chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon going to bed, within a matter of a few minutes, I started to get the chills real bad.  Then my muscles and joints started to hurt. I could not even turn over in bed without my  whole body hurting. I don?t know if I had a fever or not.  I was so tired, but shaking with chills and body hurting I couldn?t go to sleep.  Put more blankets on and took 2 Tylenol.  I was able to eventually go to sleep.  I felt better in the morning but was very tired during the day.   It felt like I had covid again.  I had the same symptoms then.  I tested positive for covid November 27 at a rehab/nursing home where I was sent  after foot surgery.
2 days after this first dose, I had some spotting which is uncommon for me. It happened again 4 days after the initial dose was given. I also noticed as of yesterday (June 3rd) that metal objects are sticking to me easily and there?s a definite pull against it when removing the items (Bobby pins, a small pair of scissors, house key). These aren?t thing I was experiencing before the shot was given and based on more research and other people?s experience, I will not be getting my 2nd dose. I?ve yet to be able to see my doctor concerning these issues.
The patient developed a diffuse rash 1 day after vaccination consistent with erythema multiforme minor
Diagnosed with shingles 10/20/07.  Seen in office 10/19, sent to ER 10/20.  Given Augmentin 10/19.
product was not suitable for use since it had been in transit for too long (with no reported adverse event); already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event); Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient, product was not suitable for use since it had been in transit for too long (with no reported adverse event) and already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event) for diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel].  On an unknown date, the suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine via unknown route in unknown administration site for prophylactic vaccination (dose, batch number, expiry date: unknown), already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event) (poor quality product administered) (latency same day).  On an unknown date product was not suitable for use since it had been in transit for too long (with no reported adverse event) (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events  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 and Regulatory Authority 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.
Allergic reaction to PEG in Vaccine; Zero antibodies after first dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the Patient received the first dose of the Moderna vaccination (date and lot number not given) and since she was allergic to PEG she got an allergic reaction from it, the HCP advised not take the second dose. Caller did not provide more information for the AE form and said she will call back again. Agent provided caller with case number.
received the GARDASIL vaccine many years ago and she commented on how badly it hurt when she received the shot; This spontaneous report was received from a female patient who was a nurse, concerning herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The nurse reported that many years ago (date unspecified) she received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) and she commented on how badly it hurt when she received the shot. The outcome of the event was not known. No additional adverse event (AE) was reported. No additional information provided.   The causal relationship between injection site pain and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Painful, red, warm, itching, 5cm diameter swelling. BENADRYL topical & oral, ice, ADVIL.
Patient describes that after been vaccinated WITH PNEUMOVAX 23 she developed an acute pain in her right breast.
Moderna Bivalent vaccine was administered approx. 16 hours after the discard date of 8/17/2023 @ 23:59pm.
Left shoulder pain began 2 weeks after vaccine. 3 days after the pain, a rash began to form on my back. The rash got bigger and received Shingles diagnosis 19 days post vaccination. Blisters have spread from upper back, to shoulder, and down left arm. Currently dealing with shooting nerve pain.
Five days after booster, started having severe abdominal pain.  Pain ranking 10/10.    Taken to ER at hospital.  Diagnosed with necrotizing pancreatitis.  Transferee to Hospital, then to  hospital.  Sent home to finish recovery on March 7th.  Treated with narcotic pain meds, TPN, no food for months.  Still on TPN.
reddness at area of injection; itchiness at area of injection; swollen area of injection; fever; soreness of arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever), PAIN IN EXTREMITY (soreness of arm), VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (soreness of arm). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever), PAIN IN EXTREMITY (soreness of arm), VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection) outcome was unknown.            Concomitant medications were not provided.
Vaccines administered 3/12/13. 1-2 hours after pt began to notice soreness in area. In AM of 3/13/13, area was red, inflames, swollen, painful, with possible mild fever, (L) tricep area of upper arm. Has taken 400mg ibuprofen 3x on 3/14/13 inflamed area. 12 cm x 10 cm with 3.5 cm x 2 cm area having small rash.
