chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right facial droop and left upper and lower extremity involuntary movements that started approximately 10 days after second dose of Pfizer vaccine. Patient was referred to neurology and movement specialist. He was started on Risperidone which resolved his symptoms. He has now been off of Risperidone for one week and symptoms remain resolved.
Allergic reaction, pressure in chest, difficulty breathing, sinus congestion - most symptoms passed in 24 hours.
Initial unsolicited report received 13 November 2014 from a consumer, who is also the patient. A 72-year-old male patient, with a history of chronic urticaria and "hyperactive immune system", received an intramuscular left deltoid injection of FLUZONE HD, (lot number not reported) on an unspecified date in November 2014. Concomitant medications included an EPIPEN. One day after vaccination, the patient reported redness and swelling of the left deltoid. One to two days after that, he developed hives on his buttocks and swelling of the right side of his tongue. He was treated with BENADRYL. He also reported that since vaccination (date not specified), he had been experiencing a stiff neck with swelling at the back of his neck to the base of his skull. He was seen by a physician and sent for an MRI, which revealed inflammation/infection between T2 and T3. Further follow-up was scheduled. The patient had not recovered at the time of the report. Documents held by sender: None.
Slight swelling at injection site. Painful when touched. No general fever, or general symptoms, all local to the site. Patient took Advil and iced the injection site.
Swelling, itching and redness and soreness on left arm at injection site as well as a swollen lymph node near left clavicle.
Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as 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 INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster).    No concomitant medications were reported.  It was reported that, booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   The reporter reported that, they could not give Moderna as a booster starting 31-Aug-2022, but they administered monovalent doses as boosters.  No treatment medications were reported.
Due to transition of care, patient erroneously received two doses of high dose influenza vaccination approximately 1 month apart.
NONE, PT RECIEVED VACCINE THAT WAS BEYOND USE DATE.  ON DAY 34 IN FRIDGE INSTEAD OF RECOMMENDED DAY 31
Loss of appetite; Nausea; Muscle weakness; Got very depressed; Really sick / Not feeling well; Soreness at injection site; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and fever. On 8th August 2019, the patient experienced appetite lost, nausea, muscle weakness, depression and feeling unwell. On an unknown date, the outcome of the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The reporter stated that, the patient experienced soreness at the injection site and a low-grade fever on day of reporting, but nothing more severe than that. On 8th August 2019, 27 days after vaccination, the patient got really sick with a fever, loss of appetite, nausea, severe muscle weakness, and got very depressed. The patient still had some muscle weakness and her "appetite was not back," but the depression was somewhat better. The patient did not feel good this past weekend. The reporter consented to follow up.
After 1st dose, patient says she had pain for 2 weeks & fever for 1 week.  She took tylenol to help with symptoms.
Patient received Moderna COVID-19 vaccine that underwent a temperature excursion; Patient received Moderna COVID-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 037F21A, 022M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The temperature in the refrigerator where the Moderna COVID-19 vaccine was kept was reached 13.1 degrees Celsius on 28-Jun-2022. On 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions.  The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found after a review of the temperature datalogger on the refrigerator, where the Moderna COVID-19 vaccine was stored.  The reporter used the online temperature excursion tool and was comfortable that the dose which was received by the patient was valid and the affected vaccine was viable for future doses.  It was unknown if the patient had side effects after any dose.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611891  Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611891:Master case
Within 15 minutes of getting the shot I felt light-headed and a little sick. Within 2 hrs. I could barely lift my arm. The sick feeling and pain and swelling at the injection site continued into that evening. I then slept for 10 hrs., something I never do. The following day (yesterday) I still felt very lethargic and slept 5 hrs. more that afternoon. Today, October 8 I feel somewhat better as is my arm but still totally exhausted.
A LITTLE ACHES; This spontaneous report received from a patient via a social media through company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s. (suspension for injection, route of admin, batch number and expiry date not reported) (dose number in series 1) 01 in total administered, dose was not reported for prophylactic vaccination on an unspecified date. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown), (dose number in series 2), 01 in total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had a little aches but she was good (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little aches was not reported (dose number in series 2). This report was non-serious.
fever for two days ( 101,6 ), always sleepy, pain in left shoulder. This was the second shot.
Kinrix administered to a 15 month-old; Received Kinrix instead of Hiberix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 12-Jan-2023 Reporter's comment: The reporter would like more information on what to look for and how to proceed. The medical information phone number and warm transfer were provided. Additional supportive information: The patient received Kinrix instead of Hiberix in the left thigh at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Coughing low fever, headache, body achy, hoarseness, tired, sinus drainage.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown ages. On an unknown date, the "unknown number of patients" may have received VARIVAX (Merck) (dose, duration, indication and lot number were not provided). No concomitant medications were reported. The reporter stated that the "unknown number of patients" may have received VARIVAX (Merck) that had multiple excursions possibly due to defrost cycles. No adverse effects reported. Additional information has been requested.
Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component; Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number XL7RB, expiry date 05-AUG-2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-JUN-2023 Clinical Supervisor/medical assistant called to inquire how to proceed. Supervisor reported a patient was inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component on an unknown date. Supervisor confirmed this was an attempt at the first dose of Shingrix.  Also mentioned they were they are still investigating so unable to provide any patient details.  Did not consent to follow-up.  HCP declined follow-up from safety.
