chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel was given to a 15 month old in error, was due Daptacel/no AE; Adacel was given to a 15 month old in error, was due Daptacel/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age) (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included Prevenar 13 and HIB   On 28-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5577AA, expiry date: 20 Feb 2021) via intramuscular route in the right vastus lateralis instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for prophylactic vaccination. Patient was supposed to receive 4th dose of Daptacel in series.   This is a case of actual medication error due to product administered to patient of inappropriate age and wrong product administered.  At the time of this 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.
shingle shots were more painful; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles by eye, it was very scary had to go to eye specialist 3 times, all good). Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2021AMR178265) and Covid-19 (received Covid shots on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got shingles shot and stated it was more painful than covid shots.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178265:Same reporter
Tingling sensation in my legs when lowering my head consistent with small fiber neuropathy reported as a possible Long Vax symptom by the journal. My physician has run all lab tests and found nothing out of the ordinary and has no explanation for this tingling.
10/29/20212 - around 11pm - most muscles,  all joints, headache; lymph nodes under left arm swelling...restless and hurting all night did not get any sleep.   Saturday 10/30/2021 a little nauseous about 8am,  in bed & slept  all day and all night long.   Sunday 10/31/2021  lymph nodes under left arm still swelled and hurts, but otherwise much better.  Monday 11/01/2021 lymph nodes under left arm still selled and hurting some.
Patient was waiting in her car, came back into clinic approximately 17 minutes after vaccination, complained of "lips-tingling".  She sat down and nurse started assessment. Complained of tongue feeling strange and had to focus on swallowing. 911 called. BP 132/88, Pulse: 89, O2sat: 95.  Feeling faint. single dose adult  Epinephrine administered at 9:37 am. BP: 130/67, pulse:102, O2sat: 98. 940- reports improving. Emergency squad arrived, transported patient to Hospital ER at 950 AM. Patient alert and oriented throughout visit.
Patient has never been vaccinated other than 2 COVID vaccines in March and April.  On day of receiving 4 vaccines above, developed redness and swelling at sites of Tdap and MMR. This persisted- now warm. No hives- no resp sxms- no lip tongue swelling. No fluctuance at site.
15 year old male fainted on the 3rd dose of GARDASIL 9; Information has been received from a physician, referring to a 15 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 22-FEB-2014, the patient fainted (syncope) on the third dose of GARDASIL 9. The outcome of syncope was unknown.       The causality assessment between the syncope and the vaccination with the third dose of GARDASIL 9 was not reported. Upon internal review, the fainted was considered as a medically significant event. This is one of three reports received from the same source; Sender's Comments:  US-009507513-2010USA004817: US-009507513-2010USA006056:
chills; sore throat; coughing; extremely tired; feels miserable with body aches; feels miserable with body aches; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 08:45 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, sore throat on 10Mar2021 17:30, coughing, extremely tired, feels miserable with body aches on Mar2021. Reported as, reporter stated that her husband received his vaccine shot at the same time, same table. This was a community vaccination clinic using the national guard. He started the chills the same time she did. His sore throat started at the same time. Yet by Saturday his throat was better but he had coughing set in. He insisted on a covid test on Saturday which was negative. He was also extremely tired, feels miserable with body aches. Something was wrong and it started the evening of the day of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Outcome of the event sore throat was recovering and unknown for other events.  No follow-up attempts are possible. Information about Lot/Batch number cannot obtained.
Chills, fatigue, body aches; pain, warmth, and swelling at injection site
pt recvd vax & devel rash on face & pain & stiffness in neck & shoulders;
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 6726091/1733AA, expiration date 04-FEB-2013, dose not reported) on 10-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Narrative: Pt received the Moderna Covid-19 vaccine on 3/1/2021 with no reported events during the initial monitoring period after vaccination. Pt reported to ED after walking to her car and noticing swelling under her eyelids and the sensation her throat "beginning to close" while driving. Pt later in the afternoon manifesting what ED physical described as a "mild allergic reaction". Pt was administered Solumedrol, Famotidine, and diphenhydramine IV. Pt then discharges from ED after solution of symptoms.
