chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both doses of the vaccine raised my blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Both doses of the vaccine raised my blood pressure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 043L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and FINASTERIDE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Both doses of the vaccine raised my blood pressure). At the time of the report, HYPERTENSION (Both doses of the vaccine raised my blood pressure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 158/93 mmHg and 153/96 mmHg. On 19-Mar-2021, Blood pressure measurement: 148/91 mmHg. On an unknown date, Blood pressure measurement: 160/97 mmHg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment lisinopril  was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079349 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079349:First Dose
Pt was admitted to hospital on 11/14/04 with Dx. of Fever, leukocytosis.  Pt. was given IV fluids, IV antibotics, Tylenol and Motrin per standing order.  Pt. was dischared to home on 11/15/04.  Pt. was presented to ER on 11/18/04 with febrile seizure, was readmitted on 11/19/04 for observation.
Felt like something poking her face /almost like paralyzed face; Teeth became sensitive to cold and hot; Worst bodyaches she has ever had; Fever; Disoriented; Nauseous; Felt confused; Could not even drive herself home; A Spontaneous report was received from a consumer, concerning a 29-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis.   The patient's medical history included unspecified teeth work on Dec 2020. Concomitant product used by the patient medroxy progesterone acetate for an unknown indication.   On 15 Feb 2021, the patient received the first dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, prior to the onset of events the patients received second dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, on the day of her second dose, the patient felt confused, disoriented and could not even drive herself back to home. On 16 Mar 2021, the patient developed fever and the worst body aches ever she had. The patient noticed that her teeth became sensitive to both cold and hot. The patient stated that her teeth were shocking in the whole mouth and the two teeth which had some work was hurting. The patient felt like something was poking her face almost like her face was paralyzed and felt nauseous. The event facial paralysis was considered medically significant and serious.  The patient tried acetaminophen which did not work and then took ibuprofen which was effective.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis were unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded.  Nausea and fever are consistent with the vaccine safety profile.
Got vaccine in the morning about 11:00 am By midnight it woke me up fever of 101 very unsettled felt like i had to keep moving then  in the bathroom with stomach issues tried laying down could not sleep my legs would not stop moving pain from head to toe massive head ache in the back of skull fever went up to 104  Delirious  could not walk 4 days in bed  taken  Tylenol
Child with large, local reaction to adult Dt with approximately 2 inches in diameter with erythema, no fluctuants, treated with cool compresses. Given 6-day course of medication.
after the written date on the vial; recent dose was 0.5 mL; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 018F21A, 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL). At the time of the report, EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that most recent dose was 0.5 mL dose given from a vial with a red cap and a label with a light blue border. The patient had not reported any symptoms after receiving the Moderna COVID-19 vaccine.  It was unknown when vial was initially stored in the refrigerator and vial did not undergo temperature excursions. No additional medications or treatments had been administered to patient since the time of that excursion.
covid vaccine causing vasculitis in some patients; 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), 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: VASCULITIS (non-serious), outcome "unknown", described as "covid vaccine causing vasculitis in some patients".  Additional information: Reporter inquired if there was anything that could be done about the COVID vaccine causing vasculitis in some patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient got lightheaded and almost fainted arund 15-20 minutes after the vaccine. 911 was called and she was taken to the hospital because her pressure was really low
Pt to ED by EMS with shortness of breath and nausea upon arrival on 2/20. Pt COVID positive upon admission, respirations are even, unlabored, pt maintained on 2L NC. 2/23 pt continues to be confused and pull at Cardiac monitor, oxygen and IV. 2/25 pt is a&ox2 with delayed responses. 2/26 pt placed on Bipap unit due to desaturation and change in mental status. Pt unresponsive, agonal breathing and sating at 70% on 6lnc, placed on 15 l high flow and NR sating at 95%. 2/27 pt alert and oriented x2, on Cold air at 10 liters nasal cannula SPO2 95%. 3/2 pt denied any pain or discomfort. 3/4 No c/o any pain.  Oxygen bumped down to 2L . 3/6 Pt alert and oriented x 2 denies any distress. Pt discharged 3/8.
