chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalization for osteomyelitis Narrative: Patient admitted to the hospital 2/22 for treatment of osteomyelitis of right index finger after sustaining a cut from a knife grinder one week prior.
Patient received an expired Lot. It expired on 9/30/22. Vaccination was given on 10/21/22.
The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. No patients had come out with adverse events. Vial was stored in refrigerator on 17-Feb-2022 10:00 am and did not undergo temperature excursion. It was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARSCoV- 2 (COVID-19) virus at time of administration. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.
Swelling, red, 3-4 inches below and anterior of injection site. Md diagnosed pt w/ cellulitis, prescribed antibiotic (Bactrim) and steroid(Medrol dose pack).
Information has been received from a health professional concerning an adult female who on 24OCT05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 659697/1038P). On 24Oct05 the pt experienced a swollen arm and pain at the injection site. She was seen by the physician and was ordered acetaminophen (Tylenol). At the time of this report, the pt was recovering. Additional information has been requested.
Myalgia, Fever, Chills, Rigors, Soreness at injection site Narrative:  Other Relevant History:
2 days after vaccine, rash developed on anterior lower legs consistent with erythema nodosum.
Ringing in both ears.  Started Sunday  3/7/2021 morning 2:00 AM woke up from sleep.  It has not stopped ringing, but some times the ring is not as loud as other times.  Sunday 3/7/2021 was the loudest ring in my ears.  I have not seen a doctor yet.  I was waiting to see if it will go away.  As of today Tuesday 3/9/021 it has not gone away.  If this issue does not go away by Friday 3/12 .  I will see a doctor about this issue.
This case was reported by a physician via sales rep and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient's initials, gender and date of birth were unknown. The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporting physician mentioned that the patients were complaining about pain at injection site post vaccination with SHINGRIX. The reporter did not agree to follow up.
fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 102). At the time of the report, PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever.         No concomitant medication information given. No treatment information provided.
Episcleritis; red, painful eye; red, painful eye; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), intramuscular on the left arm on 22Dec2020 at 16:15 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included propranolol (PROPRANOLOL), montelukast sodium (SINGULAIR), mometasone furoate (FLONASE [MOMETASONE FUROATE]) and multivitamin with minerals. The patient had no other vaccine in four weeks. The patient previously took and had known allergies with Morphine. The patient had no COVID-19 prior vaccination, had not tested post-vaccination. The patient developed red, painful eye on 04Jan2021 at 06:00 AM. The patient saw the eye doctor. Do with Episcleritis. It was also reported that the patient never had this thing before. The events resulted in healthcare professional office/clinic visit. Treatment for the events included Prednisolone eye drops. The events were resolving.   Information on the lot/ batch number has been requested.
10 days after receiving vaccine developed blotches of rash on left side arms, legs, back, hairline rash turned into blisters, and are itching. Also low grade fever after rash was gone arm hurt for about a week.
Swollen lymph nodes and pain in left underarm (side where shot was given), first noticed approximately 10pm on the evening following vaccination.  As of this report, lymph nodes are still swollen (12 days post-vaccination, 11 days since appearing) but less painful.
FELT SICK; REAL TIRED; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (FELT SICK) and FATIGUE (REAL TIRED) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (FELT SICK) and FATIGUE (REAL TIRED). At the time of the report, MALAISE (FELT SICK) and FATIGUE (REAL TIRED) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Indication to use for Humira (citrate free) Moderate to severe chronic plaque psoriasis and Moderate to severe Rheumatoid  Arthritis   No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Had break through case of chicken pox after direct exposure 4 yrs after Varivax given.
