chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist states that one of their patient received an expired dose of MENACTRA the other day with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where pharmacist states that one of their patient received an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] the other day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot U7492AA and expiration date- 26-Oct-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
10/29 site is beginning to hurt.  Took  anti-inflammatory  10/30 site swollen stiff, stomach ache, nauseous, extremely tired, spent day in bed.  Took anti inflammatory, rubbed Vick?s to see if swelling would go down  10/31 site swollen, black and blue, hurts to move arm, site feels hot and hard compared to rest of arm, puts Vick and took anti inflammatory
slight headache; minor cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 25Apr2021 (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 (Dose 1, Single), administration date: 28Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight headache"; CHILLS (non-serious), outcome "unknown", described as "minor cold chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This report is only to notify that patient received first Covid-19 vaccine on 11/20/2021  dose 0.2 ml at age 11 year 11.5 months. When he received 2nd dose of  0.2 ml 3 weeks later, the patient had turned 12 years old, he was administered 0.2 ml not 0.5 as recommended for 12 years of age (Patient reports headache and fatigue from the reduced dose of 0.2 ml and has fully recovered)
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
No adverse events occurred, the previous vaccine was Pfizer, when it was discovered that the patient was given a different mRNA vaccine for the 2nd dose the patient was notified. The patient was observed for 15 minutes after the vaccine administration per CDC guidelines and was instructed to return to care if developed any symptoms at home. In the future we will require proof of brand of first dose or look up the vaccine administered on immunet to ensure the same brand is giving for second dose if possible.
pt recv vax 16MAY95 & on that evening 5-6hrs post vax pt devel profuse sweating,low grade fever & was very tired;p/24hrs pt recovered;
Fungal infection on her tongue and throat; Immune system was down; Chills "every so often"; Changes in her sensitivity level to cold; Really bad tinnitus in her right ear; A worsening on her asthma; Tiredness / fatigue; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Really bad tinnitus in her right ear), ASTHMA (A worsening on her asthma), FUNGAL INFECTION (Fungal infection on her tongue and throat), TEMPERATURE INTOLERANCE (Changes in her sensitivity level to cold) and IMMUNE SYSTEM DISORDER (Immune system was down) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FATIGUE (Tiredness / fatigue) and HEADACHE (Headaches). On 24-Feb-2021, the patient experienced TINNITUS (Really bad tinnitus in her right ear), ASTHMA (A worsening on her asthma), TEMPERATURE INTOLERANCE (Changes in her sensitivity level to cold) and CHILLS (Chills "every so often"). In March 2021, the patient experienced FUNGAL INFECTION (Fungal infection on her tongue and throat) and IMMUNE SYSTEM DISORDER (Immune system was down). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) at a dose of Immediate inhalers and NYSTATIN for Fungal infection, at an unspecified dose and frequency. On 06-Apr-2021, TINNITUS (Really bad tinnitus in her right ear) had resolved. At the time of the report, ASTHMA (A worsening on her asthma), FUNGAL INFECTION (Fungal infection on her tongue and throat), TEMPERATURE INTOLERANCE (Changes in her sensitivity level to cold), IMMUNE SYSTEM DISORDER (Immune system was down), CHILLS (Chills "every so often"), FATIGUE (Tiredness / fatigue) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97-98.1 (normal) 97-98.1°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Healthcare professional has advised not to take second dose of vaccine.
Patient received a yellow fever vaccine intramuscular instead of subcutaneous with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional.  This case involves patient with unknown demography who received YELLOW FEVER VACCINE - US [YF-VAX] intramuscular instead of subcutaneous (incorrect route of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot UJ386AA and expiry date was not reported) via intramuscular route at an unknown administration site instead of subcutaneous route for prophylactic vaccination (incorrect route of product administration).  It was reported "Caller asked what, if anything, needed to be done".  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).  At the time of reporting, the patient experienced no adverse 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.
Alopecia areata developed after the vaccine. Patient with no history of alopecia areata before this.
Case number PHEH2012US016496 is an initial spontaneous report received from a medical assistant on 20 Aug 2012 with a follow up information received on 04 Sep 2012: This case refers to 20-year-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) intramuscularly on to deltoid muscle of left arm on 13 Aug 2012. On same day she experienced symptoms of swelling, tenderness, redness greater than 5 cm and warmth at vaccination site. The final outcome of the events, swelling, redness and tenderness was reported as complete recovery with a stop date of 15 Aug 2012 and that of warmth was not reported. No further information about the seriousness and causality of the event was reported. Follow up information received on 04 Sep 2012: Patient demographics (height and weight), batch number, vaccination site, event (tenderness), event stop date and outcome of swelling, redness and tenderness were updated.
