chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.  It was unknown whether the patient had both Acute and Chronic illnesses at the time of vaccination.  It was unknown whether any other vaccines were given to patient within 1 month prior to Moderna COVID-19.     On 23-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area).    Concomitant drugs were not reported. Patient received the vaccine on upper bicep area. It was unknown whether the event cause the patient to seek medical care. It was unknown whether the patient experienced a similar event in the past. Treatment details were not given.
expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves six-month-old female patient who was inadvertently given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ318ABA and expiry date: 18-Jun-2021] via an intramuscular route in the left vastus lateralis on 21-JUN-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of 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 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.
Pain at injection site, burning and hives to chest, progressive worsening cough, light headed.
This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 16-year-old male patient who received BEXSERO (batch number 151501, expiry date unknown). Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced generalized urticaria. The patient was treated with CLARITIN, steroids nos and MEDROL dose pack. On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient was administered with a dose of BEXSERO on Friday at 4:00 and 2nd dose of MENACTRA the same day. A few hours later the patient broke out in hives. The patient was treated with CLARITIN and the hives had come and go over the weekend until Sunday, when the patient broke out into hives all over his body. The patient went to emergency room on Sunday and he was given a steroid injection and started on MEDROL dose pack. No further information was provided.
This case was reported by a physician via a sale representative and described the occurrence of unresponsive to stimuli in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline) and Hib. On 4 April 2014, the subject received unspecified dose of PEDIARIX (unknown route and injection site; lot number not provided). In April 2014, 1 day after vaccination with PEDIARIX, the subject was found to be lethargic and unresponsive to stimuli. This case was assessed as medically serious by GSK due to unresponsive to stimuli. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 11 April 2014 from the physician: Concurrent vaccination included pneumococcal vaccines (non-gsk) ;non-GSK manufacturer; given on 4 April 2014 and rotavirus vaccine (non-gsk) ;non-GSK manufacturer; both given on 4 April 2014. Concomitant medication was not reported. The subject had no known medical history or past drug therapy. The subject's previous vaccinations went uncomplicated. On 4 April 2014, the subject received 3rd dose of PEDIARIX and unspecified dose of Hib (unknown route and injection site; lot number not provided). In April 2014, within 24 hours after vaccination with Hib and PEDIARIX, the subject experienced a hypotonic-hyporesponsive episode. The episode did not last for a long time. The subject visited the emergency room. At the time of reporting the events were resolved.
Hot flushes, sweating, sensation over neck and shoulders. Hot feeling and running a temperature.
A report has been received from a Physician concerning a seven year old, male subject, who had been receiving FLUMIST (intranasal). Patient relevant history and concurrent diseases were not reported. Concomitant medications were not reported. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Patient's mother reported that the patient was diagnosed with flu after receiving FLUMIST which started during Aug-2012. Consumer mother stated that her 2 children received FLUMIST in Aug-2012 and one child diagnosed with Type A in Jan-2013 and the other diagnosed the Type A and B shortly after. The outcome of the event of children got the flu after receiving FLUMIST was unknown. The report was considered to be non-serious.
tingling sensation starting on my right feet, then right arm, then coming up on my body up to my face.; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN8730) via unspecified route of administration on 24Mar2021 12:45 PM at single dose for covid-19 immunization. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 03Mar2021 12:15 PM at left arm single dose for Covid-19 immunization (Lot number: EN6199). Within 10 minutes after the 2nd dose of the vaccine on 24Mar2021 at 01:00 PM patient felt tingling sensation starting on her right feet, then right arm, then coming up on my body up to my face. After 15 minutes of starting to feel those sensations, they stopped and I did not feel anything else so far it has been 8h approximately. No therapeutic measures were received for the event. The outcome of the event was recovered on 24Mar2021. Information on the suspect expiry date has been requested
A nurse reported that a patient inadvertently received an intradermal injection of Pnu-Imune 23 on 09/10/2001 instead of PPD. Follow up information received on 10/1/2001 indicated that the patient developed an injection site reaction characterized by a 2-cm by 3-cm area of tenderness and inflammation. The reaction resolved after 3 days. No further information was available at the date of this report.
Pneumonia; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; This is a spontaneous report from a contactable consumer (reporting for self). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),dose 1 via an unspecified route of administration, administered in Left Arm on 03Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE (at the age of 63 years) for covid-19 immunisation.  Medical history included ongoing chronic obstructive pulmonary disease (diagnosed for a decade), ongoing hypertension (diagnosed for a decade), ongoing type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes), ongoing pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec2020 when he had pneumonia, they did not hospitalize him. He has had pneumonia 5 time since 1982. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. "He gets the flu shot every, and he has had the shingles shot. He also gets the pneumonia vaccine every 2 years." The patient experienced pneumonia (hospitalization) on an unspecified date with outcome of not recovered, itchy, on 08Apr2021 with outcome of unknown, dry cough on 08Apr2021 with outcome of not recovered and non-productive cough on 08Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Oct2020.  On 13Apr2021 He reported it to the doctor and he told the patient to skip a dose of Lisinopril that sometimes it can have those symptoms of a deep nonproductive cough. He skipped the medication, and it hasn't gotten better. He thinks it is from the COVID vaccine.  At the peak of his cough, he probably had 6 days where he coughed uncontrollably for 24 hours in a day.  He still has a cough.  Therapeutic measures were taken as a result of pneumonia. The doctor didn't do a chest X-ray or COVID test.
