chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 74 year old male patient with no known allergies. The patient's concurrent conditions included hypertension and possible high cholesterol. On 07-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneous injection, 0.65 ml on the left arm (lot L028280, expiration date 28-OCT-2016). Concomitant medications were not reported. The pharmacist reported that the patient had shingles on an unspecified date in November 2015. The reporter stated that post vaccination, the patient developed rash and pain radiating from his left arm down to the left side of his chest under his left nipple so the patient went to the hospital with what he thought was a heart attack.  He was kept overnight and treated with 2 heparin injections in the abdomen. Aortic atherosclerotic plaques test performed and result was normal for patient's age. Liver enzymes test was also performed but results were not provided.  Heart attack was ruled out. After one night, the patient was released from the hospital on an unspecified date in November 2015. The pharmacist questioned if the patient could be treated with an antiviral medication. Outcome of shingles was not reported. Additional information has been requested.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to patient number 4 of 20 patients. Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
PATIENT BEGAN SEVERELY COUGH AND BROKE OUT IN RASH 5 MINUTES AFTER RECEIVING SHOT, PATIENT STARTED USING HER INHALER AND WE GAVE HER BENADRYL. PATIENT CONTINUED TO HAVE INCREASED LABORED BREATHING, SEVERE COUGHING AND GASPING FOR AIR. PHARMACISTS CALLED 911 AND GAVE PATIENT EPIPEN. PATIENT WAS TAKEN TO HOSPITAL WHERE SHE WAS GIVEN BREATHING TREATMENT AND SOLUMEDROL INJECTION. SHE WAS LATER RELEASED TO HOME WITHIN A FEW HOURS.
Rash and redness around vaccine area about 2 cm diameter. As per pt felt warm and itchy.
Received the Moderna Booster 5/3/2022. Presented to ER with left-sided chest/back pain on 5/23. This resolved with pain medication and he was ruled out for MI. However, liver enzymes were markedly abnormal with alk phos 1029, AST 156, and ALT 296. Previous liver tests were normal in 3/2022.  Extensive work-up (including U/S, MRCP, liver biopsy which didn't have sufficient tissue and labs) showed no underlying etiology. Liver tests have improved with ursodiol. Pattern and history are most consistent with drug-induced liver injury. There were no new medications prior to the event and patient denied herbal or supplement use.
end-stage COPD, coronary artery disease, hypertension and solitary kidney who presented with progressive dyspnea. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient family shouted to nurse , upon nurse arrival patient was already  unconscious and ammonia quickly placed under the patient nose . Patient was stuffed and started having sudden body  and limb jerks movement  that involved  the arms, head and neck. Shortly after patient regained consciousness follow by a  small period  of confusion . Paramedic arrives at the scene  and patient was placed on the lateral position ,oxygen was provided and continued to be monitored by the paramedic.
Patient stated that had rash on the right arm where he had the shot a couple of hours later on 12/9/2014.  It has spread to the right arm and to his armpits today (12/26/2014).  He has not taken anything or has gone to a doctor.  He said he was going to.
p/vax pt devel n/v & abd pain;pt taken to ER dx w/acute appendicitis;appendix was removed but found to be nl;pt devel ARDS which is considered a life threatening event & pulmonary edema;thrombocytopenia present;given meds;60 day follow-up dated 10/25/00 provided no additional data.
"a very unusual side effect"; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age 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) (Intramuscular) 1 dosage form.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant Medications were not provided by the reporter.  Treatment Medications were not provided by the reporter.; Sender'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.
Continued Right shoulder pain since shot, 4 days of swollen lymph node in right armpit and right groin.
pt recv vax & devel cellulitis @ the inj site & myositis of the lt deltoid;initially was treated on an out-patient basis w/ampicillin then dicloxacillin;7 days post vax;hosp for 2 days & recv IV med;drainage of small mass in lt deltoid;
Vaccination given on 8/2/13; on 8/4/13 site of injection became very red and sore. 8/7, patient went to ER and was treated for allergic reaction and given antibiotic. Pt was having chills and fever so went back to ER the following day and was diagnosed with cellulitis. She was hospitalized for 3 days and treated with antibiotics. Patient was released on oral antibiotics and is doing well.
