chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022; No adverse event; Expired Moderna Covid-19 vaccine was given to Pediatric Patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022).    No Concomitant medications were provided.  Vaccine was given on 05 Nov 2022 around morning time. No adverse event reported from the patient. Affected vials were individual ones with size of 2.5 ml. Vial did not undergo temperature excursions.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669841, US-MODERNATX, INC.-MOD-2022-669846, US-MODERNATX, INC.-MOD-2022-669847, US-MODERNATX, INC.-MOD-2022-669850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669841:Same reporter US-MODERNATX, INC.-MOD-2022-669846:Same reporter US-MODERNATX, INC.-MOD-2022-669847:Same reporter US-MODERNATX, INC.-MOD-2022-669850:Same reporter
Approximately two hours after the vaccines were administered the patient started experiencing a ringing in her ears. This is still occurring today. Patient plans to call her primary care physician.
Experienced pain and discomfort in left breast after shot was administered in left arm.  Had an annual gynecologist appointment a month after my second dose and a lump was found in my left breast.  There was no indication of a lump prior to the vaccine. At my 2020 gynecologist appointment, a full breast exam was performed and there were no lumps or levels of concern.
Accidentally gave expired Tdap (Boostrix) vaccine.  Expired 12/04/2020.  Administered 12/15/2020.  No adverse reactions or symptoms have been reported by patient since administration.
Lymph node swelling came up on the left side of neck/collarbone. Noticed very early Monday morning, 03/29/21.  Today, 04/15/21, the swelling is almost gone.
12. 4 % PVC after the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029K20A) for COVID-19 prophylaxis.     No known allergies.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose). At the time of the report, VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 71 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of Ventricular extrasystoles, which occurred after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported 12.4 % Premature ventricular contractions (PVCs) after vaccination. The outcome was reported as recovering. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-694361 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning a 71 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of Ventricular extrasystoles, which occurred after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported 12.4 % Premature ventricular contractions (PVCs) after vaccination. The outcome was reported as recovering. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt. called and reported nausea and headache after she received the vaccines. Denies emesis, stiff neck, fever, diarrhea, infection at site, unsteadiness, and did not take any medication.
a skin rash appear on the face in 10 minutes after getting the vaccine, epipen been used,also the face begin to look buffy
I tested positive for COVID-19 on January 21, 2022 my symptoms were coughing, fever, sore throat, sneezing, body aches, I was prescribed a steroid named prednisone and a cough suppressant.
No further adverse effect reported; Patient received dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-FEB-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # S025993 has been verified to be a valid lot number hepatitis a vaccine, inactivated, expiration date reported and establish as 17-OCT-2020) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were below 36° Fahrenheit (F) and 27 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
the syringes where the plunger get stuck midway into injection; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).    Concomitant product use was not provided by the reporter.  The Device problem code for Spikevax syringe include FDA code 1670, Regulatory code A23 which include Use of Device Problem. The Spikevax syringe device was malfunctioned and the type was CIRM.  Treatment information was not provided.
dizzy; nauseous; bad ingestion; She couldnt get out of bed; arm pain; This is a spontaneous report from a contactable consumer or other non hcp(patient).A 53-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number- not reported), via an unspecified route of administration(age at vaccination 53 years) on 29Aug2021 as DOSE 2, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection,Lot number-not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that patient had the 2nd dose of the Comirnaty vaccine on 29Aug2021. After that,patient had arm pain on 29Aug2021.The next morning on 30Aug2021 she felt dizzy, she couldn't get out of bed, nauseous, with bad indigestion. Her indigestion, dizziness, and intermittent nausea were still ongoing.She was asking for more information as she will be flying some time so she was concerned about that.She asked if since dizziness was listed as one of the signs of severe allergic reaction, would that mean that her body was rejecting the vaccine.She also asked how long will her symptoms last.Clarified that dizziness doesn't necessarily indicate a severe allergic reaction, only it was listed as one of its signs. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Raised rash that itches on skin only on areas where there are tattoos. Raised largest rash that itches stops at tattoo boarders. Swelling has caused the tattoos to swell up. Smaller rash bumps can be seen on top of tattoos that look different from the large welts. Primarily only on tattoos.  OTC Topical cortisone cream has not relieved itching or welts. Prescription Topical Triamcinolone Acetonide Cream 0.1% has not made any changes.
