chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a skin graft on my leg with a wound vacuum after an accident. It is on my lower right calf since 01/31/2009. Nine days after the first dose of the vaccine I noticed a little blemish in the area of my skin graft. After getting the second dose I got a burning feeling around my skin graft. I then got a rash around the skin graft and then it was all over my body. I went to the ER and they took a culture of the rash. I was prescribed Clindamycin. The results came back positive for Staphylococcus. I had a little trouble swallowing when I was taking the antibiotic. I returned and they thought that it was like a poison ivy rash. I had weeping around the wound and the hive like rash is the worst on my leg. It was extremely poisoned. I was prescribed a steroid and a topical cream. Within a few days, the rash and the swelling went down within a few days. It has been almost three weeks and I still have some rash and the wound, but it is not painful.
Two weeks after vaccination pt reports having severe pain in right arm (non-vaccination arm) which then spread to opposite arm, legs, hands.....reports severe lethargy and weakness since vaccination
Headache loss of memory and  total confusion for 4 days. Muscle weakness sever.  Better today  June 19 2021 but not completely 100 percent
This case was reported by a healthcare professional and described the occurrence of bump at injection site in an 11-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  On 11 March 2009, at an unspecified time after vaccination with HAVRIX, the subject experienced bump at injection site, pink around injection site, painful to touch and crusted lesion.  At the time of reporting the bump at injection site, pink around injection site, injection site pain and crusted lesion were unresolved.  The healthcare professional considered the bump at injection site, pink around injection site, injection site pain and crusted lesion were probably related to vaccination with HAVRIX.  The lot number was reported as AKAVE140AC.  The healthcare professional reported that an 11 year old subject received her first HAVRIX vaccination on 11 March 2009.  The reporter could not read the subject's medical record, and was unable to determine very much from what was provided to her by the subject's father.  The subject developed a pink bump at the injection site that was painful to the touch and seemed to be crusty on top.  The subject's family denied any drainage from the lesion.  Follow up information was received on 23 November 2009 via the reporting nurse practitioner.  The subject did not use alcohol or tobacco.  Onset date of earliest sign or symptom was reported as an unspecified date in March 2009.  The nurse practitioner did not consider the events to be serious.  The nurse practitioner reported that it was unknown if the events could have been associated with erroneous administration.  A biopsy was not performed.
Information has been received from a case in litigation via a case report concerning a 48 year old female who on 12-NOV-1992, 18-DEC-1992 and 25-MAY-1993 was vaccinated with a first, second and third dose of RECOMBIVAX HB (manufacturer unknown) respectively. Subsequently, the petitioner developed multiple sclerosis. A Vaccine Court special master has ruled that a woman who developed multiple sclerosis after RECOMBIVAX HB (manufacturer unknown) was entitled to compensation. It was noted that on 28-JUN-1993, the petitioner was seen by a retina specialist for the appearance of sparks or flashes and film that she had noticed in her right eye the previous week. The petitioner continued to experience visual problems, which were joined later in 1993 by pain and weakness. A special master said "on 14-OCT-1993, the petitioner underwent a brain MRI, which was abnormal due to increased T2 signal in the posterior parietal white matter bilaterally and in the medial left brachium points." "The primary consideration would be MS." "Optic neuritis is frequently a hallmark for MS" said a special master. The special master said "since the petitioner's onset of right optic neuritis was within a month of her third RECOMBIVAX HB (manufacturer unknown) the onset is medically appropriate for causation." The government's contention that visual problems in the immediate aftermath of the petitioner's third RECOMBIVAX HB (manufacturer unknown) in May 1993 was something other than optic neuritis "seems an extraordinary stretch," although optic neuritis was not diagnosed at the time, said a special master. "The tie-breaker in this case must be the opinion of the petitioner's treating neurologist, who in 1999, when the petitioner came to him complaining of undisputed optic neuritis in her left eye, diagnosed her with having had optic neuritis in her right eye in 1993 after he examined her eyes and found pallor in her right optic nerve," a special master said. "The symptoms about which she complained in June 1993 to another physician, although consistent with a retinal problem, are also consistent with optic neuritis." Upon internal review, multiple sclerosis was considered an other important medical event. No further information is available.
Case number PHEH2013US021520 is an initial spontaneous report received from a consumer on 06 Nov 2013 with a follow-up received on 02 Oct 2014. This report refers to a 29-year-old pregnant female patient. Two weeks ago (possible 23 Oct 2013), she was vaccinated with FLUVIRIN (batch number: no provided) intramuscularly at her village obstetrics and gynecology clinic. No adverse event was reported following this administration error. Multiple attempts have been made to obtain follow-up information and outcome of pregnancy without success. Hence this case is considered lost to follow-up. Follow-up received on 02 Oct 2014: Lost to follow-up information updated.