Within 12 hours elevated temperature,extreme fatigue, flulike feelings lasting 2 days.  On  03/24/2021 back discomfort worsening every day. To Emergency Room on 03/31/2021 confirming diagnosis of Shingles
Development of flushing, hives, throat and tongue swelling, difficulty breathing, all developed within 30 min of administration, and resolved after admin of epinephrine and IM Benadryl.
patient called to state that her heart was racing. She did not take her anxiety med earlier and she was very nervous at the time of the vaccine. After a few hours she was still having the racing heart . I told her to reach out to her physician. I just wanted to make sure she was safe.
8day p/recv vax pt rpt fever up to 105f; decreased appetite & fussiness; to ER 7/31, no treatment except fever control measures; 8/2/99 to clinic c/o fever on 8/1 of 102; 8/2 rash began which was flat, scattered over torso, discrete, 2mm
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 19-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, expiration date 31-JAN-2016 (dose, dosage number, route of administration and lot # were not reported). No concomitant medications were reported. No adverse event were reported. Additional information is not expected because no authorization was given to contact the primary reporter.
itchy rash began on left arm and over the next few days migrated to back, torso, legs, feet. Painfully swollen and tender lips for week or so.  Dermatologist prescribed  Allegra 2x daily, Singular 1 time in AM, and pepcid as needed. Symptoms continued
Marked swelling of whole upper arm with tenderness and some induration.  No axillary adenopathy.  Fever and chills noted at home but temperature not taken.  Afebrile here. Patient states symptoms peaked ~12 hours after injection and have begun to subside now.  Not pruritic.
Extreme body ache; Nausea; Extreme tiredness; Feeling unwell; Headche; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 46- years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to acidic fruits/vegetables. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021 at 20:00, after 28 hours of vaccination the patient experienced nausea and headache that was not subsided with paracetamol (TYLENOL). The patient also had extreme tiredness and was feeling unwell. On 28Mar2021 (next day), the patient had extreme body aches. The patient received treatment with paracetamol (TYLENOL) for the event of headache and did not receive any treatment for the events nausea, extreme tiredness, feeling unwell and extreme body aches. The clinical outcomes of the events headache, nausea, tiredness, feeling unwell and general body pain were unknown at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right anterior chest, right shoulder, and back pain same day of flu shot. Given ibuprofen.
Received vaccine 12/17 mid morning. Awakened 12/18 with blurred vision, difficulty focusing, nausea, headaches with MOTRIN and worsening vision. Unable to drive, shaky.
Pt had onset of fever of 103F, on same day at 19:00. Pt was crying, sleepy. The next day, was lethargic, wouldn't move, wouldn't let parents hold her. Injection site on leg was red and edematous.
Pt complained of pain on shoulder where flu shot was given - especially when they lift up left arm - feels like tendonitis pain for 4 week now.
serious reaction and is on disability. She described it as continuous anaphylaxis; This is a spontaneous report received from a non-contactable consumer. An unspecified aged female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history was not provided. Concomitant medications were reported as none. On an unspecified date patient was reported as she received her first Pfizer COVID vaccine and had a serious reaction and is on disability. She described it as continuous anaphylaxis. It was unknown if the patient received any treatment. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was completely normal and physically active before the first dose, I have not felt normal since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP7534) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's autoimmune" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Allergies: Penicillin. Concomitant medication(s) included: LIOTHYRONINE; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose:01, Batch/lot number : EN6199, Anatomical Location : Arm Right, Time:19:30 pm), administration date: 03Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Almost fainted once"; Bnt162b2 (Dose:01, Batch/lot number : EN6199, Anatomical Location : Arm Right, Time:19:30 pm), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "I was completely normal and physically active before the first dose, I have not felt normal since". The event "i was completely normal and physically active before the first dose, i have not felt normal since" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was withheld. The patient receive other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Dizziness began 10Mar2021 and has not ceased. Varies from daily light headedness to extreme dizziness. Almost fainted once. Some degree of dizziness every day. Have also had extreme fatigue since 09Mar2021. I was completely normal and physically active before the first dose, I have not felt normal since. Date of start of reaction/event was 10Mar2021. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. The adverse event result in any of the following was doctor or other healthcare professional office/clinic visit. Patient did not received treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
patient sitting in waiting area after shot and after about 5 minutes patient rep alerted me that patient was not feeling well and asked for Benadryl. stated the patient was light headed, dry mouth and heart racing.  She was already drinking water when I was alerted and gave her 25mg liquid Benadryl at patient request. States this is similar feeling to when she has had other vaccines or allergic reactions to cheese and penicillin in past. Offered to call EMT but patient declined and they sat in waiting room about 10 more minutes before feeling well enough to go home.
