chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cataract; Dialysis; Feeling cold; Feeling hot; Feeling abnormal; Post procedural complication; Sleepiness; Fatigue/Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CATARACT (Cataract) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe Crohn's disease).   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), FEELING HOT (Feeling hot), FEELING ABNORMAL (Feeling abnormal), POST PROCEDURAL COMPLICATION (Post procedural complication), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness). At the time of the report, CATARACT (Cataract), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness) had not resolved, FEELING HOT (Feeling hot) had resolved, FEELING ABNORMAL (Feeling abnormal) was resolving and POST PROCEDURAL COMPLICATION (Post procedural complication) 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 product use was not reported.   Treatment information was not reported.  Company Comment: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.; Sender's Comments: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.
Received PNEUMOVAX and influenza vaccines left arm, became red/ hot/swollen the same day, treated with Bactrim DS and Prednisone.
right deltoid with 3-4 inch of redness swelling warm to touch, fever for 24 hours none after 24 hours
Felt bad the day after shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad the day after shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had temp of 105 was lethargic on 30OCT91 in evening; mom had given APAP;
Pain in bicep of vaccinated arm approx 1.5" below vaccination site upon raising elbow away from body - not a pulled muscle. Dr. did not link to vaccination. Pain ongoing; specialist prescribed physical therapy which is helping but pain still occurs.  Oongoing.
Left clavicle pain felt around 8pm. Pain differed from "sore arm" pain I was expecting. Pain traveled a bit up my neck towards my ear. It's 48 hours later and pain remains.
Joint pain in knees, toes, hips, rear end, hands. pain ping pongs throughout body. burning in legs, chills, loss of appetite. Given a course of prednisone. Helped for a short time and now symptoms have returned and are debilitating.
This spontaneous report was received from a Licensed Practical Nurse regarding a 6 months old infant. On 26-NOV-2012, the patient was inadvertently vaccinated intramuscularly with, 0.5 ml VAQTA (lot #, expiry not reported)instead of RECOMBIVAX HB. No concomitant medications were reported. No adverse effects were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
headache; sore arm after the second dose/painful arm; had a 102°F temperature; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101070851 (Pfizer).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EP7533) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (The first shot was on 02Apr2021,Lot: EP6955.), administration date: 02Apr2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "sore arm". The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "had a 102°F temperature"; MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "migraine"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm after the second dose/painful arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Context: The report is cross referenced to report ID: # (Name), from #, with the warm transfer of a caller reporting on the Pfizer Covid vaccine and who explains his fiance had the first dose on 2Apr2021 and the second dose on 23Apr2021 and stated after the second dose had a migraine, temperature of 102, and painful arm. This report was for his fiance. Patient name: (Name). Transferring agent provided the patient's first name as (Name) but the caller states on her card it was actually her legal name of (Name). Last name provided by the transferring agent: (Name), this was corrected to (Name) by the caller. patient's address was the same as the reporter, they reside together. Event of after the second dose: She had more of a reaction than he did. She had a migraine, temperature of 102, and painful arm. The events lasted about 2 days after the shot, she got bed rest and was ok. It was confirmed that this was only after the second. This information is provided from the patients card but was the same as the patient in the first report.  No follow-up attempts are possible. No further information is expected.
Febrile seizures on 5/30 & 5/31, pneumonia dx on 5/30
Uncontrollable stretching. Most of the time, able to limit the stretches so I didn?t hurt myself. Duration: 2 hours severe. Another one hour moderate.
Itchy; Big rash on her arm at the site of the injection; Not terribly painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Kinrix vaccine ordered by provider and given to a 2 yr. old.   Vaccine recommended for 4-6 yrs.  No reaction was had by the child.
