chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt DOB 05/08/80 received the 1st COVID vaccine Pfizer Lot #ER8735 at 1:02 PM. Client reported onset of dizziness on 06/11/21 around 9:00 AM. She stated the dizziness lasted approximately 4-5 hours. The client stated she ate prior to receiving the first dose of COVID vaccine Pfizer and the morning prior to the onset of dizziness. The client states she worked for 10 hours on the day of the dizziness. The client stated she did not seek treatment or take any medication following the initial onset of dizziness. The client denied any s/s of anaphylaxis or SOB following her first dose of COVID vaccine Pfizer. The client stated her symptoms resolved after she "ate food and slept all day." The client denies current chronic conditions or current medications. The client reported a history of anemia accompanied with intermittent dizziness. She denied any recent episodes of dizziness related to anemia and denied current anemia diagnosis. Client reports no known allergies. Vitals obtained at 1:45 PM were HR 68 and BP 130/65. Medical consult was submitted via text message. Approval to proceed with 2nd COVID vaccine Pfizer with a recommended 30 minute observation period was received at 1:50PM. Client was educated by RN regarding s/s of anaphyalxis, when to seek EMS, to follow up with PCP regarding dizziness, V-safe. RN educated the client regarding recommended 30 minute observation period and the client voiced understanding of this. The client received the 2nd COVID vaccine Pfizer on 07/01/21 at 1:53 PM. The client left the vaccination site AMA after receiving the 2nd COVID vaccine Pfizer, prior to entering the observation area.
Information has been received from an office manager concerning an 11 year old female with no pertinent medical history and no drug reaction who on 20-NOV-2010 was vaccinated with the first dose of GARDASIL (lot# 666597/0768Z) (route, dose not reported) and CERVARIX. Second suspect therapy included AFLURIA (manufacturer unknown). Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the patient was being seen in the office due to a 104F fever on 22-NOV-2010. No lab diagnostics study was performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-679425 (Patient Link).
Hives; Itchiness; Red bumps breaking out in arm, between thighs, breast, back of leg; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itchiness) and RASH ERYTHEMATOUS (Red bumps breaking out in arm, between thighs, breast, back of leg) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE, PREDNISONE, FOLIC ACID and LISINOPRIL for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced URTICARIA (Hives), PRURITUS (Itchiness) and RASH ERYTHEMATOUS (Red bumps breaking out in arm, between thighs, breast, back of leg). At the time of the report, URTICARIA (Hives), PRURITUS (Itchiness) and RASH ERYTHEMATOUS (Red bumps breaking out in arm, between thighs, breast, back of leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication provided included cream for itchiness.
Headache, Myalgia, Fever, chills Narrative:  Per nursing report: "2nd dose of Moderna vaccine yesterday [2/3]. States at 3am this morning [2/4] had fever, chills,body ache and headache.
heart was beating "real fast" could "feel it in her chest"; feeling lousy; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was beating "real fast" could "feel it in her chest") and FEELING ABNORMAL (feeling lousy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (She had received the flu vaccine in past years.). Concurrent medical conditions included Asthma and Hypertension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced PALPITATIONS (heart was beating "real fast" could "feel it in her chest") and FEELING ABNORMAL (feeling lousy). At the time of the report, PALPITATIONS (heart was beating "real fast" could "feel it in her chest") was resolving and FEELING ABNORMAL (feeling lousy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 88-90 88-90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
Pt had MENVEO vaccine on 10/9, on 10/10 R arm started swelling, redness and sore. Seen in our office on 10/11 and advised cool compress and MOTRIN.
The pt experienced multiple episodes of apnea lasting greater than 28 seconds. Child on apnea monitor.
Pt started getting a papular red rash with some fluid filled pockets. She came into our office 2 days after this occurred. She has a 6 yr old sister in school & who also has a rash.
Patient sitting upright on exam table. Patient tolerated MENACTRA and TRUMENBA vaccine in left Deltoid with no problems. Immediately after administration of HPV vaccine in right Deltoid, patient leaned forward as if he was passing out. This nurse leaned patient to the side so he would be laying down and not fall. This nurse noticed his entire body was contracting, having tonic clonic like movements, drooling, non-responsive to verbal stimuli or physical touch. I managed to get the patient into a supine position and elevate his legs. Seizure lasted 5 seconds. Patient came back to consciousness and asked what happened. Reported feeling tired and hot. BP 136/80, HR 85, RR 16.
Fever, headache, muscle aches, joint pain, sore throat, pain at injection site, pain throughout arm, weakness
Patient was here to get the first dose in her COVID vaccine series. Patient was accidentally given the Bivalent Booster.
