chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Conjunctivitis; First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of CONJUNCTIVITIS (Conjunctivitis), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CONJUNCTIVITIS (Conjunctivitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.). At the time of the report, CONJUNCTIVITIS (Conjunctivitis) and COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  No treatment medications were reported.  The reporter's causality for the events of Conjunctivitis and COVID-19 with RINVOQ was reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient presented to pharmacy on 10/10/2022 saying that he has a had numbness/tingling in his left arm and hand ever since the vaccine was administered on 9/18/2022.  He originally had redness and pain which has improved but he is still experiencing numbness in his left hand.  He will follow up with his doctor.
Information has been received from a physician assistant concerning a 15 year old female with exercise induced reactive airways disease and no allergies who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) IM in the deltoid 0.5 ml (lot # 657621/0387U). There was no concomitant medication. On 06-AUG-2008, six hours after receiving the first dose, the patient experienced high fever (reported by the patient's mother as 104 F). On 07-AUG-2008 the patient was examined by the provider and fever resolved, however, the patient had "exquisite" anterior cervical lymphadenopathy. The patient's anterior cervical lymphadenopathy was recovering. No other symptoms or treatment reported. The white blood cell count, urine analysis and liver function test were performed. The patient sought medical attention in an office visit. Additional information has been requested.
Pain in left eye; Pain in arm; Headache- front head still hurts; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN, PAIN IN EXTREMITY, and HEADACHE in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN, PAIN IN EXTREMITY, and HEADACHE. The patient was treated with OXYMETAZOLINE HYDROCHLORIDE ongoing since an unknown date for Headache, at an unspecified dose and frequency; TYLENOL for Headache, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and NAPROXEN for Headache, at an unspecified dose and frequency. At the time of the report, EYE PAIN and PAIN IN EXTREMITY outcome was unknown and HEADACHE had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood cholesterol: 160 (normal). On 10-Apr-2021, Blood glucose: 96 (normal). On 10-Apr-2021, Blood pressure measurement (80-120): 157 (High) Hypertension and 126/60 (normal) 126/60. On 10-Apr-2021, Heart rate: increased (High).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was in the ER for 5 hours and was admitted to the hospital because they wanted to perform some tests.  Patient states she went home and still has headache till today. Her front head still hurts.   This case was linked to US-MODERNATX, INC MOD-2021-080351 (E2B Linked Report). This case was linked to MOD-2021-080351.
On 9/28/2022, everybody in the house had COVID-19, I was feeling like I was coming down with a fever, and it went away. On 9/29 a hurricane was coming, we put up shutter even though we were sick. I did not feel ill. I just felt tired. I slept apart from everyone else. I was testing negative, but on the 9/29/2022 I tested positive. I felt great. I continued to test positive on 9/29 until 10/3rd. On 10/3/2022, I got a fever, and I was sneezing, like I was coming down with a cold. I had exhaustion and weakness, and cold symptoms, like a bad head cold symptom. I took MUCINEX and NYQUIL, I used a NETTY POT and ibuprofen. I tested positive until 10/8/2022 is when I finally tested negative. I called a hurricane response center, and they were not able to help me. Everything was boarded up. I could not get a prescription for PAXLOVID.
chills and fever 6:00AM next day,  mild sore  arm, 8:00PM same day, fever gone 3:AM 2nd day,  red rash 2nd day, no itching
fluid in joints of hands, knees, ankles, wrists, pain & swelling of paresthesias of fingers & toes;
First day usual symptoms,  headache , body aches, fever,chills, nausea, sweating. Second day, body aches, headache, heart palpitations . Until day 11 extreme body aches concentrated on lower back sacrum and thighs. Day 13 still having body aches but they have lessened slightly .
Started day one but over by day three: fever, chills, body aches,  diarrhea, over by day three. Ongoing: sore arm, headache, metallic taste in mouth, nausea, dizzy feeling.
Swollen vaccine site 6 x 9 cm raised warm area (R) deltoid (not red). Feels malaise, warm, joint aches, nausea. Diarrhea Hx weak myalgias.
The soreness and redness associated with the initial shot had dissipated by four days after the vaccination, but at 9 days after, i developed a red rash in the shape of a large circle around the injection site. The rash was accompanied with soreness and tingling down my arm into my fingers.
Pain both right and left arms and left side of neck with tingling of the lips, palms of hand and soles of the feet. Mild headache. Mild chest pains at 1900 same day. Performed breathing exercises and yoga. Took a 1.5 mile walk. Took 1000mg of Tylenol and 12.5mg of Benadryl at 1900. Pain was relieved but tingling around the mouth persist even today 12/29/20 with leg muscle tingling and stiffness in the left neck . I had to take off work 12/28/20 due to severe pain left neck. Same symptoms I have when I take the tetany vaccine.
had sided weakness - face  - arm - leg.   Patient went to ER was given tenecteplase 50mg IV.   Patient's symptoms clinically resolved
My breasts were very sore for approximately 7 days following the vaccine.  I thought that the breast on the same side (left) that I received the vaccine was more sore than the other breast (right).  One day I thought that I had put my sports bra on wrong it was so sore.  Another day I woke up from sleeping on my side because my breast was sore.  I also had some menstrual cramps.