This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 23-month-old male patient who experienced the following medically important events: pneumococcal bacteremia, pneumococcal septic arthritis, drug ineffective titer levels (serotype 4, fell short and serotype 6B and 18C) were borderline. At 23 months of age, patient received the fourth dose in 2004. In Mar-2005, at approximately 23 months of age, the patient experienced a "bad elbow" and was sent to a specialist. Clinical symptom included a high fever (laboratory value not provided). Arm culture was done and revealed pneumococcal septic arthritis (arthritis bacterial). Also in Mar-2005, the patient experienced pneumococcal bacteremia (drug ineffective). Treatment included Omnicef. On an unspecified date, "a couple of years ago," the patient also experienced titer level, serotype 4, fell short and serotype 6B and 18C were borderline (antibody test abnormal). The patient recovered from the pneumococcal bacteremia and pneumococcal septic arthritis on an unspecified date. Antibody test (results: serotype 4 "fell short,: serotype 6B and 18C were "borderline") and blood culture (results: streptococcus pneumoniae) were done on an unspecified date. No additional information was available at the time of this report.
pentacel was given to an adult stem cell transplant patient/no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that an adult was given pentacel to a stem cell transplant, no AE (product administered to patient of inappropriate age), of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE(Suspension for injection) lot number not reported via unknown route in unknown administration site.  It was of actual medication error case due to product administered to patient of inappropriate age.  It was unknown whether adverse event was experienced or not.  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 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.  Information on the batch number was requested.
Chest pain, fever, chills, headache all these lasted a day and a half. Took lots of Tylenol After the second day pain around chest and neck have subsided. 3rd day still have headache.
pt stated shortly after she got the vax her arm became hot, itchy and had hives on it.  Her tongue started swelling up and she felt very uncomfortable.  She bought some baby liquid Benadryl and took it.  Then she noticed her face had blister like hives in and around her mouth.  Her mouth was like it had ulcers.  Pt could not get in to see her PCP right away so had a tele visit about a month later and was instructed to get the 2nd vax dose  but to take Benadryl prior to getting it.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included thrombophilia (latent factor five disorder). Concomitant products included warfarin sodium (Warfarin). On 10th August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th August 2018, 3 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced rash. On 3rd December 2018, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced fatigue and fever. The patient was treated with cortisone (non-proprietary) (Cortisone Cream) and antivirals for systemic use (Antiviral). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, fatigue and fever to be related to SHINGRIX. Additional details were received as follows: The patient experienced a rash on her face which was treated with cortisone cream and it resolved in a week. After 2nd dose of SHINGRIX, the patient experienced fatigue and fever of 103 degrees F which resolved. On 3rd December 2018, the patient was diagnosed with shingles outbreak on her right shoulder area and close region on trunk to that shoulder. The patient was seen by dermatologist and diagnosed shingles and given antiviral to treat and it cleared up in 2 weeks. The patient provided lot number or expiration for the first dose of SHINGRIX. The reporter consented to follow up.
Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.
Immediate burning sensation traveled from left side of body:  arm, shoulder, neck, back,  left ear, and chest.  Then traveled across entire face eyebrows, cheeks, and lips felt numb and irritated.
Patient given Tdap, Menactra, Havrix and Gardasil-last to be given.  After given the patient laid back on the table, jerking movement witnessed.  Skin was pale and clammy  After a few seconds she was able to be aware of her surroundings. Checked by provider and given juice to drink.
Pt noted 2 small red spots on arm, spread, welt. Warm to touch on 7th day on 8/17/16. It took 1 week to happen per Pt. Dr. advised Pt. to use hydrocortisone cream OTC and CLARITIN and given info on allergic reaction: case instructions.
Woke up next-morning with back pain down to right leg. Throbs, soreness, numbness until morning.