Ache all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Ache all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Ache all over). At the time of the report, MYALGIA (Ache all over) outcome was unknown.            Med Info Agent:  AE submitted via Chatbot Ache all over is this a side effect. Patient  just received my second shot yesterday.
The night I got the vaccine I had one of THE WORST migraines of my life, after not having issues with them for over 10 years. Now I have a constant dull headache that turns to a migraine approx once per week. Have had a rash/breakout around my mouth since a couple days after receiving vaccine that has been unsuccessfully treated with several things. The month I got the vaccine I had 2 menstrual cycles and have had 2 per month since then, although my hormone levels basically show I'm in menopause after just turning  40. I have been having more severe joint and muscle pain and stiffness issues since getting the vaccine and have been unable to do workouts due to this
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016533379) on 05-Dec-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date (it was reported 13 Jun 2007), unspecified timeframe following vaccination the patient experienced allergy to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Flu shot given at approx 10am within 24 hr (L) arm red, swellign, warm to touch throbbing pain. H/A yesterday and felt flushed. Today slightly better.
Right after the shot my lower left arm got red and my lower right arm was slightly red and my face felt slightly prickly. I had premedicated with Benadryl liquid gels. When I went outside it got better. Approximately, 1/2 hour later, I started sneezing, so I used Nasalcrom with cromolyn sodium to stabilize my nasal mast cells and it stopped. Around 2 pm, my upper right arm where the shot was given was sore, but it went away in the evening on 4/30/21. I continued to take Benadryl throughout the day and cromolyn sodium as I have mast cell activation syndrome.   At approx 2:30 am on 5/1/21, I woke up with some abdominal pain or upset, upper body aches, chills, severe chattering of my teeth, and severe pain in my upper right arm where the injection was given, such that, I could barely move my arm upward. This lasted until approximately 6 am or 7 am. Even with a blanket and a heater running beside me, I was still cold and my teeth were severely chattering. At 8 am, I took an extra dose of my hydrocortisone for a total of 10mg. I had upper body aches and a headache most of the morning. It stopped in the afternoon, but the upper body aches and headache returned in the evening.  I continued to take Benadryl, cromolyn sodium, and Tylenol.   On Sunday, 5/2/21, my symptoms were gone, but I still took an extra dose of hydrocortisone for a total of 10mg.   Today, 5/3/21, I was able to reduce it back to 5mg in the morning and my symptoms are still gone.
Linear, erythemic papules located on neck bilaterally, sterum, thoratic and lumbar trunk, forearms, and thighs. No difficulty breathing. Treated with OTC Hydrocortisone and OTC Diphenhydramine 25 MG Tablets.
w/in a few hr p/vax pt began crying & inconsolable for over a day;pt adm out of concern for poss sepsis (had t101) & supportive care;condition resolved spontaneously;
suspected vaccination failure/got the shingrix series, months later was put on cellcept. Broke out with shingles; horrible case of shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mycophenolic acid (Cellcept) for product used for unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Cellcept at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Cellcept was discontinued. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional details provided were as follows: The age at vaccination was not reported. The patient got the Shingrix series and then was put on Cellcept a few months later.  She broke out in a horrible case of shingles and her doctor recommended getting the shots again now that she was off the Cellcept. The reporter asked could they repeat. It was unknown if the reporter considered the shingles to be related to Cellcept. The health care professional stopped responding when asked for credentials and disconnected the chat. The reporter did not consent to follow-up. No additional information was available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Redness, warmth, induration around site of injection at time of employee reporting incident which was 2 days after administration. Reaction began morning after vaccine given but has been worsening since. Had chest tightness and wheezing AM of 5/24, lasting several hours, none at present time. Has multiple environmental and animal allergies. She states she woke this AM and her cat was sleeping with her.
