chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose of Shingrix 4 years ago. They are there for the 2nd dose but have not received it just yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix 4 years ago. They are there for the 2nd dose but have not received it just yet.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-SEP-2023 The pharmacist stated that a patient received the 1st dose of Shingrix 4 years ago.  The vaccine administration facility was the same as primary reporter The 2nd dose have not received it just yet, which led to incomplete course of vaccination. The reporter consented to follow up via postal. The case is linked with US2023105911, by same reporter.; Sender's Comments:  US-GSK-US2023105911:Same reporter
See attached side effects which have been checked.   Abdomen cramps; ache: joints; aches: whole body; bowels: irritable, cellulitis; chills, chills fever; mood: Anxiety; concentration: difficulty; concentration: loss of, concentration: trouble; neurological: Confusion; constipation; coordination: problems; Cramps leg; balance: dizziness; balance: vertigo; balance: problems; bladder problems; cyst: right ovary cysts painful; blood pressure: high; Depression; dermatitis; diarrhea; diarrhea: constant; gagging (means nausea); gastric ulcer; indigestion: nausea; constant; Balance: Dizziness; Dry mouth; Dyspnea; energy loss; exhaustion; eyes: loss of ability to produce tears (aka sicca syndrome or Sjogren's syndrome, autoimmune); fatigue; fatigue: muscle; fibromyalgia; Flu syndrome; Gastritis; hair: turned white, then brown; hair: loss of facial; hair: falling out; head: shakes; headache: uncontrollable thump on left side; headaches: migraines; headache; hearing: ringing in ears; hearing: poor tolerance for loud noises; heart: murmur; heart: rapid pulse rate; heart: palpitations; Hypertonia; Hypokinesia; Hypotension; memory: difficult, loss, bad, loss with dizziness, trouble remembering recent information, short-term memory loss, increase in forgetfulness; Infection: fungal, pockets of infection in throat and mouth, staphylococcal, chronic to include ear and sinus; Menstrual abnormalities, loss; neurological; reading comprehension difficulty, slowed responses, unable to perform multiple tasks simulatenously, slowness, disorientation, depression, confusion, staring spells (likely minor seizures), migraine, mood swings, anxious, angry, irritable; Myalgia; sleep: Insomnia; joint: stiffness, ache; nasal: nose bleeds; lesion: brain; Nervousness; libido: loss; numbness and tingling: fingers, arms and down one side of body, leg, neck down; pain: stomach, bone and joint, muscle and joint, arthritic, ear, abdo, back, chest, in feet, like electrical shocks, charlie horse (I do not think the pain location is of great interest); Photophobia; Rash pustular, burn-type on entire body; respiratory: shortness of breath; shaking; skin: cysts developed, eczema, discoloration, sensitivity, rashes, pain; verbal skills: unable to comprehend words, stuttering, trouble finding words, struggle for words; Sleep: feel not refreshed upon waking up, unable to sleep flat without medication; Speech disorder; Voice alteration; weakness; weight gain; suicide attempt; sweating; swelling: joints, feet and ankles; Tachycardia; Taste loss of; Thinking abnormality; Tinnitus; Twitching or jerking
Patient reports she received Moderna COVID vaccine on 8/6/21. She reports shortly after (unsure of exact timeframe, possibly a day) she developed an annular red warm painful area  on the arm. Reports it has been presents for "11 days." She states she has taken 12.5mg of Benadryl and tried ice without improvement.   She was evaluated at myself at Clinic. On exam she has a 6cm x 6cm annular minimally raised area of tender blanching erythema. No systemic symptoms. Does not appear consistent with cellulitis given stability over the past 11 days.
Fairly severe lymph node swelling in armpit area of left arm (injection site); Hours after second dose causing significant pain/discomfort, persisting for multiple days; Hours after second dose causingsignificant pain/discomfort; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 10Mar2021 at 17:45 (at the age of 20-years-old) and a second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 31Mar2021 at 14:45 (at the age of 20-years-old), each as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. Concomitant medications included birth control pill for an unknown indication from an unknown date and unknown if ongoing. 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-19 vaccination. On an unspecified date in Mar2021, 2 weeks after dose 1, the patient experienced lymph node swelling in armpit area of left arm (injection site) with less severity which caused significant pain/discomfort. On 01Apr2021 at 01:00, the patient experienced the same reaction after the second dose which was fairly severe and persisted for multiple days. The patient did not receive any treatment for the reported events. The events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the lymph node swelling in armpit, significant pain/discomfort was recovering.  No follow-up attempts are needed. No further information is expected.
