chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reaction started in the car on the way home. Right arm felt hard and hurt. Redness and swelling appeared shortly there after. Swelling was from a few inches below the injection site to the mid forearm when I saw it on 9/21/18, patient reports that later that night it went all the way to her wrist. The arm was swollen, red, hot, and painful on the day of the vaccination. Patient also reported having a headache that evening. She doesn't normally get headaches. She put ice on it and took ADVIL. By the next day, still having discomfort and it was painful to the touch, but better. Swelling also subsided some. She went to her Dr. on the morning of 9-21-18 (this was the 1st time she had reported the reaction to anyone). He felt it was an allergic reaction and told her to take ZYRTEC and continue with icing the area and to see him again in a week if no improvement. After that she came to the pharmacy to report the reaction and to get the ZYRTEC. Arm still quite swollen from bicep to mid forearm. Still felt hot to the touch. 9/26/18: Follow up with patient. Her arm is still a little pink and tender, but much better. She only took 1 dose of ZYRTEC, but continued with icing the arm. Her Dr. found in her records that she actually had PNEUMOVAX 23 in 2006 and she had an injection site reaction at that time. The reaction was similar, but limited to the injection site. Patient reports being allergic to bees.
a bit dizzy; This is a spontaneous report from a contactable consumer. An elderly (65+ Years) non-pregnant female patient received the first dose of 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 unknown date in Jan2021, as single dose for COVID-19 immunization at Public Health Clinic. It was unknown if the patient received other vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested COVID post vaccination. The patient medical history and concomitant medications were not reported. On an unknown date in Jan2021, the patient felt good after the vaccine and decided to use treadmill but after just few minutes, she felt a bit dizzy and so she stopped and just rested in their chair for the rest of the evening. It was reported that the patient did not know if she was having sinus issues that day or if the dizziness was from the vaccine. No treatment was received in response to adverse event. The outcome of the event was reported as recovered.   Information on the Lot/Batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medication in 2 weeks. The anti viral details COVID 19 treatment of Paxlovid started from 06Feb2023 to10Feb2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
48 yo patient received PNEUMOVAX 0.5 ml IM in left Deltoid.  Manufacturer: Merck, Lot # L019835, Exp: 23/MAR/2017 and TDAP vaccine 0.5 cc IM given in the Rt Deltoid, Lot No.: ED2EN, Exp.: Dec 3, 2017, Manufacturer by: GlaxoSmithKline Biologicals. Approximately five days after receiving the vaccines the patient developed angioedema. Symptoms included swelling of the lips, body itching and bogginess of the throat. MEDROL DOSE PAK and ATARAX were given with improvement.
Hormonal imbalance; Fatigue; Localised muscle weakness; Fever; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HORMONE LEVEL ABNORMAL (Hormonal imbalance), FATIGUE (Fatigue), MUSCULAR WEAKNESS (Localised muscle weakness), PYREXIA (Fever) and FALL (Fall) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced FATIGUE (Fatigue), MUSCULAR WEAKNESS (Localised muscle weakness), PYREXIA (Fever) and FALL (Fall). On an unknown date, the patient experienced HORMONE LEVEL ABNORMAL (Hormonal imbalance). In 2021, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, HORMONE LEVEL ABNORMAL (Hormonal imbalance), MUSCULAR WEAKNESS (Localised muscle weakness) and FALL (Fall) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of fatigue, fever was assessed as "No reasonable possibility" for cosuspect humira. The reporter causality for the event of of Hormonal imbalance, Localised muscle weakness,fall was assessed as "Not reported" for cosuspect humira. No treatment medications were reported. 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.   Reporter did not allow further contact
This spontaneous report as received from a medical assistant refers to a 18-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 01-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
The day after the shot, my husband fell asleep on the couch for several hours. He was freezing and had a fever of 100.5 taken orally (under tongue). I gave him Tylenol and water He perked up that evening. People say the second dose is worse and I am concerned about him having a worse reaction. He was in the hospital with COVID 19  last August and September and was very ill.  He came home in a wheel chair and oxygen 24/7. He is walking with a cane now and only uses oxygen at night.  I am wondering what you think about him getting the second dose of Moderna. .?.?  Please let me know what your expert opinion is. Thank you very much.
Had MMR and Varicella (Proquad) and Pediarix (DTaP, IPV, Hep B) on 7-12-07. Developed rash on 7-22-07 on torso and legs. Had less than 50 vesiculo-papular lesions. No fever.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # L033543, expiration date 30-MAY-2017, (dose was not provided). There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
The pt developed a fever, lump on arm X 2 days, headache and weakness.
10/10/14 Mother called stating son complaining of arm sore, red, and swollen, not feeling well and having diarrhea - this am I took ibuprofen and ice pack at school. 11/5/14 all symptoms resolved completely by 2 days after.
When giving injection muscle tensed and needle initially bounced on skin. Then relaxed and able to insert needle easier. Sore shoulder the next day with progressing muscle weakness until saw Dr on 10/19. She reported diagnosis of bursitis. Treated with anti inflamatory medications and ice. Greatly improved by 10/24/2011.