Administration of PREVNAR 20 instead of PREVNAR 13 to 5 month old
PT IS 7 MONTHS OLD AND WAS GIVEN KINRIX INTSTEAD OF PEDIRIX. NO ADVERSE REACTION
Pt recvd Engerix-B 16JUN92 & had malaise, weakness, flushing, diarrhea, abdominal cramp, somnolence; 17JUN92 woke up wanted to move but couldn't; weak on lt side; dx allerg react; some tingling;
Continuous fainting; due to continuous fainting spells had to give up martial arts afterwards; Could not move; This case was reported by a consumer via interactive digital media and described the occurrence of fainting in a 12-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant), mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the fainting and activities of daily living impaired were unknown and the outcome of the mobility decreased was recovered/resolved.   The reporter considered the fainting, mobility decreased and activities of daily living impaired to be related to Bexsero.  Additional details were reported as follows: The reeporter reported that the patient received vaccine shot and had severe reaction to the shot. The patient was active in martial arts and had to give up because he started to having fainting speels afte the shot. Also the patient could not move for 24 hours and did not even lift himself up. No other information was reported. Since the product was unknown and case reported under MenBMi the suspect was conservativetly captured as Bexsero vaccine (Men B NVS).
hives; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and DYSPNOEA (difficulty breathing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced URTICARIA (hives) and DYSPNOEA (difficulty breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Nebulizer.
Fever started on 3/15/14, 102 degrees F, Rash started on 3/16/14, on back, spread to belly then to face and earlobes. Give BENADRYL, bid, to prevent scratching and TYLENOL every 4 hours if fever over 102 degrees F, call for concerns.
Woke up around 5 am ( 20 hours after shot) in excruciating pain and decided I needed to get up and walk around.  Next thing I know, I had obviously blacked out, because I was on the floor on my back and had no recollection of prior events.  Have no idea how long I was out,  but once I got my bearings and got back in bed, I was fine.
Heart rate is up; Facial Swelling; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate is up), SWELLING FACE (Facial Swelling) and DIZZINESS (Dizzy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 585-831-7758) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate is up), SWELLING FACE (Facial Swelling) and DIZZINESS (Dizzy). At the time of the report, HEART RATE INCREASED (Heart rate is up), SWELLING FACE (Facial Swelling) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Fever, muscle aches, shivering, mild headache, loss of appetite (but not full-blown nausea). In the early morning hours, I awoke burning up and shivering at the same time. When I got up some hours later, my temperature with an ear thermometer was over 100 degrees (normally it's around 97+). The fever did not feel as severe as hours earlier, which means my temperature was undoubtedly higher when I was burning up and shivering. I read about the possible side effects so was not alarmed, but I had to take two days off work and sleep it off.  The fever gradually diminished and symptoms were gone approximately 60 hours after onset of symptoms.
This is a spontaneous report from contactable pharmacist communicated through a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in 2016 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever after receiving the vaccine in 2016 with outcome of unknown.
Fever to 101 within 4-5 hours following PF injectable flu, fever continued intermittently up to 104 without other symptoms, today is day 3 of fever.
Almost three weeks after my first shot I had appendicitis and had an appendectomy on 2/16/2021.
Pt presented to clinic for PPD administration. 0.1mL of undiluted Pfizer COVID vaccine given intradermally in L forearm in error by clinical staff member. Administration error was discovered once pt had left the clinic. Call placed to Pfizer to report error and receive guidance for pt. Pfizer reported that pt should be monitored and treated for any symptoms as required. Pt should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm and should be monitored for potential local and systemic adverse events. Called pt to inform of error and check on status. Pt states she is doing well and does have localized reaction with redness, itching, and swelling at injection site. Pt will continue to monitor and seek care if necessary. Pt was previously vaccinated with 2 doses of Moderna.
No additional AE reported; inadvertently administered an expired dose of RECOMBIVAX HB; This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.    On 19-DEC-2022, the patient was inadvertently vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliter, lot # U008328, expiration date 16-DEC-2022, for prophylaxis (route of administration and anatomical vaccination location were not reported) (Expired product administered). It was confirmed that the vaccine did not experience any temperature excursions. No additional adverse events were reported (No adverse event).
Information has been received from a physician concerning a 13 year old healthy female with no known drug allergies reported who on 04-SEP-2008 was vaccinated with GARDASIL concomitantly with VARIVAX (Oka/Merck), and on 11-SEP-2008, one week later, the patient experienced a rash on her forearm.  The physician characterized the rash as papular and slightly pruritic.  The patient was recovering.  The patient sought physician's medical attention.  Additional information has been requested.
Patient was receiving his #2 Pfizer for completion of primary series.  Patient should have received a monovalent Pfizer but was given a bivalent Pfizer instead.  No adverse reactions.
