chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days, post vax, had fluid filled blisters that appeared at site of injection. Afterwards, fluid filled blisters appeared on hands and feet for 3-4 days. Afebrile. Referred to local ER on 1/28/01.
17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.
Rt arm red swollen warm to touch.  Are measures 8x6 cm. no pain.  Temp 99.
1st dose 1/13/2021 Moderna  2nd dose 02/12/2021- Pfizer   No adverse reaction noted or reported
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 29.5 (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified). It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08Aug2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18Aug2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07Aug2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided
Client reports she experienced pain approximately 48 hours after injection which required steroid injection, FLEXERIL, naproxen & VOLTAREN gel - has MRI scheduled.
Pt began with petechiae over lower extremities and buttocks that spread upward to trunk.   11/18/09:  Outpatient Hospital record received for dates of service 11/10/09 to 11/14/09.  Dx:  Idiopathic thrombocytopenic purpra.    Assessment:  Presented with 4  day history of bruising and petechiae.  Platelet count 2000.  ITP Dx'd.  Treated with WinRho IV. Slight chills after infusion.
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
Moderna COVID-19 Vaccine: 030A21A ; C/O LIGHTHEADED, HYPO TENSION, N/V; 12:20:70/40, P55, R 15; 12:26 101/70, P77, R16; 12:32 107/73 p80, r16.
Pt presented on 11/10/09 with a rash diagnosed as Henoch-Schonlein purpura . Was apparently febrile to 103F after vaccination.
This spontaneous prospective pregnancy report was received from a physician, who referred to a 34-year-old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 27-SEP-2017, the patient was inadvertently administered a dose of GARDASIL 9 (lot# N009173 and expiration date: 20-NOV-2019; dose and route of administration were not reported) as prophylaxis. On the same date, the patient also received the following vaccines: M-M-R-II (dose, route of administration, lot# and expiration date were not reported), hepatitis B virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported), influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. The physician reported, that at the time of the vaccination, the patient was 16 weeks and 1 day pregnant. The Last Menstrual Period (LMP) date was calculated as 06-JUN-2017 and the Estimated Date of Delivery (EDD) as 13-MAR-2018. The patient was exposed to the suspect products in the second trimester of the pregnancy. At the time of the report, the outcome of the pregnancy was pending and the fetal outcome was unknown. No adverse effects were reported. No treatment was provided and no lab diagnostics/studies were performed. The patient did not seek medical attention. No product quality complaint was involved.
Patient felt fine first week after vaccine. On the second week, developed itching to arms and legs. On the third week, developed swelling to upper and/or lower lips that happened off and on 4 times.  Self treated with Benadryl. Patient thought might be related to vaccine.
Patient was given Janssen covid 19 vaccine. Patient fainted during her 15 minutes post vaccine observation period. Patient regained consciousness and refused emergency medical help. Patient did not get inquired and felt better after after resting  in the pharmacy area for over 30 minutes. She was feeling better and left the pharmacy with her father.
Decreased sensation from chest/abdomen through lower extremities,  diminished strength and mobility of left side.  Symptoms started approximately 24 hours after receiving the vaccine starting with decreased sensation in the lower extremities .  02/14/2021 I started experiencing weakness on the left side.  02/16/2021 symptoms progressed to limited movement on the left side preventing ability perform normal daily functions and digestion was effected.
(L) arm with swelling, tenderness and erythematous patch involving the lateral aspect of the arm.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2007, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a medical center/hospital as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-SEP-2015, the patient was treated (by an unspecified healthcare professional) at a medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Extremities became very weak  Received Pfizer covid vaccine in March and April of 2021. With a couple of weeks, Both legs became weak affecting standing and walking. Right hand became very weak affecting the dexterity of fingers and not being able to use it for anything. Both arms were weak. Became very tired since the vaccine. Muscle strength has improved some but not like it was. Still having trouble with left arm,
Serve Red Skin irritation.  The skin feels inflamed and pins poking on the surface of the skin.  The skin always feel itchy and the skin turns bright red.   This condition occurs randomly throughout the day on a daily basic from foot to the top of the head.  The condition begin soon after the third vaccine administrated on 12/2021.   The condition hasn't stop and no history of this type of skin condition has occurred prior to the administration of these vaccines.   The patient had 4 vaccine of Moderna:   1. 4/8/21  001B21A 2. 6/3/21  036C21A 3. 12/02/21  013F21A 4. 11/30/22 023H22A
On April 5, 2021, I had a sudden loss of hearing in my right ear which resolved within about 20 minutes. On April 7, 2021, it happened again with resolution. On April 9, 2021, it happened again but this time without resolution. That evening around 9:00 p.m., I went to the emergency room at the hospital and was started on high dose prednisone. I followed up with my ENT the following week on April 13, 2021 and was tested and placed on a high dose prednisone taper and followed by dexamethasone injections in my right ear. I was fitted for hearing aids in late June of 2021 due to the sensorineural hearing loss which I suffered. I had a second episode after my booster on August 2, 2021 which I will describe in another report.
felt as if i was having heart attack. tachycardia, pain down arm, pressure in chest, brief loss of conciousness. called 911, emt treated briefly at home, then took to ER.  I reported that I'd had vax 2.5 days prior but  was told it was irrelevant. spent ~10 hours in ER, then released.  reported to cardiologist the following business day. fine since, but hesitant to get booster.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "got the COVID vaccination in May2021 and couldn't taste for 4 months". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient would like to know why the patient got the COVID vaccination in May2021 and could not taste for 4 months, got booster in Dec2021 and now still cannot taste 9 months later. The patient had never had COVID and test if the patient had symptoms and all negative, when will the patient get taste back. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itching and hives that began the night after her first dose of Moderna on 01/08/2021. Patient states she began itching in the middle of the night, it woke her up throughout the night. She states that when she woke up 1/9/2021 she had hives that covered her chest, bilateral upper arms, neck, and face, her arm was sore at the injection site and she did have pain that traveled into her shoulder blade also.