I went to the doctor to get blood test; went back on October 5 for another blood test for the blood platelets; I haven't gotten back after that and I feel tired; I also have random fevers which the doctor said its connected to the tiredness; the blood test came out on September 5th and it was 501 then on October 5th 465
I have MS (Multiple Sclerosis) and the vaccine caused my body to have a MS attack (MS Flair).  I had problems walking with my right leg and my legs started tingling with with heat.  This was not an old flair.  It was a new MS attack and several months later I am still having more issues walking with my right leg.
Patient came in for 2nd Hepatitis B vaccination. Patient received 0.5 mL IM in left deltoid. The vaccination was expired on 06/21/07. Patient was notified and informed that the dose needs to be repeated in one month. Patient verbalized understanding.
Frequent abdominal pains; Frequent bowel movements; Frequent bloody stools; On 27OCT2021, a spontaneous report was received from a patient.  A male patient of unknown age reported experiencing "frequent bowel movements" (PT: Frequent bowel movements), "frequent bloody stools" (PT: Haematochezia), and "frequent abdominal pains" (PT: Abdominal pain) approximately 10 weeks after receiving BioThrax (anthrax vaccine) on an unknown date (date not reported). The patient inquired if these symptoms are "serious adverse effects of the Anthrax Vaccine?" Any treatments received for the events was not reported. The outcome of the events was not reported.  Medical history and concomitant medication use was not reported.  No additional information with regards to this event was reported.  Company comment:  The AEs reported are not a known phenomenon to occur of BioThrax, the expression of frequency means repetition of the events that may explain other plausible causes and ten weeks after injection, there is no temporal relationship. Therefore, the Company considers the AEs as not related to BioThrax.; Sender's Comments: The AEs reported are not a known phenomenon to occur of BioThrax, the expression of frequency means repetition of the events that may explain other plausible causes and ten weeks after injection, there is no temporal relationship. Therefore, the Company considers the AEs as not related to BioThrax.
immunized yesterday 1APR93 4PM woke up 8AM vomiting 5-6 times since AM (now 2PM) listless; no fever arm sore;
I have swollen lymph nodes on the inside of my elbows, both arms.  I felt it important to note that it can happen on the opposite arm as the one that the shot was give in.
Had bad toothache that morning before 2nd dose and after 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she had Pfizer 2nd dose last week 18Mar2021. She had bad toothache that morning before 2nd dose and after 1st dose. She took Tylenol before receiving her 2nd dose. After administering 2nd dose nurse told her she should not have take Tylenol prior to vaccine. The outcome of the event was unknown.   Information for batch/lot number has been requested.
Itchy, macular rash of the arms, legs, and trunk that began approximately 3 days after vaccination. Still present 6 days post-vaccine. Also reports some cough and mild chest tightness on day 3-4 which have since resolved. Symptomatic treatment only at this time with antihistamines (oral and topical).
12 YEAR AND OLDER DOSE  OF PFIZER GIVEN TO 9 YEAR OLD PATIENT FOR BOOSTER . SPOKE WITH PATIENTS MOTHER SHE STATES HE DID HAVE MORE OF A REACTION THAN PREVIOUS 2 DOSES  , EXPERIENCING HIGHER FEVER AND LIGHT CHEST PAIN DAY AFTER ADMINISTRATION. TODAY (6/5)THE PATIENT IS FEELING BETTER AND STILL HAS SOME PAIN NEAR ARMPIT AREA OF SIDE VACCINATED ON. I INQUIRED ABOUT ANY REDNESS OR EXCESSIVE SORE NESS AT THE SITE OF INJECTION , AND SHE STATED THERE WAS NONE. MOTHER WILL CONTINUE TO MONITOR FOR SYMPTOMS AND FOLLOW UP IF NEEDED.
Raised red itchy bumps mostly on right hand but also on left elbow, left hand, and one on each leg
Patient experienced allergic reaction (rash at and around injection site, extending down arm almost to elbow) on right arm, fever, chills, and dizziness. Patient took acetaminophen to control fever and chills. Symptoms resolved on 10/30/15.
This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of PEDVAXHIB, (Lot # K015464, exp. date 09-JUL-2017 and Lot # K008680, exp. date 11-MAR-2017), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
head felt like it was on fire; nightmares of fevers; all over malaise; fever; chills and unable to keep herself warm; body ache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (head felt like it was on fire), NIGHTMARE (nightmares of fevers), MALAISE (all over malaise), PYREXIA (fever) and CHILLS (chills and unable to keep herself warm) in a 55-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.     No Medical History information was reported.    On 12-Apr-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (head felt like it was on fire), NIGHTMARE (nightmares of fevers), MALAISE (all over malaise), PYREXIA (fever), CHILLS (chills and unable to keep herself warm) and MYALGIA (body ache). At the time of the report, DISCOMFORT (head felt like it was on fire), NIGHTMARE (nightmares of fevers), MALAISE (all over malaise), PYREXIA (fever), CHILLS (chills and unable to keep herself warm) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Patient was inadvertently administered two doses of Fluzone Quadrivalent on the same day/no AE; Initial information received on 12-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female who was inadvertently administered two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on the same day(Extra dose administered).  Medical history,concomitant therapy, treatment(s), vaccination(s) and family history were not provided.   On 12-Mar-2020, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ279AA via intramuscular route at the left thigh for prophylactic vaccination. On same day she also received a dose  dose of the same vaccine  lot UJ279AA via intramuscular route at the right thigh for prophylactic vaccination.  It was of actual medication error case due to extra dose administer.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Technician gave vaccine in left deltoid.  When patient stood up, they described feeling light-headed so she sat back down and then fainted for a brief moment.  Light-headedness persisted for about 15 minutes after regaining consciousness and then patient felt well enough to walk home with father.
