chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports a warm, tender, raised, reddened area surrounding the injection site several inches in diameter 24 hours after receiving vaccination. She went to a pharmacy clinic and saw a nurse practitioner who placed her on a course of clindamycin. After 24 hours on the antibiotics she saw no change and wanted to be seen again. She reported to the hotline that she would go to be seen in the ER.
Patient became dizzy, sweaty and lost consciousness for a 'few seconds' about 5 minutes after vaccination
The day after vaccination (6/12), there was redness and warmth at the site of injection.  The nurse marked it to assess swelling.  The patient was afebrile and able to move the arm with no limits.  On 6/13, swelling and warmth was increased, so IV cefazolin was started due to suspected cellulitis.  The patient received 2 days of cefazolin and was discharged from the hospital 6/15.  The reaction was improved. DC Summary: DC DX: recurrent C Difficile colitis; pneumococcal vaccine reaction versus cellulitis; electrolyte abnormality secondary to diarrhea, resolved. HX of HTN, HX hypercholesterolemia; HX of anxiety; HX of bilateral total knee arthroplasty. Enteritis, Dehydration. Present Illness: diarrhea.  Allergies: aspirin, contrast dye and eggs. PE: temp 100.3, temp 37.6, remainder of exam unremarkable with mild tenderness to palpation in left lower quadrant and right lower quadrant. Hospital Course: rash developed that was warm on her right arm, unclear whether this was cellulitis or a vaccine reaction. Received Ancef.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 1:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medication was reported.  The patient received first, second and third dose on intramuscular route in deltoid region.  The patient received fourth dose on deltoid region.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  Patient received 0.5 of Bivalent vaccine.  No adverse reactions experienced by the patient.  It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Crosslinked case US-MODERNATX, INC.-MOD-2022-654537:Crosslinked case
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's current conditions, concomitant therapies or medical history provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M009768 with an expiration date: 23-FEB-2018. (Dose and route of administration were not reported). Administered dose of VARIVAX experienced temperature excursion of 13 degree Fahrenheit for 90 minutes, on an unknown date. Digital data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
inflammation; 1.2cm fluid collection; complaint of pain in arm since 2/20/2021; tenderness at injection site; This spontaneous report was received from a physician referring to a 33 (unit not provided) female patient. The patient's concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS). The patient has no known drug allergies (NKDA) and no pertinent medical history. The patient's concurrent condition was not reported.  On 08-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, batch/lot# and expiration date were unknown) intramuscularly (IM) for vaccination. On 17-FEB-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, batch/lot# and expiration date were unknown, IM) for vaccination.  On 11-MAR-2021, the patient was seen again with complaint of pain in arm since 20-FEB-2021 with tenderness at injection site but no erythema or signs of infection. On 12-MAR-2021, the patient had sonogram that was negative. On 21-MAR-2021, the patient had magnetic resonance imaging (MRI) which showed inflammation and 1.2cm fluid collection. Medical attention was sought. Symptoms were treated with ibuprofen (ADVIL) and warm soaks. The outcome of the events was not recovered. The causality assessment was not provided.
After receiving Flu shot within 20 minutes pain shot down my arm into my fingers woke up next morning w/ excruciating pain at injection site (deltoid not muscle).
Patient severely fatigued and unable to care for self and get out of bed for approximately 50 days.  Low grade fever and flushed or pale pallor.  Patient gradually recovered between days 50 and 60  (best estimate) but is still recovering strength and stamina.
61 y/o female present to clinic c/o left axillary pain since August 2014. Pt. states the pain started after 3 days of receiving her shingles immunization. Pt. describes pain as throbbing and burning.
Patient fainted several minutes after receiving the vaccination.  Patient was conscious and did not hit her head.  She was taken out by the paramedics
I'm afraid I got an expired vaccine/ the card has an expiration date of August; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August) had resolved.  No Concomitant medications were provided by the reporter. No Treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-Oct-2021 : Patient demographic details, Vaccine information was Updated.
The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Loss of consciousness,  when I came to  - severe projectile vomiting 5 hrs post vaccine. Followed by severe weakness that night. Next day normal side effects  - joint/muscle pain and severe headache.   All resolved about 40 hrs later.