throat closed up; tongue got big; she became numb on her right side; her vision went blurry; having a hard time breathing; throat got a weird feeling; chest pain; her vision goes in and out which she thinks is from the headache; headache; A spontaneous report was received from a consumer concerning a 61-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closed up, tongue got big, became numb on right side, vision went blurry, hard time breathing, throat got a weird feeling and started to close, chest pain, vision goes in and out when she thinks of the headache, and headache.  The patient's medical history as reported by the reporter included food allergy especially to strawberries, Medication allergies to flu shots, sulfa, phenegran, prednisone, Diabetes mellitus in 2017, Breast Cancer in 2017. Concomitant medication was not reported.  On 15 Jan at 4:45 pm 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) through an unknown route at right upper arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, 5 min after receiving the vaccine, her throat closed up, tongue got big, became numb on right side, vision went blurry, hard time breathing, throat got a wired feeling and started to close.  Within 30 min she was taken to emergency room. And after that  she also had  chest pain, hard time breathing, headache and her vision goes in out when she thinks of headache.  She was advised to get admitted in hospital, but she declined. She was still out of work. Patient had similar events when she took flu shots twenty years ago.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was reported as unknown.   The outcome of events, throat closed up, tongue got big, became numb on right side, vision went blurry, hard time breathing, throat got a wired feeling and started to close ,  chest pain, hard time breathing, headache and her vision goes in out when she thinks of headache was reported as recovering/resolving.; Reporter's Comments: This case concerns a 61-year-old female who experienced NS unexpected events of chest pain, dyspnea, throat tightness, swollen tongue, oropharyngeal discomfort, hypoesthesia, vision blurred, visual impairment, and NS expected headache.  The events occurred 5 minutes after the first dose of mRNA-1273. Events resolving. 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.
fever, diarrhea, headache, sore arm, sore underarm, mouth sores (cheeks, tongue, under tongue, gums)
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a health professional concerning a 41 year old female who on 17-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck). On 17-JUL-2007 the patient inadvertently received Zostavax (Oka/Merck).  No adverse effect reported.  No product quality complaint.  Additional information has been requested.
Discomfort to injection site; vaccine was administered in right forearm; This is a spontaneous report received from a contactable reporter (nurse) from medical information team. The reporter is the patient.  A 79 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in lower forearm right, administration date 06Feb2021 13:00 (Lot number: EL324) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis", start date: 2010 (ongoing). Family history included: "Increased BP", start date: 2001 (ongoing), notes: Controlled by medication. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2001 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 2001 (ongoing). The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 06Feb2021 14:00, outcome "unknown", described as "Discomfort to injection site"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06Feb2021 13:00, described as "vaccine was administered in right forearm". Additional information: The patient's family history also included history of cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Just hours after getting the second covid shot, I began suffering from severe shoulder pain, I am unable to move my arm away from my body. I can feel my heart beat at my finger tips. I have been brought to tears because of the agony. I can't sleep because of the pain and not being able to get comfortable. I cant even do simple things..Something is wrong..
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine   administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and   described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
Case number PHHY2014US138196, is an initial spontaneous report received from a consumer via a specialty pharmacy on 13 Oct 2014 and forwarded by Incyte (MFR control No: 2014IN003036) on 21 Oct 2014. This report refers to a 61 year old male patient. Medical history and concomitant medications were reported as unknown. The patient received JAKAFI for unspecified indication at a dose of 10 mg tablets, twice daily orally from 08 Oct 2014. Lot number and expiration date were reported as unknown. The patient also received flu shot, influenza vaccine (manufacturer unknown) at unspecified dose on 09 Oct 2014. The patient attempted to drive immediately, but could not get far due to nausea, vertigo, and general malaise. The patient was hospitalized overnight for observation. On 10 Oct 2014, the patient felt better and was discharged. JAKAFI therapy continued during hospitalization and was ongoing at the time of the report. The outcomes for the events were reported as unknown. Seriousness of the event was reported as hospitalization. Causality of the events was not reported.
Red, swollen spot about 2 inches below the injection site - minor pain, itches at time.  Swelling lasted only the first night, but redness continues.  About the size of a quarter or a little larger.
pt recvd 1 dose of Engerix-B 18AUG92 & had fever, chills, dizziness seen by MD who though sx were probably a rxn to Hep B vax; prescribed Ceclor; cleared to return to work;
He received his vaccine, he did have a sore arm but nothing else.  When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down.  He has thrown up 3 times.  His bones are aching and light headed.  He has not taken anything for the reaction, just trying to stay hydrated, very little appetite.  Does have an appointment to see his doctor today at 4:20 PM.