Slight fever; soreness at the site of injection; headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, second dose) solution for injection intramuscular on 16Feb2021 at 10:00 (at the age of 44-years-old) at single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 26Jan2021 with no adverse effect reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID. On 16Feb2021, after the second vaccination, the patient experienced slight fever, soreness at the site of injection and headache. There was no treatment for the events slight fever, soreness at the site of injection and headache. The outcome of the events slight fever, soreness at the site of injection and headache was recovering. Since the vaccination, the patient has not been tested for COVID-19.
6.5" long - 5.5" wide. Red flat rash with swelling.
It made my blood sugar level rise above the normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:30 (Lot number: FF2588) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Allergy: Egg yolks" (unspecified if ongoing), notes: Allergy: Egg yolks. The patient took concomitant medications. The following information was reported: Blood glucose increased(non-serious) with onset 30Sep2021 19:00, outcome "recovered" (2021), described as "It made my blood sugar level rise above the normal.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Arm became erythema, warm and itchy at site of injection. Erythema extends ~ 4 cm 3 days after injection. No treatments.
Patient stated that her arm was sore and a little red after the vaccine on Monday 8/16/21.  However by the end of the week on 8/20/21, she said there was a large red splotch around the vaccination site that had a bruise and was very sore.
Several children experienced chickenpox at a day care center, subsequent to several of the children receiving one dose of varicella virus vaccine live.
Information has been received from a physician concerning an 18 month old white female, noted to have had a slight cough and possible early upper respiratory infection at the time of vaccination and allergies to milk products and strawberries, who on 10/17/1991 was vaccinated with one dose of MMR II, in the right leg (lot 50897/1142T). Concomitant therapy, that same day, included one dose of diphtheria toxoid/pertussis vaccine/teta, administered in the left vastus lateralis (lot 1K21074); one dose of Hibtiter, administered in the right vastus lateralis (lot M185H2); and one dose of oral poliovirus vaccine (lot 308949). There were no other concomitant medications. The pt was examined by the physician on the day of vaccination, 10/17/1991, and was noted to be in no acute distress, with "no problems recently." She was being breast-fed at that time and was noted to be one of a set of twins. The physical exam was normal, except for a "slight cough last few days," which was diagnosed as a possible early URI. It was reported that despite this possibility, the child's mother preferred the vaccinations be given, that day. It was noted that the child did not received her 15 month immunizations or check-up. On 10/25/1991, the pt's mother called the physician's office to report that the pt had a rash on her trunk that was "red and splotchy," a temperature of 100 degrees F, and was "cranky." "Yesterday," on approximately 10/24/91, it was noted that the rash was decreased and that "today," on approximately 10/25/91, the rash was on the pt's legs, abdomen, face and neck. It was further noted that the physician's office notified the emergency room that the pt was "coming over for stat blood work." On approximately 10/25/91, the pt's mother notified the physician's office that the child was taking "hydroxyzine syrup for itch and (prednisolone) (Prelone) syrup for rash." At that time, it was also reported that the pt appeared unsteady, staggering, was not sleeping well, refused to take naps, and was fussy. On 10/26/91, the pt was examined by the physician, who noted that the rash developed on her chest, abdomen, and arms, "in the last two days" and was on her face, neck, arms, abdomen, and back, at the time of exam. It was reported that she had been having some bruising in her lower abdomen "where the rash is more confluent." At that time, it was also noted that she had been running a fever (temp 99.1 deg F) and that her nose was congested. She was diagnosed with "hives (etiology unclear), easy bruising, and otitis media." Otherwise, the exam was noted to be normal. The physician noted that "possible complications here may be allergic reaction to MM." The pt was treated with Augmentin "125 per tsp, one tsp tid five ounces, with food for the ear infection," "to be started in one to two days," and Benadryl 12.5mg qid for itching and rash. On approximately 10/26/91, CBC, chemistry profile, and ESR were obtained. On 10/26/91, she was diagnosed with erythema multiforme. At this time, the physician noted "may be allergy to MMR, but hard to say." Additional info has been requested.
Pt states she needed 2nd dose of moderna and did not have vaccine card.  After counseling and administering vaccine, patient reports she found card and upon review she already received second dose on 2/6/21.  Monitored patient for 15 minutes and explained possible adverse reactions.  She verbalizes understanding.  No adverse events during observation period.
