chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADACEL was administered today that expired 04-mar-2023 with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 43 years old female patient to whom Diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] was administered today that expired 04-mar-2023 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 milligram (mg) total (lot U6969AB and expiry date-04-Mar-2023) via intramuscular route in the right arm for immunization today that expired 04-mar-2023 with no reported adverse event (expired product administered) (latency-same day).  Action taken was 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 guidelines. 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.
Information has been received from a physician concerning a 34 year old female who in the 1970's was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the pt developed a fine red rash that did resolve completely in time. It was also reported that recent titers did not show seroconversion. Unspecified medical attention was sought. No product quality complaint involved. Follow up information from the physician's office noted that they were unsure of the reaction. They noted that the pt thought she may have had a reaction to a vaccine approx 30 yrs ago. No other details provided. No further information is available.
This information has been received from a registered nurse concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX with lot number M011665 and expiration date on 17-MAY-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent. The reporter stated that the diluent (lot number and expiration date were unknown) was stored properly. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 6 hours and 35 minutes. There was previous temperature excursion between -14 Centigrade degrees and -10 Centigrade degrees for 35 minutes and another excursion between -9 and 8 Centigrade degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008590:
Medical Assistant administered .03 ml  pfizer covid vaccine to an 11 year old child. The dose should have been .02 ml.
Minor compression impact resulted in severe right quad contusion, inflammation, and hematoma (04/18/21) that took almost 5 months to resolve after which I began to notice heart palpitations, rapid/strong heart beat, and a distended jugular vein.  I don't know when the distended vein became visible, but it was not present in photos before 2020.    I went into the Hospital ER 1 week after leg injury because of pain, then to Dr. at local Medical Center the following week. Recently (10/28/2021) I returned to Dr. with the cardiovascular concerns.
pt rcvd vax; pt devel febrile seizure; 4 - 6 hrs after shot w/ ear rolling hands jerked back; pt has cont w/sz;
Since then I've had COVID twice; Since then I've had COVID twice; Since then I've had COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Since then I've had COVID twice".  Clinical course: Patient information age 64 (unit not reported). Patient was curious about the booster portion. Patient have only had one booster. Since then patient had COVID twice. patient was curious if it would say something about the timeframe to get next booster after having COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/10 PM ARM HURT, 11/11 ITCHY RASH AT INJECTION SITE WITH DIZZINESS THAT AM ONLY.
pt states in wk following vax exp inc pain in lt arm & shoulder; self prescribed 800mg Motrin; pain not resolving to satisfaction & pt will f/u w/MD 17JUL;
Patient reports swelling, redness and tingling in arm.  She reports this happened with the first moderna injection, also happened, but more extreme, the second time
Patient presented today, 11/14/20, with a medium sized raised area with erythema and patient stated it was "hot to the touch." She did not confirm she had a fever but took an ibuprofen at bedtime to help with it. She said it began Wednesday evening, the day she got the vaccination, and her symptoms are still continuing 3 days out.
Extreme Nausea, Headaches, Chills, Arm Soreness, Tingly fingers.
My knee was swollen, body ache and fatigue for 3 day couldn't go to work. Since I heard the vaccination was stopped on 4/12 I was concerned. I went to doctor was advised to take Tylenol.
Patient received a full third dose of 0.5ml instead of the booster dose of 0.25ml. No adverse event reported.
Left arm sore  following initial  injection on  01/01/21 ,  took Tylenol and discomfort passed by  next day.  Nine (9) days later a  red rash appeared, with itching and  soreness.  Rash  and soreness slowly diminishing  6 days later.  Is it normal to have a delayed reaction?
The flu shot was given too high on my right arm. Almost on top of shoulder. I had burning pain in the area of injection that continued to move down my arm. Burning sensations, throbbing pain, arm weakness, and numbing of my hand. I had no issue before my shot. I went to my employee health person to ask if this could happen with the shot and she said usually it red and swollen, I went into the Dr. when my hands went numb. But he didn't believe me and said it was cervial radiculopathy.  I had no neck issue or pain. I told him it was beyond weird that this happen right when I got the flu shot on top on my shoulder. I see a spine dr on 11/24
this is a report of a vaccine-administration error with no known adverse event to date;  vaccinated individual is a health care worker (physician assistant) who works at two different systems and mistakenly believed he needed to receive vaccine series at each system, thus he received 2 separate series of COVID-19 mrna  vaccine, a total of 4 injections: COVID-19 (Pfizer) 1     12/21/2020   Pfizer lot # EK5730   COVID-19 (Pfizer) 2 12/22/2020 Pharmacy Pfizer  lot # EL0140   COVID-19 (Pfizer) 3 01/08/2021 Pfizer lot # EL0142   COVID-19 (Pfizer) 4 01/12/2021 Pfizer lot # EK9231
This spontaneous report was received from a pharmacist concerning a 68 year old patient. On 23-APR-2015 the patient was vaccinated with VARIVAX (Merck) dose 1, .5 ml. No co suspect were reported. No relevant medical history were reported. On 23-APR-2015, 1 day after onset of therapy the patient experienced wrong drug administered. No concomitant medication or treatment were reported. The outcome of wrong drug administered is unknown. Action taken with the suspect drug is unknown. The reporter considered wrong drug administered to be not related to VARIVAX (Merck). Additional information is not expected.
