chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms; 2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 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 (dose number=1, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/ provided to reporter at the, time of report completion), for covid-19 immunization, reaction(s): "hives". The following information was reported: URTICARIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Oct2021, outcome "recovering" and all described as "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms". The event "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms" and "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, condition aggravated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 days after injection, pt developed 9 x 7 cm cellulitis - like Rxn at injection that developed into a 6 x 8 cm dermatitis by day 15 (slowly resolving).
Information has been received from a physician concerning a 65 year old female pt who in approx. 1992 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. The pt subsequently, received a booster dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a "local type of reaction". It was noted that the area was red and warm. Unspecified medical attention was sought. Additional information has been requested.
Administered dose, patient was speaking and experienced syncope within 1 minute.  Remained unresponsive for approximately 30 seconds.  Stated he was dreaming while he was out.  Stated he was dizzy upon waking.  Stomach pain began about 5 minutes after awaking.  Remained in vaccine area until he stated he was feeling okay (30 minutes).  Stomach pain went away after about 30 seconds.  Wife and sister were with him, and able to drive.  Informed family to monitor him for a couple of days, and call EMS if needed.
Swollen lymph nodes with body aches next day after receiving vaccine. Seen in  office today 7/25/11 with symptoms x's 3 days.
I woke up on May 5th with a woosh sound in my left ear and impaired hearing in the ear.
a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Fomulation: Solution for inejction) via an unspecified route of administration on 02May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 on 10Apr2021 for covid-19 immunisation. The patient experienced a headache after receiving the 2nd dose (More than 21 days) and she took Ibuprofen. Treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had FLUAD for seniors flu shot at Pharmacy. Started not feeling well later that p.m. Progressively worse. Headaches, aches, sore throat. Never had reactions to the high dose in the past. Even had neuropathy in hands and feet for a couple of days. Is the FLUAD new this year? Noticed it had an immune booster in it. I don't think that's a good idea. Any antidote for this or does it have to run its course?
shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding current condition, historical condition or concomitant medications was provided. In 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose number, strength, route, batch/lot# and expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue 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, including but not limited to medical losses and costs including 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 would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
arm is achy and hurting; itchy rash; spot of 6 inches and 4 inches long rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash). At the time of the report, INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
On Tuesday September 27, 2022, my husband and I found out that a friend we spent the weekend with had tested positive for COVID-19. We both tested with a home test that came negative. By Thursday, September 29, 2022 I started feeling ill so I took another home COVID-19 and again on Friday, September 30, 2022, as I was feeling really ill by then. Both test came back negative. On Saturday I went to the local Minute Clinic to get a PCR test that came back positive on 10/02/2022, I was not given medication. I have been taken over the counter medication that I have at my home.
Influenza virus vaccine Fluzone injection 0.5ml IM in left lateral deltoid muscle. On 10/30/2004 in AM was noted an 8cmx4cm red skin around injection site, hard and warm to touch with tenderness. No treatment, Tylenol offered for discomfort. Continues to fade.
generalized weakness, mild symptoms - positive diagnosis of COVID-19 infection  12 days prior to hospital presentation
Information has been received from a health professional concerning a 40 year old female who on 1/25/01 was vaccinated with MMR II. On 1/27/01, the pt thought the injection site felt unusual. On 2/4/01, the pt was seen and treated in the ER for a huge boil or abscess that was swollen, red, hot and painful. Upon internal review the furuncle was determined to be an "Other Important Medical Event". The area was lanced and packing placed in the area. Therapy with Ceftin and Tylenol #3 were initiated. On 2/5/01, the pt had a packing changed in the ER. On 2/6/01, the pt saw a surgeon. The nurse reported in follow-up that the site was healing slowly and she is still recovering. Additional information has been requested.F/U additional info from the nurse indicated that the pt's recovery was ongoing ans she was healing. The abscess was considered an other medical event. No further info is available.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2022-526820, MOD-2022-526822, MOD-2022-526823 (Patient Link).
Vaccine administered intramuscularly in the left arm  deltoid muscle at approximately 8:25 AM on March 26, 2021. At 10:30 AM mild facial and neck puritis. At 12:20 PM arm became sore and painful at the injection site. A cold compress was applied for 30 minutes twice over the following 24 hours. Heat compress applied after 24 hours. Injection site pain resolved after approximately 72  hours. On March 29, 2021 soreness in the left axillary region with enlarged axillary lymph nodes. Mild left axillary lymphadenopathy remains one week after vaccine administration.