Redness and heat at injection site of MENVEO vaccine in R arm, measuring 11 x 14mm. DX: Cellulitis. Treated with Cephalexin 500mg q 6 hours x 5 days. Guardian reports symptoms have resolced.
PT CAME IN FOR 12MTH CHECKUP , GOT IMMUNIZATION READY TO BE ADMINISTERED . ADMINSTERED THE IMMUNIZATION TO PATIENT AND WAS READY TO INPUT IMMUNIZATION IN SYSTEM  I NOTICED THAT I HAD ADMINSTERED THE WRONG IMMUNIZATION. I LET MY PROVIDER KNOW OF THE MISTAKE AND CALLED HEALTH DEPARTMENT. TO BE SURE, ALSO CALLED THE CDC TO JUST BE SURE THAT ADMINERSTERING THE WRONG IMMUNIATION WON'T HAVE AN EFFECT ON THE CHILD. CALLED THE PT MOTHER AND LET HER KNOW OF THE SITUATION
swollen arm; red circle; out of breath when she talks; heart is making weird beating noise; heartbeat is faster; skips a beat; chest felt tight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise) and HEART RATE INCREASED (heartbeat is faster) in a 24-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.     Concurrent medical conditions included Arrhythmia.    On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101.         No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Patient presented with generalized tremors vs rigors, headache, numbness and tingling to bilateral lower extremities, and weakness to lower extremities. Cranial nerves intact, reflexes intact and symmetrical, normal strength to upper extremities. After observation in ED, symptoms spontaneously resolved.
18 year old female patient was given an expired dose of Menactra with no reported adverse event; Initial information received on 09-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via physician in.  This case involves a 18 year old female patient who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Jul-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6594AA and expiry date: 21-May-2021) (Frequency: once) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that "Patient Information Patient age greater than 1 year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test- 0.5 ML Strength -standard except for Fluzone HD-STANDARD Pregnancy- no pregnancy, Last menstrual period-not applicable, Due date- not applicable. If baby was delivered: delivery date and if baby experienced an adverse event- not applicable Inform that they will be receiving a follow up questionnaire- not applicable If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an Drug Administration requirement.- not applicable. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes Still using product: No".  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 the guidelines. 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.
3 days p/vax while pt had concomitant URI sx,pt devel pinpoint,hot,red,pruritic lesions on elbow,knees,anterior thighs
Information has been received from a physician concerning a 17 month old female with no past medical history and no known allergies, who on 8/1/02 was vaccinated with MMR II. There was no concomitant medication. On 8/8/02, the child developed a rash on her face which went tot he torso and legs. On 8/10/02, the child developed a fever (temp measurement not provided) which later subsided. It was reported that the rash; however, continued to linger, otherwise, the child looked well. Unspecified medical attention was sought and the rash was treated with Benadryl. No further info is provided. Additional info has been requested.
A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish/most fruits" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits. The patient took concomitant medications. The following information was reported: DYSPNOEA (medically significant) with onset 22May2021, outcome "not recovered", described as "A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right". The events "a week after i got the shot 1 morning i just couldn't catch my breathe and it's been since 2021 it's now 2 years later and i still can't breathe right" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dyspnoea.   Clinical course: Other medications in two weeks: prescribed medicines for asthma/seasonal allergies. Adverse event: A week after the patient got the shot 1 morning, he just couldn't catch his breath and it's been since 2021 it's now 2 years later and he still couldn't breathe right. AE treatment: Many asthma relieves/steroids/oxygen. Known allergies: Food which includes shellfish and most fruits. Other medical history: Asthma.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tenderness; swelling; Redness; warm; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm) and INJECTION SITE PAIN (Pain at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL and AMLODIPINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Pain at the injection site). On 17-Mar-2021, the patient experienced TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (Redness) and INJECTION SITE WARMTH (warm). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at a dose of UNK dosage form. At the time of the report, TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm) and INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant meds include  Acetoarfarin lexiprol Action taken with mRNA-1273 in response to the events were Not Applicable
No adverse effect, like a side effect, but I was instructed by Moderna to do a VAERS for an administration error. Patient recieved an invalid dose due to my syringe not being properly tight enough with safety needle packaged with syringe. Moderna COVID dose went outside the the syringe out the side in opening between the needle and syringe and not into the patient's deltoid IM like it was supposed to.
Allergies:- Metals, Codeine, Etodolac, Augmentin, Bactrim, Pneumococcal Vaccines; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways. A contactable physician reported for a 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization, codeine, etodolac, amoxicillin, clavulanic acid (AUGMENTIN), sulfamethoxazole, trimethoprim (BACTRIM) all with unspecified route, date and dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: metals, codeine, etodolac, augmentin, bactrim, pneumococcal vaccines on an unspecified date. The action taken for codeine, etodolac was unknown. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Local reaction 5 cm by 7 cm erythematous indurated area on left thigh with some darker red area at the site of the injection.