rash on leg, itching/itching rash on leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on leg, itching/itching rash on leg) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH PRURITIC (rash on leg, itching/itching rash on leg). At the time of the report, RASH PRURITIC (rash on leg, itching/itching rash on leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment for the event included Steroid injection received on 18 Mar 2021.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-148682 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19 MAY 2021 and added Reporter's address and email. Patient's initial was updated. On 16-Jul-2021: Follow up received on 16 JULY 2021 and Event outcome updated
Vaccine had a low temp excursion.  Was revaccinated on 10/26/2022
1JUN95 110PM to ER stated rash over body x 4 hr; had HIB 31MAY95 to clinic for eval; DPH given t97, irritable, t101.2; rash over body;
7 days after injection, whole upper arm became red, itchy, hard, swollen and sore. Persisted for 1 week.
whole body had hives; fever of 101.2 F; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (whole body had hives), PYREXIA (fever of 101.2 F) and NAUSEA (NAUSEA) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 041L20A) for COVID-19 vaccination.     NO MEDICAL HISTORY WAS PROVIDED.  Concomitant products included WARFARIN and PROPAFENONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (whole body had hives). 01-Mar-2021, the patient experienced PYREXIA (fever of 101.2 F) and NAUSEA (NAUSEA). On 02-Mar-2021, NAUSEA (NAUSEA) had resolved. On 04-Mar-2021, URTICARIA (whole body had hives) and PYREXIA (fever of 101.2 F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) 101.2 F.         No treatment medication was reported.   This case was linked to MOD-2021-034757 (Patient Link).
Received call from the health department this 12/7/2021.  There is a patient who received two FULL series of the Moderna vaccine.  She had come to our store on 8/7/21 asking to receive her first dose and stated she had not been vaccinated prior.  Filled out the form and received a card with follow up date for second vaccine.  She then came back on 9/19/21 to get second dose.  Today she presented to the health department to get her booster in which they verified on system that she had received a full series from both them and us.
Painless red spot about the size of an orange appeared at injection site on March 26, 2021. It had completely disappeared by March 30,2021.
Pt experienced a large raised lump about 1 1/2" to 2" irregular shape. Very warm, very thick and sore. Itched at time. It resolved in about 8 1/2 weeks.
HIB vaccine given at 0900. Patient developed wheal/flare type erythema on trunk, legs, arms but the face was spared. No erythema in (L) thigh at injection site. No fever. Patient given 15 mg ranitidine PO BID x 5 days and BENADRYL 12.5mg PO Q 6 hours PRN pruritis or rash.
Pain in the back and abdomen centralizing in the area of the Gall Bladder. Patient has no history of Gall Bladder stones or inflammation. Currently undergoing scans and tests to assess state of Gall Bladder. As of the date of submission a major flair occurred April 8th, care was sought April 11th when pain became too much, tordol shot was provided in office with a steroid pack and motrin provided to reduce pain and inflammation. Awaiting second ultrasound of the area and results of both scans.
Increased intracranial pressure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, Comirnaty Bivalent Vaccine), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Headaches" (unspecified if ongoing), notes: 2 month history of headaches. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: INTRACRANIAL PRESSURE INCREASED (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Increased intracranial pressure". Clinical course: The patient with 2 month history of headaches then received COVID vaccine and developed worsening headache the following day. Diagnosed with increased intracranial pressure 3 days after vaccine received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: SHINGRIX. Past adverse reactions to the above products included No adverse event with SHINGRIX.    On 10-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 50 microgram. On 10-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
This spontaneous report as received from a pharmacist, via field representative, refers to a 54 year old male patient. The pharmacist reported that "immediately" after an unspecified patient was administered ZOSTAVAX (lot#, dose unknown) on an unknown date, the injection site swelled "bigger than he had ever seen, it was the size of a golf ball". The pharmacist reported to the field representative that "everything had cleared up now and the patient was ok". Causality between the event and ZOSTAVAX was not assessed by pharmacist. Additional information is not expected.
Patient reported only 4 doses of Pfizer vaccines, and no bivalent booster. It was discovered after the fact that they had received a bivalent booster on 9/16/22. The informed consent form reported only 4 doses, last given on April 12, 2022.
NOTALGIA PARESTHETICA 11/17/2022 CHOLEDOCHOLITHIASIS
Myalgia chills, body ache, headache, "brain fog" Narrative:
Low grade fever  (less than 100.6) and headache for about 15 hrs
Approximately 3 hours after the vaccine, i was really dizzy and tired, the next day i had flu like symptoms and kept losing balances. And this lasted about 10 weeks
On way to car patient complained to daughter of dyspnea, had to sit down No chest tightness, wheezing, or cough No nausea, lightheadedness, diaphoresis Daughter notes patient had episode of left chest pain yesterday that resolved within 15-30min No h/o asthma, lung disease, MI No code blue called or epinephrine administered before contacting this MD for evaluation
Within 24 hours, he developed extreme fatigue, body aches, bitemporal headache and constant feeling of being cold.  These symptoms still remain.
Patient came to the office on 9/13 with her mother who was concerned that she had multiple areas of bruising to her anterior thighs that started  on 9/10 (the day following her vaccine on 9/9). She also reported fatigue. On 9/14 she came to the office again for recheck and had a few more areas of ecchymosis to anterior thighs and complained of sore throat and fatigue.