white blood cell count was very high; This is a spontaneous report from a Pfizer sponsored program. A contactable 59-year-old female consumer (patient) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included Pfizer Covid Vaccine, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient stated, she had a little rough patch after she got the Pfizer Covid Vaccine. The patient experienced white blood cell count was very high, and it was normally not that high on an unspecified date. The patient underwent lab tests included (PET Scan) positron emission tomogram was come back to show that my tumor had not grown and what I was shrinking. The outcome of event was unknown. The action taken in response to the event for palbociclib was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Forty-five minutes after receiving influenza shot, spouse of client phoned stating wife complained of chills, had vomited x T and had fever of 102.8. Fever abated after dose of Tylenol.
Fussy, loss of appetite on the day of IZ. No redness or swelling at sites of injection. Pt went to bed about 21:20, awake for 4 hours, tired but unable to sleep, awakened again at 06:30 and refused bottle. He could not stretch his arms out enough to reach for a bottle, as they were so sore. Mom checked on him and found him blue, not breathing and his eyes rolling around in his head. She called EMT. Pt was transported to hospital. Second episode of apnea in ER and was stabilized with IV's then he was transferred to another hospital. The attending doctors in ER informed her the "seizure" was the result of too many IZ's given at one time and she was she was instructed by these physicians to inform this dept. of our inappropriate administration of the IZ's. The child was given Tylenol before the shots were given, at 16:00 and at 12:30; he did not appear to run a fever. However, when the EMT's arrived he had a fever of 103.7F. He was kept overnight. He was placed on Dilantin and discharged.
The patient received an injection of Moderna on 3/5/2021, 4/1/2021 and 4/29/2021
Rashes with stinging sensation, pain and swelling on palms; Rashes with stinging sensation, pain and swelling on palms; Rashes with stinging sensation, pain and swelling on palms; Rshes with stinging sensation, pain and swelling on palms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms). At the time of the report, RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter  Treatment information was not provided by the reporter.
Around 2:00 am exp dull ache from arm to wrist ,tingling in fingers lasted all day. I called employee health was told to go to see PCP. The tingling went away after 3 days  and the dull ache lasted 5 days. I was told to take Tylenol for dull ache. I  dint have to miss any work.
I had a sore arm and a raised bump for about 3 days,  It went away.   10 days later it is back.  Hard raised bump at injection site.
an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 19-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter, lot # R033080 with expiration date 06-JUN-2020; frequency and route were not reported) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Rush appears on the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix was administrated to a female patient on 27th October 2020, an rush appears on the injection site on 28th October 2020. The reporter consented to follow up.
Information has been received from a physician concerning a 17 year old male patient with a history of exposure to mump through a classmate who on an unspecified date was vaccinated with MMR II (route, site, dose and lot number not reported). On 02-DEC-2009 the patient experienced mumps. Mumps was diagnosed on 03-DEC-2009. The patient was afebrile, developed orchitis with jaw pain and dizziness. The patient also experienced leg pain and body ache. On 03-DEC-2009 the first blood work was performed, the results were: IgM (<1:10) : <1:10. IgG (1.10) : 2.53 and serum amylase: 122. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Bilateral hand numbness and night pain--medial nerve sx  saw orth and primary MD  symptoms persist