chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PARTIAL ADMINISTRATION OF VACCINE; LOT OF VACCINE LIQUID CAME OUT RIGHT AFTER ADMINISTRATION; LOT OF BLOOD CAME OUT; This spontaneous report received from a pharmacist concerned a 23 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced partial administration of vaccine. On 04-APR-2021, the subject experienced lot of vaccine liquid came out right after administration. On 04-APR-2021, the subject experienced lot of blood came out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial administration of vaccine, lot of vaccine liquid came out right after administration and lot of blood came out was not reported. This report was non-serious.
The evening after vaccine was administered the patient says she experienced pain, redness and slight swelling at the injection site. She also said she experience chills and shaking. As time went on the patient said the injection site area become redder and the swelling increased. Patient said the swelling traveled from the injection site down to her forearm and when she presented in the pharmacy, 2 days post vaccination, her arm was red and slightly swollen in the tricep area. The actual area where the injection was administered did not look red or swollen but the patient said it was still painful. The area from her elbow to the upper forearm was very swollen (tennis ball size) and dark in color. Patient says it is painful but she can move her elbow.
Pt reported extreme fatigue, evaluated by Paramedics on scene, declined (AMA) transport to hospital.
Pt. states that after receiving the 3rd dose of Moderna 11/29/2021, started experiencing symptoms 01/2022 of constant ear ringing. ENT appt. 01/2022 with recommendations of Steroids, Hearing Aids (02/01/2022). Upcoming ENT appt. 02/10/2022.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
5 expired doses administered from a vial greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 10-Jan-2022, it was first punctured on 12-Jan-2022 at 03:45 pm and was kept in the refrigerator after punctured until it was administered. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to the room temperature was 8° to 25°C= 46° to 77°F. It was reported that 4 doses were booster doses and 1 dose was 2nd Moderna vaccine. No treatment medications were reported   This case was linked to MOD-2022-451915 (Patient Link).
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intra-nasally for flu prevention. The product expired on 04-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
Initial unsolicited report received from a other non health care professional on 01 Nov 2016. This case involves a 07-year-old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose not reported) intramuscularly in the left arm on 29 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination were reported as unknown. Concomitant medications were not reported. On 29 Oct 2016, eight hour following the vaccination, the patient experienced irritable and cranky with a headache and did not want to eat. On 29 Oct 2016 at 08:00 pm, same day following the vaccination, the patient had fever (102 F oral). On an unspecified date, post vaccination, the patient felt hot during the night and felt better next day. Lab data was not reported. Corrective treatment includes ibuprofen. On an unspecified date, the patient was recovered from the event (reported as symptoms are gone). List of documents held by sender: none.
I started soon to develop eczema after my vaccine. I went to see a dermatologist who gave me strong ointment to put on my spots. My eczema got large and had to take oral antibiotics. My eczema was on all over my abdomen, arms and legs and I have never had eczema before. I took TYLENOL the next day. I also developed a staph infection due to my eczema. I still have the eczema today.
12:13 C/o feeling hot and sweaty associated with weakness. Placed on stretcher with cold cloth to fore-   head. diaphoretic, color good. 12:15  119/48 HR 50 O2 97%  feels better lying down. States he has not eaten  since early am. H2O tolerated well. 12:25 sitting on side bed and tolerated well. 133/72  HR 57 O2 99%   12:20 feeling fine   discharged harm
Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it.  woke up once in middle of night at 4am with racing heart but went back to sleep.  Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs.  having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath.  Temps of 99.5 most of morning.  started taking tylenol total of 1 gram.  1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s).  O2 sat remained normal.  Went to ER for testing for covid in case this was covid--test negative.   Felt a little better morning of 1/4--no fever.  tried to work 1/2 day; called out sick.  lots of brain fog, fatigue mental slowing.  still having intermittent chest tightness and sob; feel like i cannot expand my lungs.  deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved.  i'm a physician, i'm concerned this was a severe reaction and was advised to report this.
The patient reports his symptoms began approximately 2-3 weeks ago.  He reports fatigue, mild nausea and intermittent diarrhea.  He reports poor oral intake over the last 4 days.  He has complained of worsening shortness of breath with a cough productive of clear sputum.  He reports intermittent chills and fever.    On evaluation in the emergency department, the patient's blood pressure is 116/71, heart rate of 93, respiratory rate of 18, SpO2 of 99% on room air, temp of 98.7°.  Patient's respiratory rate will escalate into the 50s at times.  His SpO2 decreased to 88% however recovered while on a trach mask. Patient was admitted to medical telemetry on supplemental oxygen.  Decadron and Remdesivir  And empiric antibiotics were initiated.  Was able to taper off supplemental oxygen.
Immediate syncope after injection, lasting less than 1 minute. V/S 90/60. P 80 placed in recovery position, 450X3, monitored VS, CV status - recovered completely in 20 minutes with BP increase to 110/70 (baseline) P 68.
Left sided chest wall pain ache/(discomfort) in band pattern from upper/mid back; constant; improved with nsaids (ibuprofen/tylenol); recurrent. No other symptoms. Got Tdap booster on 9/2/21. Not sure which brand or lot #. Aside- Similar chest wall pain/ache( discomfort) two weeks after second Covid 19 vaccine back in April/May. Completely resolved after a few days with tylenol  1-2 tablets as needed. No other symptoms.
