chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain from neck to shoulder and leg on right side; fever around 100.5 degrees Fahrenheit; felt "very tired"; pain from neck to shoulder and leg on right side; nausea; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain from neck to shoulder and leg on right side), MYALGIA (muscle pain), ARTHRALGIA (pain from neck to shoulder and leg on right side), PYREXIA (fever around 100.5 degrees Fahrenheit) and FATIGUE (felt "very tired") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diverticulitis, Surgery (surgery on Lungs- part of lung was removed,) and Caesarean section. Concurrent medical conditions included COPD, Emphysema and Clot blood. Concomitant products included ATORVASTATIN, MONTELUKAST, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) and VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 17-Feb-2021, the patient experienced MYALGIA (muscle pain). On 19-Mar-2021, the patient experienced NAUSEA (nausea). On 20-Mar-2021, the patient experienced NECK PAIN (pain from neck to shoulder and leg on right side), ARTHRALGIA (pain from neck to shoulder and leg on right side), PYREXIA (fever around 100.5 degrees Fahrenheit) and FATIGUE (felt "very tired"). On 19-Feb-2021, MYALGIA (muscle pain) outcome was unknown. On 21-Mar-2021, PYREXIA (fever around 100.5 degrees Fahrenheit), FATIGUE (felt "very tired") and NAUSEA (nausea) had resolved. At the time of the report, NECK PAIN (pain from neck to shoulder and leg on right side) and ARTHRALGIA (pain from neck to shoulder and leg on right side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: 100.5 (High) 100.5 degrees Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-054456, US-MODERNATX, INC.-MOD-2021-056898, US-MODERNATX, INC.-MOD-2021-056977 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054456:crosslink US-MODERNATX, INC.-MOD-2021-056898:1st dose case of patient's husband US-MODERNATX, INC.-MOD-2021-056977:2nd dose case of patient's husband
Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness; Also had odd pain shooting down to my elbow; Also had odd pain shooting down to my elbow; Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit.; It feels like there is a ball there but when I go to feel there isn't anything.; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 08Jan2022 at 13:00 (Lot number: unknown) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 27Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 13:00, outcome "unknown", described as "Dose number 3"; HYPOAESTHESIA (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness"; PAIN (non-serious), ARTHRALGIA (non-serious), all with onset 09Jan2022 at 06:30, outcome "not recovered", and all described as "Also had odd pain shooting down to my elbow"; AXILLARY PAIN (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit"; SWELLING (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "It feels like there is a ball there but when I go to feel there isn't anything". Therapeutic measures were not taken as a result of hypoaesthesia, pain, arthralgia, axillary pain and swelling.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
A physician reported the serious events of mononucleosis and tonsillitis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 28-Oct-2009. The subject received one dose before the onset of the event. In the evening, prior to admission, the subject had cough, "strep throat," and noisy breathing. In the morning of admission, his father noticed large swelling on the right side of the subject's neck and brought him to the Emergency room. The subject also had large firm tender right cervical adenitis and some nodes on the left side, as well. Complete blood count showed white blood cell count of 20 K/uL with predominant lymphs and mono." His tonsils were mildly enlarged and slightly red. Beside ultrasound did not indicate abscess. Hospitalization and intravenous antibiotics were recommended. The subject was hospitalized for three days and discharged home in good condition on 21-Nov-2009. The events of mononucleosis and tonsillitis were resolved on 21-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. Alternative etiologies for mononucleosis and tonsillitis were natural causes and infection, respectively. The sponsor also assessed the causality for the events as not related to FLUMIST.
pt recvd vax 13OCT95 & 13NOV95 came home from school early w/t100.6;also c/o gen body aches & chills;15NOV95 presented to MD w/fever of 102.4, chills, sl cough, pain on breathing, aches & leg weakness;unable to stand or walk;hosp dx'd GBS
2 hours after vaccine was administered, I developed a migraine, and was nauseated.  Then 12 hours later, I developed fever and chills and the next morning I was unable to stand on my own.  I fell twice due to lack of balance and coordination.  This lasted over 12 hours.
stored in the fridge for 40 days so 10 days over our recommended storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage) 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 were provided.