Rash on legs developed about 2 weeks after the first COVID-19 vaccination, Early treatment with Calamine lotion for itching. Rash begin spreading and made an office visit. Current course of treatment starting 2/26/2021:  Methylprednisolone, Triamcinolone Acetonide Cream, Zyrtec, Pepcid. Will recheck with the doctor after treatment. If  the rash has not improved or is clearing up a biopsy may be necessary.
A large red patch on (L) arm that is raised and warm and painful to the touch. Was seen by Dr and no treatment was needed.
Information has been received from a medical assistant concerning a 38 year old female with edema who on 07-DEC-2006 "between 9 a.m. and 5 p.m." was vaccinated IM, into the right deltoid, with a 0.5 ml first dose of GARDASIL vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 08-Dec-2006 the patient "gained 13 pounds of water weight". Medical attention was sought and the patient was treated with unspecified diuretics. On approximately 29-Dec-2006, the patient recovered from "gained 13 pounds of water weight".  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. On 29-DEC-2006, the patient recovered from weight gain and edema. Additional information is not expected.
This spontaneous report was received from a certified medical assistant, on 14-JUL-2015, concerning to unspecified patients of unknown ages. Since 06-APR-2015, unspecified patients were vaccinated with VAQTA (dose, route, frequency and lot unknown), which had been exposed to temperatures outside of the recommended range. This is one of several reports received from the same source (1507USA006969 - 1507USA007092). Additional information has been requested.
Chills (inability to get warm) began at 9am for approx 3 hours.  Increased room temp and more blankets.  Finally warmed up enough to fall asleep for 2-3 hours.  Awakened at 3pm flushed and hot.  Began tracking temperature started at 100 increased to 101.8.  Forced water by mouth during the episode.  Took a shower when temperature reached 101.8 and took OTC Tylenol extra strength.  Slowly returned to normal.
12:05 PM - began with severe headache.  Did not abate until 2:45 on 3/21/21.  Ibuprofen taken to counteract.  3:30 PM mild dizziness.  Passed within an hour  4:55 PM Fatigue.  Felt extremely tired.  Condition persisted and continues to do so as of time of this reporting.  8:15 PM Chills.  Passed by 4 AM on 3/21/21
Received vaccine on 4/16. Face numb and lips numb after 30 minutes to an hour-resolved. Later that night she had menstrual spotting (atypical for her).  1 week later 4/23/2021 left shoulder sore, large raised rash, left hand swollen, left arm numb. Left armpit felt like there were swollen lymph nodes.  STarted getting bumps in her mouth and on her labia (she has not shaven)   Ibuiprofen and Claritin to relieve symptoms (which got a bit better).  Rash started on left arm and felt a tightening of throat later.  Resolved.  Still complains of left arm tingling (4/28)
Woke up in the middle of the night of 12/21 with legs itching. Got up and couldn't walk. Ankle joints very painful. Spread to knees and finger joints, wrists, elbows, shoulders and neck. Fingers very swollen. Had a terrible migraine 5 days before. Missed 2 days of work - sore. Dr (my MS Dr) he gave me a prescription for pain. (Hydrocodone 5/500) 1 Q 4-6 hr prn. Went to work day 3 - still have sore hands & neck & shoulders but can walk.
Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia).  The patient's medical history was not provided. No concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time.  Further information regarding patient's medical history and comorbidities has been requested.
Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Due to travel and a notification of exposure, PCR COVID 19 test on 6/30 results negative. 7/2/2022 sore throat and headache that night. 7/3 developed a cough and serious head congestion with fatigue. Tested with at home COVID 19 test, positive 7/4. Tele visit with doctor on 7/6, I was feeling much better, and declined PAXLOVID. About 7/9 I felt fully recovered, but on 7/10 I tested positive on an at home COVID 19 test.
Approximately 2 hours after injection I started experiencing a sharp tingling in my chest / heart area. The tingling went down both arms to my fingertips. It came and went all night long.  I saw my medical provider who advised me against receiving the 2nd covid-19 vaccine due to the adverse reactions I was experiencing.  These side affects persisted over the next 6 weeks wearing off over time.
Severe dandruff after Moderna vaccine. My whole scalp dries up and sheds off like a snake skin. My scalp no longer produces oils. Symptoms started after first vaccine and got worse after second shot.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of varicella vaccine. Subsequently the patient developed a brain tumor. There was no product quality complaint involved. No further information was available. Additional information is not expected. Upon internal review the patient's brain tumor was determined to be an other important medical event. The patient's sibling (WAES0703USA01528) had the same experience after vaccination with varicella vaccine.
Patient vaccinated on 5/19/2021 with the J&J vaccine. Patient came into hospital on 6/3 as stroke alert. Patient given alteplase and was positive for an acute cortical and subcortical infarct lateral right frontal lobe. Patient with no prior history to coming into the hospital.
