chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 8:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.96.  Concomitant products were not provided.  On 27-FEB-2021, Excursion time was 08 AM, and 9AM. temperature was35 and 35 respectively. total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-MAY-2021, vial was moved to clinic on 24-MAY-2021. 1 vials were sent to clinic. Vaccine BUD date was 02-JUN-2021.  On 24-MAY-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Became extremely ill, severe flu like symptoms lasting over a week.  Almost went to the ED...Unknown treatment taken, rested.
dizzy, felt faint, BP low 80-90s systolic per patient. 3 days later with chest tightness, right side radiating to right AC
bilateral inner thighs like hives;urticarial chicken pox papules;small cellulitis at inject site at lt upper arm;multi pox exposures but never documented illness;
Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertension. Concomitant products included METFORMIN for Hypertension, GLIMEPIRIDE, ATORVASTATIN, AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot). At the time of the report, RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Activated partial thromboplastin time: within reference ranges. On 12-Jan-2021, Full blood count: within reference ranges. On 12-Jan-2021, Prothrombin time: within reference ranges.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication was not reported.   Reporter did not allow further contact
Significant upper arm swelling and induration around site of innoculation measuring 15cm x 8cm
Approximately 2 weeks after the shingles vaccine, client started getting intermittent cold sores above his upper lip.  This has continued.
Nausea, vomiting, abdominal discomfort, diarrhea, headache, elevated temperature, muscle soreness at site, general malaise. Symptoms abated by next morning. Treated with antacids and fluids and Tylenol.
itchy area surrounding location of vaccination; welts; the area around the shot looked like a spider bite about a silver dollar large; felt warm to the touch; nausea
mom called 4JUN97 & stated child had rash all over body fever, cant talk, drooling;advised to go to ER;5JUN pt eval @ hosp by nurse & sent home;mom states pt recovered w/only c/o redness & swelling of arm;
69 year old vaccinated male was admitted for generalized weakness, rhabdomyolysis from a fall. He alos had UTI. He testted (+) for Covid-19 infection but did not require treatment.
Patient arched back, hit head on the mirror and collapsed. Very low blood pressure and couldn't walk for 1 hr.
pt devel fever 103.5;pt given APAP;MD notified pt had high temp 103-104 w/APAP;MD reported pt ear & throat looked infected;pt would not eat & was drinking very little; eyes pink;lips dry & cracked;pt adm to hosp dx w/Kawasaki Disease;
Patient states on 05/06/2022 at approximately 0200 started having body aches/pains. Then on 05/07/2022 developed a rash on her back and chest that radiated to bilateral arms, bilateral thighs, and neck. Was seen and treated at ER on 05/07/2022 for said complaint. Patient states "they told me any allergic reactions would occur a couple days after vaccination" and "they couldn't figure out what was wrong".  Patient states they administered a "steroid shot" and discharged her home with an "oral steroid and Benadryl".
This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for the following literature source(s): A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive supplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: unknown results; SARS-CoV-2 antibody test: less than 0.04; less than 0.04, notes: after mRNA vaccine; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. Therapeutic measures were taken as a result of Covid-19. The reporter considered "both hospitalized subjects were initially vaccinated with ad26.cov2.s with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study" and "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.,Linked Report(s): US-PFIZER_INC-202200582228 Same article/ drug and different event/patient; US-PFIZER_INC-202200582229 Same article/ drug and different event/patient.
Normal flu like symptoms by 12 midnight Sat. but by late Saturday left arm developed red swollenness in upper arm and spread a couple of inches, also red and warm.  Took a photo of it. Reminded me of when I would get desensitization allergy venom shots years ago.  Still occurring Sunday morning nearly 48 hours after vaccine administered.
Severe fatigue; muscle pain; weakness; severe headache; This is a spontaneous report from a non-contactable nurse, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 15:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. On 27Apr2021 at 03:00, the patient experienced severe fatigue, muscle pain, weakness, and severe headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe fatigue, muscle pain, weakness, and severe headache was not resolved at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Vaccinee is one of five employees identified as non responders following a series of three Engerix-B injects.
lt leg circle 2" diameter-redness, warm to touch, a little swollen @ needle site;cellulitis-appearing;
Patient came in to clinic to bet Pfizer booster and did not bring in card for verification and did not get prior vaccine at this clinic. After giving shot, it was found on state website that patient received second Pfizer vaccine at a different facility on 08/24/2021 making this booster 2 months too early.
