chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-month-old female patient was inadvertently administered both Pentacel and Pediarix instead of the ACTHIB and Pediarix with no reported adverse event; patient inadvertently received an extra dose of the DTaP and IPV antigens with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 2 months old female patient who was inadvertently administered both pentacel and pediarix instead of the ACT-HIB and pediarix with no reported adverse event and patient inadvertently received an extra dose of the dtap and ipv antigens with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine via intramuscular route in the right thigh for prophylactic vaccination (strength, batch number, expiry date: unknown). Information on batch was requested. On 07-Jul-2023, the patient received a  dose of suspect Pediarix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, batch number, expiry date: unknown).  On 07-Jul-2023, 2-month-old female patient was inadvertently administered both pentacel and pediarix instead of the acthib and pediarix with no reported adverse event (wrong product administered) and received an extra dose of the dtap and ipv antigens with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable  Outcome was Unknown for the events.  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.
Patient experienced a rash and bump at the injection site, that spread to entire upper arm. Also experienced nausea and fever of unknown severity. The nausea and fever resolved by reporting date, lasting for about 2 days. The rash and bump had improved but not resolved as of reporting, 3 days later. She has been icing the area, and plans to continue to do so. She declined to use BENADRYL due to possible side effects. She had not contacted her physician, but was counseled that was a valid course of action should she wish to.
extreme feeling of being cold and moderate feeling of nausea for approximately 7 hours, followed by headache for about 6 hours (treated with ibuprofen),  fatigue for about 24 hours.
Aproximately 20-30 min after vaccine she started having a fluttering feeling in her chest and didn't feel right.  She became very weak and dizzy.  She went to the local health clinic and they called an ambulance for her. At that time her bp and hr were normal.  She felt extremely tired had a headache.  After she arrived (aprox 4PM) she started getting a rash (hive-like) on her hands and arms.
pt recvd vax & next day had t 101-103.6 x 3 days; not eating well; "pulling at ears; red throat; on 15jul94, had sz; shaking; fever down  w/in 1/2 hr;
Information has been received from the licensed practical nurse concerning a 66 year old white female with allergies to penicillin clarithromycin, penicillin, ciprofloxacin hydrochloride, and sulfa who on 11/4/03 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). There was no illness at the time of vaccination. It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 1997. The reporter also indicated that the patient contacted that physician soon after the injection. The patient experienced a sore arm with swelling, redness, and tightness on or near the injection site. It was also reported that on 11/4/03 the patient developed a very red, hard, and swollen arm. The patient was treated with ice and ibuprofen. Subsequently the patient recovered. A product quality complaint was not involved. Additional information is not expected. The reporter also indicated that two other patients experienced similar reactions after therapy with pneumococcal 23v polysaccharide vaccine.
CHILLS, FEVER, MYALGIA FOR 24 HRS. SORENESS AT INJECTION SITE. TOOK TYLENOL
Since 081921:  Kidney pain. Lasted 8 days.  Jaw pain. Lasted 3 days.  Trouble swallowing. Lasted 4 days.  Bleeding ears. Lasted 1 day.  Nausea. Lasted 4 days.  No appetite. Lasted 7 days.  Vomiting. Lasted 2 days.  Migraines. Still occurring.  Dizziness. Still occurring.  Confusion. Lasted 8 days.  Memory loss. Lasted 8 days.  Brain zaps. Still occurring.  Acute lower back pain. Unable to stand/walk without assistance. Still occurring but getting better with medication use.  Unable to sleep due to pain. Lasted 4 days.
My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on extra clothing during the day and extra blankets when I went to sleep. I think this is considered to be chills. On both Tuesday and Wednesday, I ran out of energy by the afternoon. On both Tuesday and Wednesday, my head felt heavy.
passed away sometime after 2/16/21 and before 2/20/21 in her home.  Cause of death ruled by Corner as Myocardial infarcation and congestive heart failure.  Sometime between 11 and 15 days after receiving dose 1.  did not receive dose 2 due to her passing before she could receive it.
