chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm is sore from the site of injection to the wrist; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is sore from the site of injection to the wrist) and FATIGUE (feels tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore from the site of injection to the wrist) and FATIGUE (feels tired). At the time of the report, PAIN IN EXTREMITY (left arm is sore from the site of injection to the wrist) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
FEVER; RASH  Narrative:  A 70yo male with a history of hypertension and hyperlipidemia presented to the Primary Care Medical center through Tele visit, on September 14, 2020, to establish care. A historical ADR of Influenza vaccine induced rash and fever - flu vaccine in 1977, was reported by a staff RN who had a telephone conversation with the patient on September 11, 2020. Detailed information regarding treatment, type of vaccine where it was administered and by whom was not included in the report and unable to retrieve
Extreme right foot pain, swelling, redness.  Could not put weight on foot or touch to floor.  Similar to gout, which i never had before
Patient had a 20-30 second episode of stiffening with difficulty breathing followed by 30min of sleepiness. She was admitted to hospital and labs and EEG were obtained and normal. Neurology was consulted and felt with history this was a seizure episode secondary to pertussis vaccine.
I had a technician administer a vaccine 17 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of (I had a technician administer a vaccine 17 hours after the vial was punctured) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I had a technician administer a vaccine 17 hours after the vial was punctured). At the time of the report, (I had a technician administer a vaccine 17 hours after the vial was punctured) had resolved.        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.   Concomitant medications were not provided.  Treatment information was not provided.
At 12am on 15Apr my ears just started ringing. They have been consistently ringing since then; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included iron (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and alive women's multivitamins; all for unspecified indication from unknown date and unknown if ongoing. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 00:00, the patient's ears just started ringing. They had been consistently ringing since then. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ears just started ringing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt experienced mild transient pruritus to various locations of body "moving from legs to arms then head" but not all at once. Onset 3-5 minutes after receiving vaccination. Pt reports occasionally experiences pruritus when anxious and this vaccine appointment was a source of anxiety.  Denies flushing, SOB, headaches.  Pt alert and oriented. No problems with ambulation. Pt taken to quieter location. Pt declined diphenhydramine nor zyrtec on site.  After 30 minute observation time after vaccination, pt's, sx's diminishing and pt refused transport to hospital for further evaluation, signing refusal form. Pt stating her husband is in parking lot and will transport her home.
She got her vaccine, it started like a little bump around where the vaccine was done.  The 2nd day it started a little more.  The third day she was getting 3 or 4 sores with blisters that burned and itched, and continued getting more blisters all around her arm in the front where the vaccine was given.  It burned and itching, never had this before.  She went to her doctor today and she prescribed her two prescriptions and sent her to a dermatologist.  She gave her Gabapentin 300 mg, and also was given a Valacyclovir 1 tablet as well for 7 days, and told to FU with the dermatologist.
Breakthrough infection - positive covid test on 9/8/22.  Emergency room visits on 9/9/22 and 9/10/22 due to breathing problems.  Received monoclonal antibodies on 9/9/22.  Did not work from 9/6/22 (first symptoms) to 9/26/22.  Then I tried to work half-days but it was too much.  Currently working half-days (as of 10/7/22)
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Three crazy rashes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Three crazy rashes). At the time of the report, RASH (Three crazy rashes) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-387460, MOD-2021-387461 (Patient Link).
Mom states area around vaccine red and broke out in rash all over body. appears to be roseola  rash not reaction.
15 Minutes after administration patient noticed redness on their chest, upon further exam redness extended over upper back and shoulder area, patient denied itching, SOB, or other symptoms only the red rash was present. Provider evaluated the patient 0.25 mg BENADRYL IM was administered patient observed for 15 minutes. Rash dissipated no further issues reported.