COVID arm initially for 3-4 days.  This subsided, only to repeat with second dose on 3/4/2021 for same time period. Months later severe, burning pain-bone pain at injection site began appearing at night every day. Pain SO bad it makes me cry, and I have had FIVE natural births w/o pain killers!!! Pain has become chronic daily. The pain travels to shoulder and elbow, or around all parts of outer upper arm at injection site. After booster on 12/22/2021, the pain increased. Sometimes the pain is in the background in the day as an aching... or it fires up and subsides. Sometimes the pain travels to left breast at the side and to my shoulder blade. The pain migrates around the outer arm, not chronic to one specific area. Sometimes it feels like I can pinpoint the injection sites specifically. Husband is experiencing same thing-same Moderna RNa shot-different days-same place. This is EXCRUCIATING to say the least!!! I am in AGONY. Never in my life have I experienced pain like this consistently. I have had maybe three days of relief recently after using InTerra nano hemp gel. Then my arm got used to this and does not respond to the relief anymore. I have used a heating pad in recent days for short relief. Aleve at 300mg has been used in desperation 8x's in past two weeks. Have used Lidocain patches; Icy Hot; Aspercream; another cream; massaging arm vigorously 100+ times; crying to reduce stress; Tiger Balm; hot tea and many other approaches. This is very life altering to have to deal with pain every night. It has disrupted my ability to sleep.  SO BAD!!!!!!!!
This event was an administration error.  This patient wanted to get the vaccine early because she was leaving town.   The patient received her first dose on 05/25/2021.  She was due to receive her 2nd dose on 06/15/2021.  She came to our clinic and the vaccinator did note notice that the patient was too early to receive the 2nd dose and it was given.  Per the CDC there is only a 4 day grace period to receive the vaccine early for the best effects.  The patient and her mother were informed of the error and informed that there is limited information on the efficacy of receiving the 2nd dose of the vaccine so early.
First vaccines was Moderna but Moderna was not available. received Pfizer . one hour after had a really bad headache, body ache. pain behind the ear and jaw bone . jaw area sore to touch .
Information regarding Flu Shield was received from a consumer, a 49 year old female patient who experienced injection site reaction, the site was big, red, hot. At 49 years of age, the patient received a dose in 1999. The patient's concurrent illness includes hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1999. Dose regimen was 1 dose per 1 time per day (IM). Concomitant therapy included Synthroid. In 1999, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.
approx 1 1/2-2hrs p/immun screamed high pitched scream x 30-mins -45 mins; parents put teething gel on lt thigh which was red & had a lump; woke up & screamed (high pitch) x 20 mins;
No adverse effects reported; the needle came apart where it was attached and as a result, it is possible that the patient did not receive full dose.; the needle came apart where it was attached and as a result, it is possible that the patient did not receive full dose.; Information has been received from a registered nurse, referring to a 9 months old infant of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 17-MAY-2019, the patient was vaccinated with third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # R021372, expiration date: 25-MAY-2021, therapy type: thimerosal free, strength, dose, frequency, route were unknown) for prophylaxis. During administration, the needle came apart where it was attached and as a result, it was possible that the patient did not receive full dose (accidental underdose, product use issue). No product quality issue since determined to be user error in attaching needle to syringe. No adverse effects were reported.
Immediately after second dose, patient reported feeling tingly, light headed and "off". She had had this same reaction in the past with her 1st dose and was prepared that it may happen again. Her mom and dad were both with her. She laid down for awhile and was monitored directly in immunization room for 30 minutes. She reported feeling better, back to normal before leaving with direction supervision of her parents. They report that she often has these reactions to shots or medical procedures. This is the same reaction she had to the first shot.
This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 18-year-old female patient who received ENERGIX B for prophylaxis. Co-suspect products included ENERGIX B for prophylaxis and ENERGIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENERGIX B, the 2nd dose of ENERGIX B and the 3rd dose of ENERGIX B. On an unknown date, unknown after receiving ENERGIX B, ENERGIX B and ENERGIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENERGIX B, ENERGIX B, ENERGIX B. Additional information was received as follows: The age at vaccination was not reported. The patient received a 4th dose of ENERGIX B (0.5 ml, batch number LR2T7, expiry date 24th January 2021) in accordance with Centers for Disease Control and Prevention (CDC) guidance for previously vaccinated healthcare personnel with anti-HBs titers less than 10 mIU/mL. Lab Comments: Lab test was done on an unknown date.