Myalgia, Arthralgia, weakness, fatigue Narrative:  Other Relevant History:
The vaccine triggered a migraine and I?ve been to Urgent Care once and then had to go to the hospital for an IV bag and pain meds and then went back to the ER again today for tramadol and steroid shot to attempt to break the cycle.
Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No treatment medications provided.
TDAP vaccine was administered by RN into patient's left deltoid on 6/22. Patient immediately felt discomfort and stated that her arm felt "different" than the discomfort she felt after the COVID vaccination in the same arm 1 month prior. Patient stated that she had issues sleeping and pain with moving her shoulder that increased over the next 3 days. The discomfort then continued, but did not worsen. She was evaluated by a physician on 6/29/21 and diagnosed with SIRVA (shoulder injury resulting from vaccine administration). She was given a course of NSAIDs and asked to follow up in 1 week. She declined steroid injections or any further imaging for now.
A few minutes after the injection (maybe 5 minutes), I felt very weak and like I was going to vomit or pass out. The nurse had me lay down. Then maybe 5  minutes after laying down, I started to feel itchy on my shoulders, abdomen and inner thighs. I started to see small hives on my abdomen and arm. The nurse gave me benadryl.
Information has been received from a pharmacist concerning a currently 4 year old male child who was vaccinated on unspecified dates with a first and second dose of MMR (lot # not reported). Subsequently, the patient experienced a rash after the first dose and an anaphylactic reaction after the second dose of MMR. After the second dose the patient was taken to the hospital for treatment. The mother was told that the reaction was probably from an egg allergy. The pharmacist did not know if the child was admitted or treated and released from the hospital. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC). Additional information has been requested.
Information was received from a nurse concerning a sixth grade student who on 14 AUG 1995 was vaccinated with a dose of Varicella.  On 15 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
Pt got shots in our office last week in the evening and by the next AM, his left leg was very swollen. "I can't even see his knee". We brought him back to see Dr. Dx: "acute local reaction to DTaP."
Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath and a cough that has been ongoing for three weeks.Patient even at rest has significant tachypnea usually in the 40s and sometimes even into the 50s breaths per minute. Sepsis present on admission.  COVID-19 infection was diagnosed on the eighth of this month, now is negative.  Has been on a ceftriaxone and azithromycin.  Could be due to multifocal pneumonia and PE.  Changed to cefuroxime,7-day course.  Leukocytosis could be due to steroids, recommend to repeat CBC in about a week. Multifocal pneumonia: With underlying COVID-19 diagnosed on the eighth, now is negative.  Completed azithromycin for 3 days and was on a ceftriaxone, changed to p.o. cefuroxime on antibiotic for suspicion for secondary bacterial infection, will complete the course. Acute bilateral pulmonary emboli: on Xarelto.  Echo reviewed. Mild hemoptysis: Could be due to pulmonary emboli, infarcts, remains on anticoagulation.  No recurrence. Left lower extremity DVT/SVT: Anticoagulation as above. Transaminitis: Denies use of alcohol, he has some nonspecific complaint on the right sided abdomen but negative Murphy and ultrasound shows normal gallbladder, normal liver, stable.
Redness, itching, swelling, fever at injection site and rash extending from deltoid to elbow on (R) arm.
I had a 100 degree temperature. Sinus congestion with mucous and feeling very tired. I fell from my bed. Coughing. Sharp pain in my left ear and hearing loss. Treated with antibiotics about a week later.
dizziness/light headedness; feeling unwell; Body aches; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (dizziness/light headedness), MALAISE (feeling unwell) and MYALGIA (Body aches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Non-tobacco user since an unknown date and Abstains from alcohol since an unknown date.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MYALGIA (Body aches). On 26-Mar-2021, the patient experienced DIZZINESS (dizziness/light headedness) and MALAISE (feeling unwell). At the time of the report, DIZZINESS (dizziness/light headedness) and MALAISE (feeling unwell) was resolving and MYALGIA (Body aches) had resolved.            No known allergies were reported. No concomitant medication was reported No treatment details were provided.
1st dose in 2019, 2nd dose on 12/6/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019).   On 6th December 2021, the patient received the 2nd dose of Shingrix. On 6th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. No demographics provided. The patient received the 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule. Permission denied for follow up.