Injection site pain Nausea headache vomiting fever muscle aches weakness stuffiness all at 9 AM January 13, 2022 Took nighttime cold and flu medicine over the counter and sleep Most of the symptoms were gone by January 14, 2022 injection site pain remained for over a week
The patient received her 1st COVID-19 vaccination and during the post-vaccination observation period developed left-side chest pain that radiated to her left scapula. Patient was brought to the emergency department but by that time the chest pain had subsided significantly but the left scapular pain remained. The patient was given 243 mg of aspirin and work-up consisted of ECG and Chest CT scan. Pain was deemed to be non-specific and patient was discharged in good condition.
About 10 minutes after the flu shot the patient got hot, sweaty, pale and almost passed out. We laid her down, elevated feet, checked her BP. We also gave her juice and snack when they said she hadn't eaten any lunch.
No adverse event; accidentally administered dose on 01-JUN-2023 after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, conditions, allergy, concomitant diseases or risk factor. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 01-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the expiration date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that it was unknown when the 5.5 ml size vial was initially stored in refrigerator. The vial was not exposed to temperature excursion as per HCP's knowledge.  No other adverse events were reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728180 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728180:same reporter
Missed to receive the 2nd dose of Moderna vaccine 65 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported.
Syncope, loss of urinary function (incont), loss of conciousness for approx 20 sec., fell to floor & broke front tooth, nose, & bite tongue, serous drainage noted to both mouth & nose, rash to abd area;
For 5 days after receiving the shots, the patient felt generally ill with flu-like symptoms. For the following 3 weeks there was a steady decline in weight, strength, coordination and an onset of hallucinatory effects (seeing things not present, and believing they are real) An Emergency Room visit made on Oct. 14 due to symptoms of heart attack--it was not. An Emergency Room visit made on Nov. 5 due to sudden/overnight loss of ability to stand and balance; checked for stroke, but none had occurred. Nov. 14 patent fell in bathroom, broke 4 ribs and had small puncture in spleen. Went to ER then ICU at hospital. Numerous tests performed on brain, heart, blood and lungs over  two week period Spent 14 days on nasal feeding tube and nothing-by-mouth. After EEG, brain MRI and spinal tap, still no definitive conclusion about the cause of degenerative and mental symptoms Started a 5-day course of hi-dose steroids.  Pneumonia effects ("gurgling" during breathing) stopped after first dose, but no further improvement. Tried Parkinson's treatment due to grandparent history, but no effect. Patient lost 10% body weight during 2-week hospitalization. (Normal weight 110 lb; weight at ER arrival 95 lb.; weight at end of steroid course 89 lb.) Patient, still without diagnosis, has been transferred to hospice and is dying.
I GOT THE GARDASIL SHOT AND IT PERMANENTLY GAVE ME THE HPV VIRUS, I NOR MY DOCTORS KNOW IF IT WILL GET WORSE, BUT IT IS NOT CURABLE. I AM STUCK WITH THIS VIRUS FOR THE REST OF MY LIFE. BECAUSE OF THE GARDASIL SHOT THAT WAS SUPPOSED TO PREVENT ME FROM GETTING HPV.
3rd dose given early without knowledge of second shot; 2nd dose not noted on vaccine passport.
Event occurred after 2nd dose. Patient was diagnosed with COVID Remdisivir, Tylenol Discharged home
rash on both forearms, (blisters, not itchy), temp 100.4, sore throat and earache right side, burst blood vessel right eye
CHILD'S SKIN  BECAME PALE , COOL AND CLAMMY, AND FAINTED WITHIN I MINUTE OF RECEIVING  ABOVE VACCINES.  NURSE LOWERED HIM TO THE FLOOR AND PLACED COOL CLOTH ON FORWARD AND BACK OF NECK.  NO INJURIES NOTED.  ASSISTED HIM TO EXAM TABLE TO LAY DOWN FOR 10 MINUTES .  HE REMAINED ON THE EXAM TABLE APPROXIMATELY 15 MINUTES WITH SUPERVISION.  HE WAS GIVEN JUICE.  SKIN COLOR RETURNED TO NORMAL.  HE WAS ABLE TO AMBULATE INDEPENDENTLY TO THE CAR TO DEPART. NURSE ACCOMPANIED HIM TO WITNESS HE WAS ABLE TO GET INTO THE CAR WITHOUT INJURY.
