chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving an extra dose of PENTACEL with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 months old female patient who was receiving an extra dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine for Prophylactic vaccination.  On 25-Oct-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ877AA and expiration date- 22-Mar-2024) via intramuscular route in the right thigh (strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Patient inadvertently received 2 doses of IPOL and 2 doses of PENTACEL. All 4 doses received on the 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.
I had the Janssen covid shot yesterday. The shot stung a little and made my arm sore. Later on in the evening I became tired (so far nothing I didn't assume would happen) so I took a nap. When I woke up, my arm stung worse than when I had the shot and the pain kept shooting up my shoulder into my neck. I went back to sleep, thinking it was just normal vaccine stuff. When I woke up this morning, I had chills, a fever of 101.7, and muscle aches. My body feels like I have a sunburn all over it. My right arm feels like it was stung by a scorpion. I feel dizzy and nauseous, and I have head fog. I feel the exact same way I did when I had COVID19, but with my arm hurting so bad, anything that barely touches it (such as clothes) shoots a stinging pain up my neck
Icey feeling in the head; little weakness; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U8B21-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness). On 22-Mar-2021, HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness) had 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.   No concomitant and treatment medications were provided.   Reporter did not allow further contact
Pt came in seeking moderna vaccine dose #1. Did not realize till after vaccination that pt completed 2 dose Pfizer series
Whole body itching; Welts; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9264, Expiration date: not reported), via an unspecified route of administration in arm left on 19Feb2021 at 14:15 (at the age of 59-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included diabetes. The patient had no known allergies. The patient's concomitant medication in two weeks included metformin, taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982, Expiration date: not reported), via an unspecified route of administration in arm left on 29Jan2021 at 16:15 (at the age of 59-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 20Feb2021 at 02:30 AM, the patient experienced whole body itching for 2 weeks. Welts developed on body after scratching a lot. Took benedrayl for relief. Treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Guillian Barre Syndrome   Paralysis, painful pins and needles, super cold from inside out, breathing, speaking, hearing
Arm starting tingling at site of shot and moved down my arm, into my left hand/fingers.  Right hand/fingers also started tingling.    The next night, both hands were tingling, same thing the following night (Sunday).  Monday morning, hands started tingling again again with my feet.  Right now, Monday evening, my left foot is tingling as is my right hand.  Have never had this happen before the shot, and am convinced this is all from the shot.  What do you have in the shot that causes this?
When I got home after receiving my booster I went to sleep. I was woken up with chest pain a few hours later but went back to bed. Two days after my booster while sitting at home I started feeling strong, frequent palpitations. The next day I went to urgent care and they recommended going to the ER but I was able to see a cardiologist immediately. After running tests he found I had developed an arrhythmia. I was having 11,000 PACs and 1,000 PVCs in 24 hours. I have been taking metoprolol since December and am still feeling palpitations. There were no other known causes for the palpitations.
I had severe pain in my abdomen on right hand side. I wasn't sure if it was muscle or indigestion. It went away just over 24 hours. I took  acetaminophen for it.  Call center  was contacted - advice line. This is my fourth pregnancy. Have not yet successfully given birth.
18-month-old patient that was supposed to receive Infanrix, received Pediarix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 473YA, expiry date 04-APR-2025) for prophylaxis.   On 28-AUG-2023, the patient received Pediarix. On 28-AUG-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: 18-month-old patient that was supposed to receive Infanrix, received Pediarix instead).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28 Aug 2023. A nurse called to inform that earlier that day, an 18-month-old patient that was supposed to receive Infanrix, received Pediarix instead, which led to wrong vaccine administered.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Pt started complaining of chest tightness and some shortness of breath after about 5 min called 911 and EMT arrived on site pt started feeling much better after 10-15 min of symptoms reporting regardless was   transferred to the ER for further work-up to make sure
APPROXIMATELY 10:15 PM BOTH LEGS GOT MAJOR CHARLIE HORSES LASTING 20 MiN. NEXT MORNING WOKE UP WITH HEADACHE - 102 DEGREE FEVER, OFF & ON. CHiLLS, FAST HEART BEAT - Dizzy & HARD SWALLOWiNG. VISION PROBLEMS AS WELL. * AFTER TAKING MEDS - FELL ASLEEP (TOOK MEDS FOR 2 DAYS - LT ARM STILL SORE 9-26-19 & WEAK)
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Swelling, warmth, redness and tenderness.  Treated-warm compress, BENADRYL.