Cannot sleep; Sudden pain in either forearm or hand Pain; Pinched nerve; Numbness in rt arm from shoulder to finger tiips; wake up not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips), INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain), FEELING ABNORMAL (wake up not feeling right) and NERVE COMPRESSION (Pinched nerve) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Dilaudid), Allergy to antibiotic (Doxicycline), Age-related macular degeneration, Hyperlipidemia since 21-Dec-2015, Hypertension since 21-Dec-2015, Impaired fasting glucose since 15-Jun-2017 and Sleep apnea since 06-Jun-2016. Concomitant products included ATORVASTATIN from 21-Dec-2015 to an unknown date for Cholesterol, DILTIAZEM HYDROCHLORIDE (DILTIAZEM AN) from 21-Dec-2015 to an unknown date for Hypertension, HYDROCHLOROTHIAZIDE from 21-Dec-2015 to an unknown date, SPIRULINA [SPIRULINA SPP.] from 17-Oct-2019 to an unknown date and CALCIUM CARBONATE from 09-Jul-2019 to an unknown date for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FEELING ABNORMAL (wake up not feeling right). On 15-May-2021, the patient experienced HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips). On an unknown date, the patient experienced INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and NERVE COMPRESSION (Pinched nerve). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips) had not resolved, INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and FEELING ABNORMAL (wake up not feeling right) outcome was unknown and NERVE COMPRESSION (Pinched nerve) was resolving.            Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up 2 information included no new information. On 06-Sep-2021: Follow-up information included patient demographics, medical history, concomitant and treatment information, dose 1 outcome, dose 2 info, and new events.
migraine headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovered", described as "migraine headaches".  Additional information: Reporter stated that her 82-year-old sister who got her first shot of the Pfizer Covid 19 vaccine experienced headaches and migraines for 6 months after taking the shot. Reporter then stated that her sister got the moderna shot for her second shot and experienced the same headaches / migraines. Reporter was asking if there was any information regarding these headaches. Again stated she took the first one and then started getting migraine headaches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of energy.  High fever.  In bed 2 days after both shots.  Can not regain energy even now.
Pain in my right arm and shoulder, pain in my right wrist, paiin my my thighs and hanstring, pain in my kness
COVID test nasal swab positive; COVID test nasal swab positive; patient's cycle has changed since the vaccine/came on a few days after shot 1 and 2 which was not it's scheduled dates/since the vaccines it has made it unpredictable and sporadic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and administered in arm left, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test nasal swab positive"; MENSTRUAL DISORDER (non-serious) with onset 07Jan2022, outcome "not recovered", described as "patient's cycle has changed since the vaccine/came on a few days after shot 1 and 2 which was not it's scheduled dates/since the vaccines it has made it unpredictable and sporadic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: nasal swab. Therapeutic measures were not taken as a result of menstrual disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1: Dizziness, Nausea, Fatigue, and Swelling at site of shot  Day 2: Most symptoms gone. Swelling of lymph nodes noticed in morning. Ongoing. Armpit on arm where shot was received   *Did not go to doctor. All symptoms noticed and reported from home.
I had arm pain after the vaccine for a day, but it wasn't that bad. On 05/09/2022 I started having symptoms of a cold with a sore throat and runny nose. On 05/10/2022, I tested positive for COVID-19 with a home test. I had a tele health visit with doctor and was prescribed an inhaler and I took TYLENOL for my symptoms. I was sick for two weeks with a lot of congestion. I lost my sense of taste and smell for a month.
Patient given Pfizer Bivalent vaccine on 9/20 and again on 10/3
The arm felt a little bit warm; Had some redness on the arm; Some itching; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches). At the time of the report, FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that the AE maybe lasted for 2-3 days  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-307243 (Patient Link).
pt stated that the night after the vax he started getting pain in his left knee and he fell.  He has to walk with cane since this.
A patients of unknown age, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH907AD via intramuscular route, site of vaccination were not reported), on last week (2013). On an unspecified date, after receiving vaccine the patients experienced site reactions and high amount of pain at injection site. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none. Follow up information was received on 17 January 2014: On an unspecified date, the event of "site reactions" and "high amount of pain at injection site" was recovered.
Narrative: 68 year old male with PMH of GAD, HTN, CAD, depression,  vascular dementia, COPD, HLD, and other comorbidities reported to his PCP that he diarrhea that occurred for 6 hours starting 3 hours after receiving his 3rd dose of the Pfizer COVID-19 vaccine on 10/09/21. Later in the evening, he woke up with dizziness, BP was normal.
Patient had an allergic reaction. Onsite EMS was called vitals BP 166/98  97%O2  HR 104 Patient refused evaluation or care and released against medical advise.
