chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired fluzone was accidentally administered to a patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 19 years old female patient and reporter reported expired fluzone was accidentally administered to the patient with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Sep-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 mL (milliliter) 1X TOTAL (lot U7328BA, 30-Jun-2022) via unknown route on left arm (strength was unknown) for Immunization   On 24-Sep-2022, the patient was accidentally administered expired fluzone with no reported adverse event (expired product administered) 1 day following the administration of vaccine.  No lab data was reported  Action taken was not applicable.  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 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.
Patient presented to the pharmacy today 9/8/19 complaining of arm pain upon injection site.  Upon examining her arm and speaking with the technician that administered the vaccine on 09/05/19 the vaccine was not given in the deltoid region of the upper arm.  The vaccine was given in the back of the arm where a subcutaneous injection would be given.  It is unknown if it was given im or sc.  The patients arm was very red and irritated in the area in the back of the arm where the vaccine was administered.
Malaise, sensitivity of L frontal scalp & cheek & eye. Progressed to have more pain & then vescicular rash consistent with shingles.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received- Case narrative was added
Severe chills followed by body aches and fever through the night starting about 11pm on 3/25.  Fever hit a high of 101.9F by 8am 3/26. Body aches, low energy and fever persisted throughout 3/26.with a return of chills, fever, aches and sweats during the night of 3/26-27. Treated with alternating doses of acetaminophen and ibuprofen.
Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk.  Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.
Second dose received Thursday 7/22, Thursday night had had fever of 102, Friday afternoon diarrhea began (ended Saturday evening), Friday evening began feeling fatigued and had fever of 101 as well as loss of appetite. Friday night I had congestion which is ongoing as of Tuesday 7/27 with minor improvements as well as a minor cough with some phlegm. Tuesday 7/27 around mid day I realized I have lost both taste and smell. I scheduled a visit through Doctor and the doctor advised that it could potentially be allergy related and recommended an allergy medication as well as anti inflammatory medication but to also follow up with a covid test just to be sure it isn't covid.
Diarrhea; vomiting; chills; weakness; fatigue; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot unknown reason: not available /provided to reporter at the time of report completion, via an unspecified route of administration from 07Feb2021 at 11:30 am to 07Feb2021 at 11:30 am at single dose (dose number; 1) on right arm for covid-19 immunisation. Patient was 68 years old and not pregnant at the time of vaccination. Facility type vaccine was reported as other. Patient's medical history included low thyroid, high cholesterol, mitral valve prolapse and severe leaky heart valve and known allergies: Sulfa drugs (dates unspecified). Patient concomitant drugs included Atorvastatin calcium, levothyroxine sodium (SYNTHROID), ACETYLSALICYLIC ACID (BABY ASPIRIN), Vitamins (dates, dosage regimen and indication not specified). if other vaccine in four weeks was reported as no. Patient experienced diarrhea, vomiting, chills, weakness (not serious weakness), fatigue on 08Feb2021 at 02:30 pm. Treatment received was reported as no. If covid prior vaccination; no, If covid tested post vaccination; no. The outcome of events was recovering.
Patient experienced arm pain about 15 minutes post vaccination and nausea 30 minutes post vaccination.
Itching of chest and arms, Redness at injection site, Lightheaded 15min after vaccine
ED visit for COVID symptoms, COVID positive test 9/11/21. Fully vaccinated Feb 2021. Received monoclonal antibodies in ED.
pt states she has a itchy warm hard red area about 2 1/2 x 1 1/2  below the injection site similar to a hive.
warm erythematous 4x7 induration of lt upper arm @ inject site, extending to lt elbow; 1+ small lt axillary node, t99.8;
Child was given the HPV vaccine when she was 7 yrs and 11 months old.  Father informed on 9/9/15 and father denied any side effects or adverse events following vaccination in February.
Information has been received from Associate Research Scientist and patient's mom via e-mail concerning an 8 year old female patient, who was vaccinated on 28-FEB-2003 with a first dose and on 4-JUN-2007 with a second dose of VARIVAX (routes and lot numbers not reported). The mother stated, on 11-JUN-2009 (also reported as 11-MAY-2009), the patient's rash was generalized, just under 40 spots, they were as far down as her upper thighs and as high as her shoulders. The patient had more on her belly but some scattered around her entire mid-section. The spots had been roughly doubling each day. About a quarter of them had a distinct whit dot of fluid at the center of the otherwise red spot. The patient was exposed 2-3 weeks before onset, approximately 21-MAY-2009, for "several hours" to the baby sitter with history of past chicken pox. The physician reported that the type of rash was vesicles and "paps", there were 50 lesions and generalized in distribution. The physician reported the rash as break through of varicella after two doses on 11-JUN-2009. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 11-JUN-2009. The sample was taken from vesicular lesion (specimen site not specified). The PCR results for the specimen from the vesicle lesion was negative. At the time of the report, the outcome of the patient was recovered (date unspecified). The patient sought medical attention. Further information is not expected.
