chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported having "itching" day after 1st dose, no hives or airway issues, no other s/s.  Patient self admitted to feeling anxious about 2nd dose, however wished to proceed.  Approximately 20-25 minutes post vaccine, patient felt dizzy upon standing. VS checked, BP 130/80, HR 80s, SPO2 99% RA.  Patient speaking in full sentences. Oriented. Felt fine otherwise. Patient held until 1615, symptoms did not improve, but did not worsen. Suggested patient go to Hospital for evaluation, or at the least have family pick her up. Patient met by family at 1700 and situation described as well as recommendations.  F/u 1/18 - Patient had dizziness through the next day. Dizziness improved and she then had low grade symptoms from injection including fatigue / aches / HA that also went away and felt fine 1/18/21. She did not seek additional medical care.
Saturday got minor leg pain in upper calf. Sunday spread to ankle and foot with tingling. Monday the thigh and hamstring got cramps as well with left still hurting. Continued till Friday. Tingling and muscle tightness moved to face including cheeks and jaw. Saturday night. One week later. Moved to arms.
It started with bad brain fog, and has progressed to a constant mild frontal headache and brain fog that is causing fatigue and problems with vision. It feels like my eyes don?t want to open all the way.
Red itchy painful swelling at site of VARIVAX & Hep A vaccine 2 1/4 x 1 1/2" oval red area at deltoid.
Pt noticed swelling of left arm on 1st night of vax. The arm progressively became more swollen during the next day. The pt went to emergency room that evening, left arm was swollen 5 cm greater than right arm.  Fever of 100.3.  Pt was seen by MD the following day. Swelling had decrease to 4 cm greater than right arm.
pharmacist called in to report that they have administered menactra, that has expired on 24Apr2023 with no reported adverse event; Initial information received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient and who have administered Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] that has expired on 24apr2023 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel), Vaxoral And Hpv Vaccine Vlp Rl1 4v (Yeast) (Gardasil) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine solution for injection (frequency: once, strength: standard, expiry date: 24-Apr-2023 and lot U7273BA) via intramuscular route in the left arm for Prophylactic vaccination (immunization) and administered menactra, that has expired with no reported adverse event (expired product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Welt, redness, hot to touch 3"x3" area with smooth edge. "Felt on fire" painful to touch - started day of vaccine. Today heat is resolved, area very itchy & pink in color - feels bruised.
THE PATIENT BECAME COLD TO THE TOUCH, PALE, WITH EXCESSIVE SWEATING AND WITH INBALANCE.
This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with (Merck) PROQUAD (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Patient came in day 2 post-vaccine - observed (L) back of arm with red 25 cm x 7 cm area - non raised and no itching - non tender. Reported that on day 1 post-vaccine - red, raised area tender to touch with mild itching.
This spontaneous report as received from a vaccine coordinator refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # L040054 and expiry date: 26-DEC-2017 for prophylaxis. The vaccine was exposed to a temperature frame of 33.20 Fahrenheit for 20 minutes. There were no previous excursions and there was no data logger involved. No adverse events were reported and there was no product quality complaint (PQC). Follow up information has been received from the vaccine coordinator via a telephone call on 15-DEC-2016. The coordinator was unable to provide any further information. This is one of the two reports from the same reporter. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA010971: MERCK 1610USA009679: Mfr number.
About two weeks after the third dose of the vaccine, I started to have severe low back pain. I had also had back pain after the other two doses of the vaccine which was around the same timing. I also had abdominal pain midline in the front. The abdominal pain got worse and I went to the Emergency Room. They treated the abdominal pain with Morphine and another narcotic which did not seem to help. I was prescribed Bentil and Zofran. I was later prescribed Prednisone and Flexeril. The next day I broke out in a burning rash on my trunk and the backs of my knees. I had a burning sensation in my mouth and esophagus. I went to a walk-in clinic on 10/16/2021 and I was sent to the ER. I was prescribed medication. I got weaker over the next two days. I fainted twice. I was taken by ambulance on 10/18/2021 with Right sided Paralysis after being unconscious. All tests were normal. I was transferred to the hospital. After testing I was told it was a Guillen Barre syndrome. I still have some Right Sided Neurological problems and Bladder Disfunction with shortness of breath. I have trouble swallowing and some coughing.