8yo previously healthy boy. Mom had COVID around 1/5/22. As far as we know the boy did not have symptomatic covid during or after her illness. He was not seen in the clinic for covid, nor was his 12 yo brother. There was no communication with them about this other than mom called to reschedule their appt for the 2nd COVID vaccine on 1/5 b/c she herself had covid. (Both of the kids got the first dose of the vaccine on 12/17/22)  Both of the boys got the 2nd dose of Pfizer Covid vaccine at our clinic on 2/3/22.  Mom called in on 2/9 with what sounded like a gastroenteritis over the phone and Zofran was called in. Our nurse  documented well his GI bug history and that his UOP was good and to call back PRN any problems. The nurse  remembers talking to this mom and that she did not seem worried at all?.just needed an antiemetic called in for nausea and vomiting. Patient was not having fever or abdominal pain. That call was at 8:53 on Wednesday AM. We did not hear from them again about this.  The details now get incredibly hazy due to the trauma of the whole event. Sometime during the night on Thursday night 2/10/2022 (40 hours or so after their phone call) one of the parents found him blue and lifeless in his bed. (Do not know details of what made them go check on him). Was taken to the Hospital with a full code in process. They were able to get a pulse back a few times for a brief time, but then lost him in the ICU.   This family goes to church at the same church that one of our doctors  attends,. This doctor  got a notification on the  morning of 2/11/2022 that a member in the church had died. The word that she received was that the boy had died of MIS-C (we do not know what exactly they were basing that on or who made that determination/speculation). My partner  called me 2/11/2022 AM about it since the boy is my patient. I looked through the chart and talked with my nurse  who specifically remembered the call and how completely unworried and normal  the mother seemed about the boys illness?.not in an unusual way but in a normal ?my kid has a GI bug, can you call in some zofran? kind of way. I called mom to reach out to her, but had to leave a voice mail (not surprisingly under the circumstances).  There are obviously lots of details about the history/presentation/treatment that I don?t  know. They may have sought medical care somewhere else other than our clinic before he became so significantly ill. I just don?t know since the family is in crisis mode and not returning calls or text messages. At present we don?t even know burial arrangements.
Extreme body aches, all joints &  muscles; tired, very weak for the first 5 days, as well as fluctuating B/P .Day 6 & 7 felt normal again. On day number 8 pain & aches began again to a lesser degree lasting another 5 days. By day 14 still very tired & weak with body aches only at the right knee & shoulder. 9/17/21 Slight sour throat at this point & a shooting pain form the right shoulder to the right side of the head, this last only a few seconds & has happened only twice. .Energy levels still not 100% , some what tired but functional today 9/24/2021. The tiredness comes & goes & seems to be diminishing.
Itchiness, slight pain, swelling, hotness around the injection site starting about a week after initial injection. I had pain in my arm, fatigue, chills, and swelling after I first got the shot, but they went away about 3 or so days after, however, these new symptoms began about a week after initial injection or about 3 days after initial symptoms went away.
Initial report was received from a health care professional on 09 October 2012. A female neonate patient was exposed to a dose of ADACEL, lot number C4008AA, and a dose of FLUZONE, lot number UH456AB, in utero on 14 November 2011. The patient experienced the congenital anomaly of ectopic kidney. The patient was born at 41 weeks gestation via vaginal delivery and had an APGAR score of 9 at 1 minute. The patient's height was reported as 19 cm and 7.09 kg. There were no complications during labor or delivery. The patient's mother did not experience any adverse events (case number 2011-11120). The patient's outcome was not reported. Documents held by sender: None.
Arm pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.        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.   This case was linked to MOD-2021-033873 (Patient Link).
The patient reported she felt "clammy" and noticed increased sweating. After a few minutes of sitting and deep breathing she reported numbness of her left arm and tingling in her hands. She denied diphenhydramine when offered. She denied any difficulty breathing or closing of the throat. She had no visible skin reaction.  She was advised to wait 30 minutes rather than the 15 minute waiting period. We recommended she seek medical attention, but she denied and reported the tingling an numbess had gone away. After she felt better, we had her wait for 15 more minutes. She was no longer experiencing any side effects. We recommended she follow up with her primary care provider and seek medical attention if she had any other adverse events once home.
lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899  and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm  for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot.  Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons.  He did not have a fever, but he sweated a lot.  He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before.  He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 18DEC96 & sweat out a greasy film through outside nose later that day U was groaning a little;pt exp discomfort & poss body pain;
KINRIX give IM to (L) T Also given this day 7-30-13 PQ.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium.
Client pulled back when needle was inserted stating that she had severe pain. Some vaccine dripped down clients arm. Complained of tingling of her hand. Check with client an hour later, still having the sensation. Normal movement. TC 10/2, improved slightly but still pronounced. Advised to contact her physician tomorrow if not completely resolved.
Information has been received from a consumer concerning her 68 year old sister with hypertension and "many drug allergies" who on approximately 01-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 02-AUG-2007 the patient developed a rash.  Concomitant therapies are blood pressure and cholesterol control medications (names unknown by caller).  Unspecified medical attention was sought. She was administered an antihistamine for the rash.  No further information was provided.  There was no product quality complaint involved.  No further information is expected.
Flushing feeling followed by racing heart episodes off an on. Lightheaded. Feelings at times of impending doom or death. Ringing in ears. Tiredness
HE HAD A RECTAL BLEED AND WAS ON ELIQUIS, SO THEY STOPPED ELIQUIS, THEY SAID THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE