chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Tenivac was administered to a patient with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient was administered expired dose of diphtheria and tetanus toxoids  (tenivac) was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria and tetanus toxoids via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown).  On an unknown date expired dose of tenivac was administered to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable  Outcome was Unknown  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.
Administer injected at back of arm (SQ) instead of left deltoid (IM). Pt experienced fever, body aches, nausea.
experienced sick like symptoms; fever; headaches; This is a spontaneous report received from a contactable consumer (patient) reported for herself via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced sick like symptoms with a fever and headaches. Outcome of the events was resolved on an unspecified date in 2021.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
It was reported that a 4-year-old female received a dose of Tripedia(lot#U0582AA) vaccine on 7/24/02. Patient developed a large local swelling and induration at injection site measuring 8x8cm. There were two other patients who experienced the same reaction with this lot number.
On 8/8/01, at 08:00, pt woke with swelling of glands on left side of face and neck. Child felt warm to touch and mother gave him Tylenol at 09:30. Office visit at pediatrician's and was Rx'd Cephalexin. On 8/9/01, at 11:00, the baby awoke crying with both sides of face swollen. Taken to ER and temperature was 98.8F. Rx'd Tylenol with codeine and dx'd with parotitis.
Rash around mouth and tummy. Pinpoint red bumps with pus in the mild.  Does not itch, child does not notice it. Mom states this is his only symptom.
Received vaccine at 8 am and then went to work as a PE teacher. I was on my feet all day. First signs of fatigue and chills began around 4 pm that same day. Chills and fever developed and continued throughout the night. No cough or sneezing. I woke up the next morning with a mild headache and fever (although the fever seemed lower). I took 2 Ibuprofen and within a couple hours the headache was gone and fever was almost completely gone. Symptoms were gone by day 2 afternoon. Left arm was sore at injection point for a couple days. I also had stomach gas starting on day 2 for a couple days but that could be from something I ate.
On 18Aug2021 I was diagoned with Covid 19; I was exposed at my place; This is a spontaneous report received from a contactable consumer or other non HCP (patient) via Epsilon Escalation team. A patient (consumer) of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, and Batch/Lot numbers was not reported), dose 2 via an unspecified route of administration on Jun2021 (age at the time of each vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On the patient assistance program, the patient stated received both doses of the vaccine. The first dose was taken in May2021 and the second was taken in Jun2021. On 18Aug2021, the patient was diagnosed with Covid 19. The patient was exposed at the place of employment in 2021. The patient underwent lab tests and procedures which included SARS-COV-2 test, the patient was diagnosed with Covid-19 on 18Aug2021. The outcome of the event was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician, who is also the patient's mother, concerning a 16 year old female who in May 2007, was vaccinated with the first dose of Gardasil.  In July 2007, the patient was vaccinated with the second dose of Gardasil.  Per the reporter, "the patient fainted after receiving her second dose of Gardasil in July 2007.  She has since had her third dose and did not faint."  The patient sought unspecified medical attention.  No further information was given.  Additional information has been requested. Follow-up received on 4/16/2008. Follow up information (returned correspondence) received 04-MAR-2008. The physician no longer works at the previously provided location. Additional information is not expected.
vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), administration date: Jan2021, for COVID-19 Immunization, reaction(s): "she has had a cramp in her left foot". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My symptoms were nothing more than a common cold, and not even a real bad one. I tested positive for COVID-19 on 12/21/2022. I attribute not getting anything worse than cold like symptoms because, as soon as I tested positive, I called my doctor and her nurse prescribed Paxlovid, Vitamin D, Vitamin C, and a Probiotic. Within probably 4-5 days, it was gone.
Redness, tenderness, and warmth at site of injection possible infection --> pt. referred to PCP.
Child was fussy and could not sleep through the night.  Developed a fever of 102.5 and a swollen red nodule at injection site 2 inches in diameter.
