chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intermittent twitching of right eye lasting periods of a few minutes each following booster (3rd) dose.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Dec2021 at 14:00 (Lot number: EW0191) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Polycystic kidney" (unspecified if ongoing), notes: Polycystic kidney disease; "Eczema" (unspecified if ongoing) and "polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS. Concomitant medications included: SPIRONOLACTONE and TRETINOINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6202; Administration time:15:00; Anatomical Location: Left Arm), administration date: 28Feb2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FR8727; Administration time:15:00; Anatomical Location: Left Arm), administration date: 21Mar2021, when the patient was 24 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; MUSCLE TWITCHING (non-serious) with onset 08Dec2021 at 08:00, outcome "unknown", described as "Intermittent twitching of right eye lasting periods of a few minutes each following booster (3rd) dose".  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication TRETINOINE was taken topically. Since the vaccination, the patient had not been tested for COVID-19. The event was described as first noticed at 8am morning after 3rd dose (17 hours) and again at 30 hours. Total duration of each event was about an hour. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events.
Six days after I got this vaccine my right optic nerve hemorrhaged and I am now legally blind in my right eye.
sore arm, bump, hard to lift arm after several months. if she messages area she can lift arm
more than 35 days for administration of second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up information received contains Non significant information. Added patient Race White and Ethnicity non Hispanic or latino and Patient Pregnancy as NO.
3 inch welt on arm- raised, red and swollen.  Went to the doctor several days later as it didn?t go away - had the welt/hive for almost 2 weeks post vaccine
they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; This is a spontaneous report from a contactable physician. A 12-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3183, Expiration Date: 31Oct2021), dose 2, intramuscular, administered in deltoid left on 07Sep2021 16:00 (at the age of 12 years) as single dose for COVID-19 immunisation. Medical history included asthma, mild intermittent asthma and overweight from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any prior vaccination. The patient previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EW0185 and expiration date was not reported), dose 1, intramuscular, administered in deltoid left on 17Aug2021 15:54 (at the age of 12 years) as single dose for COVID-19 immunisation; Hpv (Lot:T029522, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 12Aug2021, when the patient was 12 years old. It was reported that they had mixed 0.8ml of the diluent instead of 1.8ml with the Pfizer BioNTech covid19 vaccine which resulted in a higher dose. On an unspecified date the patient had experienced mild tactile temperature, fatigue, mild headache. Symptoms were not different from what he experienced after first dose. The outcome for the events mild tactile temperature, fatigue, mild headache was recovered at the time of report. The patient underwent the following laboratory tests and procedures: platelet factor 4: unknown results.   Follow-up attempts completed. No further information expected.  Follow-up (07Sep2021, 28Sep2021, 04Oct2021): This is a follow-up spontaneous report from a Pfizer-sponsored program includes: Relevant medical history, lab data, product details, events and narrative were updated.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169407 Same reporter/ drug/ event for different patients
Headache, Myalgia, Fever, NauseaVomiting, indigestion/heartburn, fatigue, fever 104.8 Narrative:  missed 2 days work. Symptoms abated within hours
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-JUL-2014 the patient was administered with a dose of expired M-M-R II (HSA) (lot # H012133, expiration date 29-JUN-2014, dose, route, indication not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS# 1407USA004545). Additional information has been requested.
pt recv vax; fever then measles appeared all over body, then immed was a bad head cold;
On the second day after my second vaccine shot, I developed 4 or 5 large red blotches on my upper arm. They were itchy and slightly swollen. It has been 8 days since the vaccine shot and I think the area may be slightly faded. The itchiness is not as bad as it was initially.