The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphedema.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up). At the time of the report, PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that the patient cannot find a vaccination provider that will administer a dose of Spikevax 2023 2024 in her thigh. The patient had lymphedema in her arms and must receive the vaccine in her thigh. The patient does not have a Physician and when she went to the Pharmacy to ask, they said that they only provide the Spikevax 2023 2024 vaccine in the deltoid muscle. The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up and a previous provider recommended that the patient should receive her Covid-19 vaccine in her thigh. Previously the patient could find a provider who would administer the vaccine in her thigh however at that time she cannot find a provider. The patient said that she had been to several Pharmacies and discussed her situation with corporate headquarters of Pharmacies and that they will not administer the Spikevax 2023 2024 vaccine in her thigh. No treatment information was provided.   Reporter did not allow further contact
pt recvd vax on 8OCT92 & 24 to 48 hrs later pt exp severe h/a, flu-like sx of neck & shoulders & abdo cramping; no further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included IBUPROFEN for Pain, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain). The patient was treated with DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain) outcome was unknown.            Patient called 21May2021 stating she has chronic stomach pain but states she does not think it is from vaccine 1st dose because she has had this problem for years prior and is calling because she needs to cancel 2nd dose appointment originally scheduled that day  due to the stomach pain.  Concomitant medications include blood pressure pill, anti-depressant pill, heart burn pill   Reporter did not allow further contact
Nothing reported at this time. Found incorrect dose given during balancing vaccine inventory. Provider is calling parent to discuss extra dose of Varicella.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Vial was kept in freezer until date of puncture, then stored in refrigerator.   This case was linked to MOD-2021-418964 (Patient Link).
shortness of breath; fatigue; Polymyalgia Rhumaticia; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021. The most recent information was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) was resolving and DYSPNOEA (shortness of breath) and FATIGUE (fatigue) had not resolved.            Very limited information regarding the events has been provided at this time.  Further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: The case upgraded to serious with event polymyalgia rheumatica. The event onset date and outcome of same event updated, event Arthralgia was removed, Treatment medication added.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.
Shingles; This initial spontaneous report was received from a lawyer on 02-APR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (no additional dosage regimen information was reported). Subsequently, on an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of vaccination, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future.
Severe chills, fever (99.6+ F), lasted about 60 min., treated with 500ml APAP.. Accelerated heart rate (~105), ache at injection site persisted overnight. Difficulty sleeping. Mild cough from onset of symptoms until present.
This spontaneous report as received from a nurse practitioner refers to an 18-year-old patient of unknown gender. On 24-APR-2015, the patient was vaccinated with one dose of (Oka/Merck) PROQUAD 0.5 ml, subcutaneously (lot number and expiration date was unknown) instead of the intended single dose each of MMR II and (Oka/Merck) VARIVAX. No adverse effects were reported. Additional information is not expected as there was no permission to contact the physician.
pt recvd vax 8JAN96 & started w/fever w/in 4hrs cont w/fever until 11JAN;pt turned blue & unresponsive;mom called paramedics who transported pt to hosp ER;temp @ this time 104R;dx febrile sz from immunization
got very anxious during the 15min waiting period after receiving first Moderna COVID19 vaccine... wanted to drink water, throat seemed itchy, was very shaky, tachycardic to 105, BP 139/60, RA sat 100%, clear lungs. Laid down and rested with improvement of symptoms. HR to 86, no longer shaky, no longer with itchy throat, RA sat remained 100%, BP decreased to 118/45. Able to sit up then walk with no dizziness/wooziness, felt totally back to normal after <30min and was discharged to home. No meds or ER visit.
p/vax pt devel herpes zoster;also erythematous, edematous, 1 to 4mm papules & early vesicles;rt cervical lymphadenopathy;h/a;Tzanck smear showed positive results for multinucleated giant cells;positive VZV;
NET DAY BAD LOWER BACK PAIN AND EXTREME FATIGUE...... THREE WEEKS LATER I WOKE UP WITH DOUBLE VISION.  IT'S BEEN LIKE THIS FOR 11 WEEKS SO FAR. STARTING THE 12TH WEEK IT SEEMS TO BE GETTING BETTER. ALL 6 DOCTORS I HAVE SEEN SAID I HAD A SIXTH NERVE PALSY OF MY EYE.