Headaches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches". Additional information: The reporter (patient's spouse) stated that her husband (patient) has headaches since having the 2nd dose and her husband will not be getting any more.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sick with everything; diarrhea; Feeling worse than when I had Covid-19; body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with everything), DIARRHOEA (diarrhea), FEELING ABNORMAL (Feeling worse than when I had Covid-19), MYALGIA (body aches) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), APIXABAN (ELIQUIS), FUROSEMIDE, Vastalic, Nitrofurantoin                                                 once a day, PANTOPRAZOLE, POTASSIUM CHLORIDE, SPIRONOLACTONE and ZOLPIDEM for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ILLNESS (sick with everything), DIARRHOEA (diarrhea), FEELING ABNORMAL (Feeling worse than when I had Covid-19), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick with everything), DIARRHOEA (diarrhea), FEELING ABNORMAL (Feeling worse than when I had Covid-19), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
ARM WAS A LITTLE TENDER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm was a little tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was a little tender was not reported. This report was non-serious.
After the second vaccine I was so ill I could not get out of bed. I was in bed for approx 3 months. Today my entire body aches and I feel extremely fatigued. I have not been the same since I took the second Covid vaccine. I believe in the vaccine and everyone should be vaccinated, I think I am one of those rare individuals who has had such a protracted and long illness since the vaccines. I really don't know what to do or where to seek help, only the pain in the body seems to be getting worse and I'm not well enough to answer my phone or messages, I've isolated myself since last year because I feel to sick to do anything. Hopefully you might have some suggestions or advice on what to do, doctors don't seem to know what to do. Thank you! I hope that you can provide some viable advice. God's Peace!
diarrhea; Lost weight; Compromised, exhausted; Unable to keep her level of activity up; old reflux; she was pretty tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9264) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Patient history: High cholesterol; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, LOT: EL3247), administration date: 20Jan2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "diarrhea"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost weight"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Compromised, exhausted"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Unable to keep her level of activity up"; REFLUX GASTRITIS (non-serious) with onset 2021, outcome "unknown", described as "old reflux"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was pretty tired.". The event "diarrhea" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, fatigue, fatigue.  Additional information: Diarrhea started a week to 10 days after getting the second vaccine. She got that vaccine 10Feb2021 and had the diarrhea for about 90 days. Patient Details: Height: 5 ft, 5 and a half.    No follow-up attempts are possible. No further information is expected.
Blood pressure became very elevated approximately 30-seconds after injection.  Blood pressure is normally controlled at 125/75.  The reading after injection went to 170/110.  It gradually came back down after 30-minutes and I was release by the clinic with a final reading of 150/88.  I still feel anxious and I think my blood pressure is still running higher based on how I physically feel.
died three days after Covid vaccination; Autopsy showed enlarged heart and fluid surrounding the heart; Autopsy showed enlarged heart and fluid surrounding the heart; This is a spontaneous report from a contactable consumer or other non-health care professional in response to mail sent regarding the confirmation of below mentioned query. A 13-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient after receiving his second Covid vaccine from Pfizer died three days later. The patient underwent lab tests and procedures which included autopsy: enlarged heart and fluid surrounding the heart caused by the Covid vaccination. The outcome of the events was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: enlarged heart and fluid surrounding the heart
Mother stated childs arm started swelling in the evening - the next morning it was trippled in size and spreading to her chest and neck.  Went to the Hospital and was admitted on 4/12/07.  She was told patient had a staff infection from receiving the shot.  She was put on antibiotics and discharged on 4/15/2007.  04/23/2007 MR received for an ER visit for c/o Left arm swelling s/p immunizations. PMH:  none.  NKDA. PE: Swelling and tenderness of LUE. Pain 6/10. DX:  Cellulitis S/P immunizations. Transfered to Pediatric facility for IV antibiotics.
Information has been received from a physician concerning a 58 year old female patient who in approximately 2007 was vaccinated with a dose of ZOSTER (Oka/Merck).  In approximately 2007, almost immediately, the patient experienced a local injection site reaction, after receiving the ZOSTER (Oka/Merck).  It was reported that the patient is fine now.  Additional information has been requested.