chrisvoncsefalvay/vaers-outcomes huggingface dataset:
19 month patient who received pentacel vaccine which was frozen/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133715, 2020SA133786 and 2020SA133787 (same reporter)  This case involves a 19-month-old patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]] which was frozen (incorrect product storage).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as 19 month patient received Pentacel vaccine which was frozen.  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.  There will be no information available on the batch number for this case.
Tested positive on 05Jun; Tested positive on 05Jun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN [ROSUVASTATIN CALCIUM], start date: 15Dec2020; AMLODIPIN BESYLATE AND BENAZEPRIL HYDROCHLORI, start date: 21Dec2021. Past drug history included: Morphine, reaction(s): "Known allergies: morphine", notes: Known allergies: morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on 05Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: Tested negative on 30May; (05Jun2022) Positive, notes: Tested positive on 05June. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was reported that a 36 year old male received a YF vax and a TD adult vaccination on 3-JUN-2000. Reportedly on 5-JUN-2000, the patient developed a fine rash without urticaria on his arms, legs and trunks only, no facial involvement . The patient was evaluated and treated with Benadryl. The rash resolved and the patient recovered.
Employee reportedly developed rash and itchiness on the injection site. Simultaneously noted that she has broken out blister-like lesion on her right lower back. She saw her PCP and was diagnose with Shingles. She was prescribed with Acyclovir and up unt Narrative:
44-year-old for to me from outpatient, beginning of January was tested positive for COVID. From the beginning clinical presentation was only mild. No hypoxia. The patient will is complaining include dry cough. Chest x-ray reveal bilateral patchy infiltrates. Patient still was not hypoxic at that time. Start on Decadron. From the beginning feels better until last night when she noted severe cough. She present for evaluation to emergency room. Antigen test-negative. Chest x-ray reveal bilateral infiltrate. Lowest pulse oximeter was 92.
Not breath well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4765087.  A 76-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Left Shoulder Pain" (unspecified if ongoing), notes: Left Shoulder Pain; "Interstitial pulmonary disease, unspecified" (ongoing), notes: Interstitial pulmonary disease, unspecified; "Hypothyroidism" (ongoing); "High Cholesterol" (ongoing); "Gastroesophageal Reflux" (ongoing); "Anxiety" (ongoing); "Fluid in lungs" (ongoing), notes: Fluid in lungs; "Enlarged prostate" (ongoing); "Low Potassium levels with Lasix use" (ongoing), notes: Patient's concurrent condition included: Low Potassium levels with Lasix Use. Concomitant medication(s) included: SYNTHROID; SIMVASTATIN; SYMBICORT; LASIX [FUROSEMIDE]; POTASSIUM CHLORIDE; PREDNISONE; LEXAPRO; TRAMADOL; PROAIR [SALBUTAMOL SULFATE]; TAMSULOSIN; ALBUTEROL [SALBUTAMOL]; OMEPRAZOLE. Past drug history included: Lasix, reaction(s): "Low Potassium levels with Lasix Use", notes: Patient's concurrent condition included: Low Potassium levels with Lasix Use. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Not breath well".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received Moderna vaccine and is 16 years and 11 months old.   Moderna approved for 18 years and up at time of  administration.   No adverse symptoms.
Non itchy Rash on torso, upper legs and upper arms; Difficulty breathing; Fever; Ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 71-years-old patient of an unspecified gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was nor reported, patient was 71-year at the time of vaccination), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 11:00 AM as single dose for covid-19 immunisation. Medical history included lupus, asthma, Knonw allergies: Yes. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL); allopurinol (ELAVIL); colecalciferol (VIT D3); chondroitin sulfate, glucosamine (GLUCOSAMIN & CHONDROITIN) all are taken for an unspecified indication, within two weeks of vaccination. No other vaccine received in four weeks. No covid reported prior vaccination and patient was not tested for covid post vaccination. On an unspecified date in May2021 at 12:00 AM, the patient experienced non itchy rash on torso, upper legs and upper arms, difficulty breathing, fever, ringing in ears. No seriousness criteria were reported for events. No treatments were received for events. The outcomes of events (non itchy rash on torso, upper legs and upper arms, difficulty breathing, fever) were recovered on an unspecified date in 2021 and the outcome of event (ringing in ears) was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist reported that the patient had severe adverse events after a dose of SHINGRIX, no knowledge of anaphylaxis. The event did not last as long or was not more severe as compared to other patient (refer case US2018154153). The health care professional was not sure if this case was reported previously. The basis of her call was to determine if 2nd dose could be given if severe adverse event were experienced after 1st dose. The pharmacist was asked, if there was anything to report but he was unable to provide much information. No patient or vaccine information was available.
