chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness, pain, heat at injection site that spread to 4 inches in diameter.
About 1 hour, post vax, Typhoid and Hep-A, pt had edema of face with dramatic improvement after starting Benadryl po every 6 hours per MD. Asymptomatic by 5/10/01 at 09:00. Patanol opth. drops ordered, 1 drop in each eye, every 12 hours X 1-2 weeks; Epi Pen Jr Rx given to use, prn.
Headache, pain in right arm, fatigue, loss of appetite, tachycardia x 3 days, headache and arm pain lasting through today (day 4)
Blurred vission; dizziness/ light headedness; nausea; paleness; sweating; warm and faint feeling. Patient reported feeling better while laying down, instructed to lay down, fluids refused, pulse and B/P monitored throughout duration, he reported feeling better prior to leaving center.
Redness and swelling (R) upper arm, 0.5cm papule mid arm. No fever. RX for BENADRYL every 6 hours given.
swollen lips; Oral Lesions; I developed 5 canker sore; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Oct2021 (Lot number: FF2593) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMIN & MINERAL. Past drug history included: Penicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF8839, Location of injection: Arm Left), administration date: 29Sep2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: LIP SWELLING (non-serious) with onset 11Nov2021, outcome "not recovered", described as "swollen lips"; ORAL DISORDER (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Oral Lesions"; APHTHOUS ULCER (non-serious) with onset 11Nov2021, outcome "recovering", described as "I developed 5 canker sore". Therapeutic measures were taken as a result of lip swelling, oral disorder, aphthous ulcer. No follow-up attempts are possible. No further information is expected.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The treatment received for the adverse event was  Lidocaine mouth rinse, Prednisone. Prior to vaccination, the patient was diagnosed with COVID-19.Since the vaccination, has the patient not been tested for COVID-19.
States the day after, he was weak with muscle aches. He states that this has continues every other day for 18 days.
Immunizations given 6/6. On 6/13 mother reported on 6/11 arm at IPV site became very swollen (size of quarter) with small amount of clear drainage. Afebrile. No tx.
thought you should know that it got worse after the second dose.; avid runner and now cannot run, got worse after the second dose; terrible knee pain, got worse after the second dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced terrible knee pain and was avid runner and now cannot run. On an unspecified date, patient thought that Pfizer should know that terrible knee pain and was avid runner and now cannot run, it got worse after the second dose. The outcome of terrible knee pain got worse after the second dose was not recovered and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine Aug 06 site crusted over x 4 months then fell off to expose a 1cm ulcer that persisted ever since our first visit Mar 07. I changed the dressing for bandaid  with Teffa and over course of 2 weeks it worsened/ progressed to entire upper arm and small area over face.
no side effects; VAQTA was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered for prophylaxis (lot #1971534, expiration date: 06-OCT-2024; strength, and route of administration were not provided) after the vaccine experienced a temperature excursion at 50 F for 1 hour 40 min (product storage error). There was no previous temperature excursion. No side effects were reported.  This is one of several reports received from the same reporter.
9/15/21 patient received vaccine at outside facility.  On 9/16/21 patient became tachicardic and severe headache started.
CHIEF COMPLAINT: Allergic reaction.  HISTORY OF PRESENT ILLNESS: This 50-year-old female was in her usual state of health until about 30 minutes after getting her flu shot today. She then started to have itching in her palms which she recognized as an allergic reaction, having had a similar response to a soap which she is allergic to in the past. She then began to get flushed and itchy all over and began to notice some fullness in her lips and tongue and a sense of presyncope and pending doom. She was quickly placed in one of our patient care rooms where an IV access was established and I saw her. She had a hard time providing me much history initially because she was so anxious and uncomfortable. She did not report having problems breathing. She did not feel as though her airway was closing off.  PLAN: Received 50 mg of IV Benadryl and 8 mg of IV Zofran. Over the next 15 to 20 minutes her symptoms dramatically improved and she was observed for another hour. She received 1 L of IV fluid during that time and was essentially asymptomatic at the time of discharge except for a little bit of residual swelling in her hands. The patient will take 50 mg of Benadryl at bedtime tonight. She will continue the Benadryl on a q.6h. basis for the next 24 to 48 hours unless her symptoms have resolved in the morning and she is feeling well. She was told that if she was feeling up to it she could return to work tomorrow.
Information has been received from a pharmacist referring to a 17 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 04-AUG-2017, the patient was administered the first dose of the HPV immunization series as GARDASIL 9 (strength, dose and frequency unknown, lot # M007764, expiration date 30-JAN-2018) intramuscularly as routine vaccination for prophylaxis. On the same day, the patient experienced "dizziness for 30 minutes after the administration of the vaccine". The primary reported that "having the patient drink water and having the patient sitting for 30 minutes" was treatment for the patient's dizziness. The patient "recovered from the dizziness the same day, 04-AUG-2017". No lab diagnostics was performed. Action taken with the vaccine was not applicable. The relationship between the event and the vaccine was not reported.
