chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face feels like a dry mud mask on it; Tongue tingling; Inconsistent chills; Red hot flushed skin; Anaphylactic response; Pin pricks all over her body; A report was received from a consumer who was a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event of an anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021 the patient reported that she received the Moderna vaccine . It took 35 minutes to have a systemic reaction of anaphylactic response which started with tightness in the throat, swelling tongue, itching, that became tighter and tighter along with body paresthesia. The paresthesia continued and felt like pin pricks all over her body except for her face which felt like it had a dry mud mask on it. She reported that she had no temperature but did have red, hot flushed skin. Her tongue was tingling and irritated, and she had inconsistent chills. The paresthesia and tingling tongue were "driving her nuts." Treatment for the event included diphenhydramine hydrochloride.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin, was unknown/not reported.; Reporter's Comments: Company Comment: This case concerns a patient who experienced unexpected serious systemic reaction of anaphylactic response and non-serious reactions of body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin. The events occurred 35 minutes after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # 042L20A, expiration date-unknown).  Based on the information provided which includes a strong temporal association, for all reported events, a causal association cannot be excluded.
pt recv vax & exp severe pains in shoulders, upper arms, palms of hands, fingers & excruciating pain @ the finger tips, gluteal muscles in upper thighs & calves;pt to ER & hosp;diff to to simple chores-getting dress, using bathroom, shower
4 days after the vaccine I started having chest pain while being on a call. I got lightheaded and dizzy. I went to the ER and had an EKG done. The doctor told me everything was normal and I was just having anxiety, even though I had nothing triggering any anxiety. I went to another ER the next day and did not have another EKG. The chest pain lasted 5 total days straight. My primary care doctor sent me to get a stress test a few weeks later. That doctor told me my EKG was abnormal from a few weeks ago. He said my T Wave was off. I have no known heart conditions that would have caused an abnormal EKG or the sharp chest pains I was having.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius (°C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004757; US-009507513-1803USA004758; US-009507513-1803USA004760; US-009507513-1803USA004761.
This spontaneous report as received from the medical assistant (also reported as healthcare worker) refers to an unspecified patient of unspecified age and gender. Medical history and concurrent conditions were not reported. On 16-NOV-2015 (reported as today), a patient was inadvertently vaccinated an expired dose of VARIVAX (Merck) injection (confirmed lot number: H015558 and expiry date: 16-AUG-2014) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information is not expected, because there was no consent for further contact.
I had the usual aches and pains in my joint, felt feverish, and was not able to use my arm.  My baby slowed down in movement and I was in heavy fatigue. Most alarming was the first night I felt like someone was sitting on my throat. No matter how I moved my head I couldn?t make it stop. The pressure felt like I was being lightly choked and my head felt swelled w the pressure.  This came an went for the next couple of days. By Tuesday it was so faint that I didn?t notice it as an issue anymore.
I drifted off to sleep around 9:45pm but I did not sleep long when I awoke. Realizing that I was shaking and had the chills but I felt like I was burning up, I got up just before 11:30pm and took my temperature. My oral thermometer registered somewhere between 100-101 degrees. I took 3-ADVIL (200 mg each) and went back to bed & covered up with all blankets & a quilt. Sometime during the night I awoke, realizing that I was no longer burning up. By 5:00am, I felt well again and was able to go to work.