AFTER GETTING SHOT, PATIENT PASSED OUT. I CHECKED BLOOD PRESSURE AND 73/42 AND PULSE WAS 51. CALLED 911. PUT PATIENTS LEG UP AND PUT SOME ICE ON BACK OF HER NECK AND UNDER ARM. PATIENT GAINED CONSCIOUS. FELLING OK. PARAMEDICS ARRIVED AND TOOK HER TO HOSPITAL. PATIENT WAS ABLE TO TALK AND ANSWER CORRECTLY.
2 inch diameter red, scaly, itchy spot.  Applied anti-itch cream.  Still red as of 10/18/2013 but reducing and not as itchy.
I had running nose, sore throat, and SOB. It was like a mild cold. These lasted for about 10 days. On Jan 5th, I tested for COVID-19.
After receiving the MMR Vaccine on May 11, 2017, patient slowly slipped away into what seemed to be a mind fog. He stopped giving eye contact and developed a severe complex motor stereotypy. Prior to May 11, 2017, patient met all his milestones, socially, with speech and interactively as well as normal eating habits. After the MMR vaccine patient regressed in his development socially, interactively, eating habits and also in his speech. He now sees a Neuromuscular Specialist and has a developmental delay as well as a speech delay. Once we realized that patient has developed these delays his pediatrician referred patient to begin speech therapy. It took a few months to begin this process. Patient's speech therapist is strongly recommending Occupational Therapy for patient's other developmental delay. However, the state strongly discourages more than one therapy given and only prefers that one therapy per week. Speech Therapy is a funded program through the state, however because patient does not have insurance, therefore we have to pay a percentage of each speech therapy visit. We cannot afford private Occupational Therapy treatment at this time. Mother (myself) has also found the Protocol and began that in January to help heal the brain/gut injury due to the MMR vaccine. As time went on from May 11, 2017 and watching patient slip away to this mental fog and regress in his already met milestones has been one of the scariest things I've ever seen as a parent. Watching videos recorded and picture taken of patient prior to the MMR vaccine and seeing his normal behavior and eye contact and interactions and love for various foods back then eat breaks a mother's heart.
Patient states that she had a seizure after her second dose of moderna covid vaccine. She did not seek medical attention.
This spontaneous report as received from a physician refers to a 12 year old female patient. On 29-APR-2002 and on 02-JUL-2013 the patient was vaccinated with the first dose and the second dose of VARIVAX (Merck) (lot # H020249, expire date unspecified), injection, subcutaneously. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). On 10-JUL-2013, the patient developed rash and was diagnosed with shingles after received the second dose of VARIVAX (Merck). On 10-JUL-2013, the patient noticed the rash on left hand and it spread to her arm. The patient saw the physician on 12-JUL-2013 and prescribed the triamcinolone cream 0.1%. But the next day she developed vesicular rash and was diagnosed with shingles. She was prescribed acyclovir. The event outcome was reported as recovered/resolved, but the date was unspecified. Additional information has been requested.
First series of symptoms started 7 hours after the 2nd vaccine shot, including intense fatigue, very strong headache (different from any headache I have experienced before), feverish (although no high temperature). Symptoms lasted about 30 hours.  Second series of symptoms started 5-6 days after the 2d shot, including intense fatigue, burning feet, pain in right leg, then left leg (location of pain changed but mostly behind the leg). Pain felt similar to the beginning of a cramp. Headache for over 48 hours again, feverish with some temperature from 99.5 to 100.5. Since then, pain in the leg has been on and off. Headache is gone, and fatigue is not as intense although still not back to normal.
This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot numbers M031695, expiration date 26-MAY-2017; M002268, expiration date 20-SEP-2017; M015290, expiration date 20-SEP-2017; M027879 expiration date 24-JAN-2018; M032492, expiration date 02-MAR-2018; M033611, expiration date 02-MAR-2018, dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008611:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008041:Original Case : 1701USA008041; US-009507513-1701USA008609:Original Case : 1701USA008041.
Pt started with (L) Deltoid redness same night as vaccine given 9/23/20. Site became Progressively red, hard, swollen and tender.