tingling in arm @ inject site p/1st 2 doses; MD says do not give a 3rd dose; draw blood for antibodys;
I had the 1st dose of the Moderna shot at 4pm on Saturday May 22nd. That evening at 7pm I started to feel excessively tired so I went to bed at 8:30pm. I woke up at 3am TOTALLY sick with uncontrollable chills, fever, very bad sore throat, completely congested, sinus pressure, painful cough, my entire body ached very bad, tight chest and an unbearable headache. The only thing that eased up two days later was the chills but the rest of the symptoms even worsened and I began to get multiple nosebleeds every single day! On Wednesday (4th day after the vaccine) I got SIX nosebleeds. I couldn?t reach my doctor so I sent him a message with all the symptoms. On Thursday I finally received a call from his nurse letting me know he was out of town and that most patients that have had covid get worse side effects so to take Dayquil and nyquil to help with the symptoms. Well, that did not help me. Today (7th day) is the first day I do not have a nosebleed. I have been extremely ill for 7 days now (today marks one whole week). I have felt TOO SICK to go into urgent care or the ER so yesterday I finally did a virtual teledoc appt and as soon as the doctor heard me and I explained the situation, he prescribed Azithromycin 250 mg tablet and Benzonatate 200 mg capsules which I started taking yesterday. I have been so ill all week long I had to cancel airplane tickets and work engagements as I have been totally bed ridden. This vaccine clearly had a terrible effect on my body and I refuse to take the second dose. I assume there will be an exemption to the vaccine passport for people like myself whose body reacts to this extent. I have taken many vaccines throughout my life as I travel the world and NEVER have I had a reaction like this.  Furthermore, I had heard that vaccinated people could hold a magnet to their vaccination area on their arm and the magnet would stick? well, perplexed by this I tried it today and it IS in fact true. My doctor had not ever heard of this happening and it is very disturbing to me that this happens. I am very afraid of this vaccine after seeing what it has done to me.    I am still recovering. This is not right.
I've had 2 nosebleeds within 24 hours of receiving the vaccine. I am 66 and have not had a nosebleed since I was 13.
This spontaneous report was received from a nurse, concerning an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored ROTATEQ doses were administered to patients. No adverse effects reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Systemic: Tachycardia-Medium, Additional Details: Patient reported pinching feeling in heart muscle
Severe deltoid muscle pain and could barely raise arm.  Still cannot left arm above head or behind back without pain level 8 to 10. Anti-inflammatory products do not take away pain
while administering, vaccine running down the patient's arm from the injection site, no AE; while administering, vaccine running down the patient's arm from the injection site, no AE; while administering, vaccine running down the patient's arm from the injection site, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from the pharmacist.  This case involves a male patient of unknown age who was vaccinated with a dose of FLUZONE QUADRIVALENT (0.5 ml single dose syringe, lot number: UT7005JA and expiration date 30-Jun-2021) via an unknown route in the arm on an unknown date for prophylactic vaccination on an unknown date. However, while administering, the vaccine was running down the patient's arm from the injection site.   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was a case of vaccine underdose, exposure via skin contact and product leakage (latency was same day).  Upon clarification received on 14-Sep-2020, there was no noted damage or leakage to the syringe prior to injection. pharmacist states that she was unsure where the leakage was specifically coming from. She pushed the vaccine into the patient's arm and then the leakage was noted, and she pulled the needle out. Pharmacist wants to know if she should re-vaccinate the patient.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
By evening of COVID vaccination (=2nd dose), pt  noted new L sided facial numbness.  3-4 days later, woke with focal L sided headache.  Went to ED. Facial numbness was still present at L periorbital/cheek/ear/roof of the mouth. No facial weakness.  In ED, CT head was negative.  Was diagnosed with "atypical Bell's Palsy".  Rx'd Prednisone 40 mg qd x 5 days to take only if sxs worsened, pt did not take this.  Headache subsided within 24 more hours.    Still with L facial numbness at time of virtual visit with me 4/28/21.  Pt had had MRI of the brain 3/31/21 for other purposes and declined further imaging at that time.  Recommendations were made for MRI/MRA brain and for Neurology evaluation.
Patient c/o tightness of throat.  She states it is not closing but has a tighten feeling  following with swallowing issues .  Admin 50 mg  Benadryl   by mouth.  Advised to f/u  with PCP and report to ER.  Patient verbalizes understanding.