chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slin Blemishes And Small Rash Like Areas In Face; Unbearable pain from my right hip, inner and posterior thigh, knee, shin and calf, ankle to the top of my foot; low grade fever; chills; Burning everywhere except on private parts; hurt everywhere; Itchy/burning everywhere except on private parts; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning everywhere except on private parts), PAIN (hurt everywhere), PRURITUS (Itchy/burning everywhere except on private parts), RASH (Slin Blemishes And Small Rash Like Areas In Face) and ARTHRALGIA (Unbearable pain from my right hip, inner and posterior thigh, knee, shin and calf, ankle to the top of my foot) in a 56-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 Arthritis, Fibromyalgia, Obesity and Sulfonamide allergy.    On 11-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SKIN BURNING SENSATION (Burning everywhere except on private parts), PAIN (hurt everywhere), PRURITUS (Itchy/burning everywhere except on private parts), PYREXIA (low grade fever) and CHILLS (chills). On an unknown date, the patient experienced RASH (Slin Blemishes And Small Rash Like Areas In Face) and ARTHRALGIA (Unbearable pain from my right hip, inner and posterior thigh, knee, shin and calf, ankle to the top of my foot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form. At the time of the report, SKIN BURNING SENSATION (Burning everywhere except on private parts), PRURITUS (Itchy/burning everywhere except on private parts) and PYREXIA (low grade fever) outcome was unknown and PAIN (hurt everywhere), RASH (Slin Blemishes And Small Rash Like Areas In Face), ARTHRALGIA (Unbearable pain from my right hip, inner and posterior thigh, knee, shin and calf, ankle to the top of my foot) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication also included an unspecified antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Event added. Treatment updated.
sore and tender; This spontaneous case was reported by a consumer and describes the occurrence of   in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
fairly severe anemia; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAEMIA (fairly severe anemia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAEMIA (fairly severe anemia). At the time of the report, ANAEMIA (fairly severe anemia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Patient stated she would like to get  Booster dose on 08-Dec-2021.The pharmacist wants to know if she is contraindicated.  Patient had undergone blood transfusions twice for the event.
Patient was given one vaccine Today. She was given Gardasil 9 Her second Dose. First Dose she Received 1 year ago on 7-22-2019 and reports No Adverse effects at that time. Patient Reports being very nervous about getting A shot today, Became Dizzy and Nauseous After Receiving the Vaccine. She was very pale in color. Given A Sprite, cheese and crackers and A cold pack to Apply
This spontaneous report as received from a pharmacist refers to (her daughter) a 8 weeks old female patient with immunization. The patient was vaccinated with ROTATEQ on 27-NOV-2012. No other co-suspects were reported. Concomitant medications included: DTaP (unspecified), tetanus toxoid. On 27-NOV-2012 the patient experienced developed green, mucousy diarrhea, 1 day after onset of therapy and fussy and irritable. No treatment information was reported. The outcome of developed green, mucousy diarrhea and fussy and irritable is unknown. The relatedness for developed green, mucousy diarrhea and fussy and irritable is unknown for ROTATEQ. Additional information has been requested.
Fever, cellulitis on the 2nd dose administration arm, inflammation and nodes in axilla, dizziness.
Vaccine appeared to be given too high in deltoid muscle.  Had immediate pain in shoulder. Over next 6 weeks had excruciating arm and shoulder pain and limited ROM.  Took 8-9 weeks for all pain to resolve.
Severe itching, burning sensation and warmth at the injection site, redness, sharp stabbing pain,  formation of lump/welt at injection site.
