chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling and numbness in the injection arm (left arm); tingling and numbness in the injection arm (left arm); This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1086, expiration date: Mar2021), via an unspecified route of administration in the left arm on 04Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 04Jan2021, the patient received the COVID vaccine 30 minutes ago then the patient started having tingling and numbness in the injection arm (left arm). She wanted to know if this has been reported and how long will it last. Outcome of the events was not recovered.
COVID arm; Visible bulge under arm; Super hot; Arm Pain Killing me; Redness around the injection site; Swollen lymph nodes under the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Sulfa drugs). Concomitant products included METFORMIN, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm). On an unknown date, the patient experienced INJECTION SITE RASH (COVID arm). At the time of the report, PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site), LYMPHADENOPATHY (Swollen lymph nodes under the arm) and INJECTION SITE RASH (COVID arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Mammogram: inconclusive (Inconclusive) False results were shown indicating Lymph node cancer. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) Radiologist confirmed it was not cancer and was due to the COVID-19 shot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
Rash at injection site appeared 7 days after vaccination. Lump in left armpit 6 days after vaccination.
Product Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 55RY7, expiry date 17-OCT-2025) for prophylaxis.   On 26-JUN-2023, the patient received the 2nd dose of Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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 Information: GSK receipt date: 26-JUN-2023 Vaccine Coordinator stated that Boostrix was exposed to 15.6 F and administered to a patient.  The reporter requested to follow up via email as he/she did not verify the correct mailing address.  The reporter did call back to try and get it but unable to reach HCP. The reporter consented to follow up. The nurse reported a patient was inadvertently administered the Boostrix vaccine following a temperature excursion, which led to incorrect storage of drug. This case was found as duplicate of case US2023088673. All the information from the case US2023088673 was merged into this case. The case US2023088673 was deleted and this case stand as case of record for this patient.
Doc. varicella lesions feet, ankle, abd. Fever onset 7/16/12. Tx - monitor sxs - no meds.
This spontaneous report as received from a healthcare worker referred to a 67 year old female patient with a history of having fever blisters and with drug reactions/allergies to penicillin. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (1 vial, subcutaneous, lot#, dose/frequency were unspecified). Patient developed "fever blisters" on her lips on 16-MAR-2013 after receiving a dose of ZOSTAVAX. Patient had sought medical attention via seeing the physician. No lab diagnostics studies were performed and no treatment was given for the event. The outcome of "fever blisters on her lips"was reported as not recovered. Drug relationship was not provided. Additional information has been requested.
client reported next day woke up to feeling generalized body aches, sinus pressure/headache, feeling warm breath. temp at reporting time was 97.2 oral
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. Total 77 Monovalent doses were administered after the BUD to patients 12 and up.37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.
expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M204 and 010L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of Gardisil vaccine (yeast). The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." At the time of the report, the patient's outcome was unknown. Additional information has been requested.
several people I had known who got the shot, developed shingles anyway. those who contracted shingles after having the shot were probably given the live virus/Suspected Vaccination failure; developed shingles anyway; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this reported. The reporter put off himself/herself getting the shot, as the reporter knew several patient's experienced shingles after getting shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with case US2021AMR178371, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178371:Same reporter
A spontaneous report was received from a consumer who experienced sore arm, low-grade fever, headache, nausea and felt ill. The patient's medical history included anxiety.  Products known to have been used by the patient, within two weeks prior to the event, included vitamin D, ethinylestradiol norethisterone acetate and sertraline. On 31-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient received her vaccine on 31-Dec-2020.  She reported a sore arm that resolved on 02-Jan-2021 (onset date/time not disclosed).   On 09-Jan-2021, approximately ten days after receiving the vaccine, she experienced low-grade fever, headache, nausea and felt ill.  AS of 10-Jan-2021, patient stated that she felt better. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events, sore arm, low-grade fever, headache, nausea and felt ill, was not provided. The event, sore arm, was considered recovered/resolved on 02-Jan-2021. The events, low-grade fever, headache, nausea and felt ill, were considered recovered/resolved on 10-Jan-2021.; Reporter's Comments: This case concerns a 31-year-old female who experienced NS events of unexpected malaise and expected pain in extremity, headache, pyrexia, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Awoke on 1/29/21 with dizziness and fatigue, which interfered with daily functioning and led to some lost time at work.  Ibuprofen taken, but no further treatment.  Resolved by midday.
