chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions).    No concomitant medications were provided.  It was reported that between 24-May-2022 and 3-Oct-2022 several patients received monovalent and bivalent Moderna Covid-19 vaccine that had undergone several temperature excursions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673181, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673869, US-MODERNATX, INC.-MOD-2022-673878 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673181:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter US-MODERNATX, INC.-MOD-2022-673878:same reporter
arm started itching, then rash formed, then hard time breathing, treated with benadryl and epipen, ems arrived and started feeling better, took to hospital
14SEP92 pt recvd vax; 15SEP92 pt felt feverish & sluggish; sore on vax sites; 16SEP92 pts arm red-warm-raised w/o red streaks; 65 x 48 cm was hard area (4" x 4" red area);
This spontaneous report as received from a physician refers to a newborn baby on unknown age and gender, who was vaccinated with doses of RECOMBIVAX HB (lot # and doses not reported) on 31-AUG-2012 and 06-SEP-2012. No adverse symptoms reported. Additional information has been requested.
Patient was administered the 2nd dose of the vaccine series, previously no reaction to the first dose. Upon standing up, the patient experienced syncope and was caught by the administering pharmacist. Administering pharmacist called for help from the other pharmacists and 911 was called. The patient was set to the ground and administered epinephrine in case of anaphylaxis. The patient was monitored for 3 minutes at which point he seemed to start aspirating. He was then rolled to his side for prevention. Approximately 5 minutes later, the patient came to as EMS arrived on scene.
localized redness & swelling seen in office 24OCT95;rxn children's Ibuprofen
I developed a swollen supraclavicular lymph node above my left collarbone. It appeared just a few days after receiving the vaccine. No other side effects were noted aside from a sore arm and some itchiness around the injection site that lasted for 5 days after getting the vaccine. The lymph node is still swollen but is not worsening or painful. My sore arm and the itchiness have improved and are no longer an issue.
Patient was experiencing symptoms after 10 minutes of receiving J&J vaccine. He passed out for 5 minutes without any verbal response; with signs of seizure. He has a history of the same reaction with another vaccine. He got epinephrine 0.3mg IM Lot OFM625 Exp. Nov. 22. The ambulance was called and the patient's care was transferred to the paramedic. The patient was transferred to the ER.
Covid 19 booster; injection site arm pain; minor shoulder pain; minor headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3(booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid 19 booster"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site arm pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "minor shoulder pain"; HEADACHE (non-serious), outcome "unknown", described as "minor headache".  Additional information: Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stopped by the pharmacy on 08/14/19 informing pharmacists that she seemed to have an allergic reaction of injection site reaction to the SHINGRIX vaccine 2nd dose she received on 08/08/19. She consulter her physician who told her to use ice pack and take BENADRYL. Upper arm looked red and irritated with minor swelling. She said it was not painful but bothered her and slightly itchy. Patient will follow up with MD if symptom still persists after BENADRYL dose on 08/15/19. Reviewed steps all protocol steps were followed and completed by RPH correctly for safety for patient and pharmacist.
Patient received MMR and Menactra 5/10/05. Then seen 5/12/05, 24 hours later developed high fever 104. Seen 5/12/05 P/E were normal. Febrile illness. Resolved in 36 hours. Follow up on 7/19/05: Also complained of new onset headache associated with AE.
Received 3 Moderna vaccines in 2021.  Received 1 Pfizer vaccine in June 2022.  In July 2022, developed eyelid contact dermatitis 1 day after using shampoo.  Many instances of eyelid contact dermatitis with different shampoos and facial products containing cocamidopropyl betaine and caprylic/capric triglycerides.   Also developed contact eyelid dermatitis after using an eyedrop that contained few ingredients: Glycerin 0.2%, Hydrochloric acid, sodium hyaluronate, sorbitol, trometamol, water.  Dermatitis resolves after avoidance of products containing those ingredients.
Vaccine was administered higher on my arm than usual; first 24 hours/through the night arm was heavy and sore and continued through the next day. Pain settled deep into the shoulder joint. Range of motion restricted and painful--most acutely upon external rotation. Initial assessment by primary physician (10/19/17) dx as "frozen shoulder" and referred to Orthopedist (pending 11/28/17) and physical therapy (11/6; 11/10; 11/16). Two prescriptions of prednisone (20 mgx3; 8 days taper); nightly ice compress. Pain lessens when taking prednisone but otherwise can be excruciating; sleep interrupted by not being able to move without pain.
GIVEN EXPIRED DOSE OF VACCINATION; This spontaneous report received from a pharmacist concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced given expired dose of vaccination. The action taken with covid-19 vaccine  was not applicable. The outcome of the given expired dose of vaccination was not reported. This report was non-serious.
COVID-19/hospitalization/death Narrative:  Patient received two doses of the Pfizer mRNA vaccine on 1/17/21 and 2/10/21. He was admitted on 3/5/21 with COVID-19 pneumonia which progressed to severe disease. Patient died on 3/21/21 attributed to COVID-19. Patient had underlying B cell follicular lymphoma, previously on chemotherapy. Reported does not feel patient's hospitalization or death was attributable to the vaccines, however following FDA Emergency Use Authorization, "The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS): vaccine administration errors whether or not associated with an adverse event, serious adverse events* (irrespective of attribution to vaccination), cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death."
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 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:44 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, 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 30.55. Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. 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 brand 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.