Itching inner elbow; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a elderly female patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) for prophylaxis.   On 29th January 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in an unknown deltoid. The patient had experienced itching/ continuous itch on the inside elbow.
This spontaneous report as received from a medical assistant refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not provided. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9 (strength, lot and expiration date were not provided), intramuscular after the product had experienced a temperature excursion. There were no concomitant medications and adverse effects reported. No product complain was involved. Additional information has been requested.
Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tricuspid valve repair (new heart also needed a pig valve repair on the tricuspid valve), mitral valve repair (on the old heart), cardiac resynchronization therapy / implantable cardioverter defibrillator insertion, surgery (Surgery for IV placements), hospitalization (was in the hospital for 45 days and 3 operations), shingles and meningitis. Previously administered products included Nucala with an associated reaction of heart transplant (was taking Nucala for several months in September 2019 for EGPA and experienced hospitalization, heart transplant, Tricuspid valve repair and surgery, refer case US2021AMR260553). Concurrent medical conditions included eosinophilic granulomatosis with polyangiitis and short-term memory loss.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient reported she was going into the health care professional's (HCP) office for three 100 mg injections but she did not recall the formulation used for Nucala.  She had to stop taking Nucala because she had to have a heart transplant and her heart transplant surgery was performed on 5th September 2019.  The patient was in the hospital for 45 days and 3 operations.  The patient reported that the new heart also needed a pig valve repair on the tricuspid valve.  She said her HCP decided to stop her on Nucala because of the surgery and that she would be on several new medications including anti-rejections drugs.  The patient said that her HCP was looking to restart her on Nucala for eosinophilic granulomatosis with polyangiitis (EGPA).  The patient also received the second shot of Shingles vaccine a couple of weeks before the date of reporting in anticipation of starting Nucala again.  She had arm pain from the Shingles shot, but no other symptoms. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260553:same patient
I started with a lot of GI issues like nausea and diarrhea which got progressively worse. I had a headache that got worse and I developed a sore throat the next day which lasted for a few days. The headache lasted for 4 days. I took a COVID-19 Home Test on July 06, 2022 and it was positive. I called my doctor and made him aware. I also called my immunologist who scheduled me to get antibodies at the local hospital.  The nausea is gone but I am still having diarrhea. I am taking Zofran as needed for the nausea and diarrhea.
Pt recvd Hep B vax on 27APR92 & the evening of the vax pt exp severe abdo cramps & a sore arm @ the inject site; No further details were provided;
Day after vaccination patient went to ER with a rash at injection site that turned out to be cellulitis.
fever; headache; lot of general malaise; yellow coloration in my eyes; skin rash; This is a Spontaneous report from a contactable consumer. A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at 16:28 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 20Apr201, the patient presented fever, headache and a lot of general malaise, currently presenting yellow coloration in eyes and skin rash. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Product Complaint; Fluarix less volume administered; while administering Fluarix the syringe leaked most of the volume out; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 18-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number AF749, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 07-NOV-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 07-NOV-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: Fluarix less volume administered) and syringe leak (Verbatim: while administering Fluarix the syringe leaked most of the volume out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-NOV-2023 The nurse called to report while administering Fluarix the syringe leaked most of the volume out which led to incomplete dose administered, syringe leak and pharmaceutical product complaint. The reporter consented to follow up via mail. The vaccine administration facility is the same as primary reporter.
Mother contacted school clinic on the morning of 05/13/2015 stating that student was fine yesterday afternoon, but in the evening she started feeling tired and aching and high fever of 102.  Mother states of the morning of 05/13/2015 student still did not feel well and continued to run temp. Took to care center and temp was per mother 104.8 and was taken to ER for further testing. When I spoke with mother she stated the only s/sx were temp and aching and fatigue.
Syncope and collapse.   10 minutes after injection, while sitting, I got very dizzy and hot.  Apparently I passed out and had to be given two nose sniffs with ammonia to get me awake.  Was told by nurse that she had to rub my sternum to get me awake.  This lasted a few minutes after which I was clammy all over, but feeling better.
Redness, swelling, itching and pain at site of injection (L) arm treating Kw/ KEFLEX, prednisone, BENADRYL.