large localized rxn-entire rt upper arm swollen, erythematous & pruritic-pt reports fever & chills x 24hrs (less than 101); recovered on APAP & seldane;
Patient is an 82-year-old male with past medical history of dementia, CVA 2017, with right-sided weakness and expressive aphasia, gastroesophageal reflux disease, CABG, CAD, HLD, HTN, history of MI.  Patient presenting to emergency department for further evaluation of generalized pain and balance problems.  Caregiver at bedside reports symptoms began this morning. Last known well was the night before he went to bed.  Caregiver reports patient having difficulty with walking, noticed his gait was abnormal which is not his baseline.  She also stated patient is currently at his mental baseline, also states pain he was experiencing is resolved.
he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine". Additional information: Caller reported that he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine. Caller wanted to know if it is safe to get the next booster. Caller asked does Pfizer recommend that he get the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain post pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) injection on an unspecified date. Outcome of the event was recovered as it lasted 24 hours. No follow-up attempts are possible, information about batch number cannot be obtained.
Symptoms: Hives/urticaria, chest tightness/pain, trouble swallowing - began 12 days after Moderna booster.  Treated in Emergency Room with Prednisone taper, Benadryl, Allegra.  Symptoms are still active after 2 months.
Information has been received from a physician concerning a female who received the three doses of GARDASIL.  Recently in July 2008, the patient had soft tissue pain and swelling over the injection site which has persisted since the third injection.  The patient complained of pain when raising her arm.  The patient was referred to physical therapy.  Soft tissue pain and swelling over the injection site and pain when raising her arm, were considered to be disabling.  Additional information has been requested.
Per physician office, patient called them approximately one hour after receiving injection complaining of facial and eye swelling.  They advised her to take 25mg Benadryl PO.  She presented to their office 15 minutes later with no improvement, so they administered 25 mg Benadryl IM.  Patient improved and was sent home to take Claritin daily X 7 days.
18 yo WM c/o dizziness and feeling hot 15 minutes after receiving  the 1st dose of the Pfizer vaccine. Patient evaluated by NP/EMS; VS, 12 Lead EKG and IV fluids stated. 911 called;  PT PMHX of Asthma and Seasonal Allergies. NKDA; FD arrived, re-assessed, and transferred PT to Medical Center for further medical evaluation.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain (experienced after 1st dose, refer case US2018GSK094619). In 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain. On an unknown date, the outcome of the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain were not recovered/not resolved. The reporter considered the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain to be probably related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not provided. In the vaccination night at 2 am, the patient began shivering and could not get warm. The patient would get hot then cold. He also had a headache, body and stomach aches and felt sore all over. The patient declined to provided contact information or additional details.
This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with two doses of PNEUMOVAX 23 injection, lot # N010109, expiration date 20-NOV-2018 (exact dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1803USA007661:
I feel horrible; feeling so hot/my body is so hot inside; tingling in my body; hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) 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 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in my body) and PAIN (hurting a lot). On 22-Sep-2021, the patient experienced FEELING ABNORMAL (I feel horrible) and FEELING HOT (feeling so hot/my body is so hot inside). At the time of the report, FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) outcome was unknown.            No concomitant medication provided. no treatment medication was reported.   Reporter did not allow further contact
Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L0321834, expiration date 25-NOV-2016, dose and route unknown). The vaccines were stored under 3 degree centigrade for 13 hours and 8 minutes. There was previous temperature excursion. It was called because of a data logger. No adverse effects were reported. Additional information has been requested.
"Patient is a 82 y.o. male with past medical history significant for hypertension, hyperlipidemia, renal transplant at a health care facility in 1978, squamous cell carcinoma, basal cell carcinoma and type 2 diabetes who presented to the ED from a local clinic w/ a cc of cough and sob. Symptoms started about five days piror to presentation. Symptoms have included cough, sore throat, weakness, sob, decreased appetite, increased fatigue, congestion, myalgias, chills. Denies n/v, diarrhea, urinary symptoms, fevers, rash, cp. Tx tried at home tylenol w/o much success. Has been vaccinated for covid with a total of 5 vaccinations as well has had his flu shot. "
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient ever had COVID + test or diagnosis. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's age was reported as 48 years and 5 months  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  The patient did not experienced any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process after an audit was conducted  The vaccine NDC code was reported as 80777-0273-99  No treatment information was provided by the reporter.