twinges (of pain) in his left thigh; soreness at the injection site (left shoulder).; nerve pain perhaps shingles-type nerve pain; asked if the shot was given intramuscularly  / is not sure because but the person administering the shot did pinch his skin up; he couldn't get comfortable while sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injection site pain, nerve pain and intramuscular formulation administered by other route. In December 2020, the patient experienced discomfort. On an unknown date, the outcome of the pain in extremity, injection site pain and discomfort were not recovered/not resolved and the outcome of the nerve pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in extremity, nerve pain, discomfort and intramuscular formulation administered by other route to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix around 2:00 or 2:30 pm in the left deltoid. The customer care asked, if the shot was given intramuscularly and the patient said he thinks so but was not sure because but the person administering the shot did pinch his skin up and he states that he did not recall his skin being pinched up for Shingrix dose 1. He indicated that he did not know if pinching the skin up would have affected the ability of the needle to reach the muscle. When asked the patient if the injection was done on the back of the arm and he said no.   The patient was experiencing soreness at the injection site (left shoulder). This had not resolved. He reported that yesterday by evening he experienced twinges (of pain) in his left thigh. He was not sure if it was nerve pain perhaps shingles-type nerve pain. The pain was on the inside of the left thigh, high up, sharp and local. He said the pain kept him up for a couple hours last night (in the middle of the night) because he couldn't get comfortable while sleeping. He said the pain comes and goes and he did not injure himself or do anything out of the ordinary. He said the pain comes in waves. The pain was a little better this morning  but he did have a sharp leg/thigh pain right before calling. The patient was calling because he wanted to see if he should call his doctor. He was concerned that maybe the pain could be something serious like a blood clot. He stated he was almost sure this the thigh pain wa related to the Shingrix shot because it started a few hours after getting the shot. The reporter consented to follow up.
UrticariaPruritus  HOT flashes, prickly skin of jaw line to chest  EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
I am reporting my positive test for COVID on 04/19/2022. I serve migraine, cough, chills, body aches, nausea and fatigue. My symptoms are moderate to severe. I have been off work for about 10 days. My Teladoc prescribe me Pavlovic and Mucinex and Tylenol.
This spontaneous report as received from a medical assistant, via a company representative, refers to an unspecified number of patients of unknown age and gender. The company representative learned from medical assistant that most healthcare professionals routinely administer PNEUMOVAX23 to their patients every 5 years, resulting in patients receiving more than 2 doses of PNEUMOVAX23. Dosing information, route of administration and lot numbers were not provided. No adverse effects were reported. No further details were provided. Additional information has been requested.
Pt came in for flu vaccine-received vaccine without any issues-mom left office and approx 5 mins. later mom returned with child limp in her arms. Pt was fully conscious when returned to office-no jerking/stiffing. No loss bowel/bladder.
Awakened by onset of intense itching at 0300 both wrists and both flanks, rapid progression within 30 minutes (in spite of 50mg benadryl at 0315) to involve entire flexor surfaces of both arms with numerous and confluent urticarial wheals and redness, circumferential abdomen and lower trunk, behind and including both ears and lateral scalp, lateral thighs and posterior knees.  No oral swelling / mucosal involvement, no respiratory symptoms.  Itching subsided somewhat after 3 hours but wheals remained in above distribution with q 6 hour benadryl 50 mg + zyrtec 10 q 12 for 36 hours.  Began to fade somewhat at 24 hours, mostly resolved at 36 hours except on arms.  No prior similar reaction to anything prior in my life.  Discussed with PCP who prescribed steroid pack but as sx began to subside at 24hr did not take.
Pt states arm pain began as soon as the injection started on 1/3/19. It radiated down arm and to back, head, ear, & mouth. Pt states pain hasn't stopped since injection and can not eat. I advised her to see her doctor. Pt said she couldn't until Monday. I advised her to see an urgent care or ER.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 09May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Took Paxlovid beginning the day after testing positive; (23May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (24May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (25May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (28May2022) Positive, notes: On Day 15, symptoms returned with a lot of nasal congestion, cough, muscle aches and fatigue No fever as with initial diagnosis, but felt badly. Test on Day 16-positive result, strong like initial diagnosis. Therapeutic measures were taken as a result of covid-19.  Clinical course: Took Paxlovid beginning the day after testing positive. Symptoms improved beginning with the second day and continued to improve. Tested again on Days 11, 12, 13; all were positive, but second line was faint as opposed to dark on the initial testing. Doctor advised that I could test positive for a while, and to stop testing and said I was not considered contagious. On Day 15, symptoms returned with a lot of nasal congestion, cough, muscle aches and fatigue. No fever as with initial diagnosis, but felt badly. Test on Day 16-positive result, strong like initial diagnosis. Contacted doctor and spoke with triage nurse. She thought this was most likely a continuation of the initial infection and not a new infection, and that according to CDC guidelines, I was not considered contagious. But that I should mask and avoid being around others considered vulnerable. My wife and I decided I should isolate again. I am on Day 4 of that and beginning to feel some relief of the symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200779934 Same reporter/patient, different drug/events
Erythema Multiforme rash developed on hands and feet starting 4 days after Covid vaccine.