The patient was given a high dose Fluzone vaccine, but was only 60 years old at the time.
Chest tightness, wheezing, fever, chills, generalized muscle aches, appetite absent. Initial report received on 21 November from a health professional. A 49 year old female, whose medical history and concomitant medications were unknown received a right deltoid intramuscular injection of FLUZONE (lot number U2760AA) on 20 November 2008. The patient had no illness at the time of vaccination. Thirty minutes after vaccination, the patient felt chest tightness and wheezing. Within another hour, the patient experienced fever, achiness, and chills. The patient also had no appetite. Corrective treatment was not reported. The patient had recovered on 21 November 2008. Follow up information was received on 29 December 2008 from a healthcare professional. The reported indicated that there was no new information to report. Follow-up information received 23 January 2009 from a healthcare professional who reviewed the case had no new relevant medically significant information to provide at this time. Follow-up information received on 09 March 2009 from a healthcare professional. The patient had no medical history and no concomitant medications. It was unknown if she had received Fluzone in the past, but she had previously received flu shots. The symptoms were reported to have lasted seven hours. The patient was not evaluated by a health professional.
Approximately 2 min febrile seizure, sent to hospital via EMS from home.
Information has been received from a RN concerning a 56 yr old female who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N). On the evening of 03Nov04 and again on 04Nov04 the pt developed explosive diarrhea. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00638, 0411USA00945 and 0411USA00946).
Developed a lot of flu like symptoms (chills, feverish, a little weak), soreness at injection site. Thats resolved then developed rash 2 days after (yesterday). This is when he noticed it at least. The rash is on abdomen on both sides. A little itchy. Not painful. Not spreading but is a little more red today. Gets reactions to laundry soap in the same area.
Facial swelling and erythema starting about an hour after vaccines given, visibly improving by 12:30 pm the same day. Treated with diphenhydramine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. In August 2015, the patient was vaccinated with the first dose of VARIVAX and M-M-R (measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)) (manufacturer unknown). On 09-AUG-2018, the patient was vaccinated inadvertently with PROQUAD lot # N020010 with expiration date on 13-JAN-2019, by intramuscular route for prophylaxis. However, no adverse effects were reported.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025J20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), IRON and MAGNESIUM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-May-2021. On 12-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 12-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Glucose tolerance test: normal (normal) Normal. This test was done on 02-MAR-2021. In February 2021, Ultrasound abdomen: normal (normal) Normal.         No relevant treatment medications and  were provided. Action taken with mRNA-123 is not applicable.  On JUN-2018 The previous pregnancy was reported with Live, full-term birth.  There were no chronic or long-standing health conditions. There is no maternal history of subfertility. No complications or acute illnesses during this pregnancy to date
Approximately 1 week after 1st vaccine was given, upper arm starting going numb.  This continues to happen periodically throughout the day.  Tingling sensation first and then numbness occurs.  Usually lasts 10 minutes or so and happens approximately 8 to 9 times a day.
lightheaded  Vital Signs: B/P: 136-90 HR: 82 Resp: 22 O2Sat:99 Skin Signs: Warn and Dry Circulation: Cap Refill <2 sec Treatment: Lightheaded improving as we speak. Did same with flu shot 4 yrs ago. Stayed an extra 10 mins for observation.  Repeat Assessment @ 13:15 Vitals: B/P: 128/88 HR: 78 O2Sat: 94 Discharged self.