chills/slightly elevated; fatigue/slightly elevated; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills/slightly elevated), FATIGUE (fatigue/slightly elevated) and PYREXIA (Slight fever) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21H and 031L200) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Macular degeneration, Pulmonary fibrosis, Drug allergy (Percocet), Chronic bronchitis and COPD. Concomitant products included VITAMINS NOS for Macular degeneration, MOMETASONE FUROATE (ASMANEX) for Pulmonary fibrosis, RITUXIMAB (RITUXAN) for Rheumatoid arthritis, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ATORVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), LEVOTHYROXINE and VITAMIN D3 for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (chills/slightly elevated), FATIGUE (fatigue/slightly elevated) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 12-Mar-2021, CHILLS (chills/slightly elevated), FATIGUE (fatigue/slightly elevated) and PYREXIA (Slight fever) had resolved.            The patient got rituximab infusions every 6 months for rheumatoid arthritis.  The patient had a compromised immune system due to the rituximab.    The patient normally had fatigue with rheumatoid arthritis, but with the vaccine patient had a double dose of fatigue.  Patient reported that she is taking Rituximab for Rheumatoid Arthritis(RA). It is also reported that there are flare ups of RA, but the patient is not sure whether because of the vaccine. Patient states that possibly the vaccine caused immune system to respond therefore a flare up in RA.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Medical history updated. On 25-Jul-2021: No new information reported. On 07-Aug-2021: Non-Significant Follow up received and reporter information updated
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GJ6665) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long covid previously" (unspecified if ongoing); "known allergies: Penicillin reaction" (unspecified if ongoing), notes: decades ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid : treatment start date: 15Jul2023; treatment stop date: 19Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258965 same patient, different drug, different event;
Patient received vaccines noted below on Oct 31st 2008. No complications noted at time of administration. Father called office on 11/1/08 at 12:10pm to report ? atypical febrile seizure through the night of 11/1/08. Temperature reported to be 99.8 rectally. Father stated child's extremities were stiff,was crying, sweating and had a bowel movement at approx 3am and lasting 30 seconds.  Episode witnessed by father who also is a adult neurologist.
Pruritic rash on arms, chest, back, and scalp. Non-pustule, no blisters. Non-urticarial. Could see and feel rash tactile. Nausea starting on 1/20/2011. Intermittent headache starting 1/20/2011.
Pediarix, ActHib and PCV were administered in the afternoon of 9/8/2008. About 4 am the next morning the foster mom noticed the child's fontanel was protruding about 1/2 inch above her head. The foster mom called the baby's doctor, but couldn't get in right away. She then took the baby to the Emergency Room. By this time, the fontanel had reduced in size by about 1/2. The ER doctor did not run any test and sent them home. The next day, Wednesday, the foster mom was still concerned so she took the baby to her doctor. At that time, the foster mom's doctor, had an ultrasound done on the baby's head. Everything was reported to be normal. No other findings have been reported.
Because I had allergic reactions to the 3 Pfizer vaccines in 2021 and a neurological reaction to the Pfizer bivalent booster in 2022 (my legs gave out and I fell) I took a Zyrtec prior to getting the Novovax this fall and also had the shot given to me in 2  half doses while waiting 40 minutes between the two. There didn't seem to be a reaction at first but on my way out to my car I noticed that my toes and feet had numbed up completely making it difficult to walk. I did however get home but then had the regular fatigue reaction I get each time so I slept for the following 24 hours. It has taken 10 days for the feet to mostly go back to normal.  No treatment though I did report it to my PCP.
First dose of Moderna Covid-19 vaccine given to 17yr 7 month female. Observed for 15 minutes per protocol and no adverse reactions reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "unspecified autoimmune disease, asthma" (unspecified if ongoing), notes: unspecified autoimmune disease, asthma; "unspecified autoimmune disease, asthma" (unspecified if ongoing), notes: unspecified autoimmune disease, asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant),SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as  COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I don't have lot number. I do have the RX# 0278215. NDC IS 58160082311. At 3:00 a.m. couldn't sleep, developed fever which lasted about 30 hours ranging from 99.9 to 101. I was weak, had aching in joints, loss of appetite, sleepy, headache, chills, one episode of diarrhea. Was unable to work on 4/30/21. On 5/1/21, weak, occasional chills, sleepy, headache, loss of appetite. On 5/2/21, started to feel better with increased appetite. Noted a red sore area right below injection site which was hot to the touch, about 2" x 1" below injection site.
Extremally sleepy, went to her house did not eat and went straight to bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Extremally sleepy, went to her house did not eat and went straight to bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SOMNOLENCE (Extremally sleepy, went to her house did not eat and went straight to bed). At the time of the report, SOMNOLENCE (Extremally sleepy, went to her house did not eat and went straight to bed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications includes  medication for the shaking on her arm and leg when she goes to sleep, after the brain surgery. No treatment related information has been reported.     Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: TCR Document received on 14-JUN-2021 Contains event outcome updated.
The first day I had pain in my arm, which I expected. But the next day, my arm became swollen, with a large lump in it about 4 cm wide   The lump is just not getting better, but it is still there. The other issue is I have muscle ache and soreness starting the day after the shot, and it has never gone away.
This study case was received from the investigator in a trial on 04 June 2012. A subject (age, date of birth and gender not reported) received the following vaccinations: On 01 December 2011 an injection of ACAM2000 (lot number not reported), on 29 November 2011 an injection of anthrax (manufacturer and lot number not reported) and on 30 November 2011 an injection of rabies (manufacturer and lot number not reported). On 19 December 2011, the subject was diagnosed with unspecified disease of pericardium. Medical history was not reported. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
lump in my armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump in my armpit) 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 AXILLARY MASS (lump in my armpit). At the time of the report, AXILLARY MASS (lump in my armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up appended contain NNI
Pt came to office 8-31-12 stating since she received flu shot on 11-4-11 she had (L) arm pain at the site. Reports at the time their was some bruising at the site. Pain improved for a few months then worsened. Took ibuprofen x 3 wks. Pain with driving, lifting arm above head or behind back.
Patient came in for routine care. 4/3/08 - was given two vaccines MCV4 and Varicella. Woke in AM w/severe localized reaction. Checked by Dr in office. No fever, slight induration, slight itching. Benadryl 1 q4hrs. Call if increase in size or fever.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 6/14/2022,  8/23/2022,  8/29/2022  --  RECURRENCE OF SAME SYMPTOMS
Pt recvd MMR vax on 09AUG90; Following vax, pt devel diffuse morbilliform rash; @ time of report pt had recovered;
no known prenatal exposure to varicella;no known subclinical varicella disease;vaccinated age 5 w/varivax 13FEB96 w/o problems or side effects;sudden devel of rash dx as shingles 10mo later 31DEC96;
Patient was admitted to observation level of care on 12-29-21 with increased weakness and leg pain. Patient has a medical history that is significant for  Rheumatoid arthritis. It is noted that the patient tested positive for covid on 12-29-21 upon admission.
This spontaneous report as received from a Registered Nurse refers to 4 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-JUN-2016 the patient was inadvertently vaccinated with ZOSTAVAX lot # L034724, expiration date 09-DEC-2016. Dose and route were not provided. Additionally, the patient was also vaccinated with VARIVAX, lot # L026410, expiration date 15-FEB-2017. Dose and route were not provided. No other suspect or concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a parent concerning her daughter who was vaccinated with GARDASIL (lot #, date not reported).  The parent reported that the daughter fainted and "started moving around as though she was going to start convulsing".  The second dose of GARDASIL (lot #, and date not reported) was given.  It was reported that the patient sought medical attention (office visit).  No further information was available.  Upon internal review, the patient's convulsion was considered to be an other important medical event.  Additional information is not expected.
Patient reports about 24 hours s/p #1 vaccine -> mouth edema and throat edema. No epipen usage but was given benadryl/atarax with good relief.
I was giving a Pfizer Covid vaccine to a 6 year old patient. The mother was holding the patient in the chair and was holding the patient's left arm down. As I was administering the vaccine, the patient jerked her arm very quickly. Some of the vaccine was not administered as it was on the outside of her arm. I estimated that over 50 percent of the vaccine was administered, so I did not do a second dose.
13JUL92 pt recvd Engerix-B & w/in an hr devel inflammation & tenderness @ site of inject; that evening began a fever; 14JUL92 devel nausea & lightheadedness; later in the day diarrhea & bloody stool; 15JUL92 devel tingling & tenderness;
On March 9, 2023, I noticed I was having, what I thought was, allergy symptoms.  I was having runny nose and drainage with a little bit of a cough.  I also began to sneeze.  I tested positive for COVID-19 on March 12, 2023.  I had chills and low-grade fever and congestion.  I took Benadryl to help.
Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to 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, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the 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 will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine Live (ZOSTAVAX).