Welts with Swelling and itching at the injection 8 hours after receiving injection. Body aches, chills,
Patient came in to the store for flu vaccination. Patient was accidentally given the Tdap vaccination. Patient was notified right away with the mistake and is very understanding. Patient was given the right vaccination after. Told patient there has been no adverse events due to multiple doses except potential pain. Patient last received shot in march 2015.
Hours post injection patient noted a subconjunctival hemorrhage on the left eye. Patient does not present with any other symptoms an allergic reaction, or vision strain.
9/22 Pt called RPh to say her arm is very red. Pt. was asked if was warm and if pt running temperature. Pt said yet and was directed to ER. Pt. diagnosed with cellulitis and filled Rx. 9/27/13 followed up, pt is improving. 9/28 doing better.
Patient complaint of redness on left arm and neck also was flushed in face. No complaint of shortness of breath or rash. Vital signs within normal. Pulse Ox %100.  Symptoms improved and was discharged home at 1040.
swelling in their left septic joint (knee).; swelling in their left septic joint (knee).; Initial information received on 23-Jan-2023 regarding an unsolicited valid serious case received from a nurse.  This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 19-Jan-2023, the patient received 0.25 ml(milliliter) (dose 2 ) (once) suspect influenza quadrival A-B multidose vaccine preserved, suspension for injection, (lot number: UJ899AB, expiry date:30-Jan-2023) via intramuscular route in the left thigh for Prophylactic vaccination (immunization).  On 21-Jan-2023, the patient developed swelling in their left septic joint (knee) (arthritis bacterial) (joint swelling) (latency:2 days) following the administration of influenza quadrival A-B multidose vaccine preserved.  It was reported that "The area was drained by an orthopedic in the hospital and the infectious disease team is involved".  No lab data were reported.  Action taken: not applicable.  An infant received Antibiotics (intravenous) for both events as treatment.  At time of reporting, the outcome was Unknown .  Seriousness criteria: Medically significant for septic joint and its symptom.; Sender's Comments: Sanofi company comment dated 25-Jan-2023: This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose].The time to onset was compatible with the role of vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based on information provided, the role of an individual vaccine cannot be assessed.
Pt recvd 3 doses of Engerix-B on 21sEP90, 21OCT90, & 2APR91 & SEP91 Hep b surface antibody was neg;
Muscle soreness / Muscle aches; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 10:20 (Lot number: EN6203) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "Muscle soreness / Muscle aches". Therapeutic measures were not taken as a result of myalgia.  Additional Information: The patient stated that after the first dose of vaccine, she felt fine. She experienced muscle soreness after the first dose of the vaccine when she was age 64 and it was three weeks ago (04Mar2021). She had muscle soreness on the same day that she got the first dose of the vaccine but the muscle soreness was gone by the next day (05Mar2021) and did not require treatment. She was on other medications but they had nothing to do with the events. The patient stated that she could feel the first dose and could feel a muscle ache. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician office. The patient did not receive prior vaccinations within 4 weeks, had no family medical history relevant to the adverse event, and no relevant tests done.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021334925 Same patient and drug; Different dose and events
Patient noticed left arm was sore a few days after vaccination, neck was sore, this soreness/tenderness still persists to today (1-8-21), patient states he never experienced any loss of motion (able to move arm normally).  This was his first flu vaccine ever, only got the flu shot because of the TV saying he should due to covid-19.  No fever/headaches, etc.  Just uncomfortable pain in his left shoulder where the vaccine was administered.
Day of vaccine around 18:00 pt. started experiencing itching/burning sensation over whole body. Pt. described as "stinging". Pt. developed pin head size dots on body, received BENADRYL at 19:00.
itch on both hands; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch on both hands) and ERYTHEMA (redness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itch on both hands) and ERYTHEMA (redness). On 13-Feb-2021, PRURITUS (itch on both hands) and ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR : AE outcome updated. Patient declined further follow-up
vision loss in right eye,seeing retina specialist - dx with Toxoplasmosis which had been dormant until receiving  vaccine. Heavy menustral flow with prolonged bleeding time which is unusual
Two tonic clonic seizures experienced 6&12 hours post chemotherapy (4 days post vaccine) regimen, cycle 2 of adriamycin and cytoxan
Patient is fully vaccinated.  COVID positive on 5/7/2022 at ED visit. 50-year-old male with a history of amyloidosis, dermatomyositis, diabetes presents to the emergency department for chest pain.  Patient states that on Thursday, he had symptoms of cough, congestion, rhinorrhea, sore throat, shortness of breath.  He took Tylenol, last dose at 8 AM.  Today, he woke up with left-sided chest pain that was nonradiating and sharp in nature.  Shortness of breath is constant. CT: IMPRESSION: 1.  No CT evidence of acute pulmonary emboli. 2.  Stable multiple bilateral subcentimeter pulmonary nodules, largest in the left upper lobe measuring 8 mm. Stable multiple enlarged bilateral mediastinal and enlarged bilateral hilar nodes.Although findings may be granulomatous in etiology, neoplastic process not excluded. Appropriate follow-up recommended. 3.  Right lower lobe subsegmental atelectasis. 4.  Patulous distal esophagus with air-fluid level. Correlate clinically for reflux esophagitis. Medications given: aspirin and iopamidol. Discharged home.