This case was reported by a healthcare professional and described the occurrence of diarrhea in a 32-year-old male subject who was vaccinated with TWINRIX for prophylaxis. On 14 September 2006 at 10:00 am. the subject received the 3rd dose of TWINRIX in the right arm. On 14 September 2006 at approximately 3:00 pm, 5 hours after vaccination with TWINRIX, the subject experienced diarrhea. The subject was seen at a physician's office and was treated with anti-diarrheal. The outcome of the event was not reported.
Maybe taste affected; Chills; Pain in joints and muscle; Pain in joints and muscle; Eyes aching; This is a spontaneous report from a Contactable (patient). A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:15 (Batch/Lot Number: EL9269) (at the age of 69 years) as dose number unknown, single for covid-19 immunisation. Medical history included major anxiety and depression, aortic valve regurgitation, bladder disorder (taking Botox for bladder problems), multiple sclerosis, hypersensitivity, all from an unknown date and unknown if ongoing. No other vaccine in four weeks. Concomitant medications included fluoxetine; duloxetine; trazodone; pantoprazole; metformin hydrochloride (METFO); all taken for an unspecified indication, start and stop date were not reported. The patient experienced maybe taste affected, chills, pain in joints and muscle, eyes aching, all on 24Feb2021 with outcome of not recovered. It was unknown if treatment was received for events. No COVID prior vaccination and patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Anxiety; Irritability; high or low mood; feeling restless; changes in sleep habits; loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; IRRITABILITY (non-serious), outcome "unknown", described as "Irritability"; MOOD ALTERED (non-serious), outcome "unknown", described as "high or low mood"; RESTLESSNESS (non-serious), outcome "unknown", described as "feeling restless"; SLEEP DISORDER (non-serious), outcome "unknown", described as "changes in sleep habits"; DIARRHOEA (non-serious), outcome "unknown", described as "loose stools".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at 0800 on 1/12/21. First symptom was on 1/12 at 2000 when I had a headache and malaise so I went to bed early. Woke up at 0200 on 1/13 with nausea, body aches and chills. My temp felt fever-ish (100.4 via temporal scan). So I took Tylenol and Pepto to go back to sleep. Same symptoms carried throughout the morning of 1/13. By noon 1/13 = my L arm where the injection had occurred was swollen, painful and hard to move. That evening I had a presyncopal event where I felt flushed and nearly passed out. My L arm continued to hurt but the swelling moved down into my lymph nodes where lymphadenopathy continues to be a problem until now.
Severe body rash on both arms, wrist to shoulder. severe body rash on partial trunk, left leg, chest, breasts and face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 06Apr2021 at 13:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 16Apr2021, the patient experienced severe body rash on both arms, wrist to shoulder, on partial trunk, left leg, chest, breasts and face. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body rash on both arms, wrist to shoulder, on partial trunk, left leg, chest, breasts and face was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Slight headache; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced slight headache on an unspecified date with outcome of recovered.    Information about Lot/batch number has been requested.
25 days post vax pt experienced lid edema and urticaria (upper arms, chest, shoulder). The duration of the symptoms are stated as 3 months. Treatment consisted of Lisino Apis D30 and Sulfur D30 but without lasting effect. After Influenza C30 was administered 01/21/1999 the symptoms increased then completely abated. It is also stated that 2 weeks post vax severe herpes labialis occurred along with lid edema and nettles which increased with cold and sleep, with intense.