2 degree temperture rise - slight headache - chills - increase in pulse - lethargic   not concerned as I expect this is just a normal reaction
*Urgent diarrhea  within less than 48 hours , nausea / vomiting  *cough , nasal congestion , fever , severe headache , nausea / vomiting  , onset 8 days afterwards  * COVID-19 Positive on 10/25/22
Aches in my joint/I can hardly get on my chair, cause my hands and my knees, ankles hurts so much; My hand are so swollen I can not hold a pen; I can hardly get on my chair, cause my hands and my knees, ankles hurts so much; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced aches in the joint and can hardly get on the chair, cause the hands and knees, ankles hurts so much causing arthralgia on 2021 with outcome of not recovered , the hands are so swollen that the patient can not hold a pen causing peripheral swelling on 2021 with outcome of not recovered and pain in extremity on 2021 with outcome of not recovered.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
vials were thawed directly from the freezer each time they needed to administer a dose; No adverse event; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No known conditions for relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 01-Jun-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 (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication not reported.   The vial did not undergo any temperature excursions.   Treatment medication not reported.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-138343, US-MODERNATX, INC.-MOD-2021-138839, US-MODERNATX, INC.-MOD-2021-138889 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: follow up received on 17-06-21 with gender; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138343: US-MODERNATX, INC.-MOD-2021-138839: US-MODERNATX, INC.-MOD-2021-138889:
Swelling, redness.  Pt had last Pneumovax on 06/02/03, vial was stored too cold.
CDC Reports that 3 mo infant received DTP/OPV on 23AUG89 and died 25AUG89.
ON DAY OF ADMINISTRATION PT DEVELOPED 103-104 FEVER, MALAISE AND FATIGUE, CRYING W/OUT CONSOLATION. ON EXAM 3 DAYS LATER SHE WAS 105 FEVER W/MILDLY BULGING LEFT TYMPANIC MEMBRANE.
pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Previously administered products included for Shingles: VARICELLA ZOSTER VACCINE LIVE (Patient had first marketed Shingle vaccine years ago with LOT #044A21A).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site left arm). The patient was treated with VALACICLOVIR at a dose of UNK,twice daily. On 13-Feb-2021, INJECTION SITE PAIN (pain at injection site left arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: unknown (Inconclusive) Blood work performed and diagnosis was "shingles".     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication reported   This case was linked to MOD-2021-068478 (Patient Link).
Severe pain, inability to use arm. Fever Tm = 103.7. Induration, erythema, swelling lasting x 4 days.
Mild Muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild Muscle pain in her left injection site arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was reported.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Mild Muscle pain in her left injection site arm). At the time of the report, MYALGIA (Mild Muscle pain in her left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant include unspecified steroids and antibiotics. Treatment information was not reported.   This case was linked to MOD-2021-273492 (Patient Link).
Approx. 1 hour after receiving vaccine, mom noted patient to be unresponsive in back seat of car. Patient's eyes rolled back in head, tongue was hanging out, drooling and mumbling. Symptoms were resolved by the time patient got to ER. Developed croupy cough that night and fever the next am.
Patient scheduled for the 2nd booster shot.  Moderna vaccine  0.25ml administered per nurse.  After vaccination, nurse realized patient did not meet CDC criteria for 2nd booster.  Patient notified and was unaware that he did not meet the criteria.
After the second vaccine my left eye swelled up again Going on day four now and it's not getting any better.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8729, Expiry date was not reported), via an unspecified route of administration on 08Apr2021 at 15:15 (at the age of 56-year-old) in Arm Left as dose 2, single for COVID-19 immunization. Patient medical history reported as none. The Patient had no known allergies. The patient concomitant medications were not reported. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: En6204 and Expiry date was not reported), via an unspecified route of administration on unspecified date, (at the age of 56-year-old) in Arm right as dose 1, single for COVID-19 immunization and experienced left eyelid swelled. The Patient was not received other vaccine in four weeks. The Patient was not diagnosed with COVID-19 prior vaccination. The Patient was not tested COVID-19 post vaccination. On 09Apr2021, the patient experienced after the second vaccine his left eye swelled up again going on day four now and it's not getting any better. The Patient was not received treatment for the event. The outcome for the event was not recovered.  No follow up attempts are possible. No further information is expected.
Pain, redness/localized swelling at site. Fatigue, poor appetite. Advised to take Aleve or OTC pain meds, ice the area. Advised to call if symptoms worsen.
Information has been received from a master of public health concerning her 13 year old son with seasonal allergy and a history of born premature 36 weeks who on 06-JUL-2010 was vaccinated subcutaneously with a booster 0.5ml dose of VARIVAX (Merck) (lot# 666369/0226Z) and a booster 0.5ml dose of VAQTA (lot# 667932/0568Z) IM into the left arm because he was going to another country and needed booster for the above two vaccines. Other concomitant therapy included ZYRTEC. It was reported that the patient received the first dose of VARIVAX (Merck) (lot# not reported) when the vaccine first came out and in 2004 or 2005 he had a mild outbreak of chickenpox. On 08-JUL-2010 the patient developed a dry throat and hamstrings and quads of both legs hurting. The mother thought it was due to her son playing baseball and football. On 09-JUL-2010, in the morning, the patient developed sore throat, loss of appetite, fever of 100.2F, sweating, felt nauseous and lightheaded when stood up but when laid down was fine. On 09-JUL-2010, at 8:30, the patient went to the physician's office, and the fever was down to 99F and the patient was feeling better. There were no laboratory diagnostics studies performed. At the time of this report, the patient's legs were still achy and unknown if his appetite had come back. Follow up information has been received from a registered nurse concerning the 13 year old male student who on 06-JUL-2010, at 12:05, was vaccinated with the second dose of VAQTA (lot# 667932/0568Z) IM into the left arm; at 12:09, he was vaccinated with the second dose of VARIVAX (Merck) (lot# 666369/0226Z) SQ into the left arm. There was no illness at time of vaccination. On 08-JUL-2010, the patient developed fever of 99.5F, fatigue, body aches, sore throat and possible viral illness. The patient received no treatment except fever reducer and pain reliever. On 10-JUL-2010, the patient recovered. Additional information is not expected.