chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; on 3/7/2017 a 12 month old patient was administered 1 dose of PROQUAD and 1 dose of VARIVAX, On 7/31/2019 the patient who is now 3 years old was administered 1 dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a 12-months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 07-MAR-2017, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# N028459 (is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX)), expiration date: 07-JUN-2018, dose and route were not reported) and one dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# was reported as N035689, expiration date: 06-FEB-2018, dose and route were not reported) for prophylaxis (overdose).  On 31-JUL-2019, the patient was 3 years old and was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018933, expiration date: 02-JUL-2020, dose and route were not reported). No adverse effects were reported.
I had positive pregnancy test 11/19/21. I had COVID booster  vaccine 11/29/21 with 12 hours of severe joint and muscle pain, 102 fever and shaking chills that occurred 12 hours after vaccination (treated with Tylenol) . I had first US 12/9 that showed gestational sac measuring 5 weeks when I should have been around 7 weeks pregnant. HCG started declining and miscarried 12/15. Time of vaccination is around the time my pregnancy stopped progressing.
Given Tdap 7-1-15. Seen by occupational medicine 7-10-15 after arm with redness, swelling, temp 100.6. Had superficial redness 7-8-15. Had put VICKS VAPORUB after shower to area. 7-7-15 had soreness in arm prior, temp 98.8-7-8-15. Antibiotics given have made improvement in arm.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 16-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 and an expiration date of 06-JUL-2016 (route and anatomical location or administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported were 34 and 31 Fahrenheit (F) (1.111111111 and -0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
7/24 10:30 PM started vomiting, lasted all night. Ate nothing, but tried milk and vomited that as well. Also had a temp of 102.5. Gave Tylenol at 9:30 AM 7/25. Took to ED 7/25 where received IV fluids for continued vomiting and diarrhea. 7/28 took to family physician who said "could possibly" be attributed to vaccinations.
Chills, fever, incontrollable tremble, unable to talk, only one side of the mouth moves while talking and other side does not , nauseous, headaches.
Left thigh with swelling, redness, 3" X 3" reddened, raised area and fever (unknown how high).
Chest pain over heart area, pounding, fast-beating heart, pulse 101, fever 100.3, headache, fatigue, shakes, teeth chattering, muscle aches, injection site pain radiating to left side of neck,urinating every 20 minutes.
Patient experienced numbness in the left arm/hand (thumb, index, and ring fingers). He stated this started right after receiving the vaccines and the numbness has continued consistently since that date (two weeks)
first Shingrix vaccine in August of 2020, and then the pandemic hit; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination is not applicable for this report. The patient did not received 2nd dose yet due to the pandemic hit and she got a letter from her pharmacy that the first dose was more than 2 to 6 months ago, which led to social problem. The patient is about to start Nucala in the coming weeks and questioned restarting the vaccine series since the first dose was more than 6 months ago. The reporter consented to follow up.
After vaccination, developed hard, painful lump at vaccination site. Swelling increased and became red and itchy, spreading to 3 inches in diameter over 3 days
Approximately 3 days after vaccine given in 3-26-08 (TdaP), pt developed numbness of left middle, ring and little fingers that perisited unchanged. (Same arm that vaccine administered.)