Sore arm about 4 hours after receiving vaccine. Next morning: woke up feeling fatigued and had 3 bouts of diarrhea in total (each time after eating).
Slight fever Cough Sore throat Stuffy nose Extensive muscle aches Soreness at vaccination site Fatigue and malaise All occurred within about 18 hours and then abated; they were severe enough that if I hadn't known I had gotten a shot, I would have gone to the ER I continue to have soreness at the injection site and significant knee pain
No problems at vaccine administration later 10 days shingles rash developed with neuropathics throughout body. Pt saw Dr to verify active shingles outbreak. Started on left side body.
Inboxed my doctor with this message on 8/18/2021: I received my 1st Moderna COVID shot on 8/16/21 and having allergic reactions that I thought would pass by now. I woke up to swollen eyes on Tuesday, vomiting having dizziness with blurred vision ..as I am sending you this message I'm dizzy and lightheaded and it seems like the floor is elevating as I walk. What do I do now.
Dizziness,Headache,Equilibrium off  3 Weeks after 1st Shot for period of 3 days . Severe Headache, Fever of 101 degrees, Exhaustion after 2nd Shot End of June 2021 experienced Flashing in peripheral  Vision Right Eye followed by detached retina  diagnosed  by July 11 Emergency Surgery performed July 11, Complications occured followed by additional Surgery on Aug 5,2021
3 days of severe diarrhea followed by dehydration; 3 days of severe diarrhea followed by dehydration; This is a spontaneous report from a contactable consumer. This 31-Year-Old male consumer (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 31 Years). Medical history and concomitant medications were not reported. No other vaccine in four weeks. COVID not tested post vaccination. No known allergies. No other medical history. On 04Apr2021 20:00 patient experienced 3 days of severe diarrhoea followed by dehydration. No treatment was received for events. The outcome of event was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Cold chills, vomiting, fever and body aches started 12 hours after 2nd dose of vaccine. Treated with ice packs on sore muscles and Tylenol.
A few minutes after the last injection (TB test) pt states she feels faint. Face turned pale and she passed out while sitting up for about 20 seconds. She came to, I laid her on the floor and elevated face with a cool cloth x5 min. Felt better and left office at 11:15AM.
This was a retrospective study of pediatric patients attending a hospital from 2006 to 2012. Patients with a diagnosis of DiGeorge syndrome were identified; their charts reviewed and immunologic data were abstracted. To be included in the study, the were required to have received the Hib vaccine, PCV (either 7-valent or 13-valent), diphtheria vaccine, and tetanus vaccine. Immunologic testing done at, or closest to, the time of vaccine titer measurements were included. Patient who did not have titers for the above-mentioned vaccines nor complete immunologic testing, including T- and B-cel subsets, lymphocyte mitogen proliferation, and immunoglobulin levels, were excluded. This study was approved by the review board. Information has been received from the author of a publish literature article regarding 3 pediatric patients of unknown age and gender with DiGeorge's syndrome. On an unspecified date, the patients were vaccinated with a dose of Hib vaccine (Manufacturer unknown) reported as "Hib vaccine" (Lot number, expiration date, dose and frequency were not provided). Concomitant medication was not reported. Overall, mean Hib vaccine (manufacturer unknown) titer was considered protective. Though, the three patients had nonprotective titers which were considered as vaccination failure. The immune parameters were within normal range (average CD3 count 2281 mm3, CD4 count 1536 mm3, CDS count 606 mm3, natural killer cell count (NK) count 947 mm3, IgG 712 mg/dL, IgA 33 mg/dL, IgM 58 mg/dL). Two of the 3 had normal lymphocyte responses to phytohemagglutinin, the third had low-normal response. One of the 3 also did not have a protective response to any of the pneumococcal serotypes, although she had normal T, B and NK cell levels, normal immune globulin levels and normal response to phytohemagglutinin. The outcome of vaccination failure was unknown as this was a retrospective study, additional testing was not done in the three patients. Additional information has been requested.