chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has dementia, trouble communicating; The patient has dementia, trouble communicating; Experienced side effects from the first two shots; This spontaneous case was reported by a pharmacist and describes the occurrence of DEMENTIA (The patient has dementia, trouble communicating) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-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 DEMENTIA (The patient has dementia, trouble communicating) (seriousness criterion medically significant), COMMUNICATION DISORDER (The patient has dementia, trouble communicating) and VACCINATION COMPLICATION (Experienced side effects from the first two shots). At the time of the report, DEMENTIA (The patient has dementia, trouble communicating), COMMUNICATION DISORDER (The patient has dementia, trouble communicating) and VACCINATION COMPLICATION (Experienced side effects from the first two shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. The patient experienced dementia, trouble communicating and experienced side effects from the first two shots. Treatment medication were not reported. Company Comment: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of dementia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-415894, MOD-2021-416025 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of dementia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a physician concerning a 6 year old male who on 01-NOV-2004 and 15-NOV-2007 was vaccinated with the first and second doses of MMR II. On 19-JAN-2010 the patient experienced mumps. On 22-JAN-2010 the patient was diagnosed. Other symptoms included pain under both ears and poor appetite. The patient had bilateral parotitis and a fever of 100 degrees F. It was unknown if the patient had orchitis, sequelae or exposure to others with mumps. The outcome of the mumps was unknown. Additional information has been requested.
Patient in today for first dose of Pfizer Covid Vaccine- I administered in error 0.3ml of Pfizer Bivalent instead of Pfizer Monovalent
light headed; my arms hurts a little; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program (002591). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arms hurts a little".  No follow-up attempts are possible. No further information is expected.
The day of the vaccine: very tired, and not able to focus well. Then almost 11 days later. Happened 10.5  days after the vaccination: Extreme fatigue for 3.5 days, beginning April 3, 2021; April 6, evening: pounding heart for about 15 minutes, feverish, nausea, threw up; Took  2 tums, then 3 baby aspirin, and  went to bed. Slept well . OK now.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Bactrim. Past adverse reactions to the above products included Drug allergy with Bactrim. Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (DUORESP), SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and PROBIOTICS NOS for an unknown indication.    On 12-Nov-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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving. Not Provided          It was reported that on 30-May-2022,  there was a rebound after day nine of Paxlovid drug treatment.  Device date: 04Jun2022  Company Comment: This spontaneous case reported by a patient concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a second dose of mRNA-1273.  She was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, after 9 days there was note of rebound Covid19 infection.  The ongoing Covid19 pandemic could e a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a second dose of mRNA-1273.  She was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, after 9 days there was note of rebound Covid19 infection.  The ongoing Covid19 pandemic could e a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
pt recv vax;exp itch,swelling & inflammation at inject site;inflamed area as large as dollar coin;this is one of 11 patients who exp the above rxn p/vax
soreness at injection site; vaccine looked like water/clear and not white to off white color; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color) and VACCINATION SITE PAIN (soreness at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Ischemic cardiomyopathy and Coronary bypass in 2019. Concurrent medical conditions included Allergy (yellow jacket hornets). Concomitant products included CARVEDILOL (COREG), LOSARTAN, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color). On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color) had resolved and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) The Roche Elecsys Anti-SARS-CoV2 S test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received contains  lab data - Positive result for test spike Protein antibody test  received after vaccination. On 25-Jul-2021: Follow-up information received contains No new information.
CRAMP IN LEFT LEG; CRAMP IN RIGHT LEG; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced cramp in right leg. On 13-APR-2021, the subject experienced cramp in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramp in left leg, and cramp in right leg. This report was non-serious.
SM developed redness, swelling, pain at anthrax injection site within 24 hrs.