fatigue - 24 hours; vomiting 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2022 10:15 (Batch/Lot number: unknown) at the age of 77 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: Oct2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 10:00), administration date: Feb2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue - 24 hours"; VOMITING (non-serious), outcome "recovered", described as "vomiting 2 days later". Therapeutic measures were not taken as a result of fatigue, vomiting.  Additional information: Facility type vaccine: Hospital, If other vaccine in four weeks: No. Adverse event fatigue - 24 hours. Vomiting 2 days Later. If covid prior vaccination: No. If covid tested post vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I've been more tired since I had the vaccine; I got a nosebleed and an old cut on my arm started bleeding.; I got a nosebleed and an old cut on my arm started bleeding.; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (I got a nosebleed and an old cut on my arm started bleeding.), WOUND HAEMORRHAGE (I got a nosebleed and an old cut on my arm started bleeding.) and FATIGUE (I've been more tired since I had the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced EPISTAXIS (I got a nosebleed and an old cut on my arm started bleeding.) and WOUND HAEMORRHAGE (I got a nosebleed and an old cut on my arm started bleeding.). On an unknown date, the patient experienced FATIGUE (I've been more tired since I had the vaccine). On 24-Jun-2021, EPISTAXIS (I got a nosebleed and an old cut on my arm started bleeding.) and WOUND HAEMORRHAGE (I got a nosebleed and an old cut on my arm started bleeding.) had resolved. At the time of the report, FATIGUE (I've been more tired since I had the vaccine) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
knees joint swollen; really bad muscle pain in her leg; really affecting her work and her energy; Pain is so bad; more fatigue than usual; knees joint sore; normal aches; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (knees joint swollen), PAIN IN EXTREMITY (really bad muscle pain in her leg), ASTHENIA (really affecting her work and her energy), PAIN (Pain is so bad) and MYALGIA (normal aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M2CA and 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acupuncture (3 times).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (normal aches). On an unknown date, the patient experienced JOINT SWELLING (knees joint swollen), PAIN IN EXTREMITY (really bad muscle pain in her leg), ASTHENIA (really affecting her work and her energy), PAIN (Pain is so bad), FATIGUE (more fatigue than usual) and ARTHRALGIA (knees joint sore). The patient was treated with IBUPROFEN for Pain, at a dose of over last 2 weeks is taking more ibuprofen. At the time of the report, JOINT SWELLING (knees joint swollen), PAIN IN EXTREMITY (really bad muscle pain in her leg), ASTHENIA (really affecting her work and her energy), PAIN (Pain is so bad), MYALGIA (normal aches), FATIGUE (more fatigue than usual) and ARTHRALGIA (knees joint sore) had not resolved.            Concomitant medication included cholesterol medicines.   Patient primary care physician told her didn't think this could be a side effects of the vaccine, but she states never ever had this thing before.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-AUG-2016, the patient was vaccinated at a physician's office by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-May-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has received numerous subsequent treatments for ongoing and worsening symptoms of recurrent shingles and residual nerve pain causing paralysis and immobility of her left arm. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, residual nerve pain causing paralysis and immobility of her left arm was determined a significant medical event. Additional information has been requested.
Injection site was hot to touch; Euphoric feeling; A physical buzz; Itchy injection site; Swollen injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-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 VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. The patient reports that she felt relieved and happy after her vaccination.
expired Tenivac was administered/no AE; Initial information was received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA028498 (same reporter).  This case involves a female patient who received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC (Dosage form- Injection) ]/no AE(expired product administered) for prophylactic vaccination[lot U5856AA, expiry date:26-JAN-2020, other dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event 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.
Patient had what looked like a vasovasgal response after both vaccines were administered. HPV was given second. I laid the pt back and applied ice to arm at site. Gave pt apple juice and crackers. I stayed with her for 20 minutes, checked vitals and she was stable for D/C.
The patient's mother reports that the infant received his H1N1 vaccine injection on 12/3/09. On 12/5/09 the mother noticed noisy breathing, irritability, wheezing and a cough and took the baby to a physician who diagnosed him with asthma. On 12/9/09 another visit to an ENT doctor led to a diagnosis of a respiratory viral infection as well as asthma. He was prescribed a VENTOLIN inhaler QID and fluven 2 puffs BID. The patient had no prior history of asthma or allergies, though he was scheduled to have a sleep study in April to assess possible breathing difficulties during sleep. His symptoms have since resolved.
Left arm with red welt 2 1/2 by 1 inch wraps around arm, not hot to the touch. Spoke with after hours triage @1958p. Went to U.C. (Sun Health Surprise). Diagnoses with cellulitis put on Zmax.