Lab Notes: Nasal Swab/Positive; Lab Notes: Nasal Swab/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Lot number: Fe3592) at the age of 51 years as dose 2, single and administered in arm left, administration date 25Aug2021 (Lot number: Ew0187) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Lab Notes: Nasal Swab/Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab.
Given 3rd GARDASIL on 5/27/2009 - swelling/ redness started within 24 hours - seen 5/29/09 - treated with MOTRIN, BENADRYL. No previous Rxn to GARDASIL
Received second dose in series of Hepatitis B vaccine on 3/18/09.  Reported that she started vomiting on 3/19/09.  Was treated at an Urgent Care facility and was diagnosed with "serum sickness after Hepatitis B vaccine."  Treated with Phenergan 25 mg. orally Q8HPRN.  Nausea & vomiting continued.  She was seen in the ED on 3/21/09 with complaints of abdominal pain and rash.  She had reported to Employee Health with a rash over forearms and neck a day prior to receiving the Hepatitis B vaccine.  Was treated in the ED with IV zofran and dilaudid.  Discharge diagnosis was gastroenteritis.  Discharged with precriptions for zofran and vicodin.  Seen @ Employee Health on 3/23/09 and had another episode of vomiting.  Was sent home by the Employee Health Medical Director.  Returned to Employee Health on 3/25/09.  Reports feeling better...vomiting subsided.  States she did have an episode of vomiting after receiving the first Hepatitis B vaccine but did not report it.
Feeling funny in upper abd & center of chest. ? esoph reflux. No wheezing nor stridor given 37.5 ml BENADRYL PO watched for 30 min. Sent home no further signs. Will go home w/ mom to eat dinner. Call 911 if problem return.
The patient was administered a booster vaccine with a published expiry date 10/15/2021. She was monitored for 15min after the injection. Tolerated the injection with complications.  No adverse effects noted.   The patient is 37 wks pregnant.  Her pregnancy hx. includes: anxiety, female infertility, genetic disorder carrier, hx. of cesarean section, hx. of gestational diabetes, and RhD Negative.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 16-FEB-2015 the patient was vaccinated with improperly stored VAQTA (strength: 25/0.5(unit unspecified), lot # K005323 with expiration date of 10-FEB-2017; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 12-NOV-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
I had very bad insomnia; anxiety; extreme fatigue; brain fog for over a week after the vaccine; Later I had night sweats.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), vitamins (MANUFACTURER UNKNOWN) and herbs (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously did not take any drug in the past. On 03Apr2021, the patient had very bad insomnia, anxiety, extreme fatigue and brain fog for over a week after the vaccine. Later patient had night sweats. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of anxiety and included treatment with lorazepam (MANUFACTURER UNKNOWN) and homeopathic remedies. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad insomnia, anxiety, extreme fatigue and brain fog was recovered on an unknown date in Apr2021. The clinical outcome of the event later I had night sweats was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
After injection, small amount of blood came to surface of skin and small lump /nodule formed..  Patient iced and massaged area.  Swelling went down but bruise developed at site.   Patient stated that still bruised on 11/21/23.   iced and massaged area
Felt heart racing, palpitations, irregular heartbeat three days after receiving vaccine.  After 24 hours went to ER at Hospital.  Received EKGs, Echocardiogram, chest x-ray, and it was determined that I had premature atrial contractions.  Administered atropine and lovenox but symptoms continued and my heart rate and blood pressure kept dropping.  A cardiac catheterization was performed the next day and there were no signs of blockage.  Cardiologists believe that the vaccine may have caused the symptoms since there had been no other changes in my life, routine, medication in those previous three days.  Prescribed flecainide for 30 days and scheduled to see Primary Care and Cardiologist for follow up in 10 days.
Headache; Chills; Body ache; low soreness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the patient got the first Pfizer COVID shot, Thursday and the patient had low soreness but the patient was ok for the most part and then like Saturday night the patient just got fatigue, had a headache, the patient got the chills and really been the same thing since Saturday night one thing was left was the headache. The patient was wondering how long do the side effect would last? had been so fatigued. The patient had not been able to go to work. The patient stated that last Thursday had body ache. The patient questioned Is it normal and How long is this supposed to last. Outcome of the event headache was recovered on an unspecified date in 2021 and for rest all events the outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 week after 1st injection, injection site began to swell and itch. Symptom is still persisting 2 days later.