Headache in the back of head above neck, Constant ears ringing sometime increase to a higher level for 10-15 second spans. Balance sometime off when waling light headed, Lack of energy and Fatigue. Pain in chest area behind each side of Ribs.
(1)Red, itchy splotches on and around injection site-- took oral benadryl 4 nights till gone (2) Stopped up ears began same day as above symptoms with one round of 3 or 4 sneezes. Disappeared gradually by same day as above mentioned splotches.
pt recv vax 17OCT97 & devel pain & swelling of pneumo vax area which also got warm;swelling progressed to elbow & below & stayed warm on 17OCt & 18OCT;pt still has discomfort;inflammation;weak;
On 5/5/2021 pt says the left side of her body became very sore from her shoulder to her elbow.  On 5/10/21 she developed an x-shaped rash around her left arm pit and left breast.  The lymph nodes are swollen under the left armpit.  On 5/11/21 pt went to Dr. and was diagnosed w/ Shingles and prescribed Valtrex.  She was told to take Ibuprofen for the pain.
Covid arm on injection arm - rash that itches and red circle around it and on my other arm I have itchy, hot, raised bumps
SEVERE ALLERGIC REACTION; This spontaneous report received from a patient by a Business partner (Pfizer Consumer Healthcare, 202101813326) was received on 23-DEC-2021 and 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 not reported, batch number: Unknown, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination (dose series no- 0). The batch number was not reported and has been requested. Concomitant medications included malic acid. On an unspecified date, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe allergic reaction was not reported. This report was non-serious.
Pt presented back to clinic 1 hour after vaccine administration with c/o sore throat, leg pain, headache, and hiccups. Dr assessed pt in clinic at this time and every c/o resolved except hiccups. Pt was sent home in care of his mother. Mother called at 2:00 stating pt also had vomiting once at home.
On 4/14/2023 upon reconciling the Covid Bivalent booster, it was noted that the vaccine given on 4.12 23 had expired on 4/3/2023.  Expiration date was incorrectly documented as 4/23/23.
he tested positive for hepatitis B virus with little EAG; his erythrocytes were a little high,; Hepatocytes was high; hematocrit was high; lymphocytes were high; his glucose was high; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer sponsored program.   A contactable 39-year-old male consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), into the left arm on 21Apr2021 at 9.00 (at the age of 39-years-old) at single dose for COVID-19 immunization. The patient had received the fist dose of vaccine on 31Mar2021 (Lot: EP7534) in the left arm at 09.00. Medical history included psoriasis diagnosed 25 years before reporting when he was 15 years old. Family history included his mom died of cancer, but she did a lot of drugs and stuff. Concomitant drugs were none. The patient reported that 2 weeks after 2nd dose of vaccine he had blood work done. He said the result came back a little weird on 10May2021. Erythrocyte were a little high, Hepatocytes were high, hematocrit was high, lymphocytes were high, and it says he tested positive for hepatitis B virus with little EAG. Caller states his glucose was high but he thinks that's just from what he was eating. The patient stated that the events required a physician office video visit. Caller stated his doctor was having him do another blood work test. Caller stated the doctor thought maybe it was the vaccine that did it. At the time of reporting the outcome of the events was unknown.
Since the second shot I have had a continuous ringing in the back of my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 16:30 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Administration time: 04:45 PM, Vaccine location: Left arm, Lot unknown reason: Unable to locate or read the details), administration date: 25Jul2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 16Aug2021 04:00, outcome "not recovered", described as "Since the second shot I have had a continuous ringing in the back of my head". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Facility type vaccine was reported as pharmacy or drug store. The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.