8/9/17-Redness and sore to touch. 8/9/17 at evening went to clinic-BACTRIM DS. 8/10/17 went to PCP and he took off BACTRIM DS and suggested steroid shot. 8/14/17-Reddness and soreness gone, light pink under skin.
Treatment of COVID-19; Treatment of COVID-19; Moderna Booster Dose Number: 4 / Pfizer / BioNTech Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9703) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 at 10:00 as dose 1, single (Lot number: M013L20A), in left arm, on 02Oct2021 at 10:00 as dose 2, single (Lot number: Mo12M20A), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: 017F21A) and on 05May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "Cvd" (unspecified if ongoing), notes: other medical history: Cvd; "arthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Perhaps ibuprofen, reaction(s): "Known allergies: Perhaps Ibuprofen", notes: Known allergies: Perhaps Ibuprofen. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022 at 12:00, outcome "unknown", described as "Moderna Booster Dose Number: 4 / Pfizer / BioNTech Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Elderly (65+ Years). Other medication in 2weeks was reported as unknown. Patient received Paxlovid treatment from 03Jan2023 to 07Jan2023 for Covid-19.
Patient received an extra booster dose.  Patient had received 1st booster 02/15/22, and extra booster 6/27/22
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 26-SEP-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
really dizzy and felt like she could pass out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (really dizzy and felt like she could pass out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023M20A and 013L20B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure low.   On 24-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-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 DIZZINESS (really dizzy and felt like she could pass out). At the time of the report, DIZZINESS (really dizzy and felt like she could pass out) outcome was unknown.            Concomitant medication included Blood pressure medication. No treatment reported.  First dose of the suspect product was administered on 27Jan2021 with batch number 013L20B Second dose of the suspect product was administered on 24Jan2021 with batch number 023M20A   This case was linked to MOD-2021-413990 (Patient Link).
Rash on left leg above knee; This is a spontaneous report from a contactable consumer(patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: El92645121), via an unspecified route of administration, administered in left arm on 04Feb2021 12:45 (at the age of 50-year-old) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, sinusitis and allergies: penicillin. The patient previously took Levaquin, Codeine and had experienced drug hypersensitivity. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZAL); levothyroxine sodium (SYNTHROID); magnesium glycinate; vitamin b complex (VITAMIN B) daily; ascorbic acid (VITAMIN C) daily. On 04Feb2021 12:00, the patient experienced rash on left leg above knee. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Patient actually received the SHINGRIX (NOT the ZOSTAVAX), but it was not an option to select above so I selected ZOSTAVAX. Following the night of the day she got the vaccine, patient woke up in the middle of the night with pain and soreness from head to toe. Patient said she could barely walk, move, get out of bed, or get dressed the next day. She also reported frequent sleeping for long periods of time during the 36 hours following vaccination. Patient also reported that her arm was red, swollen, and warm.
Arm was brusied near site of injections and swollen and red to touch. Redness spread throughout the inside of the arm all the way down to the elbow and around to the outside. Patient used ice and ibuprofen.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported about temperature excursions with freezer in the facility. It had happened for weeks since April 2022.The batch numbers were reported as 065K21A and 045L21A.The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered two temperature excursions since April, both lasted less than 1 minute.   The vails were stored back in frozen state.  No visual inspection noted any vaccine state change.  Date the vials moved from freezer to refrigerator was unknown.  No proposed desired Use by Date.  No treatment information was provided.   This case was linked to MOD-2022-591989 (Patient Link).
Cellulitis-like reaction to the injection site that is red, swollen, firm, hot to touch, and has a burning sensation a week after vaccine administration. Have taken Benadryl, ibuprofen and have been prescribed an antibiotic,
Client received the 1st COVID vaccine (Pfizer, Lot # EW0161, EXP: 07/04/2021) at 16:47. Two EMT's reported on site of incident. At 16:53 Client complains of nausea, dizziness and headache, after six minutes in observation. Clients vitals were takes at 16:53 blood pressure: 130/89, heart rate: 88, respirations: 14. oxygen saturation 98%. Client mentions history of needle phobia and anxiety, client stated she hasn't eaten, her last meal was at 2am. Client is alert and oriented to person, place, time and date. Client  denies chest pain, abdominal pain, shortness of breath, or any noticeable rashes or itchiness. At 17:00 Client states headache, nausea and dizziness are subsiding, vitals were taken at that time, blood pressure: 143/88, heart rate: 80, oxygen saturation 98%. At 17:03 a manual blood pressure was obtained 134/88. Client was given water and juice and was advised to stay an additional 30 minutes in observation, Client refused to stay the additional time but agreed to stay for the whole 15 minutes in observation. At 17:11 Client  stated that headache, dizziness and nausea is "feeling better." Onsite advised client to follow up with primary provider. ER precautions given if conditions worsen. Client agreed and verbalized understanding about information provided. At 17:11, clients vitals blood pressure: 139/90, heart rate: 76, oxygen saturation 97%. Client left facility with a steady gait at 17:14.
