chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 21, 2021, I woke up with severe swelling in muscles, joints, ligaments.  This condition has lasted till present, although the severity varies.  My primary, NP ordered blood tests that ruled out a number of possible conditions.  She theorized that either I was suffering from acute osteoarthritis,  a reactivation of my chronic Lyme caused by the vaccine, or a reaction to the vaccine itself.
On 5/5/00, the pt received her 1st dose of Lymerix. She received her 2nd dose on 6/6/00 and 4 days, post vax of 2nd dose, on 6/11/00, she had a positive home pregnancy test. Date of LMP and expected date of delivery were not specified. The most recent information received on 6/12/00, reports the outcome of the pregnancy as unknown.
Since I received the second shot on 5/11/2021 I've had soreness in my upper arm where the injections where. It has not stopped during this time, some days are worse than others, some days it's barely noticeable and other days it hurts to use that arm. It doesn't feel like a muscle strain, it feel burning and tender to the touch.
is really messed up and never felt like this before and feeling so bad; blurry vision; neck is so stiff now; left shoulder is blueish; left arm pain; legs feel like dead weights; he can hardly walk at all; unbelievable extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (unbelievable extreme dizziness), FEELING ABNORMAL (is really messed up and never felt like this before and feeling so bad), VISION BLURRED (blurry vision), MUSCULOSKELETAL STIFFNESS (neck is so stiff now) and SKIN DISCOLOURATION (left shoulder is blueish) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (unbelievable extreme dizziness). On an unknown date, the patient experienced FEELING ABNORMAL (is really messed up and never felt like this before and feeling so bad), VISION BLURRED (blurry vision), MUSCULOSKELETAL STIFFNESS (neck is so stiff now), SKIN DISCOLOURATION (left shoulder is blueish), PAIN IN EXTREMITY (left arm pain), LIMB DISCOMFORT (legs feel like dead weights) and GAIT DISTURBANCE (he can hardly walk at all). At the time of the report, DIZZINESS (unbelievable extreme dizziness), FEELING ABNORMAL (is really messed up and never felt like this before and feeling so bad), VISION BLURRED (blurry vision), MUSCULOSKELETAL STIFFNESS (neck is so stiff now), SKIN DISCOLOURATION (left shoulder is blueish), PAIN IN EXTREMITY (left arm pain), LIMB DISCOMFORT (legs feel like dead weights) and GAIT DISTURBANCE (he can hardly walk at all) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  He had taken two aspirin for his arm pain.   This case was linked to US-MODERNATX, INC.-MOD-2021-090270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090270:dose 1
PATIENT STATED 8 DAYS AFTER RECEIVING VACCINE SITE BECAME ITCHY RED AND WARM TO THE TOUCH. STATED TODAY (2 DAYS AFTER ADVERSE REACTION STARTED) SITE IS NO LONGER ITCHY BUT STILL A LITTLE RED. STATED SHE THOUGHT AT FIRST IT WAS AN INSECT BITE. CALLED DRUG COMPANY AND WAS TOLD REACTION CAN TAKE PLACE UP TO 7 DAYS AFTER VACCINATION AND IT NON-LIFE THREATENING, BUT COMMON REACTION TO VACCINE. RELAYED THAT TO THE PATIENT.
tested positive for COVID in Aug 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID in Aug 2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031h21a, 043l20a and 037k20a) for COVID-19 prophylaxis.     It was reported that patient had no allergies.  Previously administered products included for Product used for unknown indication: FLU vaccine. Past adverse reactions to the above products included No adverse event with FLU vaccine. Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (tested positive for COVID in Aug 2022). At the time of the report, COVID-19 (tested positive for COVID in Aug 2022) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information provided.   This case was linked to MOD-2022-690232 (Patient Link).
