg was administered for 2nd time.  Pt once again reported some decrease in chest and throat tightness; VS as medics arriving: O2 100%, HR 94, RR 20;  medics arrived for transported to hospital at 1532.
Patient reports the nurse used the upper 1/3 of deltoid region, had difficulty injecting. She felt immediate pain, and a "dead arm " sensation.  Has significant discomfort, right shoulder decreased rom.  Sought care 11/11/20.  Started aleve, ice.  Now has mild improving symptoms
Patient complained on 11/30/09 of L ankle pain, stated Sx began after H1N1 vaccine on 11/23/09. Patient stated she went to ER, but was released.
Area where Varivax was administered became very red and swollen on 8/13 per mother. Child was seen by physician on 8/14/14. Physician noted "14 cm erythema upper arm with several vesicles." Quarter size area of induration noted. Mother had been administering ibuprofen and acetaminophen and applying cold compresses. Recommended Bendadryl and Ibuprofen. Later in the afternoon on 8/14 mother reported red area had gotten larger. 8/15 red area started going down and by st 8/16 red area was completely gone and child recovered.
He got his vaccine, around 3-4 days after the vaccine he started getting spots all over his body, arms, legs, back and head.  He saw a dermatologist, took a biopsy and determined to be psoriasis.  He did not have this prior to that.  He did have eczema in the past in high school.   He was treated with some creams as his insurance would not pay for a biological medication, which is $7,000.00.  He has spent a lot money on creams and biopsies and now reporting it as it is getting out of hand.  The creams keep it in check, but if he misses a day then he gets red red and inflamed, but the creams make it crusty and so forth.
Day 1-After immunization on Jan 8, 2021-covid 19 moderna vaccine-no symptoms or concerns on this day Day 2- Woke up at 3am-headache, chills, felt cold,  fever 101.4F-took ibuprofen as needed Day 3-Woke up trouble breathing-history of asthma, used inhaler and resolve, temp at 99.7 continued to take ibuprofen as needed Day 4- No signs or symptoms
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-OCT-2014, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX (lot # J007208, expiration date 20-SEP-2014, dose, route not reported). No adverse effect reported. Additional information has been requested.
Following morning after vaccine: Adverse events started at 6:00 AM -Fainting? 3 times. Hit my head on the tile. Fainting occurred until 12 Noon. -Excessive Sweating-6-noon. Clothing was drenched -Diarrhea-Morning -7:00 AM -Vomiting-7:00 AM -Headache-All Day -Pain at injection site-All Day
This case is linked with case number 2012-09363 a Mother Case over dose of FLUZONE (lot number UH717AC) without any adverse events. This case was also linked with 2012-11230. Initial report received from a healthcare professional on 04 October 2012. A patient, whose age, gender, date of birth, medical history and concomitant medication not reported, exposure of FLUZONE via breast milk (dose number not reported, Lot number: UH717AC) on 28 September 2012. It was reported that after vaccination to mother her baby who was breasted, tend to more sleeping. Baby also developed cough on unspecified date. Corrective medications and laboratory investigations were not reported. The patient's outcome was unknown. Follow-up information received on 04 October 2012 in the medication error report from a nurse: It was reported that the baby now had cough and was not sleeping; however previously reported as tend to "more sleeping". List of documents held by sender: none. This case was also linked with 2012-11230.
This is a spontaneous report received from a contactable consumer (patient/himself). A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201, expiration date: unknown), at the age of 72, via unspecified route, left arm, on Apr 10, 2021, at 12:50, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Apr 10, 2021 (after the vaccination), patient experienced a little swelling of his bottom lip. He took 2 Benadryl but didn't think it helped any. He also wanted to know if he should get the second dose in 3 weeks. No vaccines taken 4 weeks prior vaccinations, The outcome of the events: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.
Received a full dose as a booster/full dose and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    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 ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised) had resolved.            No Concomitant product use was reported. No treatment information was provided. Company comments includes This is a case of Accidental Overdose that concerns a 71-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up information received included patient's age and medical history. Added patient's age and updated type 2 diabetes as patient medical history.; Sender's Comments: This is a case of Accidental Overdose that concerns a 71-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.