fatigue, nausea, headache, fever 100.9, all over muscle achiness, shakiness, stomach pain, pain and heat at site of shot. They started when I woke up at 6 a.m. the day after but at this time I don't know how long they will last because it's only been one day.
headache; cough; sinus drainage; This is a spontaneous report from a contactable other Health care professional via Pfizer sponsored program, reporting herself.  A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch no/Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. Medical history included exposure to covid positive (with Negative results). Concomitant medications were not reported. It was reported that she exposed to covid positive but not tested positive however on an unknown date patient was experienced with headache, cough, and sinus drainage and asked if it was ok to get the second dose of the vaccine on the 03Mar2021. On an unknown date, the patient underwent lab tests and procedures which included covid-19 results negative. The outcome the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very, Very Large Bruise in arem area of shot adminitration. Red line underneath. This bruise stayed for 2+ weeks. Now, I have constant pain, palapable hard lump, limited range of motion, clicking of joint, and stiffness.
depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "depression".  Additional Information: The report is cross referenced to report ID: RGCF0L8T. The reporter stated that her girlfriend's aunt experienced depression after getting a Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481511 same reporter/drug, similar AE, different patient;US-PFIZER INC-2021481483 same reporter/drug, similar AE, different patient
Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired
Within 5 min of receiving vax pt collapsed & had several jerky movements of head & arms, unresponsive for less than 1 min, then stood up, followed instructions, but was not verbal.  Lie down for 20 min p/ which color return. Incont of urine
PCP notes in progress notes upon the patient return on 1/12/2021 Hospital course  CT head/CTA neck/CT perfusion studies concern for possible right ICA and MCA thrombus, transferred to neuro ICU. TPA ( s/p alteplase).  CTA shows >90% R ICA stenosis. Vascular consulted.  Started on AC (heparin, plavix and loaded with brillanta). Pt underwent R TCAR (Transcarotid Artery Revascularization) on 1/11. No post-op complication. pt stable/neurologically intact.   Pt offers no acute concerns. pleasant, pain is controlled. No CP, sob, palpitation. neck incision CDI. HR and BP controlled. He is happy to back to the rehab.   CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF RIGHT CAROTID ARTERIES
Pt states when she awoke the next day after vaccine she had pain in the arm, pain with movement and a rash on her arm extending from the vaccine site distally.
pt. c/o of light palpitation shortly after taken the 1st dose of Pfizer vaccine which lasted for 4 mins and then resolved.  VS were stable.  pt. advised to follow up with PCP if symptoms re-occur again.  No sore throat, itching or hives noted.  BP 116/78, HR 107, R 20, o2 sat 98%
Her teeth started crumbling out after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and ALPRAZOLAM (XANAX) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose). At the time of the report, DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2021-273887 (Patient Link).
upper respiratory infection; I got sick; This is a spontaneous report from a contactable consumer (patient) reported from a Pfizer Sponsored Program. A 77-years-old female patient second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 as DOSE 2, SINGLE for covid-19 immunisation and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. The patient reported that on an unspecified date in 2021, I got sick with an upper respiratory infection, which lasted 10 days-2 weeks and that's why I got the labs done. Patient reported lab test done in Jul2021, and it showed no antibodies. My doctor can't say anything. My endocrinologist didn't say anything. I need clarification on what I need to do. Patient stated that there were others like me; they didn't had antibodies. I need someone to advise me to take it again or not. No one can tell me that. It's the vaccine itself that didn't take in my system. The patient underwent lab tests and procedures which included lab test with result no antibodies on Jul2021 (testing negative for antibodies/it showed no antibodies). The outcome of the events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
pt exp gen body aches p/vax 6 days later, devel a rash on abd which progressed w/in a few hr to gen welts;pt was seen by MD who administered IM Celestone or oral zyrtec;this is 1 of 2 pt from this facility to devel an allerg rxn p/vax;
Shortness of breath, positional chest pain, increased heart rate over 7 days.  First time in my life I have had such symptoms.
On Dec 3rd, 2021 I went to ER because I had bilateral weakness in all of my limbs. I was diagnosed with Guillain Barre syndrome. 6 weeks later after an EMG test, it was determined I had an AMAN type. I have nerve damage in both hands and legs and feet.