I broke my left leg when I was 19 and I think it might just be finally catching up to me. It feels like I am standing on a needle. My doctor prescribed me naproxen and shoe inserts which hasn't done anything yet. I have a ORAF plate in my left leg. When I went to the doctor, and they did x-ray, and it came back normal besides the plate.
At 11: 14 am the recipient reported a change in her breathing, stating it was faster. The recipient was checked out by EMS and signed a refusal to the hospital. The recipient stated she was nervous about getting her shot.
12/9/16 1:00p injection site presented with no visible issues below site rt. upper arm, above elbow is warm to the touch. Site is approximately 6 in (l), 3 in (w). No fever. Pt. complains she "can't put weight on it". Notified MD 1:16 pm 12/9/16.
administered to a patient after the expiration date; boostrix vaccine has been given to neonate; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a neonate male patient who received DTPa (Reduced antigen) (Boostrix) (batch number FN74Z, expiry date 28th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the Boostrix was administered to a neonate patient after the expiration date, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow up via postal.
DEEP VEIN THROMBOSIS; FRACTURE IN RIGHT FOOT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, postural orthostatic tachycardia syndrome form dysautonomia, myasthenia gravis, latex allergy, morphine drug allergy, iodine allergy, ibuprofen drug allergy, sulfa drug allergy and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total administered on 11-MAR-2021 to Left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced fracture in right foot. On 21-NOV-2021, the patient experienced pain in the calf and went in to ER (emergency room) and was diagnosed with DVT (Deep vein thrombosis) in the right calf using an ultrasound and was discharged on the same day. Patient stated that she do not think that this had any thing to do with the vaccine but it was provoked by the fracture and stated her doctors do not know why exactly but said it was likely due to fracture (fairly common). Patient never had DVT (Deep vein thrombosis) before though and had fractured same foot before. She said DVT (Deep vein thrombosis) has not resolved and she saw her vascular dr. Laboratory data included: Diagnostic ultrasound (NR: not provided) DVT (Deep vein thrombosis) in the right calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis, and the outcome of fracture in right foot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220116203-covid-19 vaccine ad26.cov2.s- deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 4/5/2022, I received my second Moderna booster. On maybe 4/9/2022, I attended a "super spreader event," which was a wedding. On the afternoon of 4/11/2022, I began to not feel well. I felt a bit tired and had a slight runny nose, a sore throat, and sniffles. I took an at-home test for COVID and got a positive result. I sent an email to my doctor and informed her of my situation. A few hours later, I got a video call from a HCF, in which I spoke to a nurse practitioner. A PCR test was scheduled; I took it and got a positive. I was also scheduled to receive a monoclonal antibody infusion around 1 PM on 4/15/2022, which I did receive. After about 4 hours, I felt great. My sniffles were gone, and I could breathe normally. The next day, I felt even better.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
On  Saturday, 1/23, 72 hours after the vaccine; I experienced a severe headache with nausea around 1;30 PM.  The pain persisted for several hours.  I vomited around 4:30pm and began to feel better.  I remained queasy until Monday, 1/25.
This spontaneous report as received from a 32 year old female consumer with allergy to acetaminophen and allergy to ibuprofen referring to herself. None pertinent medical history were reported. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous, for prevention of chickenpox (dose number, dose, anatomical location, lot number and expiration date were not reported). None concomitant therapies were reported. On 27-AUG-2014, the patient experienced dizziness, runny nose, sneezing, itching and swelling at the injection site, redness and shortness of breath, after receiving (Oka/Merck) VARIVAX. No treatment was given for the adverse events. None laboratory diagnostics studies were performed. The patient did not seek medical attention. The outcome of shortness of the events was reported as not recovered. Additional information has been requested.
Patient has a reaction; a little pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little pain and soreness) and ADVERSE REACTION (Patient has a reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 18-Mar-2021, the patient experienced PAIN (a little pain and soreness). On an unknown date, the patient experienced ADVERSE REACTION (Patient has a reaction). At the time of the report, PAIN (a little pain and soreness) and ADVERSE REACTION (Patient has a reaction) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided   This case was linked to MOD-2021-080058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up information received on 21-APR-2021  :  Event updated
Swelling in axilla. Seen by video visit. Advised tylenol/benadryl. No further testing ordered.