Fever, nausea, vomiting, stomach upset - kidney "shut down" - unable to urinate - excessive sweating
PT COMPLAINED OF RASH AND SWELLING OF ARM FROM COLLARBONE DOWN TO 2 INCHES ABOVE ELBOW THAT DEVELOPED A FEW HOURS FOLLOWING VACCINATION. PT PRESENTED TO PHARMACY 48H AFTER VACCINATION; RASH AND SWELLING HAD GONE DOWN (PER PT) WITH ICE APPLICATION, BUT WAS STILL EVIDENT.
Tested positive for covid-19 on June 6, 2022.  Heavy nasal congestion for two days or so.  Isolation for 10 days.
Rheumatoid Arthritis, Arthralgia, Back Pain. This report described the occurrence of a burning sensation in a male patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. Medical records were subsequently provided. The patients medical history included trauma to different joints and rotator cuff problems, atypical chest pain on exertion (first reported on 08 march 2001 and noted to be "Resolved" on 03 may 2001), dyspnea on exertion (first reported on 08 March 2001). Concurrent medications included atorvastatin (Lipitor). The patient received injections of LYMErix on 04 April 2001, 07 May 2001, and 04 April 2002. On 04 April 2001, the patient also received his first dose of hepatitis B vaccine (manufacturer unknown). His second dose was received on 04 May 2001 and his third dose on 04 October 2001. On 03 September 2003, the patient's attorney alleged that the patient "suffered burning of the forearms, swelling of his wrist, hand, fingers and ankles, pain in his shoulders, legs, back and feet beginning one to two weeks after his second (LYMErix) vaccination according to the client." Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. The patient was evaluated by a rheumatologist on 26 march 2002, for intermittent joint pain and swelling primarily of the wrists and hands. The pain was described as a burning sensation that lasts approximately one week. The patient had diffuse swelling of both hands (including digits) and had decreased range of motion in wrist with flexion and extension. There was no warmth or erythema noted. The clinical impression was that the patient either had arthralgia possibly due to an inflammatory process, or that he had an auto-immune disorder, or possibl a "Lyme vaccine induced syndrome". He was placed on Celebrex. The joint swelling subsided but he continued to have aches and pains and morning stiffness. The patient was subsequently diagnosed with rheumatoid arthritis on the basis of red, hot, swollen and painful fingers, hands, painful knees and painful feet. His rheumatoid factor was "extremely high" manifested by value of 1410 IU/L (upper limits normal 20), his HLA B27 was negative, antinuclear antibody was negative, C-reactive protein was normal, sed rate was normal, and he had a negative Lyme titer. X-ray of hands was normal and he was placed on methorexate. Within five weeks, he improved significantly and has been maintained on 15 mg of methotrexate weekly.
Body and muscle pain, joint pain, nausea, headache, taste change, fatigue, body weakness
Extreme fatigue starting approximately 18 hrs after vaccine and continual for 17 days now.  Double the amount of stools per day and softer than usual continual since vaccine. Widely fluctuating temperatures since ranging from 94.6 through 101.6. Can't maintain consistent temperature. Stabbing headache on days 15 - 17.  Clicking sound frequently while talking either in back of throat/sinuses (I can't tell where it is coming from, a couple days after vaccine given and continuing.
Starting about 48 hours after receiving the vaccine, I started having really having bleeding early in the morning. I had just finished my period less than a week before (maybe a couple of days previously). It was extreme bleeding and lasted for about 10 weeks (end of June). I was going through the largest sanitary pad size in about 45 min. Right at the point where it started to taper off, my doctor almost wanted me to be hospitalized due to the severe bleeding and anemia. She thought that this heavy bleeding episode was likely caused by the vaccine. I started a prenatal vitamin and iron supplement to help my body during the episode and stopped when the episode was over.
Approx. 1 inch area of redness, itching & tiny bumps around varicella injection site. Swelling started at day 7 following vaccine. Mom called to report on day 11 & site still getting larger.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 22-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD (dose and route unknown; lot # L023114 with 24-DEC-2016) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Patient had 1st dose of pfizer and 45-60 minutes later had anaphylaxis in which an epipen was administered. Patient was taken via ambulance to The hospital