a dose of expired Pneumovax 23 was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 11-FEB-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, administered intramuscularly, as prophylaxis, lot number S012245, expiration date 09-FEB-2021 (expired product administered) (frequency and anatomical vaccination site were not provided). The reporter confirmed there were no previous temperature excursions. It was also reported that vaccine was "supported 1 month post expiration date per post expiry memo". Any decision for re-vaccination, would be up to the healthcare provider.  The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Worst headache of my life, severe chills, night sweats, flu-like muscle soreness, extreme gas, fever
Information has been received from a physician concerning a female with a history of injection site reaction (vaccine unknown) who was vaccinated with the first dose of GARDASIL 0.5ml (Lot number not provided).  Subsequently the patient experienced "allergic reaction" at the injection site.  The outcome of the adverse event was unknown.  The physician was not going to give the patient the rest of the series.  It was reported that the patient sought unspecified medical attention.  Additional information has been received from a physician concerning the 22 year old female with allergies to CECLOR, AUGMENTIN and PENICILLIN who on 20-JAN-2009 was vaccinated IM with the second dose of GARDASIL 0.5ml in the arm (Lot number 661766/0652X).  "2 days after the vaccine administration" (on 22-Jan-2009), the patient developed lower extremity pruritis.  "On third day" (on 23-Jan-2009) the patient experienced swelling of hands, pruritis of the feet and scattered "hives" by description.  The symptoms resolved at time of exam.  The patient reported similar prior reaction to CECLOR.  Further information is not available.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral. Previously administered products included Shingles and SHINGRIX with an associated reaction of pyrexia (1st dose received on 16th Feberuary 2018, refer case US2018213937). On 16th April 2018, the patient received the 2nd dose of SHINGRIX. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th April 2018, the patient experienced nausea, lethargy and fatigue. On an unknown date, the patient experienced weight loss and appetite lost. On 17th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the weight loss, appetite lost, nausea, lethargy and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, weight loss, appetite lost, nausea, lethargy and fatigue to be related to SHINGRIX. Additional details were reported as follows: A patient reported that he had already submitted to VAERS. The patient only experienced a sore arm, which resolved the next day of vaccination. The patient reported that patient only experienced a sore arm, which resolved the next day. The patient reports that the next day, he began to feel lethargic, and needed to sit for several hours. The patient then began to feel nausea and fatigue. The patient went to the doctor in May, and had blood work which was normal. The patient went to urgent care with fatigue and nausea in June, and was ordered a series of scans, including an MRI, CT scan, and lumbar puncture. All were normal. The patient saw a neurologist as well and was checked for heavy metals, which was negative. The patient still feels the symptoms and the fatigue and nausea are still present. The patient also lost 24 pounds and needs to force himself to eat 3 meals a day.
Severe, blinding headaches for 3 week straight ? Advil, Tylenol, and Benadryl had no relief Shortness of breath starting that afternoon and lasting about a week Extreme Arm swelling ? first day the size of a walnut, second day grew to a softball, third day grew to the size of a football that lasted well into the next week Fingers on left hand swollen, tingling, and loss of dexterity starting at day three lasting into week 3 after the shot  Waves of hot flashes and uncontrollable sweating episodes ranging from 20 minutes to 2 hours lasting two weeks. Red rash, swelling, and hives on neck, shoulder, and back starting day 5 after the shot lasting 1 week Skin on arm very hot and red with oozing sores in a crescent shape covering the whole bicep below the injection site starting 1 week after and lasting 1 week ? sores are still healing
Two days post vax, the pt experienced left thigh swelling with no redness. Pt was treated with ibuprofen and warm compresses.
Patient received FLUZONE HIGH DOSE on 9-16-17. Patient came to the pharmacy on 9-28-17. The patient had been seen earlier in the day by her PCP because of pain in her shoulder going down her arm on the arm she got the vaccine. Patient said she has been experiencing this pain for close to 2 weeks.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHEA (Diarrhea) and ANOSMIA (Loss of smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep), AGEUSIA (Loss of taste) and PYREXIA (Low grade fever). On 09-Feb-2021, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) had resolved. At the time of the report, JOINT STIFFNESS (Joint stiffness that got worse) had not resolved and DECREASED APPETITE (Loss of apetite), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep) and AGEUSIA (Loss of taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9-100.1 (High) 99.9-101.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided.
Chills, Body Aches, Fever of 101/102 for 3 days.
Tinnitus; headache; This is a spontaneous report from a contactable other Health Professional (patient). A 37-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 09Jan2021 10:00 at single dose in right arm for covid-19 immunization. Medical history included chronic pain, hypothyroidism and anxiety, allergies to medications, food, or other products included sulfa.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine, eszopiclone (LUNESTA), ibuprofen (MOTRIN), celecoxib (CELEXA). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The patient experienced tinnitus and headache on 11Jan2021. The outcome of the events was recovering.