Pain at injection site, sore deltoid muscle, malaise, fever (100.4F), nausea, upset stomach, headache
Body Aches; Fever (101); Rash (small red spots) on chest and back; Dry/wet cough; Dry/wet cough; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the left arm on 21Apr2021 at 12:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included loratadine (CLARITIN), fluticasone propionate (FLONASE), vitamin d nos (MANUFACTURER UNKNOWN) and unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 11:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient previously received fluconazole (MANUFACTURER UNKNOWN) and experienced drug allergy. On 22Apr2021 at 03:00, the patient experienced body aches, fever of 101 (unspecified unit), rash (small red spots) on chest and back and dry/wet cough. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as result of the event fever which included treatment with some paracetamol (TYLENOL). The clinical outcome of the events body aches, fever (101), rash (small red spots) on chest and back and dry/wet cough was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax 24SEP97 & that noc c/o a stomach upset & was consequently taken off augmentin;seen @ MD office on 25SEp97 & devel a fever 103.5, chills, & arthus pain;
COLD LIKE SYMPTOM; FELT SICK/NOT FEEL WELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced cold like symptom, and felt sick/not feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold like symptom, and felt sick/not feel well. This report was non-serious. This case, from the same reporter is linked to 20210442783.
Shot at 930 am. 8 pm started getting sharp cramps / pain in lower stomach. By 930 I had chills, teeth chattering, body aches. Stomach pain increased. Felt similar to birthing contractions. Woke up with headache, body so sore I could hardly walk around or sit. No appetite or energy all day. random stomach pangs throughout the day.
Received vaccine at 3:30 and started with symptoms at 9:00pm.  Headache, stiff neck, chills, nausea.  Was feeling much better by 1:00pm the following day.
Patient received a localized reaction on the left arm where it became red and tender. Red area keeps expanding. Reaction started 48 hours after second dose
Patient inadvertently received the Pfzier Bivalent vaccine on 9/30/22 although she hadn't received a primary series.  No adverse events noted.
My 6-year old daughter had her Varicella booster shot and broke out 17 days later with a Chickenpox rash on her face near her mouth and in her nostrils, as well as two spots on her forearm.
This spontaneous report as received from a pharmacist refers to a currently 68 years old female patient. She had no drug reactions/allergies. No information on her medical history or concurrent conditions was provided. On 06-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously, lot # K008883, expiration date 20-SEP-2015. Concomitant therapies included methotrexate (manufacturer unknown), folic acid, propranolol hydrochloride and simvastatin (manufacturer unknown). In approximately October 2014 the patient experienced cellulitis at the injection site. The patient sought medical attention via an office visit and was prescribed an unspecified antibiotic by a registered nurse. The outcome of cellulitis at the injection site was reported as not recovered/not resolved. The relatedness between use of ZOSTAVAX and the adverse event was unknown. Additional information has been requested.
Pt admitted to hospital <24 hours after receiving dose #1 COVID-19 Moderna vaccine with abdominal pain, nausea/ vomiting, dyspnea, generalized myalgias and arthralgias.
Roughly 24 hours after second covid19 Moderna shot, had uncontrolled vomiting for about 6 hours along with other common side effects.  Was unable to hold water down or sit up without vomiting or drive heaving.
I received the Phizer COVID booster shot on 1/4/2022. Later that day I began to experience sore breasts and cramps. The next morning on 1/5 I woke up with light bleeding. On 1/6 I had heavy bleeding and cramps, and also a lump in my left lower armpit. On 1/7 I still had the lump and was experiencing heavy bleeding. On 1/8 I still had heavy bleeding but the lump dissipated. On 1/9 I had light cramps, bleeding was less heavy at the end of the day, but it was still persistent. On 1/10 I had light cramps, but the bleeding was still persistent. same as 1/9. On 1/11 the bleeding subsided, and on 1/12 there was no bleeding. I am reporting this because I had not menstruated for at least the last five years, but began to do so shortly after the booster shot, and believe that the booster shot triggered menstruation.