SEVERE VOMITING, NAUSEA, SORE THROAT, FEVER, SWOLLEN LYMPH NODES
On 11/23/00 at 03:00, woke up with sharp muscle pain in legs/feet, also has muscle pain in trunk, shoulder, arms and neck. Injection is red, warm and hard. No fever. Treatment included ice, heat, Advil and Benadryl with minimal relief. Still experiencing symptoms.
left shoulder and neck muscles were incredibly tight; left shoulder and neck muscles were incredibly tight; left shoulder and neck muscles were incredibly tight and were restricting movement; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 32-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included ADHD, oral herpes. Concomitant medications included methylphenidate hydrochloride (RITALIN), valaciclovir hydrochloride (VALTREX), lysine (L-LYSINE), and calcium pantothenate; nicotinamide; procaine hydrochloride; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride (VITAMIN B COMPLEX) and FIS; all from an unknown date for an unspecified indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 05:00, the patient experienced left shoulder and neck muscles were incredibly tight and were restricting movement. Patient took 800mg of Ibuprofen to try to soften the side effects 18 hours after the injection, and it was not changing anything. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events was resolving.    No follow-up attempts are needed. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added. In addition, concomitant medication: "vitamin b complex" and events "left shoulder and neck muscles were incredibly tight and were restricting movement" were recoded.   No follow-up attempts are needed. No further information is expected.
Per parent report, fever 101-102 started the evening of 6 mo vaccines and continued every day until incident 8/22/17 with no other symptoms. Evening of 8/22/17 pt felt normal then had a <1 min. episode of staring/arm shaking/breath holding followed by a period of sleepiness/lethargy. Event is consistent with a simple febrile seizure followed by a post-ictal period. On arrival to ED, temp 103, normal CXR, O2 sak 100%, normal exam. Discharged to home. Examined by myself (Dr.) the following morning (8/23/17). Normal temperature and exam in clinic. CBC normal except mildly low platelets (105).
Post/vax, pt walked about 10 ft & fell to floor. His back arching, fists clenched & appeared to be in posturing pos, unresponsive to name. Then pt started responding, color pale but no complaints of pain or discomfort. Pt left doing fine.
Expired MMRV given . Messaged Mother to: schedule immunization appointment to repeat dose or may obtain a MMRV titer if desired
Varicella received 4/5/17. Area has erythema and edema approx. 10 cm in diameter with few papules at touch. Warm to touch and slightly tender. Reaction vs cellulitis ?
Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 28-JAN-2013, had been administered a dose of GARDASIL exposed to temperature of 11 C (lot number 672834/0131AE, expiration date 16-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information about the patient´s medical history, concurrent conditions and concomitant medications was provided. On 06-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB, intramuscular for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved.
Chronic hives as determined by my Primary Care doctor and an allergist. I have now been experiencing them for over a year and have to take Xyzal  and Pepcid every night otherwise they itch like crazy. Despite taking over the counter meds and them temporarily helping to prevent the itch, hives still appear randomly throughout my body during the day.
Heavy heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heavy heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced TACHYCARDIA (Heavy heartbeat). At the time of the report, TACHYCARDIA (Heavy heartbeat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow up received contains no new information.
Pt presented with lingering mild cough and dyspnea after his home diagnosed COVID-19 from 2 mos prior, that seemed to improve with his Moderna vaccine series 2/23/21 and 3/23/21. But he also had new LUQ abdominal pain and painful breathing. On exam he had a firm tender enlarged spleen versus several cm abdominal mass. WBC was > 185, 000, peripheral smear (by lab director) was "full of blasts". I sent patient same day to ER, he was admitted, prelim diagnosis: CML, awaiting pathology results but has started chemortherap as of today (4/19/21).
Developed Arrhythmia in pattern of Bigeminy and mild to moderate Left Ventricle Hypertrophy
Case number PHEH2011US03633, is an initial spontaneous report received from a medical assistant on 07 Sep 2011 with follow-up received on 18 Oct 2011: This report refers to a child female patient. She was administered only the MenCWY liquid conjugate component of MENVEO (batch number X10059) without being reconstituted with the MenA conjugate component, intramuscularly into right deltoid on 30 Aug 2011. She was also vaccinated BOOSTRIX into left deltoid on 30 Aug 2011. No adverse event occurred following this administration. Follow-up report received on 18 Oct 2011: Concomitant vaccines and patient demographics updated.
low fever; pain; redness; had a bit of bruising; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 3 weeks after receiving Shingrix, the patient experienced fever, pain, erythema and contusion. On an unknown date, the outcome of the fever, pain, erythema and contusion were unknown.   It was unknown if the reporter considered the fever, pain, erythema and contusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age grp was selected as an adult as per indication. The patient got of Shingrix vaccine about three weeks ago. The patient had the normal side effects of pain, low fever and redness. The patient also had a bit of bruising.
A non-serious report of conjunctivitis was received from a nurse concerning an eight-year-old male.  No medical drug or drug history was reported for this patient.  The patient received FluMist at 6pm on 12-Dec-2007.  Within eight hours of receiving the FluMist, the patient had severe conjunctivitis, with intense redness of sclera and purulent drainage from both eyes.  The outcomes for the reported adverse events were not reported.  Additional FluMist dosing is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
swelling redness warm to touch moved from injection sit to a large fluid filled bump on inner elbow
Onset of swelling, pain, color change to right lower extremity on 6/30/2021.   Presented to office for evaluation and to establish care on 9/13/2021
head congestion, swelling in throat, chills, fever 99.5, generalized, malaise, myalgias, arthralgias beginning 2-3 hr p/vax;
pt recv vax 20OCT98 & 25OCT98 pt exp edema of both legs, periorbital edema & nephrotic synd;As of 24NOV98 pt not yet recovered;
Information has been received from a physician and the office manager concerning an 18 weeks old female patient who on 10-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Patient developed a rash/swelling on her face and trunk the day after receiving 2nd dose of Pfizer vaccine. She did not contact the pharmacy until 02/05/2022. At that time, the rash and swelling resolved. She also stated she had a feeling of high heart rate. Patient does not have a PCP but advised to see a physician. She, however, has not as of this time.