Arm sore; Headache; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 21May2021), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 69-years-old) as dose 2, single for covid-19 immunisation.  Medical history included Allergies, Can't see, pollen allergies. Onset prior to being administered Pfizer COVID-19 Vaccine doses. Her allergies are so bad. The pollen count in (Name) is really high right now with temperatures in the 80s. Because of getting old she can't see. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for hypersensitivity, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity and Cough medicine. Historical Vaccine included BNT162B2 as dose 1 on 26Jan2021 (Batch/Lot Number: EL1283; Expiration Date: 30Apr2021) for Covid-19 Immunisation (at the age of 69-years-old). On 17Feb2021, the patient experienced arm sore and headache. Treatment was given for the events. She had nothing the first day, on the 16Feb2021; onset of headache was when she woke up on 17Feb2021; it was a pretty good headache, the kind that hurt behind the eyes. She normally does not get headaches very often. Sore arm and headache were nothing that some Tylenol and sleep could not handle. She has taken 3 doses of Tylenol since onset of events. Injection up on the shoulder of left arm right after 09:00 was reported. She had to get a magnifying glass to read CDC vaccine record card. Patient asked if she can take Tylenol, Aspirin, Benadryl, Cough and Cold medicine (Theraflu)  and if it interfere with the vaccine if she take it. This consumer reported having had nothing but a good experience getting the Pfizer COVID-19 Vaccine injections. She called to ask if it is ok to take Aspirin, cough medicine or Benadryl after getting the Pfizer COVID-19 Vaccine. She clarified that she had preexisting allergies with onset prior to any Pfizer COVID-19 Vaccine doses; she normally would take Aspirin, cough medicine or Benadryl for those allergies but wanted to make sure it was ok to take before she took any since getting the vaccine doses. She reported height between 5ft, 7in and 5ft, 8in; she used to be 5ft, 8in but she is probably 5ft, 7.5in now. Outcome of the events were recovered on an unspecified day in 2021.   Follow up (19Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported included patient's weight, relevant history, outcome of the events and clinical informations.  No follow-up attempts are possible. No further information is expected.
I am writing this report on behalf of my mother.  I am a RN, BSN, and my parent's health proxy.   This is the third in the series dose of Pfizer BioNTech - first vaccination date 2/4/21 lot number E19264 &second dose 2/27/21 EN6205.      My mother noticed a shadow in her vision in her right eye upon awakening after administration of third vaccine dose within the first week.  She went to her local eye doctor & she was referred to Dr to follow up on November 29, 2029.  The doctor noted a blood vessel leakage responsible for this issue, and stated follow up and monitoring necessary - a six week appointment has been scheduled with potential need for medication injection if issue persists or worsens to manage condition.  Additionally, my mother has always been healthy with no significant medical history.  Since the initial vaccination in February, she has experienced chronic fatigue  effecting her activities of daily living.  She is also experience neurological tremors with facial twitching, shaking of her hands and legs.   Her physician has described this as a 'functional tremor' although there has been no medical tests or investigation to support a non-serous diagnosis to this point.     She also has had exacerbation of back pain and gastrointestinal issues with ongoing diarrhea and urinary tract infections.
Patient states she had a localized reaction, an approximately 2 inch by 2 inch area that was red and hardened and swollen.
No Additional AE; HCP called to report that a dose of expired PNEUMOVAX 23 was inadvertently administered to a patient.; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 03-OCT-2023 (reported also as yesterday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml) series, expiration date a few days before the end in September 2023, administered for prophylaxis (dose number, lot number, vaccination scheme, frequency and route of administration were not provided), the expired dose did not suffer any temperature excursion, the healthcare provider (HCP) could not confirm the exact date of expiration or the lot number for the product(expired product administered).   No additional adverse event (AE).
Pre-filled syringes were placed in the cooler, reported a temperature below 0°C, Human error: Yes Duration of excursion: 1 hour with no reported adverse event; products been administered post excursion patients with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 86 patients of unknown age and demographics who were administered Influenza Quadrival A-B vaccine [FLUZONE QUADRIVALENT] post excursion where pre-filled syringes were placed in the cooler, reported a temperature below 0°c, human error: yes duration of excursion: 1 hour with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Oct-2023, the patients received an unknown dose of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT8040JA and expiry: 30-Jun-2024 via unknown route in unknown administration site for immunization.  On an unknown date, it was reported that the pre-filled syringes of Influenza Quadrival A-B vaccine were placed in the cooler, reported a temperature below 0°C, human error: yes duration of excursion: 1 hour with no reported adverse event (product storage error) (unknown latency).  On 13-Oct-2023, the patient had been administered Influenza Quadrival A-B vaccine post excursion patients with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  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 the 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.