Not feeling well before 2nd dose; diarrhea before 2nd dose; Sore throat before 2nd dose; Runny nose before 2nd dose; Achy before 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Not feeling well before 2nd dose), DIARRHOEA (diarrhea before 2nd dose), OROPHARYNGEAL PAIN (Sore throat before 2nd dose), RHINORRHOEA (Runny nose before 2nd dose) and MYALGIA (Achy before 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well before 2nd dose), DIARRHOEA (diarrhea before 2nd dose), OROPHARYNGEAL PAIN (Sore throat before 2nd dose), RHINORRHOEA (Runny nose before 2nd dose) and MYALGIA (Achy before 2nd dose). At the time of the report, MALAISE (Not feeling well before 2nd dose), DIARRHOEA (diarrhea before 2nd dose), OROPHARYNGEAL PAIN (Sore throat before 2nd dose), RHINORRHOEA (Runny nose before 2nd dose) and MYALGIA (Achy before 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       While being sick and is saying that her doctor does not want her to get the 2nd dose tomorrow.   Reporter did not allow further contact
On November 5, 2008, I received a flu shot where I work at, and right away I started having symptoms from vaccine. From Nov, 5 2008 until July 1 2009 I had no treatment due to no Insurance, so I had to deal with the pain the best I could, So when I got Insurance I went to the DR and now under treatment. I am now taking Medicine for pain but not doing any good. I have to take sleep aide due to pain in arm cause I can't sleep, and now Having to take Cymbalta due to depression cause of not being able to use arm like I use to. And I have to take 900MG of Gabapentin for pain. At times if I keep my arm immobile it goes numb on me. I also had a mini Stroke I believe due to all this going on. So any help would be very greatly to me. Will provide any other information if needed due to this...Thank you very much. DR says it's damaged Nerve. So please help me.
A few hours after receiving the Shingrix vaccine at the clinic at work I started to get severe body aches. A few hours later, after going to bed I started vomiting uncontrollably - about 10 times all night long, even when there was nothing left in my stomach. The next morning I went to visit my PCP who gave me some anti-nausea medication. I fully recovered after 48 hours.
Injection site started itching; it feels like a knot under the skin; Injection site is swollen; Injection site is red; Injection site is hard to the touch; Injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416Z0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Highly allergic to insects, bee stings and some drugs.).    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site was a little sore). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch). At the time of the report, VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include Benadryl.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
I had gotten a Shingle shot at our health dept./Suspected vaccination failure; Had shingles twice/ the second time was the worse; Lots of pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice. The second time was the worst. The patient stated that, they were really really bad and had lots of pain. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
a 12 years old patient was accidently administered a dose of Flublok vaccine/No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2011, expiry date: 30-Jun-2021), via intramuscular route in the left arm accidentally on 24-Sep-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  The patient had no concomitant medications.  It was an actual medication error due to the inappropriate age at vaccine administration (latency: same day).  At the time of report 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided) reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009243: US-009507513-1811USA009124: US-009507513-1812USA009244: US-009507513-1812USA009241.
Pt reportedly received Pneumovax vaccine on 22 Dec 04 and developed arthralgia to her shoulder with swelling to the immunized arm. Shortly there after she had difficulty breathing and was diagnosed with pneumonia by her PCP. No interview with client as of 2/22/05. Available data gathered from CHCS II databank and referral source.
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 56 years old female patient who received vaccine DAPTACEL instead of Tdap and reported that gave a DTaP shot to a 56 year old patient that was supposed to be given TDaP. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Feb-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5202AA and expiry date: 16-May-2019) (dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Patient received FluMist vaccine on 10/20/05 after 48 hours she felt weak, generalized, with vomiting and diarrhea.
Within 3 days large red rashy type patch around injection site much larger than original bandaid. Within 9 days mild itchy rash on neck and across back and a number of raised red bumps all over back-but back bumps not itchy.  Rashes passed within a day. Rsised bumps still present to some extent.
Extreme pain  for a week, limited motion and weakness left  shoulder and arm since 12/8/05. Treatment: Vicodin, Prednisone, Physical therapy.
Patient had headache, lethargy, dizziness, vomiting, and incoherence.
Baby face puffy, lip swollen, ?wheeze; was in car seat <2 hour after visit. Faded. In evening face was blotchy 6:20 pm. Fed poorly, passed a green stool. No care sought. Called 11/22 and was seen. Normal exam. Breast fed. ? reaction to milk (dairy) or walnuts.
No additional AEs; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-MAY-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe, 0.5 mL, intramuscularly (IM), lot # U018632 with expiration date 11-JAN-2023, intramuscularly, for prophylaxis (strength and anatomical location were not reported). No additional adverse event was reported.
flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an adult patient of who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
LOST MOST OF HAIR DUE TO THE JANSSEN VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced lost most of hair due to the janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost most of hair due to the janssen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211127938.
face itching; face swelling; face was red from my neck up; chills; joint aches; body aches; Fever; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills) and ARTHRALGIA (joint aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced FACE OEDEMA (face swelling) and ERYTHEMA (face was red from my neck up). On 20-Mar-2021, the patient experienced PRURITUS (face itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and HYDROCORTISONE (topical) for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.8 (High) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.