LEFT CALF PAIN; THICKENED SALIVA; NOSE BLEED, RIGHT NOSTRIL; WEAK; TIRED; FEELS NOT NORMAL; FELT SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 to Left Arm for prophylactic vaccination. The batch no is not reported but a follow-up will be requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced felt sick. On an unspecified date, the subject experienced left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, and feels not normal. The action taken with covid-19 vaccine was not applicable. The outcome of the left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, feels not normal and felt sick was not reported. This report was non-serious.
Large red circle, approx 3 inches in diameter around injection site. Very slightly raised, not itchy, slightly warm to the touch. Pt has remained non-febrile.
Pain in arm; Headache; Not feeling well; Exhausted / Very tired; Left of stomach really hurting; feet are cold, hands are cold; Feverish; Muscle pain; Joint pain; Throat hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 26th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain. On an unknown date, the outcome of the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced pain in her arm, a headache, not feeling well, exhausted, very tired, left of her stomach really hurting, her feet were cold, hands were cold, she felt feverish, muscle pain, joint pain and her throat hurts. The patient was inquiring about recommendations for treatment. Provided medical advice disclaimer. GlaxoSmithKline provided Shingrix Frequent asked question's response in reference to what should a patient do if experiencing side effects after receiving shingrix. The patient referred to health care professional. No further information reported. The reporter consented to follow up.
Approximately 11 days after receiving the Moderna booster, itchy hives all over body, randomly appearing and disappearing.  Hives on scalp, face, neck, back, arms, legs, hands, abdomen, chest.  Also, random itchy palms and bottom of feet with no hives.
Local rash and raised bumps for 3 days. Resolving 12-16-02.
This spontaneous report was received from a pharmacist refers to an unspecified 65 year old patient (gender unknown). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, (lot #, expiry date, dose and frequency not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
an expired dose of Acthib was given to patient yesterday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information  (Reference number- 00632469) and transmitted to Sanofi on 08-Jun-2021.  This case involves a 9 months old male patient who received a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ266AAA and expiry date: 05-Jun-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 07-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.   Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  The reporter asked for recommendations.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No Adverse event. Patient received vaccines past beyond use date. Manufacturer and Patient have both been notified.
This spontaneous report received from a phlebotomist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-NOV-2016, the patient was vaccinated with VARIVAX (Lot: K016128, expiry date: 23-SEP-2016) (dose, route were not reported). The phlebotomist reported that the patient received an expired dose of VARIVAX. No adverse effects were reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX somewhere else. The healthcare professional reported that, in June or July 2018, the patient experienced shingles. The healthcare professional did not have any further information.
Right arm went numb.  Called EMS they airflighted me medical center.  Gave me tpa
a lot of pain in the joints, the shoulder and the neck; a lot of pain in the joints, the shoulder and the neck; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 57-year-old), via an unspecified route of administration on 25Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced a lot of pain in the joints, the shoulder and the neck. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202100973686 Same reporter/product/event, different patient
About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not being able to breath. Face and neck were turning purple. My dad was about to call 911 when he finally was able to calm down and catch his breath. His lungs and chest burned afterwards and he was completely spent for days after.
Shortly after receiving flu shot, patient started with itching and swelling at injection site that persisted, there was no redness and no systemic reaction. Nurse spoke with mom and she stated this happens whenever she gets a shot and she didn't want nurse to administer benadryl. School nurse administered ice to site. Mom was advised if symptoms persisted or worsened than we would need to administer benadryl. Follow up call to mom and she stated symptoms have resolved without any additional care.
Redness and swelling on right arm between shoulder and elbow. Pt is also having muscle soreness in right arm. Recommended ZYRTEC tab and Hydrocortisone 1% cream.
UNDERAGE AT TIME OF VACCINE ADMINISTRATION. DOB LISTED AS 1/13/2009 ON CONSENT BUT IMMTRAC RECORD DOB IS 7/13/2021.
