chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain, stiffness and joint swelling (hands and lower legs ); pain, stiffness and joint swelling; pain, stiffness and joint swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 08Aug2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bilateral Carpal Tunnel Syndrome" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Recurrent Headache" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "Chronic pain of multiple joints" (unspecified if ongoing); "Trigger Ring Finger of Right Hand" (unspecified if ongoing). Concomitant medication(s) included: TORSEMIDE; FLONASE [FLUTICASONE PROPIONATE]; PROPANOLOL HYDROCHLORIDE. Past drug history included: Erythromycin, reaction(s): "Known allergies". The following information was reported: ARTHRALGIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "pain, stiffness and joint swelling (hands and lower legs )"; JOINT STIFFNESS (non-serious), JOINT SWELLING (non-serious) all with onset 05Sep2021, outcome "not recovered" and all described as "pain, stiffness and joint swelling". The events "pain, stiffness and joint swelling (hands and lower legs )", "pain, stiffness and joint swelling" and "pain, stiffness and joint swelling" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia, joint stiffness, joint swelling. Additional information: If Covid prior vaccination: No, If covid tested post vaccination: No, If other vaccine in four weeks: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax; mom noted redness,induration & warmth on outer aspect of lt thigh;19apr95, mom took pt to clinic;at this time redness,induration & warmth was in inner aspect of thigh & approx 4" in diam; to cont apap;to PED for further advice
Product storage error; No adverse event; 14 of February around 10 o'clock AM which was administered expired February 13, 2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 of February around 10 o'clock AM which was administered expired February 13, 2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Feb-2023 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (14 of February around 10 o'clock AM which was administered expired February 13, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 of February around 10 o'clock AM which was administered expired February 13, 2023), PRODUCT STORAGE ERROR (Product storage error) 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 (14 of February around 10 o'clock AM which was administered expired February 13, 2023) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication information provided. It was reported that in their internal system it kicked back and it said that vaccine was expired 13-Feb-2023. Vaccine was properly stored in the freezer up until the date of administration.  No treatment information provided.
1 week post injection still having progressing generalized muscle pain and weakness especially over shoulders and arms. On day 4 developed Achilles tendonitis R foot as off this report date having generalized inflammation  and weakness-this is now 6 days post injection and trouble sleeping. Also experiencing episodes of hand tingling and numbness
1540-Vaccine administered at pharmacy 1600-Onset of dizziness, facial numbness 1605-Numbness bilat. hands, decreased capillary refill >6 seconds, decreased sensation bilat. arms, flushing in face/warmth-speaking with co-worker ACNP (home at this time) 1608-Took 50 mg Benadryl PO, 10 mg Pepcid PO, and 4 mg methylprednisolone PO 1615-Increased HR from 84 to 110 bpm continued dizziness and numbness. No pain, redness, or itching at injection site. 1630- HR 86-numbness in hands, arms, and noted in bilat. feet, delayed cap refill all extremities. Got into warm shower to improve circulation, laid down dizziness continuing. 1735-Tingling/vibrations in hands and feet, decreased dizziness. Temp 99.4 HR 105 1915-Dizziness resolved, feeling in lips returned with pulsating sensation, feeling returned bilat. arms with aching noted. HR 108. Tingling in fingers, toes remains. Cap. Refill returned < 3 seconds. 1947-Mild headache
Headache, Myaglia, fatigue Narrative:  missed work following second dose due to symptoms
Pt inadvertently given Moderna vaccine when first dose was Pfizer. Site lead notified. Pt observed for 15 minutes. No immediate reactions noted.
Patient developed and kept low grade fever x 1 week past administration of MMR vaccine. CBC was done.
Right eye watered non stop for 3 hours. 30 mins after injection. Got nauseous and dizzy.  A couple days after shot I got a rash on my right arm wrist and hand and on both legs. I took Benadryl for a week to get the rash to go down and not scratch. Which made me sleepy and useless.  Moderna shot
PATIENT DEVELOPED A RED RASH AT THE INJECTION SITE DAYS AFTER THE VACCINE. THE RASH HAS BEEN OCCURRING INTERMITTENTLY SINCE VACCINE ADMINISTRATION.
Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot   on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
Gallbladder, appendix enlarged and removed, enlarged liver, small intestines, and stomach, severe abdominal pain.
chills-t103.8 oral w/joint aches, twitches of limbs, 6 hrs p/vax; vomiting started following day 10AM, no appetite, diarrhea on third day, had tiny red dots on skin around & under eyes & to the hairline & red flat dots around inject site;
Verbalizing soreness to (L) arm area where vaccine was administered. States it has been sore since she received vaccine and it has not been resolved. Client has ROM in arm. No weakness, numbness or tingling reported. Pain is a 7-8 on scale of 0-10. Did not take pain meds till 11 days after receiving vaccine.
Patient reported feeling flushed during observation period.  Pt. gets anxious with shots and has chronic HTN.  Pt. was hypertensive.  Pt. stated she felt better and was advised to go home and relax, check BP when rested, and check with primary care provider.  If needs emergent attention go to nearest ER.
Information has been received from a registered nurse concerning a 17 year old female who on 08-AUG-2007 was vaccinated with her second IM dose of Gardasil.  On 15-AUG-2007 the patient experienced tingling sensations throughout the body.  Medical attention was sought via physician contact.  The patient was also examined by a neurologist (physician's name and outcome was not known). Lab diagnostic studies performed included "blood work" and "CAT scan" by the neurologist.  The patient's recovery status was unknown.  "It was reported that the patient did not have any problems with the first dose of Gardasil."  There was not product quality complaint.  Additional information has been requested.
Systemic: Body Aches Generalized-Severe, Systemic: severe back pain-Severe, Additional Details: previous series was moderna with no adverse events
When the needle went in, the patient said, "ow"; patient had received MMR II several years ago but there was no record of her receiving it so she got another one on 07Sep2019; The pharmacist inadvertently gave it ( content of one vial) intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist, concerning a 21 year female patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On an unspecified date, several years ago, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, (strength, dose, frequency, route of administration, lot number and expiration date were not reported), however there was no registry of this vaccination, then on 07-SEP-2019, the patient had a new vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) (extra dose administered) which was inadvertently administrated intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis, expiration date reported as 09-DEC-2020 (strength, dose, frequency and lot number were not reported).   On the same date, upon administration of vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), when the needle went in, the patient said "ow" (injection site pain).   At the time of reporting, the outcome of injection site pain was unknown.   The causal relationship between the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II)  and injection site pain was not provided by the reporting pharmacist.
A report was received from a health care professional on 12/4/03 concerning an 11 month old vaccinee of unknown sex who inadvertently received Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin instead of Fluzone. No side effects were noted at the time of vaccine administration to the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up received on 6/28/04. An 11 month old female received 0.25ml Fluvirin on 11/6/03. No adverse effect were reported.
Within 2-3 hours post vaccine administration developed pains mild chest and shooting down left arm. which continued into next day. 10-30-07 co doctor-EKG: work-? pulled muscle. 11-2-07 enzymes checked. WNL- Pain completely resolved 11-9 or 11-10-07 ( was instructed to take ibuprofen prn - did not take as pain was tolerable. No further episodes of pain since resolved.
Hives. Received Dexamethasone IM and Benadryl po.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL 9, (dosing regimen and frequency unknown) (lot number and expiry date unknown) intramuscularly. No concomitant medications were reported. On an unknown date the patient fainted after receiving the shot for GARDASIL 9. It was reported that the patient sought medical attention and was at the physician's already. It was unknown if the patient received  treatment for the event. The outcome of syncope was reported as recovered. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
Sudden onset of debilitating arthritic pain and immobility in left knee and left hip began roughly 3-6 months after 2nd shot in April 2021 and continues now into January 2022.  I have absolutely no history of arthritis.
Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days; Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not information. Treatment information was not product. Care giver is looking for places to reschedule for second shot
After five minutes after patient recieved vaccine the patient felt sick and threw up and lost color in her face and had some visual disturbances. The Patient was transported to the hospital, but unable to reach patient to see what the out come was.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 21-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
The client notified Health District on 11/29/05 of her symptoms after receiving her flu shot on 11/18/05. She is experiencing a throbbing pain in her right arm and shoulder. She describes it as a constant throbbing pain that persists regardless of any OTC pain relievers that she has taken. Client states that she has taken the flu shot in the past without incident. She has been advised to follow up with her family physician.
On 1/9/01 the pt experienced a knot in neck. On 1/11/01 a rash was experienced on back and on the abdomen. The pt was afebrile.
A sore arm; Full body aches; Headache that was turning to a migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Headache that was turning to a migraine), PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L02A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Headache that was turning to a migraine). On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches). The patient was treated with PARACETAMOL (TYLENOL) for Migraine headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Headache that was turning to a migraine) outcome was unknown and PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications reported. Patient stated full body aches and a sore arm which lasted for 2.5 days.
This spontaneous report was received from a licensed vocational nurse and refers to three patients of unknown age and gender. The patients' medical history, concomitant therapy, drug reactions or allergies and concurrent conditions were not reported. The nurse reported one anonymous patient was vaccinated with improperly stored VARIVAX (Merck) (lot number L027287, expiration date 21-JUL-2017, dose, frequency and route were not reported) on an unspecified date and two anonymous patients were vaccinated with improperly stored VARIVAX (Merck) (lot number K026386, expiration date 15-DEC-2016, dose, frequency and route were not reported) on unspecified dates. The nurse reported that the doses were exposed to several "defrost cycles". No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Could not think straight; Swelling at the injection site; Redness, swelling, rash and swelling at the injection site; Rash and swelling at the injection site; Red injection site extended swelling, rash, pain; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, immediately after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroids). Shingrix was discontinued. On an unknown date, the outcome of the difficulty thinking was not recovered/not resolved and the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the difficulty thinking, extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was over 50 years old. Shortly after receiving Shingrix, the patient experienced a fever up to 105 F and redness, swelling, pain, rash and swelling at the injection site that extended all the way down to the patient's elbow.  The patient could not think straight.  As a measure, the patient received treatment at the emergency room and was given Benadryl and steroids.  The patient was considering not receiving the 2nd dose of Shingrix. The reporter was consented to follow up.
Case number PHEH2012US016120 is an initial spontaneous report received from a pharmacist on 10 Aug 2012: This case refers to an unknown age group male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly on unspecified date. No adverse event was reported following this administration error.
The pt complained of swelling in hand. Nurse evaluated the pt. No swelling was observed. The pt had difficulty closing right hand this morning. Received the vaccines the day before.
Nausea, feeling clumsy and shaky, no appetite, pain in arm, swollen and hard at injection site. Red rash at site.
Client presented to the Clinic on 11/1/2022 for COVID-19 Moderna 12+ Bivalent Booster (0.5mL dose). Client inadvertently received COVID-19 Moderna 12+ Monovalent (0.5mL dose). Following CDC guidance, the recommendation is that providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. If a repeat dose is given it must be adminstered at least 2 months after the dose given in error. This nurse called the legal guardian (Grandmother) of client on 11/1/2022. Client's grandmother was understanding of the situation that took place. Ensured that this incorrect dose was not harmful and provided education on what to expect after vaccination. Notified client's grandmother that the client could still receive his COVID-19 Bivalent Booster, 2 months from today.
no additional AE reported; Caller was Medical Assistant. Caller reported AE for Patient.  Patient was administered expired MMRII; Expired / Administered Detail Summary is located within following space.  Caller did not wish to be contacted in the future regarding the event. No; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 20-JUN-2022, the patient was vaccinated with a expired measles, mumps, and rubella (recombinant human albumin (rHA)) (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot  number T020655, expiration date reported as 16-JUN-2022, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event reported.