tested positive for covid in a PCR test after her booster; Now she is nursing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid in a PCR test after her booster) and MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced COVID-19 (tested positive for covid in a PCR test after her booster) and MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing). On 20-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing) had resolved. At the time of the report, COVID-19 (tested positive for covid in a PCR test after her booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2021, SARS-CoV-2 test: negative covid-19 test (Negative) negative Covid-19 test. On 20-Dec-2021, SARS-CoV-2 antibody test: negative covid-19 test (Negative) negative Covid-19 test. On 20-Dec-2021, SARS-CoV-2 test: positive pcr test (Positive) Positive PCR test.         No concomitant medication was reported.  No treatment medication was reported.  Patient was not pregnant now but was pregnant during the first 2 shots of the vaccine. Now the patient was nursing.  This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Maternal exposure during breastfeeding and Covid-19 as an added event. The events occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event covid-19 outcome as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Maternal exposure during breastfeeding and Covid-19 as an added event. The events occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event covid-19 outcome as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Per phone call from mom 7/28/04 11:46, dime size red bumps at injection site. Will use cool compress to site; Tylenol as needed. Return to clinic if worsens.
Patient under the age of 18 received the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine) had resolved. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was perform. Additional information was provided that reporter had forgotten that Pfizer was the only product given for under age people. she had mistakenly given the suspect drug instead of Pfizer Covid-19 vaccine.
Within 5min of injection. She complained of pain numbness down right arm. Also complained of right throat pain. denied sob. diaphoretic; Ice pack given, rest. pulse 82
Pain in right shoulder joint, pan In right hip joint,. Pain in lower pelvic area and leftlower leg swelling. Difficulty keeping balance at times. loss of strength to right shoulder and right hip
Patient states that she started experiencing pain the day of injection, starting at the injection site on her left arm.  First the pain radiated up to her shoulder and neck, and now it has moved down from her elbow down to wrist.  She has not seen a doctor yet.  She is still experiencing pain, and feels a burning sensation.
SORE ARM, NUMB ARM, HEADACHE, NAUSER, TIRED, VOMIT.
Injection site reaction: red, raised circle about 4 to 5 inches in diameter around injection.
0.8 mL instead of 1.8 of diluent was mixed with pfizer vial.
Approximately 8-10 hours after my vaccine, I had standard symptoms I was expecting. Aches, chills, a sore arm.  Then I notices my heart rate increasing.  I checked my pulse with a home pulse oximeter and my resting heart rate was  around 120.  Over the next few hours I began feeling very short of breath, unable to walk any distances without my heart rate increasing and becoming dyspneic.  I then was experiencing some heart palpitations.  I went to the Emergency Department around 12 hours after my dose.  They noted my tachycardia, but I had a normal echo.  My D dimer was elevated so they completed a CT scan to rule out a pulmonary embolism.  Once this was ruled out, they sent me home and told me to come back if my symptoms didn't resolve.  Over the next 3 days I experienced tachycardia and dyspnea with any activity or even at rest occasionally with my heart rate suddenly slowing to 50-60 beats per minute.  My heart rate eventually evened out by the 4th day after my shot.  The next month however I experience some gastrointestinal discomfort including reflux that caused a sore throat and the loss of my voice.  That took a few months to resolve.   My PCP ordered a cardiac workup in 10/2021 as I still currently experience heart palpitations.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 038A21A), on 05May2021 as dose 2, single (Lot number: 006C21A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 071F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023 to 04Feb2023.
a 1 year-old female patient received Act-HIB, that vaccine was later noted to have expired prior to administration, with no reported adverse event; Initial information was received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 year-old female patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB], that vaccine was later noted to had expired prior to administration (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 20-Aug-2021, the patient received 0.5 mL (once, total) dose of suspect HIB (PRP/T) VACCINE [strength: standard] (lot UJ401AA and expiry date not reported) via an intramuscular route at the thigh for prophylactic vaccination.  It was reported "Do they need to re-administer it? Was it still good? The Medical Information agent confirmed the spelling of demographics with the caller for accuracy".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the 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.
Information has been received from a 82 year old female patient with diabetes, penicillin and TOPROL allergies, who on 17-MAR-2008, was vaccinated with a dose of ZOSTAVAX (Merck) S.Q. into the left arm.  Concomitant therapy included insulin.  The patient received the vaccine while she already had shingles and shortly after on 17-MAR-2008, her shingles worsened.  She had experienced severe nerve damage.  The patient's shingles and severe nerve damage persisted.  The patient sought unspecified medical attention.  No further information is expected.
No adverse event, administration error. Patient received TDaP instead of 4th dose of DTaP. Disease control was contacted and we were advised since this is the 4th dose in the DTaP series, the TDaP counts as the 4th dose and does not need to be repeated.