Sudden onset itching and burning similar to a mosquito bite or bee sting right at injection site. Arm became warm at site and a white welt appeared along with a red ring around.
Started with chills, then severe headache, cannot get up, body ache, fever, sweating.  It's the third day today, 10/30/2022 and headache got worst.  Blurry vision, sensitive to light.
Patient has not reported any adverse events, but they received the Moderna Bivalent booster as their 2nd shot when they only received 1 monovalent Pfizer shot
Swollen lymph nodes more than 8 days after injection.; This is a spontaneous report from a contactable consumer (patient). An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 as dose 2, single for COVID-19 immunization, at workplace clinic. The patient medical history included known allergies: Penicillin. Other medical history was not provided. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient received no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 18Feb2021, the patient experienced swollen lymph nodes more than 8 days after injection. The event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
PATIENT HAD AN UNEASINESS WITH RASH TO LEFT SIDE OF FACE AND TINGLING OF LIPS.  PATIENT WATCHED FOR ADDITIONAL 15 MINS UNTIL RESOLVED
Right arm started hurting the day after the vaccination given (in right arm deltoid). There was never any redness or swelling or warmth per patient & none was evident on 10/6/11 when she came to pharmacy to report the arm pain. She gets influenza vaccine annually & has never experienced problem before. Referred to PCP.
reaction in the site at the arm; A spontaneous report was received from a 66 year-old patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed a vaccination site reaction.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included a cholesterol medication.  On 28-DEC-2020, 9 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 05-JAN-2021, the patient developed a reaction at the injection site on the left arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccination site reaction, was unknown.; Reporter's Comments: Based on the 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.
Rash on her torso (no hives, no elevations) 48 hours after her 1st shot of Pfizer vaccine.  She reported this to her Oncologist and he recommended her to take the second dose in 3 weeks.
Pt received dose #2 Moderna COVID vaccine. Reported tachycardia, dizziness which resolved spontaneously and immediately, R eye tightness. Patient reports similar symptoms associated with first vaccine but occurred that evening. Patient reports symptoms resolved quickly. Patient with VSS and no acute distress noted during visit. Discharged home without escalation of care or intervention. Entered by employee for tracking.
Asthma attack, swollen tongue, throat, burning mouth and lips, burning eyes, temp 99.1, weak, blisters on soft palate and possibly down throat.
Knot appeared about a week after the vaccination and she has had arm soreness and a dime-sized knot at injection site since
dose of Pentacel that was administered after being reconstituted with sterile water/no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an eight month male old patient who was vaccinated with a third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, lot UJ060AAA, expiry date 14-Oct-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 21-Jan-2020.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It is an actual medication error case due to wrong solution used in drug reconstitution. It was reported that a dose of Pentacel was administered after being reconstituted with sterile water.  At the time of reporting, no adverse event was reported.  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.
Approximately a week after the second dose developed lesions on arms and trunk.  Contacted Dermatologist who thought it might be a short term reaction to the vaccine.  When conditions persisted, recontacted Dermatologist who took a sample.  Lab stated it was eczema, and could have been caused by the vaccines effect on my Immune system, the condition which I have never previously had persists today.  I do not regret the vaccination, but do regret the eczema if caused by the vaccine.
Headache, shoulder and neck ache, swelling began 10/01/14. 10/02/14 became worse, I was lethargic and my neck was very stiff 10/03/14 unable to move my neck at all it was completley stiff. I went to my family phsician as the vaccine was given to me at my place of employment. She examined me and sent me to the ER for a CT scan and lab work. SHe was concerned that I developed meningitis. Dr. gave put me on prednisone, Flexeril, and naproxen. Put me out of work for three days.