Starting less than 24 hours after the second vaccine, I began having severe joint pain in hands, wrists, ankles, knees and elbows. Over the next couple days the severe pain improved however some mild joint pain persisted in the wrists, ankles and hands. Over the next 1.5 weeks the joint pain progressively worsened to the point that I could barely use my hands or sleep at night. I initially thought that the joint symptoms were still just vaccine side effects but since things were still getting worse 2 week post-vaccination I saw a rheumatologist on 1/20/21. He believed that my presentation was consistent with underlying inflammatory arthritis rather than vaccine side effects. Over the next couple weeks I had a thorough rheumatologic workup including extensive lab work and imaging, and was ultimately diagnosed with inflammatory polyarthritis with enthesitis with my triggering event for the initial arthritis flare being the second Covid vaccine. I was initially started on high dose prednisone (up to 60mg) and methotrexate with an upward titration but was unable to tolerate the medication due to side effects and lack of improvement in the enthesitis and have since started cimzia with plan to taper off of methotrexate. It is now 2 months since my initial diagnosis and my arthritis is controlled but I continue to have troublesome enthesitis in my hands and elbow.
This spontaneous report was received from a registered pharmacist concerning patients of unknown age and gender. It was reported that the reporter had observed other pharmacists injecting ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously into patients posterior arms, in the area just above the elbow, not the deltoid region. The reporter was not aware of any patients who received doses of ZOSTAVAX administered to a non-deltoid region experiencing any adverse effects. She did not know which specific patients may have received ZOSTAVAX in a non-deltoid subcutaneous region. No concomitant therapy was reported. Additional information has been requested.
Rash on both arms x 2 days. Patient shows me up close left arm patchy red spots. Thought maybe a little rash on neck. Has rosacea of face, no acute rash. No new medications or soaps, no feeling of throat closure or shortness of breath.  Had first COVID-19 vaccine the day prior to rash, wonders if adverse effect Had some itching of knee area last night, and maybe a red patch there that resolved. Took benadryl 25mg last night for the rash. Ran out of over the counter allegra.  No blistering of hands lips or mouth. No fever, but doesn't have thermometer on hand  Had a headache the day after the vaccine, took tylenol (and no previous reaction to tylenol)   Used to get redness of face and arms that improved with cleaner diet, cutting out preservatives and more natural cleaners.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 28-JUL-2014 the patient was vaccinated with M-M-R II (lot # K000174, expiration date 11-JUN-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Breakthrough case admission after three vaccines  Pfizer 2/25/21 Lot# EN6202;  Pfizer 3/18/21 Lot# En6202; Pfizer 11/11/21 Lot# FF8841
received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The nurse reported that a patient received a dose of Menveo reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
high fever at 101.5 degrees; intense shivering; a severe headache; 12 hours of extreme fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroxine sodium (Levothyroxine).   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, 11 hrs after receiving Shingrix and an unknown time after starting Levothyroxine, the patient experienced fever, shivering, headache and fatigue. On an unknown date, the outcome of the fever, shivering, headache and fatigue were recovered/resolved.   The reporter considered the fever, shivering, headache and fatigue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 60 or 61 years. The patient experienced fever at 101.5 degrees, intense shivering, a severe headache and 12 hours of extreme fatigue. The entire reaction began 11 hours after the shot and ended 18 hours after that. The patient tried looking at the clinical trial results for Shingrix, but was not qualified to understand the information as presented.      Lab Comments: on an unknown date body temperature was recorded
Patient had an extremely sore arm that worsened after a few days and persisted for 8 days.
Cellulitis to injection site approximately 5 inches in diameter. Rx Cephalexin 250mg X 5d
According to pt and his wife, flu-like symptoms including stabbing lower abdominal pain, numerous diarrhea episodes, muscle aches, and fatigue the evening after he had taken his 1st dose of the oral typhoid vaccine. There was no nausea, chills or vomiting. His doctor made a house call. He was treated with loperamide and oral rehydration fluids. This was 24 hrs after onset. Within 12 hrs beginning to feel better.
Arm pain, red, warm, swollen. Upper arm had a lot of erythema; lesion was pruritic. Treated with prednisone, Periactin, and cool soaks.
Fever 100 F, abdominal pain, nausea, vomiting, and tremors. Diphenhydramine and famotidine.
dizziness, lightheaded, black out, cold/clammy skin, profuse sweating, ringing in the ears  911 was called and responded to by both fire and medical paramedics  vitals were taken and patient was observed for an additional 20 minutes before leaving when he had returned to a stable condition
Vaccine stored in refrigerator on 11/4/21, expired product 10/3/2021, administered date on 11/15/21.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/4/21, expired product 10/3/2021, administered date on 11/15/21.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/4/21, expired product 10/3/2021, administered date on 11/15/21.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/4/21, expired product 10/3/2021, administered date on 11/15/21.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that the vaccine was stored in refrigerator on 4-Nov-2021, there was no temperature excursion and the patient did not experience any adverse event. No treatment medications were provided.