A spontaneous report has been received from a consumer concerning a 6 month old female patient. Patient's relevant history, concurrent disease and concomitant drug was not available. The patient had been receiving FLUMIST quadrivalent (intranasal), started on an unknown date. It was reported that a patient received FLUMIST in the fall of 2014when she was six months old, she only received one influenza vaccination. After receiving the vaccination she has continued to be sick, she's had the flu, several ear infections, croup, and pink eye. Action taken with the suspect vaccine FLUMIST was unknown. The outcome of the event of flu, ear infection, croup, pink eye and received FLUMIST at 6 months old was unknown. The report was considered to be non-serious by the reporter.
patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed.  Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
I would like to report my side effects from the 2nd moderna vaccine shot on 5-23-21 I had fever, chills, and throbbing knee pain to the point I couldn?t walk on that leg, it felt like I got shot in the knee. I don?t recall which knee. I took Tylenol and went about my life.  I then experienced on and off knee pain throughout the summer months of 2021 maybe 1 or 2 times a month. The pain was not nearly as bad as the initial vaccine shot side effects. I took Tylenol and it would go away, so I didn?t pay too much attention to it. I want to say around September 2021  I woke up in the middle of the night with the worst throbbing knee pain just as bad as the one I had with the moderna side effects. Took Tylenol again and this same thing happened 1 or 2 times again between September-November 2021  Around December 17 2021 I experienced knee pain that did not go away, It was a different kind of pain more stinging and burning sensitive to touch, I also got a small rash on my hips, at that point I could feel the pain down my legs and in my arm,a stinging burning pain. I went to urgent care they did some blood tests, everything came back normal. I also had a phone appointment with my primary care doctor around December 22 2021, she did blood test as well as X-rays of my knees, again everything normal. I did test positive for COVID December 30 2021.  It?s now January 22 2022 And I?m still in knee pain/joint pain/dull back aches, now I?m having pain in the back of my knees, my pain is everywhere at this point in time. Im tired all the time, I have no appetite. There?s definitely something wrong in my body. I think it might be linked to the moderna vaccine.
Injection site swelling, redness, itchiness lasting more than 1 week. Swelling and redness is splotchy and 1-2 inches surrounding injection site
Twelve days post vaccine started with equilibrium off, cloudy mind, shortness of breath, fatigue. Progressed to severe fatigue, tingling in hand and foot on right side of body. Lost motor function on right side of body 17 days post vaccination.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 23 years old female patient who received her 1ml first dose of IMOVAX RABIES (Batch number, expiration date, dose, route and site of administration was not reported) and a dose of IMOGAM RABIES-HT on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Missed dose of vaccine and extra dose administered of Immunoglobulin. A patient received her first IMOVAX injection and missed her day 3 dose of the IMOVAX. The patient received IMOGRAM on day 0 and also on day 3. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (27Mar2021), described as "Slight soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 8:00 PM patient started to become nauseous/vomiting and had a fever. Patient then became delirious and combative. Ambulance was called and patient was taken to Hospital and was given IV TYLENOL. By the next morning the patient broke the fever and was coherent. Patient received CORTROSYN 0.25 injection on 9/18/2017- no reaction.
papular lesions surrounding an erythematous firm subcutaneous lesion approx 1cm;afeb;had been on ATB for otitis;
Facial flushing; Temperature of 99.9F; Discomfort at top of head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 28-Jan-2021, FLUSHING (Facial flushing) and BODY TEMPERATURE INCREASED (Temperature of 99.9F) had resolved. At the time of the report, HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-090085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received and contains :Outcome was updated for event Headache : the event was said to be resolved upon using Paracetamol. And patient was taken 2nd dose of Vaccine and still had sore arm
Rash all over the torso - on top of breasts and under breasts and all over the belly. Redness - very red and peeled. Lasted about 1 week.
Repeated nose bleed (3) after second Pfizer COVID vaccine shot; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced repeated nose bleed (3) after second pfizer covid vaccine shot. The outcome of the event was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
This spontaneous report as received from medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 11-JAN-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M025864 and expiration date: 24-MAY-2018 (route, dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of more than 5 grades F (Fahrenheit) but less than 14 grades F for 2 hours and 30 minutes, and more than 14 grades F but less than 46 grades F for 12 hours and 15 minutes. Data logger was involved and there was no previous temperature excursion reported. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007989:
Fever, chills, body aches, vomiting, sore throat, cough. Fever to 102.3 on and off throughout coarse of illness which has lasted 12 days. No one else sick at home.