Influenza (FLU) Vaccine Adverse Reaction Template: Employee calling to report a reaction after receiving a Influenza vaccine.   Vaccine Name - Unknown Vaccine Date - ?9.20.2023  Date of Symptom Onset - Saturday (?9.23.2023) Symptoms - ?Pain to Right arm with pulsating sensation, warmth, redness, swelling and bruising (R forearm); Pain when lifting R arm (Can raise however painful); Tenderness to R arm with bent elbows; R-side Neck stiffening. Last day of work and shift - ?9.25.2023; EE is currently at work. This nurse advised to leave work due to report of moderate pain.
1p (Friday)- Received shot and felt normal rest of afternoon  7p - Started feeling lethargic and dizzy 8:30p - Started getting full body chills and shivers, felt freezing, headache and fever started 10:30p- Body shivers stopped. Fever 102 F 11:30p- Fever 104 F 12:00a- Extremely rapid heart beat, couldn?t slow it down with breathing. Fever still 104 F 1:00a - Fever 103F. No sleep 8:00a (Sat)- Temperature came down to 100F. Bad headache and body aches, worst in hips and legs/knees. By Sunday, temperature back to normal and headache subsided. Still aches in right hip/leg.
Fever, severe leg pain, shortness of breath, dizziness, coughing and disorientation.
pt recv vax & the next day exp gen papular lesions (some w/vesicles) that resembled chicken pox, a low grade fever (99.8) & itching;An ER or MD visit was required;tx w/atarax;MD suspected that this adverse event could be chicken pox;
This spontaneous report was received from a medical assistant and refers to an 11 year old patient of unknown gender. The patient was vaccinated with LIQUID PEDVAXHIB on 07-MAR-2006, 19-MAY-2006 and 09-FEB-2007 (dose, route of administration, lot # and expiration date were not reported). No other information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-MAY-2017, the patient was supposed to receive a dose of MENACTRA (manufactured by Sanofi). Instead, the patient was vaccinated with an extra dose of LIQUID PEDVAXHIB injection via intramuscular route, lot number M046140 with expiration date on 27-SEP-2019 (dose and site of administration were not reported) in error. The label of LIQUID PEDVAXHIB said "Meningococcal Protein Conjugate" and so it was confused with MENACTRA because both products had "meningococcal" on the label. No adverse effects have been reported. There was no product quality complaint involved. Additional information has been requested.
About two months after receiving my second dose, I started to notice that when I smile, my cheeks spasm on both sides. I'm not able to fully smile. I have been to see a neurologist, but they did not find anything. I am still having this issue today.
headaches were more intense; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches were more intense) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache (Patient reported that he usually had headaches).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches were more intense). At the time of the report, HEADACHE (headaches were more intense) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme rash and swelling of left arm and left lymph nodes as seen by Dr. on 4/27/21  after first Moderna vaccine 4/16/21. Dr. reported to me she heard a heart murmur which was previously not diagnosed to me. I complained of shortness of breath and lightheadedness and irregular heart palpations after receiving the vaccine. 5/18/21 appointment with cardiologist Dr. who scheduled echocardiogram on 6/11/21. Results are Atrial and Mitral value leakage. As of 12/24/21 still experience same symptoms. Medication is 25 mg Metoprolol Er succinate.
Body aches, chills, tachycardia, shortness of breath, and fever of 101.5 from morning of 11/14/21 to morning of 11/15/21 Sore, swollen lymph node under left armpit beginning 11/15/21 and persisting through today 11/16/21 Pain at injection site, shortness of breath and tachycardia on exertion persisting through today 11/16/21
Patient complained that muscle aches and pains began shortly after administration, advancing to severe lower joint pains, impeding movement by the next morning.  She also developed fever, chills and diarrhea.  Her symptoms worsened over the first 48 hrs then began to improve.
This spontaneous report as received from a nurse (primary contact also reported as physician), refers to a 17 year old female patient. No concurrent conditions or medical history were provided. The nurse reported that, in 2011, the patient was vaccinated with the first dose of GARDASIL and, in June 2014, got the second dose of GARDASIL injection (doses, route of administration, indication, lot# and expiry dates unspecified for both). Third dose was not administered. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as there is no consent to contact with the physician.