A little tired after second dose; White blood cell count high; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and FATIGUE (A little tired after second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White blood cell count high). On 08-Apr-2021, the patient experienced FATIGUE (A little tired after second dose). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and FATIGUE (A little tired after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, White blood cell count: high (High) above normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   This case was linked to MOD-2021-072595.
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HPV-IPV vaccine. On an unknown date, 42 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 42 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinating diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinating diseases up to 3 years after vaccination. The results of human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinating diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinating diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Information has been received from a 90 year old male who on 05-MAR-2007 was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. On approximately 29-APR-2009 the patient experienced shingles on his left side. The patient reported that it was not as painful as he thought shingles would be but very itchy. Unspecified "blood work" had been performed (result not reported). The patient had sought unspecified medical attention. At the time of reporting, the patient was not recovered. Additional information has been requested.
1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration). At the time of the report, PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.
Patient came to see me the day after her flu vaccination. She had a reaction to the vaccine.  Approximately 2 inches below the vaccine administration, there is an area approx. 3inches X 5 inches that is red, raised and itchy.
Body aches, high fever, chills, head ache. Have been bearly able to complete daily activities
No additional AE reported; patient was administered improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 6-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 25-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Information has been received from a licensed practical nurse concerning a 65 year old female who on 28-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On an unspecified date the patient developed a rash at the injection site where she was vaccinated with vaccinated with ZOSTAVAX (Oka/Merck). It was also noted that the patient had shingles on her arm. Unspecified medical attention was sought. At the time of reporting the patient had not yet recovered. There was no product quality complaint. Additional information has been requested.
No adverse effects. Child was given pediatric dose of second vaccine. She turned 12 one week before the vaccine. Parent scheduled appt for pediatric dose.
Light headed with Tachycardia. A&Ox4. Refused transport by EMS.
Child seen in office on 5/11/15 with c/o fever and lethargy x1 week. Attempted TYLENOL/MOTRIN for fever. Went to ER on 5/8/15. Received IVF for dehydration. In office found patient to be hypotonic, (+) weakness noted, (+) tongue protrusion repeatedly. Patient sent to hosp for admit. Nerve conduction study done-abnormal. Treated for Guillain Barre syndrome over 5 days with IVIG.
Began with fever night of vaccination. Fussy decrease appetite 12/4/12 T-102.9 (A) in office 12/7/12 T- 101.1 (A) in office.
At time of injection: dizziness lasting several hours. Later that evening began to have scratching feeling in throat, but could not see any signs of swelling no difficulty swallowing. Injection site redness, large red, raised wheal at site of injection lasting several days.   7 days after vaccine, at injection site a larger wheal was present and lasted several days. I was advised by my PCP not to receive the second dose due to risk of allergic reaction
pt recvd vax & devel redness; hot to the touch & hard lump in rt arm; tx w/ ice massage, apap;
Cx came into pharmacy approx. 2pm with a complaint about pain in her arm and redness for the past few days after getting a SHINGRIX shot on Tues 5/8/18 at noon.... pt complains pain at injections site and redness. She states it started evening of shot and has persisted (2 days - today is 5/10/18).  She states so painful when she rolls over at night onto that arm the pain wakes her.... pt showed me the site and the redness was about the height of her hand and about as wide.... she also stated it was warm to the touch but not hard... (NOTE: pt did have a single bubble looking bump at the edge of the redness toward the back of the arm which she doesn't know if it was there before the shot). I suggested pt to see her Dr. and have her evaluate the area an bump... pt says she'll try to see Dr. in am before she goes away.  Also, pt did state she has never had a reaction from a shot before and I is leary and doesn't want to get the 2nd dose.
Patient initially developed a local reaction on the Friday she received the vaccine. On Sunday, she presented to the emergency department with a rash that was treated with Benadryl. After the Benadryl, she had improvement in her symptoms and was discharged home. On Monday, she presented to our emergency department with return of her symptoms, diffuse urticarial, and fevers to 101. Biopsy of the rash returned as superficial and deep perivascular dermatitis with eosinophils consistent with dermal hypersensitivity reaction. Her infectious disease workup remained negative. During her hospitalization, her highest temperature recorded was 102.5F. She is presently being treated with famotidine, hydroxyzine, loratadine, diphenhydramine, and IV methylprednisolone. Her skin rash is visibly improving, although she remains febrile and still has the rash. She at present still hospitalized.
Hives on torso 05/12/04 evening. Spread to arms/legs.  No angioedema/stridor/zep or neuro compresses noted.
Pt reported swollen and red painful arm. Potentially also might have a fever. Onset of symptoms was approximately a day after the vaccine
Patient experienced pain, swelling, redness in left arm at injection site. Approximately 14 hours post injection, also experienced nausea. These symptoms lasted 48 hours, except for nausea.
A pharmacist reported that a patient received an injection of Tetanus Toxoid. Subsequently, the patient developed erythema at the injection site. No further info was available at the date of this report.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-APR-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt was admitted on 2/13 due to hip and low back pain.  He was scheduled for the OR for neurosurgery, but had a pre-operative COVID test on 2/15.
Caused hardened lump surrounded by swelling and redness throughout entire arm and left-breast-area. Pain now moving to back.