He is having an issue with the taste, when it comes to food; Weird headache; Body Aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 18-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,formulation: Solution for injection, Batch number/Lot Number: EWO150),via an unspecified route of administration ,administered in arm right on 05Apr2021 14:10 (at the age of 18-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,formulation: Solution for injection, Batch number/Lot Number: EW0169), via an unspecified route of administration,administered in arm right on 26Apr2021 14:05 ((at the age of 18-years-old) for covid-19 immunization .Medical history included allergy,attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. Concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder ,Once a day,start and stop date were not reported; Cetirizine taken for hypersensitivity Once a day ,10mg ,start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 the patient experienced he is having an issue with the taste, when it comes to food on, weird headache, body aches. The reporter did not even know, what even make him to eat. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Rash all over body after HPV, MCV injection within 24hrs. Seen in ED unclear if hives were secondary to IZ.
The patient presented with swelling and redness on upper arm approx 2 inches from injection site 1 day post-injection.  Her upper arm was hot and painful to touch, and she report she was ill the night of the injection with a temperature, aches, runny nose, and sore throat.
every time eats lettuce, shows blood in stool; Pneumonia; reoccurring urinary tract infections; sick with allergies; bronchitis; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4318495-00 (Agency).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159438) at unk (citrate free), subcutaneous for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "sore arm"; HAEMATOCHEZIA (medically significant), outcome "recovered", described as "every time eats lettuce, shows blood in stool"; PNEUMONIA (medically significant), outcome "recovering"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "reoccurring urinary tract infections"; HYPERSENSITIVITY (non-serious), outcome "recovered with sequelae", described as "sick with allergies"; BRONCHITIS (non-serious), outcome "recovering". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of haematochezia, pneumonia, pain in extremity, urinary tract infection, hypersensitivity, bronchitis.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, sore arm, reoccurring urinary tract infections and sick with allergies with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of pneumonia and bronchitis was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, reoccurring urinary tract infections and sick with allergies, pneumonia and bronchitis was not provided. The reporter causality for the event "sore arm" was possible for Pfizer BioNTech COVID-19 vaccine (Tozinameran).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Blood in stool", "Pneumonia", "Pain in arm", "Recurrent urinary tract infection", "Allergy", "Bronchitis" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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 and Investigators, as appropriate.
This is not an adverse event, it is an administration error. Patient was asking  for administration of Vaccine #4 and wanted Pfizer BiValent and patient received Pfizer MonoValent.
Right thigh was red, warm after injection of DTAP; area noted to be red and warm beginning on 08/26/2003.  Treatment was Zyrtec 5 mg by mouth day.
Woke with sore throat and thirsty, ate yogurt for breakfast and had emesis immediately. Seemed to be OK after that and tolerated lunch. After lunch, developed hives on face and neck. Took Benadryl at 13:25 PM.
Pt recvd MMR on 29JUN90; On 02JUL90 devel rash on face & upper chest, fever of 104, redness of eyes, generalized weakness, anorexia & joint pain; 03JUL90 taken to ER; 3 wks post vax devel bilateral enlargement of salivary glands;
Site: Pain at Injection Site-Severe, Systemic: Diarrhea-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium
Pt recvd 3 doses of Hep B vax 03AUG90, 04SEP90, & 05FEB91 & pt did not seroconvert following the 3 doses of vax; In MAR91 pt exp h/a, dizziness, low back pain, sleep disturbance & malaise; @ the time of report, sx persisted;
On 02/28/2022 within a 48 hour period I suffered about 95 percent hearing loss in my right ear. I have seen two doctors to date, and they se no infection and have no explanation. Hearing loss is now going on six weeks.
Back pain, Shortness of breath, hospitalization, cardiac cath r/o MI which was negative, CTA chest initially indeterminate for PE then repeat was negative after being on hepairn infusion. LE edema showed popliteal vein slowing consistent with precursor of DVT. Patient placed on xarelto and discharged for outpatient cardiac MRI r/o mycocarditis. Total hospital time 3 days. Patient was tachycardic and hypoxic with back pain, despite negative imaging suspicion for VTE/DVT/PE was very high. Now suspicion elevated for myocarditis
pt rt arm hurt & was painful immed p/vax;pain in rt shoulder, neck & rt arm;pt states felt like a pinched nerve;broke out w/mac pap rash;c/o coldness axilla to fingers of rt arm was cold to touch, color change blanching, sl numbness;
Pt recvd vax JUL92 7 2 to 3 wks later exp coughing, congestion, low grade fever, lightheadedness & joint pains; No further details were provided;