Headache, Myalgia, Fever, fatigue Narrative:  Other Relevant History:
Thigh become red, swollen and warm to touch. That evening she developed a 103 fever, was lethargic and refusing all food. She ended up being sick for an entire week after this. She was completely fine prior to the vaccine.
I started having a sore throat, runny nose and a headache. My son called and told me he tested positive for COVID-19 and we had just returned. I went to get tested and it was positive. No prescription was provided. I took TYLENOL for a slight headache. I still have a runny nose which seems normal for me this time of year.
Pt recv vax on 12/10/98; on 12/11/98 pt exp swollen face, itching all over w/ hives; tx=Benadryl tablets
Hives on day # 3,4, and 5.  Responded favorably to Fexofenadine.
Initially, around 1500hrs on Monday, January 4th, roughly 40 minutes after the injection, I developed a scratchy throat, a headache, and nausea.  I got home from work, and having no appetite due to nausea, I fell asleep on the couch around 1800hrs. Severe fatigue had set in. I did not wake up until 0500hrs the next morning to go to work on January 5th. I felt like I had not slept at all, however the scratchy throat had gone away. I worked all day with the nausea and headache. Throughout the day I developed chills, cold sweats, diarrhea, fever, and I felt like my mind was foggy (I had felt feverish since Monday night, but Tuesday was the first time I took my temperature that showed I had a fever.) I went home that night and slept all evening and well into the next morning. On the morning of Wednesday, January 6th, my symptoms had again gotten worse, so I called my primary care physician. He fit me in and tested me for the flu and for COVID. He prescribed me Ibuprofen for the headache/fever, and Ondansetron for the nausea/vomiting. My flu test came back negative on Thursday, January 7th, and my COVID test came back negative on Friday, January 8th. The fever finally broke on Friday evening and Saturday, January 9th  was the first day I woke up without a fever.  I still have the headache as of today, January 11th, and a low grade fever has returned. I am still very fatigued as well.
This patient had a migraine headache. treated it with Imitrex, responded , but persisted for days. The migraine was with aura, blurred vision, resolved completely, brief. Right deltoid with erythema and induration / nodule formation, and tender; continues to improves. Generalized aches (arthralgias and myalgias) continue to improve.
I felt aching/cramps during the night so I got up to use bathroom, next thing I remember is  being aware that I was on the floor in front of the toilet  and felt soreness/bump on back and front of head.  I went back to bed and felt much better  in the morning .  I still feel soreness from bump on the back of the head.
Tdap vaccine yesterday afternoon. At 2AM had fever of 101.2. Tx with ADVIL. At 10AM had fever of 103. No other symptoms.
positive for Covid; positive for Covid; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is first of six reports. A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 65-year-old on 28Mar2021 (Lot Number: ER8734; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced positive for COVID on an unspecified date. Caller states she is reporting a situation. Caller states that there is an outbreak of Covid in the long term care setting, and there are 7 or 8 people positive for Covid. Caller states all of the individuals have already received the Covid vaccine, and 6 of them received the Pfizer Covid-19 vaccine. Caller states that the Lot# is ER8734 and they were received at (Address Withheld) on 28Mar2021.  Transferring agent stated, "Caller on the line report an AE for the Pfizer BioNTech Covid19 vaccine. She is calling to report an outbreak of covid in the long term care setting where she works at. She said that they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine. She said all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. She said that they received the vaccine at (store) at (city, state) and I didn't confirm the date of first dose or second dose yet but she gave me the date of 28Mar2021." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date.  The outcome of events was unknown. As of 19Aug2021, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Complaint confirmed unique was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101063533 same product and event, different patient;US-PFIZER INC-202101063334 same product and event, different patient;US-PFIZER INC-202101063595 Same product and event, different patient;US-PFIZER INC-202101063605 same product and event, different patient;US-PFIZER INC-202101065553 same product and event, different patient
Convulsions and rapid heart rate followed by pericarditis / myocarditis symptoms which gradually developed over 2 weeks.