chrisvoncsefalvay/vaers-outcomes huggingface dataset:
may have been administered the dtap-ipv portion separate from the hib portion with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00356816) and transmitted to Sanofi on 12-Nov-2020.  This case involves patient with unspecified age who may have been administered with the DTaP-IPV portion separate from the HiB portion with no adverse event (product preparation issue), while patient was receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Inappropriate reconstitution technique.  A nurse reported a possible medication error which was described as the Dtap-Ipv portion may have been administered separate from the Hib portion. Reporter did not know if there had been a medication error with the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE or that she dont not know if the DTap-IPV portion had been administered or if a consumer was only needing a HIB portion due to being only prescribed the HIB.  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.  There will be no information available on batch number for this case.
Addendum: Patient made aware of HM vaccines due which included Influenza, Covid-19 and Hepatitits B (3rd dose). During provider visit, patient questioned regarding HM vaccines due, stated she want to receive the Hepatitis B and Influenza vaccines and did not want to receive the Covid vaccine at this time, which was heard by the writer as her agreeing to receive the Covid-19 vaccine and not the Influenza vaccine.   The administering CA did initially verbally verify with patient that she was going to be administering the Covid-19 and Hepatitis B 3rd dose vaccine. After CA administered both vaccines, the patient questioned which shot she received on each respective arm, at which point she realized that she had received Covid-19 but was expecting to receive the Influenza vaccine. The patient became upset as she had not wanted to receive Covid-19 vaccine today (has received 4 doses prior).    The writer went to speak with patient and clarify the incident. She was noted to be tearful and stated she was worried about side effects of the Covid vaccine, discussed the new vaccine (pfizer monovalent) has been well tolerated with no side effects or minor side effects reported. She expressed understanding and noted no immediate reaction or side effects.
discoloration at injection site,swollen,painful and a rash above and below injection site.Chills,fever (new -today).Pain when trying to lift arm.
HEART ATTACK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned 2 adult patients of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: extremely healthy before shot. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patients additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, both patient had heart attack from the shots, they were tested positive (suspected clinical vaccination failure) and got sick (suspected covid-19 infection) (Dose number in series 2). Laboratory data (dates unspecified) included: coronavirus disease (COVID-19) virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000218635. The suspected product quality complaint has been confirmed to be voided (did not describe any product quality complaint) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220250720, 20220250507 and 20220251028.; Sender's Comments: V0: 20220251156- covid-19 vaccine ad26.cov2.s-Heart attack. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. .20220251156- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Moderna Covid-`19 Vaccine EUA Day 2 after receiving vaccine: headache,  chills,  generalized aches, injection site and arm soreness Resolved by  Day 3
A week after, I stated to have tendon pain in my left thumb/wrist and I don't have a carpal tunnel syndrome type job or do anything that would make that happen. It started happening at night and it progressively got worse and I made a appt with Dr. (about two weeks ago) and she had me do a mobility test which was uncomfortable for me. She gave it a name but I can't remember it. She prescribed thumb splint and resting my hand. It's in the splint now. I have been in the splint now for a week and I will wear it for four to six weeks. It stays on all the time except to take a shower or wash dishes.
lot of pain in my knees and my joints; It is in my left knee and right knee only; I can hardly walk; This is a spontaneous report from contactable consumer (patient).  A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiry date: unknown), via an unspecified route of administration on 26Mar2021 (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 in Oct2020. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma once a day. The patient experienced 10 days later lot of pain in his knees and his joints; it was in his left knee and right knee only (reported as worsened), he could hardly walk on 05Apr2021. Clinical course reported as I had the Pfizer shot 26Mar and 10 days later lot of pain in my knees and my joints. It is in my left knee and right knee only today and I can hardy walk and my question is I had Covid back in October, 1st of November and I had the first shot in March, will the second shot be worse? I am really concerned because I can hardly walk the way it is. Therapeutic measures were taken as a result of the events not as an Ibuprofen, they say over the counter like Aspirin. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient was seen at her PCP and treated with the Hep A vaccine. She presented to our facility (hospital) with throat swelling, mild facial edema, and difficulty breathing. In the emergency department she was treated with BENADRYL 25mg IV, famotidine 20mg IV, and SOLU-MEDROL 125mg IV.
Patient received vaccine and waited at drive through pod for 15 minutes after receiving. Patient returned stating she had vomited in her car, has a pounding headache, and feels flushed. Patient evaluated by EMS and chose to go to the hospital.
Diarrhea and vomiting. Severe pain in left arm. Started as hot sensation and itching in left ear. Led to left eye twitching for a few hours. Then had sudden onset of numbness and tingling in left side of face from where eye is twitching down left cheek and left side of neck, down to left shoulder.
Flu-like symptoms, ache, sweaty, chills, headaches, sensitivity to light, itchy rash. Symptoms started 10/8/07. Treated in the ER 10/10/07 and 10/14/07.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Child had fever for 1 week prior to breakout of vesicles; broke out with blister like rash on 11/30/03; no itching.
has hives on the abdomen, itching with a low grade fever for 48 hours post injections, wasn't able to lift arm for 4 days after vax. Felt very tired and slept a lot and took IB. Feels ok now but rashes are fading and still itches.