I passed out twice and had to be hospitalized. I had the same thing happen last week. I had a loop recorder this last time and it showed that I had some pauses in my heartrate, so I had to have a pacemaker put in. I was also told that I have had pinpoint strokes.
On 1/19, mom noted a lesion on pt.'s right shin which grew quickly and was about 4 cm in diameter with erythema/ possible ecchymosis in the center. Noted another lesion on her left forehead at wich time she came to the office. She had 2 other lesions the next day; on her forehead and another on the left shin.  She was not limping. She was not in pain. No bruising. Otherwise normal health
This spontaneous report as received from a physician refers to a male patient of unknown age with unspecified allergies and no pertinent medical history. On approximately 29-MAY-2014 (reported as about two weeks ago), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot#, expiry date unspecified). No concomitant medications were reported. On approximately 08-JUN-2014 (reported as 3 or 4 days ago), the patient developed a rash and he was seen by an unspecified primary care physician. The patient was put on oral and injectable steroids, which had little effect on the rash at that time. The physician stated that he had not yet seen the patient, but the patient had a diagnosis of "urticarial vasculitis". No laboratory tests were performed. The outcome of urticarial vasculitis was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Veteran developed small bump behind left ear on 3/23/21, then on right ear morning of 3/24, two hours later to right upper leg, then spread to groin, then entire abdomen /chest area.
About 2 hours after vaccination my heart rate spiked to double the resting rate and body felt numb, almost resulting in fainting. Similar feeling to being drugged, I was driving at the time and had to pull over as I didn't feel capable. Lasted for about half hour, and heart rate remained somewhat elevated for the rest of the day. Have not had such an episode before.
Almost complete loss of appetite within 4 hours of injection. Has not had a meal in almost 48 hours from lack of appetite. Vomited within 48 hours of vaccination.
Patient received the 1st dose of Moderna COVID-19 vaccine instead of the Pfizer COVID-19 vaccine, which is indicated for his age group.
26JAN95 pt recvd vax & exp angioedema & breathing diff, hives;taken to ER-rx Epi/breathing tx/DPH/steroids-improved;9FEB hives & angioedema persists
The patient's left arm turned red and swelled; the swelling was from the elbow to the shoulder. The redness and swelling remained for about one week. The patient also reported feeling "achy like the flu" for about one week. No medications were taken to relieve these symptoms and no treatment was sought.
pt recv vax around 3PM on 17MAR97;pt began inconsolable crying @ 7PM;parent called nurse @ 9PM & was instructed to take pt to ER;took to ER dx hypersensitive rxn to vaccine;
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19) and INJECTION SITE PAIN (Pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L02A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19). On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment included ice.
Information has been received from a physician concerning a 21 year old female patient with 2.4 centimeter haemorrhagic ovarian cyst, possible irritable bowel syndrome, gastrointestinal symptoms and anxiety. On 28-APR-2007 she was vaccinated IM In the left arm deltoid with a first dose of Gardasil. 3 days post vaccination on 02-MAY-2007 the patient experienced headache, dizziness, blurred vision and "vomiting all the time." On 06-MAY-2007 the patient went to emergency room (ER) and was seen but not hospitalized. On 06-MAY-2007 patient was hospitalized with unknown diagnosis. All types of test were performed; head computed axial tomography (CT scan of the brain), complete blood cell count (CBC), magnetic resonance imaging (MRI) with normal results. Stool culture test was taken and there was a trace amount of blood. She was treated with intravenous (IV) fluids. On 09-MAY-2007 she was released from the hospital. She was still dizzy. The outcome was unknown. Additional information has been requested.
Swelling and pain in Left shoulder, entire deltoid extending to mid chest, mid back and axilla. Erythema deltoid to mid humerus. Sling, ice, ibuprofen for treatment severe pain with movement or touch.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. "Within the last 5 years", on an unspecified date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, route not reported, 0.5 ml/single dose). Concomitant medications were unspecified. The physician reported that the patient developed severe PNEUMOVAX 23. Unspecified treatment was given for the event. The patient had sought medical attention via an unspecified way. Outcome of the event was reported as recovered on an unknown date. Additional information has been requested.