Colicky; intestinal cramping; stomach gurgling; few coughs; burning up; irritable; slightly lethargic; Spaced out; Patient's leg was slightly swollen; This spontaneous report has been received from a consumer (patient's mother) concerning to a 4-month-old male patient.  The patient's concurrent conditions included gastrooesophageal reflux disease. His medical history was not reported. Drug/allergy reactions included dairy protein sensitivity. Concomitant therapies included famotidine and probiotics (unspecified).  On 16-DEC-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported), administered orally for immunization. Consequently, on 05-MAR-2021, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported) for immunization. Other suspect vaccines administered on the same day included influenza virus vaccine (unspecified), diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid, and pneumococcal vaccine (unspecified) all for immunization (strengths, doses/routes/frequencies of administration, lot numbers and expiration dates, were not reported). It was also stated that the brand names/manufactures of those vaccines were unknown.  On 05-MAR-2021, her son was colicky, had intestinal cramping, she could hear his stomach gurgling, a few coughs, and he was burning up. He was irritable and slightly lethargic. She reported that her son was staring into space for a good 5-10 minutes. The next day, 06-MAR-2021, her son was still colicky from sun up to sun down. She said the only thing that helped his symptoms was acetaminophen (TYLENOL), a warm bath, and nursing him. She did report that her son's leg was slightly swollen from where the vaccines were administered. Before the caller hung up, she did want to mention that her son received the first rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (on 16 DEC 2020) and developed similar symptoms after administration as the ones she was reporting today. The reporter did not seek medical attention.  The outcome of the reported events was reported as recovered on 09-MAR-2021 or 10-MAR-2021.  The causality assessment with the suspect vaccines was not reported.
after 15 minutes, pt reported to pharmacy that she was having itching near injection site and on upper back. No rash was visible other than where she'd been scratching. Administered 50 mg of diphenhydramine PO and had her wait another 15 minutes. She said she was no worse after 15 minutes. Offered to have her stay later, but she wanted to leave. We reached out to pt at 2:30pm and she sated that she's feeling fine.
Slightly Firm Injection Site; Positive Reaction; Felt more energetic; Feels healthier post second vaccination; Overall Health Improved; Sore Arm a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm a little), IRRITABILITY (Slightly Firm Injection Site), ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic) and FEELING OF RELAXATION (Feels healthier post second vaccination) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Disorders of carbohydrate transport and metabolism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm a little). On 25-Feb-2021, the patient experienced IRRITABILITY (Slightly Firm Injection Site), ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic), FEELING OF RELAXATION (Feels healthier post second vaccination) and FEELING OF RELAXATION (Overall Health Improved). On 25-Jan-2021, PAIN IN EXTREMITY (Sore Arm a little) had resolved. On 26-Feb-2021, IRRITABILITY (Slightly Firm Injection Site) had resolved. At the time of the report, ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic), FEELING OF RELAXATION (Feels healthier post second vaccination) and FEELING OF RELAXATION (Overall Health Improved) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-027902 (Patient Link).
2 days following vaccination, pt. developed generalized itching and painful sores on her back. She went to her doctor on the 3rd day post-vaccination. Her doctor called the health dept. and reported that the pt. had 2 vesicular lesions on her back that looked like shingles. He prescribed an antihistamine, lyrica and valtrex. No labs were ordered.
Client fainted, and became unconcious. Client assisted to floor, and EMS called. Feet elevated, cold packs placed on extremity, and VS initiated. Client A&Ox3, and concious. EMS arrived, VS initated, Blood Glucose, and EKG initated. EMS discharged client.
Pt was administered Covid Pfizer vaccine #2 after 12 hrs of dilution but within 24 hrs of postdilution.
Reports was dizzy after vaccine and for a few days after and then around 7-4-21 arm began hurting and having neurologic issues