Client left the clinic after staying for 15 minutes and returned c/o rash.  Client stated that rash appeared at about 5-10 minutes after he left the clinic.  Rash was noted on his left temporal area, left upper arm around the injection site and a 0.6 diameter "mosquito bite-like" bump on his left forearm.  Diphenhydramine 2 capsule of 25mg PO given to client.  Vitals taken; BP- 136/92, Pulse- 71, Temp- 94.8; O2 Sat 97%.  No other symptom. Medical director of the clinic stated that client could take another dose of Diphenhydramine 50 mg in 30 to 60 minutes and repeat every 6 hours prn. Instructions given to client and he stated understand.  Called client at 4:45 pm, client stated that the rash was gone but tender at the sites of the rash. Sleepy, no other complaint.
Syncope 15 minutes after the shot. 32y.o healthy female. I received my first dose of Pfizer yesterday and passed out 15 minutes later. Was taken into the hospital with a heart rate below 40. Discharged from emergency with "syncope, abnormal EKG".
Mother called at 5:45 pm stating pt. crying since 3 pm (Non-stop)-consoles long enough to "catch her breath" then screamed again. Mother stated patient cried in "cycles" until 8 am the next day.
Suspected vaccination failure; got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In December 2020, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both doses during first half of 2020 and still got shingles in December 2020. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sore arm; body aches; pain in legs; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 14:00 (Lot number: EL3247) at the age of 45 years as dose 2, single 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, Unknown Manufacturer), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "pain in legs"; HEADACHE (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain in extremity, pain, pain in extremity, headache.  Additional Information: It was reported that, the patient became aware of the adverse events on 19Mar2021, 24hrs after receiving the 2nd vaccine dose. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was diagnosed with COVID-19 and not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
got the flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).    This case involved an adult patient of an unknown age and gender who got the flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site.   On an unknown date, unknown latency, the patient stated that well back in the 60's I received a flu shot and got the flu (Influenza) from it.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
On 11/20/09 vomited 3 times and had profuse, clear, watery diarrhea which persisted for 3 days.  On 11/21/09 developed blotchy, itchy rash on neck, face, buttocks, feet.  Rash would come and go, lasting for about 1/2 hour at a time, disappearing from one area and appearing somewhere else on body.  Father called on 11/30 to report above occurance.  Still had rash at that time, although down to one episode a day instead of multiple episodes.  Diarrhea had resolved although stools were still a little loose but not frequent.  No fever at anytime during past 2 weeks.  No egg allergy.
Long term well controlled Type 1 diabetic, on insulin pump -- on day following vaccination blood sugar spiked to 399, remained elevated for 48 hours, then normal since.
Patient with 1 J+J vaccine who admitted after a fall with a  positive COVID test.  Provider d/c note:  "Patient was admitted post-fall with chest pain. She was found to be covid positive on admission.  XR chest showed fracture of rt 6th-8th ribs.  Trauma workup otherwise negative. She was evaluated by PT/OT who recommended rehab on discharge.She was discharged in stable condition to nursing facility."
Site: Pain at Injection Site-Severe, Systemic: lump under the arm after 2 days-Severe
Swelling of arm redness on area. Doctor is treating with Ibuprofen and Cutivate topical cream 0.05%.
spontaneous hives,extremely painful and extremely extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy). At the time of the report, URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy) outcome was unknown.            No concomitant medication reported.  The patient had spontaneous hives for the past 5 weeks, said that it was severe on its first 2 weeks and it's extremely painful and extremely extremely itchy.  For the treatment of hives the patient had taken primarily ordinary antihistamines and then stronger antihistamines.
When I got the first shot my arm was just a little stiff; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "When I got the first shot my arm was just a little stiff".  Additional information: It was reported that, when patient got the first shot arm was just a little stiff, didn't had have any kind of symptoms or anything.  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-202101090747 similar report from same reporter
12/05/2021 presented to ED for abdominal pain, nausea, vomiting and diarrhea. PMHx of DM.
Covid Arm;  large rash developed at injection site (left arm) began on day 8. Painful lymphnode swollen under arm (armpit) on left arm began day 7.
I did not have an acute response - response was gradual and progressive.  The month following my last vaccine, I noticed having trouble lifting things (bilateral elbow pain) and difficulty going from a sitting to standing position. Felt as if I had gone through a gluteal workout. Symptoms persisted, so I notified my PCP.
1430: 29yo female with complaints of throat itching and tightness. Allergies: Latex, eggs, dairy, wheat Epi-pen has been used in the past.   Patient given Benadryl 25mg Po by Physician on duty Patient symptoms resolved and patient discharged home with friends and boyfriend to watch over patient.
got a slight headache over my eyes; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that I do not think they connected me to the right person, I had my first shot of Pfizer (Unspecified Medication) in January, got a slight headache over my eyes like they said you would and then after that off and on I get that slight headache, I got my second shot in February, in fact it would be 2 weeks today that I had it and I was still giving the headache and some pain in my temple. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. .
Breakthrough case admission after 3 vaccines ; Pfizer 3/17/21 lot# EN6207;  Pfizer 4/7/21 lot# EW0150;  Moderna 12/14/21 lot# 070H21A
I started having problems with both legs, pains on both sides of my gluteus maximus that runs down both legs, the pain is stronger on the right side, I made an appointment to see my doctor, we discussed my symptoms, she gave me a shot of cortisone and a prescription of Tizanidine. I only took the Tizanidine for a couple of days, I have been doing at home physical therapy to help myself be more mobile.
Child received his 2nd varicella on 9/9/08 in right deltoid. He had a small rash on 9/10/08 which enlarged to a 4cm x 2.5cm indurated and erythematous - Non tender
pt recvd vax; arm red & swollen; pain & numbness in fingers; unable to lift lt arm; fever of 100.6;