Felt really sick; Flu; Chills; Vomiting; Headache; Pain in every joint in body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really sick), INFLUENZA (Flu), CHILLS (Chills), VOMITING (Vomiting) and HEADACHE (Headache) in a 76-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 COVID-19 from September 2020 to October 2020. Concurrent medical conditions included Blood pressure high and Anxiety.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (Felt really sick), INFLUENZA (Flu), CHILLS (Chills), VOMITING (Vomiting), HEADACHE (Headache) and ARTHRALGIA (Pain in every joint in body). At the time of the report, MALAISE (Felt really sick), INFLUENZA (Flu), CHILLS (Chills), VOMITING (Vomiting), HEADACHE (Headache) and ARTHRALGIA (Pain in every joint in body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure and Anxiety medications. Treatment medications were unknown.
Pt was vaccinated outside (country) with COVISHIELD (4/23/21 - lot #4121Z054; 3/10/21 lot #4120Z011).  Pt was accidentally given Moderna booster
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 31Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 19Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly elevated blood pressure" (unspecified if ongoing), notes: Rx treated. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was Paxlovid treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201286149 Same reporter/patient, same drug, different AE;
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 010M20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 030M20A) and on 01Feb2022 as dose 3 (booster), single (Lot number: 037F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2023) Negative, notes: Tested negative for 2 days after treatment course ended; (19Apr2023) Positive, notes: Tested positive on day 4 after treatment course ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 10Apr2023 to 15Apr2023.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot GJ3274 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ3274, bulk and fill lots GJ2419, and GJ2425. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163470 Same reporter/patient, different drug, different event.;
This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vAQTA lot # M033611, expiration date: 03-MAR-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007030: US-009507513-1701USA009339: US-009507513-1701USA009337:
Rash-trunk, chest, arms, conjunctivitis. Fever 15d post vaccination MMR-illness. Pt had received Remicade in June for RA.
My child was experiencing severe stomach pains, crying episodes and could not get comfortable. Her feeding habits changed, pulling away from the breast, tugging on my nipples, crying while feeding, scrunching up and stretching out, her stomach was hard and bloated to the touch. Then after much effort, she would expel frothy, foamy, grass green colored diarrhea, high toxic scented diarrhea. Her bottom was red and inflamed. After her stomach was relieved, she would return to my breast for food, however the behavior at the breast would resumes in a vicious cycle. This has been continuous for the past 4 weeks, and has not ended. Prior to this she was eating every 4 hours during the day and sleeping 6-8 hour at night. Now she wants to feed after every bowel movement and this is approx. every 2 hours day and night. She fusses while feeding and after feeding - she does not have more then a 2.5 hour stretch of sleep now, generally she is sleeping about 1/2 hour between feedings and is fussy before and after she goes to sleep. The Dr. said it must run its course, but it has been 5 weeks and counting. I have been providing her with over the counter gas drops and solutions to alleviate the discomfort, and she will go to sleep for about 30 min. once I administer these drops. This is ongoing, and there is not a definitive recovery time based on the Dr. visit and that this is how she is fighting the Rotavirus and it must run its course.
arm sore; Arm discomfort; dizziness; This is a spontaneous report from a contactable consumer (patient) based on the information receive by Pfizer. This case is one of the two reports with first dose information. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation or prophylaxis. Medical history included ongoing osteoporosis, intervertebral disc protrusion, nerve compression (4th disc slipped on 5th disc and pinched a nerve) from 2018 to an unknown date; hypoaesthesia (numbness in feet); substance-usage history was significant for surgery to bone pressing on nerve causing numbness in feet from an unknown date and unknown if ongoing; spinal laminectomy on 27Jun2018 for 4th disc slipped on 5th disc and pinched a nerve, removed bone pressing on nerve causing numbness in feet. The patient's concomitant medications were not reported. The patient previously took Fosamax for osteoporosis and teeth were clear after one year of therapy; Forteo for bone density decreased and experienced shaking, tremor (drug body shook left to right). The patient experienced arm sore, arm discomfort on an unspecified date and dizziness on 02Apr2021 with duration just a few minutes also less than an hour. The patient underwent lab tests and procedures which included bone densitometry of -3.6 n/a in 2018, and -3.5 n/a on Jun2020. Clinical outcome of the event dizziness was recovered on 02Apr2021 and it was unknown for other events.  Follow-up attempts are needed. Further information is requested.