Fever 105, chills, vomiting, diarrhea x 24-48hr then resolved
Stomach cramping; A spontaneous report was received from the nurse on 05DEC2022. It described a patient (age and gender unknown) who had "stomach cramping" (PT: Abdominal pain upper) following the administration of Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that on an unknown date, the patient received Vivotif and experienced stomach cramping as a side effect after taking three doses of Vivotif capsules. Reportedly, the last dose of Vivotif has not been administered yet to the patient. The outcome of the reported event was unknown, at the time of this report.  Action taken with Vivotif was unknown with respect to the reported event.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Company comment: It was reported that a patient had stomach cramping (abdominal pain upper) following the administration of Vivotif for immunisation. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: t was reported that a patient had stomach cramping (abdominal pain upper) following the administration of Vivotif for immunisation. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The case is considered non serious as per medical assessment
it started with a red raised painful and itchy rash apx 5 in diameter with swollen toes, fingers and lips. we were in ER and given Benadryl and itchiness and swelling gone but that area remained. over the next few days it turned a dark blue/purple still itchy and spread further down from the calf to the ankle on the back of the left leg.  now it covers apx 5 in by 10 in and is dark purple lacy and itchy. the cbc was done yesterday and is normal.
Pt had left arm pain.  Varicella SQ site was hot to touch w/ red, hot knot approx. 2-3" in diameter.  Redness of arm from elbow up to 2" above site.  Had shakes, no fever and did not feel cold, stomach pain - nausea, vomiting.  No diarrhea.  As of 10/27/09, pt feeling better, able to eat and drink.  Still has red arm and knot at varicella vaccine site.
The vaccines that were administered to the patient were the correct vaccines the error was that VFC vaccines given to a patient with commercial insurance.
MULTIPLE ATYPICAL FEBRILE SEIZURES. AMBULANCE CALL, ER VISIT AT HOSPITAL, TRANSFER TO ANOTHER HOSPITAL. 2 NIGHTS IN THE ICU, 1 NIGHT PEDIATRIC FLOOR STAY. ANOTHER FEBRILE SEIZURE OCCURRED 11/23/2010. ER VISIT.
Patient 12/21/04 reports bi-lateral inflammatory rash, swollen nodules on right arm, site of pneumococcal injection. Taking Benadryl. patient recovering at home.
When I woke the next morning I had a moderate headache, sore muscles all over which intensified throughout the day, intense pain in the spine between shoulder blades and when I tried to walk, my limbs would not do as I wanted.  They moved in wide circles- arms and legs.  This lasted through the day and next day it was sliightly better.  Balance was poor.  Had to hold onto things to walk.  Also I had fatigue.
Large hard, red lump that is warm to the touch appeared at the site of the injection. Bump is about the size of a golf ball.  Symptoms began appearing a little over 24 hours after receiving the vaccine.
Noticed today that left arm is a bit swollen . Has a pinkish color and slightly warmer than corresponding area on right arm.  Slight soreness when area pressed.
almost had anaphylaxis; my arm was swollen down to my elbow; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylaxis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant) and swelling arm. On an unknown date, the outcome of the anaphylaxis and swelling arm were unknown.   It was unknown if the reporter considered the anaphylaxis and swelling arm to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shingles shots a couple months apart. After the first one patient almost had anaphylaxis and his or her arm was swollen down to elbow and the swelling almost went to neck. Even though the patient had this adverse reaction he or she was still wanting to take the shot because he or she did not want to get shingles. The patient heard how horrible it was so. For tolerance of 2nd dose refer case US2021AMR187628. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187628:same patient, same reporter
Patient is fully vaccinated. COVID + 11/25/2021.  Hospitalized 11/25-11/30, 2021. 81 year old male patient, known to our service, presented with generalized weakness, SOB, and dry cough. He was recently admitted and discharged for flank abscess with IR drainage. Patient was supposed to continue with oral levaquin 500 mg and flagyl 500 BID for 10 days. Pt states he had an appointment for his nephroureteral drain to be checked with IR today. Denies any CP,  N/V/D at the time of evaluation.  Admitting dx:  UTI, weakness, chronic kidney disease, infection due to urinary stents, COVID.  Pneumonia due to COVID, acute hyposic respiratory failure, CXR with left lower lobe infiltrate. L side flank abscess treated with stent exchange and drain/aspiration of pus, antibiotics. AKI: started on Patiromer or Lokelma. Hyperkalemia, HCTZ 12.5 mg daily for 2 weeks. Patient discharged.
Rash/hives on chest and throat. Remedied with benadryl 50mg PO
9/12/03 presented to office with nontender ecchymosis of shoulders, lower extremities. No adenopathy. Reports swelling of shoulder where shot given for 2 1/2 days after shots.
falls; This is a spontaneous report from a contactable consumer. The consumer reported similar event for two patients, this is the first of two reports. A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in a nursing home due to falls after receiving the vaccine. The outcome of 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- same reporter/drug/event, different patient