Patient received the vaccine and walked out the pharmacy, within a couple minutes he felt dizzy and fell to the ground. His head was caught by the dad with him and he was responsive when asked questions. Pharmacist checked his blood pressure (138/84) and heart rate was 81. Called 911 and they arrive in a few minutes. They exam him and checked his sugar (84). He looked fine and was taken to the ambulance for further exam/care.
Pt received vaccine on 5/24/16 approx. around 5 pm. Mom called clinic on 5/26/16 around 3:45pm Stated that pts left deltoid was red, hot and swollen. Mom did not give any Tylenol or ibuprofen, no treatment given. Child was to be brought into clinic to have ppd read, so at this time we were able to see the childs left deltoid. And it was in fact red, warm to touch, and was swollen.  Offered an apt at urgent care for 5/26/16 but parents declined. They were to give pt Tylenol or ibuprofen and apply warm compresses to the left deltoid throughout the evening and was advised to call in the am so we could discuss if child needed to be seen that day (5/27/16). I called child's mom, she stated that the child's left arm was better. She followed instructions and she doesn't feel child needs to be seen at this time. Redness and swelling dereased.  Mom states she will call if condition changes for this child.
I experienced a lot of coughing that lasted a couple days so I went and got tested on Tuesday and found out that I was positive for COVID. I quarantined for 10 days and was placed on a z pack and other prescriptions to treat the symptoms. By the end of the 10 days, the symptoms had dissolved.
The caller stated he is not experiencing any symptomatic side effects. No additional AE details; he was exposed to a reconstituted MMR-II which was inadvertently squirted in his eye; he was exposed to a reconstituted MMR-II which was inadvertently squirted in his eye; This spontaneous report was received from a pharmacist referring to himself, a male patient of unknown age. Information regarding his medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-AUG-2022, the patient reported he was exposed to a reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, with lot #W001519, which upon internal validation was considered a valid lot# with expiration date reported as 13-JAN-2024, administered for prophylaxis, and to sterile diluent solution for injection/infusion, with lot #U034538, which upon internal validation was established as a valid lot#, with expiration date reported as 14-MAY-2024, which was inadvertently squirted in his eye. The reporter stated he was not experiencing any symptomatic side effects.
Fever, CoughWheeze, fever, chills, congested, runny nose, cough; by wednesday he had weakness and difficulty with ROM in left arm; progressively worse by monday 1/25 Narrative:
LOTS OF PAIN IN BACK KNEE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included slight back knee pain. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lots of pain in back knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lots of pain in back knee was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: COVID 19 Treatment; (Apr2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received the treatment of COVID-19 as Paxlovid on 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) , covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168488 same reporter/patient, different product/event;
3 days after vaccination, site of injection became red with a blistery rash, felt hot to the touch and achey.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/26/2021-8/31/2021. Death 8/31/2021. Vital Records data not available yet.
On 10/29/00 onset of nausea and dizziness while in shower, felt unsteady and off balance with whoring vertigo, bilateral tinnitus broke out in a cold sweat and vomited. On 10/30/00, had severe dizziness and was unable to walk without losing balance, veering off to sides. Seen by MD where I work and was given Vistaril IM for nausea and vomiting and scopolamine patches. On 11/2/00, seen in ER as there is no improvement and now also have blurry vision, no appetite with nausea and vomiting, severe tinnitus bilaterally and decreased hearing with bilateral ear fullness. Given IV Phenergan and Antivert. Dx'd with viral labyrinthitis that could take 3 weeks to go away. On 11/10/00, saw ENT because was getting worse; feeling weak and shaky. Rx'd with Valtrex and Valium. Had 3 subsequent flu visits with ENT and Rx'd prednisone, 2 more 7 days courses of Valtrex and Dyazide to decrease fluid in inner ear. Repeat Audiogram on 12/6/00 showed improvement. Unable to drive or work for almost 4 weeks due to severe vertigo and unsteady gait. On 12/29/00, developed swelling of right jaw and neck that is tender to touch and moves when swallowing but no sore throat. I have upper back pain (feel like my head is too heavy for my neck to support. Left arm and leg weakness. On 12/19/00, pt (functions continue to deteriorate). Fatigue and tires easily from 11/01/00 to present 1/8/01. Treatment: Vitamins, Tylenol, physical therapy, rest and flu shots.
pain at injection site on 2/2/21; on 2/3/21 felt tired and had a severe headache; then on 2/4/21 found a lump under the left arm and it is still there today, 2/9/21
Heel Pain; Feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible). On 26-Mar-2021, PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible) had resolved. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient said she is feeling fine and her events were resolved the next day after they have started.
Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference.; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference.; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference; This is a spontaneous report from a contactable consumer (patient reported for self). A 41-years-old (non-pregnant) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 20Feb2021 09:15 (at the age of 41-years-old) (Batch/Lot Number: EL9267) as dose 2, single for COVID-19 immunisation. Medical history included diabetic, high blood pressure,  pcos (polycystic ovarian syndrome), anemia and known allergies to latex, iodine, peanuts, bees, all from an unknown date and unknown if ongoing. Concomitant medication included insulin glargine (TOUJEO), atorvastatin, lisinopril, paracetamol (TYLENOL), iron and ibuprofen (ADVIL [IBUPROFEN]), all drugs were taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EL9265) administered in Left arm on 30Jan2021 14:30 (at the age of 41-years-old) for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The patient experienced swollen, raised, itchy rash/bump at injection site. approximately 3 inches in circumference on 21Feb2021. The patient had not been tested since the vaccination. Patient did not receive any treatment for the events. Outcome of all events were not recovered.  Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable nurse communicated to a sales representative. A 3-year-old female patient received "a supplemental dose" of PREVNAR13, intramuscular, on 18NOV2010. Relevant medical history, concomitant and past product history were not reported. On 18NOV2010, following administration of the vaccination, the patient developed high-pitched, prolonged crying. At the time of this report, the outcome of the event was unknown. Follow-up (29AUG2011): Follow-up attempts completed. No further information expected.
1st shot - perfect - no side effects 2nd shot: Severe shivering, feeling cold - even though the house was 80 degrees, diminished mobility  Treatment: pain reliever, bed rest & sleep, 4 covers & sweat pants/shirt Lasted approx. 10 hours.
2:00pm - headache and body aces started 5:30pm- headache, body aches, low grade fever and chills 5:45pm- was driving with my children and felt a wave of heat, followed by extreme nausea, was able to pull over my vehicle and then fainted. After passing out, I started to seize. Rapid breathing, lost feeling of my arms and legs. Ambulance was called. I was transported to the hospital.
Had two stools with blood in them the day of vaccination and the following day (one stool with blood each day).  Had extra loose stools for 2-3 weeks afterward and seemed to have and upset stomach and was often unhappy for 2-3 weeks following the vaccines.  All seemed to be related to stooling and stomach concerns.
sore arm; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at singled dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown. The patient took ibuprofen after the first dose. She took 800mg of ibuprofen right before the second dose since her arm was sore.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Headache; Nausea; Fatigue; Vomiting; Stomach Pains; Chills; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to ampicillin (MANUFACTURER UNKNOWN) and Augmentin antibiotics. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 04:00 the patient experienced headache, nausea, fatigue, vomiting, stomach pains and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events headache, nausea, fatigue, vomiting, stomach pains and chills were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient broke out in hives for 3 weeks an hour and half after receiving dose 1. Patient also stated she had SOB 1.5 after dose 1. Patient presented to site for dose 2 on 4/30/2021 and was disqualified based on reactions after dose #1. Patient only took Benadryl s\p vaccination. No other medical intervention reported.
The first day fatigue, soreness, nausea. Left arm was very sore. 3 days afterward my arm was burning, red rash, sore and very inflamed at the site of injection. It was very uncomfortable and took over the entire left upper arm. Paid on the bottom side of my upper arm. Slight pain in left chest.
Sudden onset of hemi-body (left side) choreoform movement. No family history. This occurred one day after vaccination with Pneumovax.  Diagnosis made by Neurologist.
A have raised itself on 1/8/2021 at the injection site (left arm deltoid). The hive started at 2 inches diameter and is now about 3 inches diameter. Give us slightly sensitive to touch. On the left collarbone is also an inflamed lymph node.
Swelling were injection site, pain/soreness, tendernes headache and fatigue; itching and red rash Rx: cold compress and tylenol. Has lasted for 9 day currently.
Patient passed out and had two seizure like episodes about 1 minute and 3 minutes after immunizations.