Was given a flu vaccination and approximate halve the dose dripped down patient right arm. Unsure if lose of dose was poor connection between needle and syringe. First pregnancy at week 37.5, EDD is 11/17/2021. Patient weight is 91.7 kg. Infectious disease was notified and was instructed to have patient return to receive full  dose of vaccine. This recommendation was verified through the CDC website.
pt recvd MMR & became weak & limp; pt was placed on a chair; eyes rolled back & pt was unresponsive to verbal stimuli; PHN used spirits of ammonia pt responded to this; then pt became faint again for another 30-60seconds; pulse 63 weak;
Information has been received from a physician concerning a 12 month old male with no allergies or medical history who on 07/18/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644790/0333N).  Concomitant vaccination on the same day included a dose of MMRII (Lot # 639918/0880M). There was no other concomitant medication. On 07/28/03 the pt developed a maculopapule rash primarily on the trunk and also on the neck, arms and face. Unspecified medical attention was sought. The pt was treated with Benadryl and Ibuprofen as needed. At the time of the report, the condition had not subsided. A product quality complaint was not involved.  Additional information has been requested.
Community acquired pneumonia, unspecified laterality; Acute cystitis with hematuria; COVID-19 virus infection; Acute hypoxemic respiratory failure due to COVID-19; Hypokalemia; Acute respiratory failure with hypoxia
Information has been received from a 20 year old female with no drug allergies and irregular pap smear who on an unspecified date were vaccinated with 3 doses of GARDASIL, respectively. Concomitant therapy included ORTHO TRI-CYCLEN. On approximately 04-MAY-2011 (reported as in the last week) the patient experienced genital warts. The patient was treated with podophyllin for the genital warts. There was no lab diagnostics performed. The current physician had not record of the patient receiving the GARDASIL shots. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician concerning the patient who on 23-NOV-2007, 30-JAN-2008, 04-JUN-2008 were vaccinated with the first, second and third dose of GARDASIL, respectively. On 09-MAY-2011, the patient developed the outbreak of genital herpes and genital warts. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Case number PHEH2013US024403 is an initial spontaneous report received from a nurse on 19 NOV 2013. This report refers to a patient of unknown age and gender. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12126), reconstituted with sterile water instead of MenCYW-135 liquid component  intramuscularly on 19 NOV 2013. No adverse reaction reported following this administration error.
After dose #2 I had to go to eye Dr for glasses. Eye changes were sudden and caused me not to be able to see with out glasses  After #3  I had to go back to eye Dr early for a change in prescriptions because my eye sight became so bad that I could no longer see with my present prescriptions.   After #3  I began to start itching within 5 days. I was still itching 7weeks later. Itching was all over body especially extremities. I itched so bad that I ended up having sores from scratching. After 7 weeks, I went to Dr and was given steroid shot and oral antibiotics.
The next day I was just out, minor fever, light headache, and it has been ongoing, I also have achiness.
PT stated that he had never received a vaccine before 7/28, but upon further investigation, a record for the same vaccine was found and administered one month before the 2nd dose. PT was notified of the error and claimed not to have received a dose before 7/28, but records show otherwise.
Hib (Pedvax) #1 given 2/10/06. Pt returned to clinic, swollen right anterior thigh. Dx. Infection to site. Local reaction due to vaccine. Rx with Augmentin for 10 days. Returned again 2/17/06. No improvement after 2 days of Augmentin. Admitted to Pediatrics for vaccine injection site reaction. Discharge Diagnosis: Hemophilia B, Blanching.
Case number PHEH2014US024278, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 06 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
DEVELOPED RED ITCHY SLIGHTLY WARM PATCH  5 CM WITH A FEW SATELLITE VESICLES 9 DAYS AFTER MODERNA VACCINE NUMBER 1 AT INJECTION SITE ON RIGHT UPPER ARM. IMPROVED COMFORT AND DECREASED ITCHING WITH ICE CETIRIZINE AND TOPICAL OTC HYDROCORTISONE CREAM. SIZE DECREASED BUT STILL PRESENT PER PATIENT REPORT ON  MARCH 1, 2021
HEADACHE; TIREDNESS; FEVER OF 102; MUSCLE ACHES; NAUSEA; FEELING SICK; LEGS HURT/SORE; THROWING UP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213 (B or D)218, and  expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced feeling sick. On DEC-2021, the patient experienced legs hurt/sore. On DEC-2021, the patient experienced throwing up. On DEC-2021, the patient experienced tiredness. On DEC-2021, the patient experienced fever of 102. On DEC-2021, the patient experienced muscle aches. On DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102. On 07-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of throwing up, tiredness, fever of 102, muscle aches, legs hurt/sore, feeling sick and nausea was not reported. This report was non-serious.
2 or 3 days after vaccination, injection site became red, warm and itchy.  Went away after 3 days.  No medication or treatment was needed.
I've been really sick since I had the COVID shot last year; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I've been really sick since I had the COVID shot last year".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received influenza vaccine in left deltoid and PNEUMOVAX in right deltoid on 9/23/13. On 9/25/13, patient noticed quarter-size welts on right arm and shoulder surrounding area of injection. Patient presented to pharmacy and pharmacist on duty suggested BENADRYL and follow-up with physician. Patient took BENADRYL and rash resolved by 9/29/13.