Subject in pneumococcal vaccine trial, with sever COPD, was admitted to hospital. Vaccination took place on 6/13/07 and admission was on 5/26/08. According to the physician, the relationship to treatment is 'unlikely'. We would be happy to forward the Report Form upon request. 8/12/08-records received for DOS 5/25-5/30/08-DC DX:Pneumonia. Presented with shortness of breath. Fever 101.2, chills, chest pain with cough, nausea and vomiting.
RASH ON LEFT SIDE OF LEG STARTING MID LOWER BACK AND WRAPPING AROUND THIGH IN PATTERN OF DERMATONE RASH HAS VESICLES AND IN APPEARENCE IS SHINGLES.  DX SHINGLES IN SAME LOCATION AS PROQUAD VACCINE.
Chest pains shortness of breath, headache, backpain  and coughing.
During night after the vaccine was given she awoke sweaty and had body aches and in the morning had body aches, weakness, and anxiousness. She took some Ibuprofen and was feeling better after that but still felt weak.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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)) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 63 adult patient out of 190 reported who was received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Provider summary "patient is a 74 YO female who was admitted to the hospital with sudden chest pain after finding out the news that her brother had passed. Cardiac catheterization revealed mult-vessel coronary artery disease. The patient was recommended for surgery. She was brought to the operating room on 7/1/2022 and underwent CABG x 3. The patient tolerated the surgery well. She was managed in the ICU and PCU setting. Postoperative course was uneventful. The patient was tested for COVID-19 per policy and was found to have asymptomatic COVID-19. She was put in isolation. The patient remained asymptomatic throughout her hospital stay. She was discharged home in stable condition on postoperative day 6. Her discharge CXR showed a stable moderate R pleural effusion. The patient was sent home on diuretics. "
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips.    @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better."   Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days.   Pt advise to call if s/sx return or get worse.   Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
The patient said she had chills and shortness of breath the night of the vaccine, then today she was very weak and tired, and had a headache.
24 hours post vaccination, I started with an intense headache - left frontal orbital and maxillary - 7/10. This headache remained constant, unrelieved by motrin or tylenol. on 12/13/2021, I was admitted for double vision with the headache which was now a 8-9/10.  After the hospital stay I followed up with a neuro-ophthalmologist multiple times for the constant headache. I was on several rounds of steroids, the final round of high dose steroids improved my headache somewhat. The double vision improved.   As of today, I still have a left frontal, orbital, and maxillary headache that is intermittent - a pain level 4/10.  ***I have NO prior history of headaches. The ONLY time I ever had a headache was after my 2nd COVID-19 Pfizer shot. It only lasted 24 hours and then disappeared.
On 4/7 we discoverd 5-6 small marks the size of a pin prick on our sons leg- some raised some not. 4/8 he developed a low grade fever high of 101- the fever came and went for 3 days, he was slightly cranky and slept more than normal the small marks by Sunday were covering his legs, arms and back. Most were upraised. Fever broke on Monday.  He was still more tired than normal. We took our son to the Dr., Monday who determined it was a reaction to the MMR and advised no treatment. As of today no fever, and most marks are gone he just has a handful on his leg.
Patient started to be itchy and started to get a rash and welts, as patient described. Patient took BENADRYL and it helped, but as soon as the effect of the BENADRYL wears off, she would get rash and welts again. Patient stated her whole body was itchy.