This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutters) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 017A21A/017F21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart flutters) (seriousness criterion medically significant) and HEADACHE (a headache). At the time of the report, CARDIAC FLUTTER (heart flutters) and HEADACHE (a headache) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.  Company Comment: This case concerns a 56-year-old female patient with no known medical history, who experienced the serious, unexpected event of cardiac flutter and non-serious expected event of headache. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is unknown, patient reported headache after booster dose, but outcome of event headache after second dose is unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Re-challenge of both first and second dose as unknown.   This case was linked to MOD-2021-381116, MOD-2021-381126, MOD-2021-381116 (Patient Link).; Sender's Comments: This case concerns a 56-year-old female patient with no known medical history, who experienced the serious, unexpected event of cardiac flutter and non-serious expected event of headache. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is unknown, patient reported headache after booster dose, but outcome of event headache after second dose is unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Pt developed abdominal pain & 6Jun90 admitted to hosp. DX pancreatisis & required surgery
blood clot; Migraine; Hot & cold; ringing in ears; shooting pain in arm; Nausea; rashe; swollen face; fatigue; brain fog last 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 12:00 (Lot number: 8182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (disability, medically significant, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "blood clot"; MIGRAINE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Migraine"; FEELING OF BODY TEMPERATURE CHANGE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Hot & cold"; TINNITUS (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "ringing in ears"; PAIN IN EXTREMITY (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "shooting pain in arm"; NAUSEA (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Nausea"; RASH (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "rashe"; SWELLING FACE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "swollen face"; FATIGUE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "brain fog last 2 months". The events "blood clot", "migraine", "hot & cold", "ringing in ears", "shooting pain in arm", "nausea", "rashe", "swollen face", "fatigue" and "brain fog last 2 months" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Oct2021) negative. Therapeutic measures were taken as a result of thrombosis, migraine, feeling of body temperature change, tinnitus, pain in extremity, nausea, rash, swelling face, fatigue, feeling abnormal. Treatment received for the adverse event included Blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Vision kind of off on both eyes but more in the left eye; Facial muscle side effects, one side of his face's senses appear to be stronger that the other side; Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects). At the time of the report, VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects) had not resolved.            Eight days later following vaccination on Monday the patient started to experience like side effects, facial muscle side effects, one side of his face's senses appear to be stronger that the other side, vision kind of off on both eyes but more in the left eye. The symptoms were ongoing. Concomitant medication included Colitis medication. Treatment medications were none.
About 30 hours after vaccination pt started getting daily, but intermittent fevers and extremity edema. Presented for evaluation and found to have workup consistent with new diagnosis of systemic lupus erythematosus complicated by lupus nephritis.
Pt exp low grade fever, & arthralgias for 48-72 hrs p/vax;
Right after my shot, my arm started to spasm. I started having pain in my chest that radio to my back and face. My face started getting numb and swelling. I was cover with hives all over. I took Benadryl. They wanted to give me an epi-pen. I went home. I stay in bed the whole weekend. So, now I have heart troubles. I went to doctor about it, and he advised me not to get the second dose.
Swollen lymph nodes; Could not turn head; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 20May2021 at 12:30 (at the age of 61-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 10Jun2021 at 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received nitrofurantoin (MACROBID) on an unspecified date for an unknown indication and experienced drug allergy.  Concomitant medications included semaglutide (OZEMPIC), bupropion (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) and MULTIVITAMIN; all taken for unknown indication from unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after the first dose the patient experienced swollen lymph nodes on the same side of neck where shot was given and could not turn head to side because of swelling. And the events went away in two weeks after first shot. On 12Jun2021 at 08:00 the patient experienced an episode of swollen lymph nodes on the same side of neck where shot was given and could not turn head or lean head to side because of swelling after the second dose. Since the vaccination, the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. On 04Aug2021, the patient underwent PCR and the result was negative. The clinical outcome of the events swollen lymph nodes and could not turn head were not recovered at the time of reporting.
Patient developed hives over most of her body that was quite itchy the morning after shot administered. Rash lasted several days. When pt brought to our attention it decreased significantly. Pat instructed to take BENADRYL.
Patient reports that right calf , knee and heel very sore after both Pfizer doses but reported that it got got feeling better 3 to 4 days after first dose and expects it to resolve after this second dose in a few days -- told pt to let us or doctor know if it doesn't improve or gets worse
10 days after rubella (lot #0268L), patient developed low grade fever, headache, rash, joint pain, cervical adenopathy, fatigue.
5 minutes after vaccine I felt a dizziness, by Sunday the room started spinning like severe vertigo and then my left ear started ringing and getting louder, the vertigo was then off and on, now it's a week later I still have vertigo and the ringing is still going. The Audiologist doctor said mild hearing loss in the left ear called sudden sensory neuro loss and I'm scheduled for an MRI.
High-pitched, loud, continual tinnitus in both ears has interfered with my ability to sleep, and is almost impossible to ignore when I'm awake. I have had mild tinnitus that comes and goes in one of my ears for a year, but this is unlike anything I've ever heard or experienced before.
Headache,  Myalgia, Arthralgia, Fever, CoughWheeze & Syncope Narrative:
pt stated that her left arm is red, warm and swollen about the size of a baseball at the injection site. Pt had a fever, temp was 100.6.  She has body aches, headache, lightheadedness, has fatigue and her mind is foggy. she has taken ibuprofen.  Pt will contact PCP if her symptoms get worse.
Hospitalization: 2/2/2023 - 2/5/2023 (3 days); Presentation to the ED: shortness of breath, chest pain and nausea vomiting and diarrhea. COVID + date: 2/2/23. Treatment: Azithromycin and Rocephin, bronchodilator.  Discharge to: home. 038K20A 1/29/2021; 013M20A 2/26/2021.