From initial information received on 05/11/04 from a physician regarding an adverse event occurring in the USA, It was reported that a 24 year old female pt received a TD ADS ADULT vaccination administered IM in the LA on 05/06/04. Approximately 8 hours later the same day, she experienced pain for 2-5 hours and 5 hours later the area began to swell up and became sensitive. On 05/07/2004 she had a large swollen tender but soft area, cellulitis was suspected and the pt was being followed. The recovery status of the pt was not reported., From additional information received on 08/20/04 from the responsible physician, it was reported that the pt recovered without medication in 5-6 days. The pt received her last dose of TD ADS Adult 3-5 years before and had no previous rxn. Additional lab information was also provided. No further information is anticipated, this case is considered closed. .The reporter of this case is the same reporter of case 200401857.
Vaccine was administered more than 4 days before it was supposed to be (5 days). First dose was administered 04/16/21
p/vax pt devel a lot of pain 10/22/99 @ inj site;states pain subsided 10/23 but returned 10/24 & then severe throughout upper arm w/a sensation of rawness under arm;
Patient received booster dose shortly upon arrival to pharmacy. No other accompanying family members. Completed paper work independently. After review by pharmacist, no contraindications were noted and vaccine was administered. Patient appeared lucid at time of vaccination. No adverse drug events noted during 15 minute observation period. Pharmacist was later informed by family member (daughter) that patient had dementia but acted out independently. Daughter stated patient had conracted COVID-19 on 10/18/21 and received monoclonal antibodies as part of treatment course. Hosptal personnel instructed daughter that patient shoiuld not receive further vaccine for 90 days after administration of. Patient did not indicate that information on the Vaccine Administration Record and Informed Consent at the Pharmacy and his action were not known by the daughter until after the event had occurred. No observable adverse reactions noted approximately 11 hours after the event.
Cancerous Tumor in the Large Bowel; Vaccine caused sore arm; MARKETING PROGRMAE NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4373879-00 (AbbVie).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 01Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 31Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COLON CANCER (medically significant), outcome "recovered", described as "Cancerous Tumor in the Large Bowel"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccine caused sore arm". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "cancerous tumor in the large bowel" and "vaccine caused sore arm" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of Large intestine carcinoma (Colon cancer) was not reported and Vaccination site pain was possible.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Cancerous Tumor in the Large Bowel and Vaccine caused sore arm was not provided.  AbbVie's opinion is that the event of Cancerous Tumor in the Large Bowel is not assessable. AbbVie's opinion is that there is no reasonable possibility that the event of Vaccine caused sore arm is related to HUMIRA (ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, Vaccination site pain, Colon cancer and BNT162B2 is considered possible.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198), on 25Mar2021 as dose 2, single (Lot number: ER8732), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 04Nov2022 as dose 5 (booster), single (Lot number: FM9992) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient got the flu shot and notes throat tightening and SOB. Felt like "cotton mouth". Pt presented to Urgent Care, given EPIPEN upon arrival and BENADRYL injection at 9:30 PM. Sent to nearest ER.
The patient experienced a terrible headache and facial swelling, especially upper and lower eyelids. The patient experienced extreme weakness the rest of the day and evening.
Palpitations followed by bilateral rash on axillary, chest, antecubital, inguinal, popliteal regions.  Suspect EM.
Hives all over her body; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FK5127, Expiration Date: 31Aug2022) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Hives all over her body".  Additional information included: The reporter wanted to know if that was a reported reaction to 5-11 age group and if so, how they should proceed with second dose.  Follow-up attempts are completed. No further information is expected.
Fatigue, left neck muscle swelling, left cervical chain tender lymphadenopathy.
4 hours after HPV child became lightheaded and tired and remained that way till the next morning then returned to normal. No sx since.
Patient complained that it "felt like her throat was closing up."  Pt was not visibly struggling to breath or any change in skin tone.  Asked if she had experienced any other allergic type reactions before and if this was a similar feeling and she stated yes.  Offered an Epi-Pen and calling an ambulance and pt denied stating she would rather try Benadryl first.  Gave pt #2 25mg Benadryl with some water and pt sat with her companion while we observed.  After 15 minutes pt stated she was feeling much better and as she had a driver we sent her home.  Instructed to contact her MD before her second dosage.
COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jul2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Jul2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: No issue with the vaccine. Patient received Paxlovid from 08Jul2023 to 13Jul2023 as treatment for covid-19. known allergies no  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.
Jaw pain in my right jaw for a week before going to the Dentist for an examination.  Had also had post-nasal drip on the right side for about a week.  Was taking occasional Sudafed and using Flonase to help with sinus pain.  Read about jaw pain online and found that a sinus infection could express itself as jaw pain.  After the Dentist's examination and reviewing x-rays, he recommended that I see my Primary Care Physician about a possible sinus infection.  Saw my PCP the same day.  He was skeptical that a sinus infection could cause jaw pain and suspected TMJ instead.  When he looking in the right nostril and saw redness, he prescribed Cefdinir (300 mg.) for 10 days followed by an anti-inflammatory twice daily for 5 days afterwards.  I finished the antibiotic 9/12/21.  Jaw pain is diminished.  Post-nasal drip has stopped, although I have muffled hearing, for which I continue to use Flonase on my PCP's recommendation.  I had muffled hearing before, so this is not new.  He recommended that I see an ENT if the problem continues.
Full body ache, especially in joints that started approximately 18 hours after the injection but resolved within 24 hours, and a swollen lymph node in left armpit that was first noticed approximately 29 hours after vaccine.  Swelling is painful, especially with arm movement.  Lymph node has not resolved.
Patient critically ill with COVID, admitted 8/18/21, still hospitalized in ICU on vent with Acute resp. failure on 9/20/21.  First dose of Pfizer COVID vaccine on 3/17/21 (Lot number ER8727), second dose of Pfizer COVID vaccine on 4/7/21 (Lot number ER8731).
No additional AE/PQC.; HCP calling to report she inadvertently administered PROQUAD and VARIVAX together. No side effects were reported. No additional information provided. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to an 1-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / first dose, lot #X011110, expiration date: 18-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). On 06-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / 1st dose, lot #W012163, expiration date: 12-APR-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called to report that she inadvertently administered PROQUAD and VARIVAX together. No side effects were reported. No additional information provided. No additional AE/PQC.  Lot Number W012163 is valid for Varivax. Lot Number X003061 is valid for 9395. Lot Number X011110 is valid for Proquad. Lot Number X011110 is rHA.
Patient said 2 hours after vaccine was given her arm began feeling really sore (from top shoulder to elbow).  Then about 2 and 1/2 hours later, her chest felt really tight and she kept coughing.  She also had fever and experienced "disoriented dreams".  By about 9:00 am on 10/11/10, her symptoms subsided.  She feels fine now but really weak.
Developed Low grade fever 7 days post vaccination. Developed swollen hands and feet (right sided hands first then developed into bilateral swelling of both hands and feet). She was crawling and cruising furniture which ceased 10 days post injection. She was admitted and diagnosed with vasculitis of an unknown origin. She is pending a bone marrow biopsy to R/O Leukemia, but it is not probable.  Final result on duration, tx, outcome still pending. 12/12/06 Received medical records from hospital which reveal patient transferred from outlying hospital on 11/27/06 for bilateral swelling of hands & feet along with fever & decreased oral intake.  Temp on transfer was 102.2  D/C home on 12/1/06 to be f/u by rheumatolody & hematology.  D/C on tapering steroids Final DX: systemic inflammation; secondary dx included lupus anticoagulant & possible hereditary spherocytosis. Records did not include rheum or heme consults & requested again. 12/18/06 Received medical records from PCP which reveal patient was in good health but fussy/cranky with frequent spitting up from birth.  Well child on day of vax.  Next visit 11/25 had low grade fever, cranky & not sleeping or eating well for 2-3 days.  Exam revealed only that patient was teething & had an ulcer on the tip of her tongue.  Next note is from 12/4 after hospitalization & indicates resolving arthralgia & viral syndrome.  To be followed by rheum/heme as outpatient. 12/22/06 Received consults as requested & case closed. Final DX: Systemic inflammation; secondary dx: lupus anticoagulant; possible hereitary spherocytosis.