Admitted for pneumonia due to COVID-19; tx w/steroids, singulair, zinc, abx, O2. Weaned to RA for dc home
NUMB IN UPPER CHEST; LOT OF NUMBNESS IN LIPS ROOF OF MOUTH; NUMBNESS IN THE RIGHT SIDE OF FACE AND JAW/ THE NUMBNESS WAS SPREADING TO OTHER AREAS OF FACE/HEAD/NECK/NUMBNESS OF NOSE WHERE IT ATTACHED TO LIPS; NUMBNESS THROAT; BURNING IN THAT AREA OF NOSE WHICH WAS VERY UNCOMFORTABLE; HARD TO SWALLOW; TINGLING IN THAT AREA OF NOSE WHICH WAS WEIRD FEELING/ TINGLING IN UPPER CHEST; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, non alcohol user, penicillin allergy, degenerative at herniated disc, arthritis, asthma, and macular degeneration, and other pre-existing medical conditions included: Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, cetirizine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride/paracetamol for drug used for unknown indication, montelukast sodium for drug used for unknown indication, nabumetone for drug used for unknown indication, and bevacizumab for macular degeneration. On 07-AUG-2021, the patient experienced burning in that area of nose which was very uncomfortable. On 07-AUG-2021, the patient experienced hard to swallow. On 07-AUG-2021, the patient experienced numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips. On 07-AUG-2021, the patient experienced numbness throat. On 07-AUG-2021, the patient experienced tingling in that area of nose which was weird feeling/ tingling in upper chest. On 07-SEP-2021, the patient experienced lot of numbness in lips roof of mouth. On 05-OCT-2021, the patient experienced numb in upper chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lot of numbness in lips roof of mouth, numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips, numbness throat, numb in upper chest, burning in that area of nose which was very uncomfortable, hard to swallow, and tingling in that area of nose which was weird feeling/ tingling in upper chest. This report was non-serious. This case, from the same reporter is linked to 20211017044.
SEVERE PAIN, REDNESS AND WARMTH IN UPPER ARM, MALAISE, FEVER, SOME SOB AND CHILLS, SHE TOOK TYLENOL THAT NIGHT AND FELT SOMEWHAT BETTER ON 11/13, BUT STILL FELL GENERALIZED BODY ACHES.
Itching all over her body but more at ankle and inside of elbow.; immediately after vaccination her face become red for 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (immediately after vaccination her face become red for 15 minutes) and PRURITUS (Itching all over her body but more at ankle and inside of elbow.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9000182) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ERYTHEMA (immediately after vaccination her face become red for 15 minutes). On 22-Jan-2021, the patient experienced PRURITUS (Itching all over her body but more at ankle and inside of elbow.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) ongoing since an unknown date at an unspecified dose and frequency; TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency and ACETONIDE DE FLUOCINOLONE at a dose of unknown. At the time of the report, ERYTHEMA (immediately after vaccination her face become red for 15 minutes) had resolved and PRURITUS (Itching all over her body but more at ankle and inside of elbow.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax
Hip joint pain, same side as shot.  Likely Transient Synovitis.  No virus in month preceding onset but did have flu shot.  Do not know if it is realted but thought it would be important to track in case it is.
7 hours after injection, experienced extreme tiredness.  Overnight, awoke with body aches, joint pain, and injection site pain.  Early morning awoke to body aches, headache,  and extreme fatigue.  While not chilled, needed three layers on top and two layers on bottom and on feet.  Temperature at 8AM was 97.0.  Voracious appetite and ate normally and with vigor.  Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite.  Ate normally.  Body aches and joint pain were gone.  About an hour later, temperature returned to normal but headache persisted.  No longer fatigued, but still tired.  Headache persisted that evening and still present at this writing, 8AM Monday.
This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were unknown. It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to SHINGIRX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional did not had any patient or vaccine details at the time of reporting. The healthcare professional reported that several patients complained of arm redness, sore arm, and swollen arm after receiving the SHINGRIX vaccine. The healthcare professional did not had any additional information on the adverse events.
Several days post vax, the pt developed a high fever and a varicella like rash.