Painful and itchy red lump, hot to the touch,  4" in diameter. As of 5/14/15 lump is still growing.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, as a single dose for immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced numbness after being vaccinated by his physician. After informing a physician patient could not feel his upper limbs on an unspecified date, the physician ignored the complaint and told patient that it would pass. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. The outcome of numbness was unknown.
A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm ached but not too much but my body ached all over like you get with the flu which I've never had. I was like that for 2 days. I didn't want to eat or do anything. Then I tried to keep eating a little & drinking anything water, coffee,&  tea hot & iced . On the 3rd day I felt better not well but better.
I used to have occasional Atrial Fibrillation but after this 4th dose my this has become been constant. My PCP recommended that I see a Cardiologist for my heart condition, I have an upcoming appointment on 5/13/2022 at a local medical facility. My doctor also wants me to have a sleep study.
Flu like symptoms started Wednesday 10/30/19, she was getting worse through the weekend and went to the hospital on Sunday 11/3/19. The doctors at the hospital thought she was having a stroke, but it was determined to be a reaction to the vaccine. She was only given IV fluids and her regular medications at the hospital.
sore arm not long after given the vaccine followed by headache, body aches, chills, fever, nausea approximately 12 hours after getting the vaccine
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about concomitant medications, pertinent medical history, drug and allergies provided. On an unknown date, the patient was vaccinated (as a child) with unspecified dose of hepatitis B vaccine (manufacturer unknown) (reported as unspecified hepatitis B vaccine) injection (lot#, expiration date, frequency, indication, route and site of vaccination were not reported). Subsequently, on an unspecified time after receiving the hepatitis B vaccine (manufacturer unknown) the patient had titers drawn, which showed that the patient had no immunity to hepatitis B. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
mild symptoms; COVID arm; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm). At the time of the report, ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) 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.   Concomitant medication was not provided treatment was not provided
pt recv vax IM instead of SC;pt sought unspecified medical attention;pt exp mild local pain which lasted for one day;pt recovered;
PATIENT WAS VACCINATED AT APPROXIMATELY 1342HRS, AS THE PATIENT WAS EXITING THE VACCINE ADMINISTRATION SECTION, HE VOICED "FEELING DIZZY". PATIENT IMMEDIATELY LOST HIS BALANCE AND WAS STABILIZED BY STAFF MEMBERS. PATIENT NEVER HIT THE FLOOR NOR DID HE FALL. CHAIR AND SUPPORT WAS PROVIDED FOR SAFETY. NURSE PRACTITIONER ASSESSED PATIENT, ALERT AND ORIENTED, PATIENT NEVER LOST CONSCIOUSNESS. ALL VITAL SIGNS WITHIN  NORMAL LIMITS  B/P: 93/54, HR: 63, O2: 97%, T: 97.9, R: 22, RBS: 117. PATIENT VOICED FEELING BETTER AND WAS TRANSFERRED TO POST VACCINE AREA FOR 30 MINUTES OBSERVATION TIME.  PATIENT WAS REASSESSED AND VOICED FEELING WELL. PATIENT WAS THEN TRANSFERED. NO MEDICATIONS OR TREATMENTS ADMINISTERED.
Vaccinated with Pneumovax, .5ml in the right deltoid on 11/09/2006.On 11/15/2006, contacted the health department: said she developed pain in the right arm and shoulder approximately one hour after being vaccinated. Unable to lift her arm by 11/15/2006. Seen by Dr. on 11/15/2006. Referred to a rehabilitaion specialist on 11/20/2006. Dr.  gave IM cortisone and Advil.
This spontaneous report was received from a Medical assistant concerning to unspecified patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 19-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, the expiration date: 27-MAY-2017 (expired product administered) (dose and route were not reported) for prophylaxis. There was no concomitant medication provided. There was no adverse effects reported nor Product Quality Complaint (PQC) involved.
Pneumovax given on 5/15/06 right deltoid. 5/16 pt came to MD with right arm erythema and edema at inj site, despite use of acetominophine and ice packs x5.  MD and Allergy MD saw patient and prescribed prednisone 60mg qd. 5/17 the patient returned with increased swelling and erythema to upper arm extending to elbow, erythema to shoulder and side of neck.  Pt face is flushed and states she "does not feel well". No temp, chills or sweats.  Pt stated she did take prednisone as prescribed.  pt admitted to hospital for IV antibiotics, re: cellulitis.