7 days after first vaccine left arm developed hives and severe itching.  10 days after first dose Left hand developed clear white itchy  rash.  18 days after first vaccine SEVERE swelling in right left and knee as well as severe cramping in calf muscle.  OTC meds, ice and heat...nothing helps.  Can not put pressure on that leg at all.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old male patient of an unspecified race received TRUMENBA and second dose of MENACTRA at 1DF single dose both as prophylaxis on 15Jun2017 at 0.5ml single dose via intramuscular route. Medical history and concomitant medications were unknown. On the same date the patient passed out within about 5 minutes. The patient went to ER as a precaution and it was unknown if the patient was admitted to the hospital. The outcome of the event was recovered.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
mucus on throat; stuffy nose; runny eyes; whole body pain; joint pain; feeling really sick; tired; sleepy; right sided ear aching; she got really sick and has been so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: INCREASED UPPER AIRWAY SECRETION (non-serious), outcome "unknown", described as "mucus on throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffy nose"; EYE DISCHARGE (non-serious), outcome "unknown", described as "runny eyes"; PAIN (non-serious), outcome "unknown", described as "whole body pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feeling really sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy"; EAR PAIN (non-serious), outcome "unknown", described as "right sided ear aching"; ILLNESS (non-serious), outcome "unknown", described as "she got really sick and has been so sick".  Additional Context: The caller was calling about the Pfizer covid vaccine. The caller took her second shot and after she took it she got really sick and has been so sick. The caller didn't know if this was normal. The caller has had a lot of mucus in her throat, a stuffy nose, runny eyes, whole body pain, joint pain, has been feeling really sick and tired and sleeping. It didn't happen with the first one, but it did with this one. The caller's right sided ear was aching. All of this started within 4-5 hours after the vaccines. The caller started feeling sleepy and laid down and couldn't hardly move because of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HIP AND SEVERE JOINT PAIN; MUSCLE ACHES; NAUSEA; TIRED AND KIND OF WEEK; This spontaneous report received from a consumer 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 was not reported, administered on 08-APR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced tired and kind of week. On 09-APR-2021, the subject experienced hip and severe joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, nausea, tired and kind of week and hip and severe joint pain was not reported. This report was non-serious.
nerve pain worse in her heels; nerve pain worse in her heels; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00156463) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Arthritis.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain). At the time of the report, PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain) outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information included Cancer medication and Arthritis Medication. No treatment medication information was provided.
12-15 hrs p/vax t100.6, h/a, nausea, anorexia; local react lt arm (deltoid sore, warm; no redness; continued 100.2 fever, h/a on 9APR 24 hrs later; mom reported sx gone 10APR p/ f/u on 15APR no problem;
Pneumococal vaccine used in a less than 2 year child;   Information has been received from the authors in a published literature article, entitled as stated above, referring to a 12 month old, adopted, female patient with  family history not available.  At 4 months of age, she developed persistent wheezing poorly responsive to bronchodilators. At 6 and 9 months of age, she had two chest X-rayconfirmed pneumonias treated in the hospital with IV antibiotics and O2 supplementation.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis.     At 12 months of age, the infant was enrolled in a study approved by the Hospital. Immunological evaluations revealed a combined immunodeficiency with normal absolute CD3+ T cell numbers, CD4+ Tcell lymphopenia (627 cells/µl) with a reduced proportion of naive T cells and T regulatory cells, increased frequency of memory CD4+,CD8+ cells, and CD45RA+CCR7- CD8+ Tcells (TEMRA). High-throughput sequencing of TCR Vß (TRB) repertoire in sorted CD4+ T cells, CD8+ T cells, and T regulatory cells in the patient demonstrated a polyclonal repertoire with reduced diversity and prominent clonotypic expansions, associated with a higher proportion of unique clonotypes containing cysteines at the apex of the CDR3, consistent with a T cell repertoire enriched for self-reactive specificities likely due to defective thymic selection.  Reduced numbers of switched and unswitched memory B cells, hypogammaglobulinemia (IgG 338 mg/dL), and impaired vaccination response to Haemophilus influenzae type B and Pneumococcus were also present.  A copy of the published article is attached as further documentation of the patient's experience.
Began to experience shortness of breath, persistent chest pain, and fluttering sensation in heart. All symptoms began about 5-6 days after vaccination and lasted about a week. Symptoms lessened and did not experience again after the second dose.
stuffy and runny nose, headache loss of taste and smell body aches.  Tested Positive for COVID-19
Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events under same suspect product for 10 patients this is 7th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low oestrogen, can't concentrate/can't focus, can't sleep, depressed, and has anxiety. It was reported that the reporter who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in April, she had low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proved that she has low estrogen. She went on to state that she was aware of 10 people who experienced the similar reactions. When she was requested the date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called  the wrong number because she had received both doses of the Pfizer vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Estrogen: low. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
1st dose of PFIZER-BIONTECH COVID-19 VACCINE last 03/24/21/Wife tested positive: 04/03/21; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19), via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient and her husband had their 1st dose of PFIZER-BIONTECH COVID-19 VACCINE last 24Mar2021 and 2nd dose will be on 14Apr2021. They have tested positive for COVID after a few weeks. Wife tested positive: on 03Apr2021 and husband tested positive: 06Apr2021. Event out come was unknown.  Additional information for Lot/Batch number has been requested.