Pt experienced rash on legs which then spread to entire body including face. Itchy. Patient took BENADRYL which helped relieve symptoms.
R arm posteriorly, 1 3/8 blister area, increase arm red 4.5 inches in length, 5.5 inches in width, warm to touch.  L arm no s/s of reaction.  Sx noted 11/22 AM.  Drs Eval: 11x15 cm, 2 cm vesicles in center of R upper arm lat/post, nontender, no red streaks; T: 99.7 degrees (tempered).
A physician reported that a 13 month old male received three doses of Prevnar vaccine (dates of immunization not specified). The child also received all the other "usual" immunizations (not identified). During the week of 8/12/02, the child was taken to the ER due to a fever. The pt first appeared to have periorbital cellulitis. X-ray was positive for sinus infection and WBC was 24,000. A bacterial antigen test was positive for pneumococcus. When a sub-culture was attempted, the organism died and identification of the pneumococcus serotype was not possible. The child was treated with amoxicillin and potassium clavulanate (Augmentin) and ceftriaxone sodium (Rocephin). He was febrile for 3-4 days and is improved. This case was considered serious since these events were considered medically important in this case. No further info was available at the time of this report. **Follow-up report on 9/18/02: Follow-up received from 9/4/02 from MD. The blood culture grew straptococcal pneumoniae and the child did well. An MD reported that a 13 mt old male received 3 doses of Prevnar (pneumococcal 7-valent conjugate) vaccine (dates of vax not specified). The child also received all the other "usual" immunization (not spec'd). During the week of 8/12/02, the child was taken to the ER due to a fever. The PT first appeared to have periorbital cellulitis. X-ray was positive for sinus infection and WBC was 24,000. A blood culture was positive for atreptococcal pneumoniae. When a sub-culture was attempted, the organism died and identification of pneumococcus serotype was not possible. The child was treated with amoxicillin and potassium clavulanate (Augmentin) and ceftriaxome sodium (Rosephin). He was febrile for 3-4 days. This case was considered serious since these events were considered medically important in this case. No further info. was available at the time of this report.
numbness to the site of the injection, followed by numbness up her left arm, neck , scalp and face.  Lasted for  a week. seen by NP, 3/31/21 who gave her prednisone and it has since resolved completely.
I felt sick. I had flu like symptoms. I had body ache and stuffy nose. My sugar level when out of wack.  My sugar level was high.  These symptoms lasted for about a month.  I spoke to my doctor about this. My sugar levels are still evaluated as of today.
Headache, local site reaction-swelling/lump; tired, sweats; chills Narrative:
Significant (R) arm (upper and lower) swelling with redness and mild tenderness.
redness & swelling lt arm x 1day;pt was seen by MD on 14OCT95 & was dx cellulitis
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing); "Walnuts allergy" (unspecified if ongoing), notes: Walnuts allergy. Concomitant medication(s) included: SYNTHROID, start date: Aug2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had other medication in 2 weeks. Patient had taking any other medications/products within 2 weeks of starting COVID-19 treatment & Patient had previously receive a COVID-19 Vaccine. Patient had Known allergies was walnuts and Other medical history: Autoimmune disorder. Patient did not had seriousness criteria-results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Patient had COVID treatment with Proprietary medicinal product name: Paxlovid, indication for use in the case: treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Improper storage of product in use; No additional adverse events; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T032932, that has been verified to be valid for varicella virus vaccine live (Oka/Merck) (VARIVAX) , expiration date reported as 28-SEP-2022, 1 dosage form for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above of less 3 Celsius degrees (C) for a time frame of 3 hours; the vaccine did not experience previous temperature excursions. No adverse events were reported
GENERAL ACHINESS AND SWOLLEN GLANDS; DEVELOPED FEVER 100.8; WENT TO ER ON 10/10
DIZZY - ABOUT 4 DAYS AFTER VACCINE.  I STILL FEEL DIZZY FROM TIME-TO-TIME 7 MONTHS LATER FAST HEART RATE FOR AWHILE. I RECEIVED A RESTING ECHOCARDIOGRAM ABOUT 8 DAYS AFTER VACCINE AND MY LEFT BUNDLE CONDITION WAS WORSE. CARDIOLOGIST PRESCIBED LISINOPRIL FOR 6 MONTHS AND MY RECENT ECHO IN LATE AUGUST WAS NORMAL LEFT BUNDLE