Patient received vaccine at approximately 12:30 pm. At approximately 12:32 pm patient experienced brief moment of syncope and light headedness. Patien'ts father had him lay down and then was moved onto a cot. Feet were elevated and patient was given Caprisun drink. At approximately 12:40 RR 15, P 89 and 98% O2 Sat. BP 90/55. At 12:45:  BP 90/66 P 72 99% O2 Sat. At 12:55 BP 90/60 and patient's mother reported his baseline as of March 2020 being of similar pressure. Body temp was noted at 98.6 F. Patient had feet support removed and slowly patient sat up on cot. He was given a second Caprisun when he was able to sit up fully on his own power, and given additional water when able to stand. At 1:10 pm patient was released with his parents and able to leave the clinic.
could not lift arms above her shoulder; still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift arms above her shoulder) and ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]), ENALAPRIL MALEATE (LOTRIL [ENALAPRIL MALEATE]) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift arms above her shoulder). The patient was treated with Physical therapy (Ice pack) for Arthralgia. In June 2021, ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) had resolved. At the time of the report, MOBILITY DECREASED (could not lift arms above her shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-138290 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-Significant Information. On 20-Jul-2021: Concomitant Product updated, Event outcome updated.
10year-old male patient who yesterday (March 31st 2021) received Kinrix by error; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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 10 year patient received Kinrix by error, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    No concomitant and treatment medication was reported. HCP wanted to know if these patients could receive the Moderna bivalent booster shot after this incorrect dose, and how long should they wait to receive it. HCP stated that she would send the patient identifiers via email.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master
Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored VARIVAX (lot # L000456, expiration 06-JAN-2017; lot # L008269, expiration 11-MAR-2017; lot # L015045, expiration 29-APR-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA013229: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501:
On 2/17/2021 I received my first dose of Pfizer Vaccination in my left arm. On 2/26/2021, I woke up with a swollen neck and a golf ball sized mass near my lymph node on the left side of my neck. I immediately went to an Urgent Care, who prescribed antibiotics and had an Ultrasound conducted on 3/1/2021, with inconclusive results.  On 3/18/2021, I had a MRI of my neck, which resulted in the neck mass being possible malignancy and metastasis (cancer). On 3/28/2021, was admitted to hospital due to neck mass increase in size and symptoms getting worse. CT scan also stated the neck mass as possible malignancy, head and chest were negative. 3/29/2021, hospital conducted an IR biopsy, which resulted in negative for malignancy. 3/30/2021, I was released from hospital. On 4/2/2021, I went to the Emergency Room due to symptoms getting worse. 4/2/2021, had a CT conducted that stated possible malignancy and had a scope of my throat with negative results. On 4/5/2021, hospital conducted an IR Biopsy which resulted negative for malignancy, however favoring inflammation and an abscess. On 4/15/2021, symptoms got worse and fluid was able to be drawn from the neck and sent to the lab, with negative results. On 5/3/2021, surgery was conducted to remove the lymph node and the mass in the neck. Neck Mass was biopsied, was negative for malignancy and negative for infection. On 5/13/2021, hospital Infectious Disease Division, stated the COVID Vaccine could have triggered an immune response, which contributed the issues I was having. On 5/17/2021, Infectious Disease Division conducted more test and blood work for various infections, which all had negative results.
1st dose on 2021, never received the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 15 Jul 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 13-Oct-2022 Reporter's comment: The pharmacy technician reported that the patient received first dose of Shingrix series. The patient never received the second dose.  The reporter did not have the lot number and expiration date information for the first dose. At the time of reporting, the second dose was not administered.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
After the second shot I developed extreme insomnia and anxiety and was functioning on very little sleep. I then developed a very strange shortness of breath and was misdiagnosed at first doctors visit with perimenepausel anxiety. A few later I started retaining water in my legs and went to urgent care at the advice of my doctor since she had no appointments asap.
patient received Gardasil 9 several years ago and is now back at the pharmacy to complete the series; This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date (reported as several years ago), the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, (route of administration, lot # and expiration date were not provided) for prophylaxis. On 18-DEC-2020, the patient went back to complete the series and was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. The outcome of inappropriate schedule of product administration is unknown.