Left upper arm became very red, warm to touch, tender. Limited ROM with inflammation. TX= P.O. Antibiotics, pain meds, subsequent IV antibiotics.
shots that was given three days after his initial shot, was given in the buttocks with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient).  This case involves a 68 years old male patient who got shots that was given three days after his initial shot, was given in the buttocks with no reported adverse event while receiving vaccine Rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, about 2 and a half months ago, the patient received day 0, 7, and 14 in the arm and 3rd dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection with unknown strength, batch number & expiry date via unknown route in the buttock nos with no reported adverse event (incorrect route of product administration) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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.
23JUL94 evening started w/achiness in joints for 4 days, testicles were swollen for 1 day; intermittent irritability; fever started 29JUL94 104.6; rash started on trunk-then to arms & legs & face-red bumpy rash; no appetite, conjuntivitis;
After the 15 min of waiting I started feeling tingling on the left side of my body where the shot was. The next day it felt worse and I contacted Nurse who talked with a doctor. The doctor recommended I go to Emergency. Emergency doctor said I passed all outward neurological exam to rule out stroke. He did not recommend an MRI or blood work, said it was up to me, or I could wait till Monday to call my Physician.   It has gotten a better, but I still feel tingly on the left side of my face and sometimes in my left arm. I had no prior sensations before the shot on 3/25/21
I gave patient a Fluvirin shot, Lot 98432P1 at 12:10 on 11/3/09. She left and went to lunch. She fainted about 1/2 hour later. The paramedics were there. They examined her and said she just had low blood sugar. Called 11/4/09. She says she is fine - feels well.
had a fever of 104 for four weeks; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated her son in law (patient) had a fever of 104 for four weeks. Caller stated she had the second dose of the pfizer covid 19 on 16Mar2021. Caller stated she is still getting symptoms she does not like. Caller stated her symptoms started four days after the vaccine and have continued for four weeks. Caller stated she is sleepy as she could possibly be. Caller stated she has chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles are aching all over. Caller states she aches in her knees but mostly the shoulders and lower arms. Caller stated that she has a headache at the back of her head on the top. Caller stated that she has a pain that goes down the right side of her headache to her shoulder, arm and back Caller stated her eyes are burning all the time noting it is hard to open her right eye. Caller stated she is swallowing phlegm. Caller stated she still feels bad. Caller wanted to know if she should keep resting Caller asked if it is normal to feel this way after four weeks and how long should it be. Caller stated that she has heard of other people that feel worse than her, have severe things and get very sick. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416802 same reporter/drug, different patient/AE
This spontaneous report as received from a physician via company representative refers to a 20 year old female patient. On an unknown date the patient was received all three doses of GARDASIL (lot#, dose, frequency and route unspecified). On an unknown date in recently the patient was diagnosed as being positive for HPV 16 and 18 and was also diagnosed with carcinoma, stage II. Patient underwent LEEP procedure, no results available. The patient sought medical attention via office visit. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Acute Lung Failure; pain in her bones; Zostavax administered on 08-MAY-2019 and 07-JUL-2019; This spontaneous report has been received from a lawyer and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 08-MAY-2019, the patient was inoculated with the first dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On or around 07-JUL-2019, the patient was inoculated with the second dose of zoster vaccine live (ZOSTAVAX). On an unknown date, shortly after receiving the second dose of zoster vaccine live (ZOSTAVAX), the patient suffered pain in her bones and developed a fever that caused her to be admitted in the emergency room. On an unknown date, she was diagnosed with acute lung failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of acute lung failure was determined to be medically significant.  The events were considered to be disabling.
Pt came to pharmacy the following morning with upper left arm (deltoid to just above elbow) red, swollen and warm to the touch. I advised an antihistamine and told her I would follow up with her the next day. Rxn progressed over 24 hr to below the elbow so she went to the ER.
Rash, bright red area under the arm will get red & swollen, irritated & chaffed/dry. Resolves & flares every few days