1 month following 1st gardasil injection patient reports muscle weakness or pain, non-progressing. Also c/o fatigue.  Medical records received DOS 5/27/09 to 6/16/09. Assessment: Acne vulgaris, fatigue, multiple joint arthralgia, acute bronchitis, acute pharyngitis. Patient presents with acne, generalized fatigue, muscle cramping all over, pain multiple joints, oral contraceptives.  ICD-9 Codes: 706.1, 780.7, 719.49, 466.0. 462, V72.3
No additional AE reported; Pharmacist was aware that the vial should contain 0.5 mililiters for a full dose, so decision was made not to vaccinate patient; Pharmacist was aware that the vial should contain 0.5 mililiters for a full dose, so decision was made not to vaccinate patient; Pharmacist withdrew solution from involved vial and found that it measured just over 0.3 milliliter in her syringe. Pharmacist was aware that the vial should contain 0.5 mililiter for a full dose; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, the patient was supposed to receive a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 milliliter (one vial), lot # T024556, expiration date 08-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The pharmacist withdrew solution from the involved vial and found that it measured just over 0.3 milliliters in her syringe. The reporter was aware that the vial should contain 0.5 milliliters for a full dose, so decision was made not to vaccinate the patient and instead, the solution was returned to the vial (underfilled vial). No other defects were noted by pharmacist.   The reporter stated that the rubber stopper was present and it did not appear to be protruding from the vial, it was flush like normal. The crimp (metal seal) was on tightly and properly and there was no evidence of cracks or breakage on the vial. There was no leaking noticed and the reporter also noted that there was no residue of any past leakage. The vial flip cap was in place when received, but was removed when withdrawing contents. There was no evidence that the stopper has a puncture mark. The pharmacist stated, that the meniscus of liquid was at bottom of label; the reporter had to slightly peel label to view liquid level. At the reporting time, the pharmacist did not have any other vials to compare to. The vial was determined to be underfilled after withdrawing the contents with a syringe; the vial appeared to be underfilled by about 0.2 ml per calculation. The pharmacist used 3 ml syringe (BD Precision Glide Luer-Lock Syringe), 25 gauge. The pharmacist also had another pharmacist withdraw the solution with a different syringe/needle (of same manufacture) and found the same result. The vial was inverted while withdrawing the solution. The entire volume in the vial could be removed. Prior to withdrawing, an equal volume of air (0.5 ml) was injected to the vial. No pressure or resistance was noticed when withdrawing the product in that the product sprayed out of needle insertion site or from around the crimp and stopper.   No adverse event (AE) was reported.
Very red all around arm and swelling, skin very tight and hot. Later that night a blister formed in the injection sight and then other blisters kept forming.
March 1 first injection. March 3rd I had an emergency surgery for a knee injury that occurred on March 1, slept most of the day and the entire night without my CPAP. The day after surgery I started experiencing intermittent  palpations for several days before subsiding. March 26 had second injection. 2 1/2 hours after injection started experiencing palpations intermittently throughout the weekend and on the Monday morning became lightheaded and dizzy with an increased heart rate (114) and bursts of rapid palpations, & LLE edema. Unsure if the edema was related to the vaccine or the knee surgery. No lower extremity edema was present 2 days post-op. Sent to ER
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Varicella vaccine 1/17/12. Pt went to ED for "spider bites" on 1/28/12. He had 3 pox 2 on his left leg & 1 on his trunk. Spoke to mom today, resolving.
Myalgia, Fever, Diarrhea, NauseaVomiting, Fatigue Narrative:
Moderna vaccine first dose. Almost immediately after receiving immunization, experienced rapid heart rate and hot temperature/flushing that last around 30 seconds before decreasing. No further adverse reactions other than moderate sore arm pain.  Never had a reaction like that to a vaccine before Moderna.
I got the chills; sore arm at injection site; general fatigue; aches; fever of 100.4; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 at 09:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation at clinic. Medical history included hypertension from an unknown date and unknown if ongoing, glucose tolerance impaired from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. The concomitant medication within 2 weeks of COVID-19 vaccination included Prescription medication; diet supplements. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 04Feb2021 at 15:30 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No Known allergies were reported. On 26Feb2021 at 12:30, the patient experienced I got the chills, sore arm at injection site, general fatigue, aches, fever of 100.4 units unspecified. Only lasted that one day. The patient underwent lab tests and procedures which included body temperature was 100.4 units unspecified. No treatment was received for the events. The outcome of the events was reported as resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.