Patient became faint and passed out twice within minutes of receiving vaccine.   Patient came to both times relatively quickly.   EMT at the scene evaluated patient and his vital signs were all normal.    Patient then stated "this happens sometimes"
02/08/22 presents to ED for "Failure To Thrive". PMHx of "Afib on eliquis/plavix, DM, HTN, hypothyroid, CVA, vascular dementia"
I administered a 5-11 aged vaccine to a patient older than 12 years. No reactions were noted. Primary physician spoke to the patient and advised that we would give the correct dose in 21 days from now.
Dizziness, Headache, Myalgia, Fatigue, Narrative:  Other Relevant History:
This case meets vaccine breakthrough criteria review.  SxS Appetite change, fever, cough, abdominal pain, back pain, myalgias, headache
This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with Havrix (GlaxoSmithKline). The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported. On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Havrix in an unspecified thigh. At an unspecified time after vaccination with Havrix, the subject experienced welt injection site. The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly "At the time of initial reporting the outcome of the events was unspecified. Follow-up information received on 11 May 2007 indicated that Havrix was administered to the subject subcutaneously. The events resolved and according to the reporter, they were related to administration of Havrix.
Next day: chills, fever, aching all over, sore throat, coughing, lethargic. Still have severe coughing. Missed work. Symptoms subsided 4 days later. Still sick.
Patient was given first Pfizer vaccine dose on 9/8/21.  Starting feeling symptoms of dizziness and slight nausea on 9/9/21.  On 9/10/21, patient was very nauseous and vomiting.  Vomiting continued to get worse in the next few days ending in a hospitalization on 9/13 - 9/18.  Vomiting was as bad as 30 times per hours (per patient).  She also reported that she had an increase in blood pressure during her hospitalization, but unsure of what day that occurred.  Headache was a side effect that was reported starting on 9/9/21, but unsure of when that subsided.
chest pain, muscle spasms, pain in leg, Narrative: This is a 50-year-old female with history of hypertension, obesity, diabetes who received first dose of Moderna Covid-19 vaccine on 3/26/21 around 1:37 pm. Within 24 hours, the patient reported episodes of shooting pain to her left upper chest and left arm then radiated to left leg and calf area. She also had headaches and elevated blood pressure. The patient did not report the event until 4/10/21. She was evaluated at the Emergency Department (ED) on 4/10/21 for atypical chest pain/arm pain. She was sent out on hydrocortisone 2.5% cream, baclofen for muscle pain, and meloxicam for pain. On 4/14/21, patient returned to ED as she was still experiencing multiple episodes of left sided chest pain radiating down to the left arm. Patient had nuclear stress test which was negative for any reversible cardiac etiology. Pt had mri and mrv which were both wnl. Her lisinopril dose increased and pt's bps are now well controlled. As of 4/16/21, patient reported that she still has lingering left arm pain but symptoms much improve. She was discharged home in stable condition on 4/16/21.
Eye pain & itchy & puffy; Eye pain & itchy & puffy; Eye pain & itchy & puffy; itchy face & neck & torso; sharp shoulder pain; greatly increased leg numbness & back pain; greatly increased leg numbness & back pain; hurts to lift left arm for a few days; bad sulfur body odor smelled by self & others for a few days; mild headaches; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Ew0164), via an unspecified route of administration, administered in Arm Left on 21Apr2021 17:00 (57-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included spinal stenosis from, fibromyalgia, mycotic allergy from an unknown date and unknown if ongoing and Known allergies of Molds. The patient previously took amoxicillin and experienced drug hypersensitivity, neurontin and experienced drug hypersensitivity. Concomitant medication included fentanyl, hydrocodone bitartrate, paracetamol (NORCO), methocarbamol (ROBAXIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took unspecified dose number of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Ew0150), via an unspecified route of administration, administered in Arm Left on 31Mar2021 as unspecified dose number, SINGLE for covid-19 immunisation and experienced sulfur body smell, arm pain, sharp pain to little fingers on both hands, headache, itchy face & neck & torso for several days. On 21Apr2021 18:00, the patient experienced eye pain & itchy & puffy, itchy face & neck & torso, sharp shoulder pain, greatly increased leg numbness & back pain, hurts to lift left arm for a few days, bad sulfur body odor smelled by self & others for a few days, mild headaches. The patient has not been tested positive prior to vaccination and post vaccination. Treatment was not received for the events. The outcome of events was not recovered.  No follow-up attempts are required. No further information is expected.
Tinnitus.....beginning to affect ability to sleep...appointment has been made with specialist Nov 9, 2021
3hr p/shot T104 R;off/on T for 24hr;checked 24hr p/shot, exam nl except mild ROM; Tx w/ amox; had URI Sx for 1 wk prior;
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 25-year-old female patient. The patient's medical history included thyroid cancer, endometriosis, irregular menstrual periods, "psych issues", motor vehicle accident and facial nerve damage. She had no concomitant medications or drug reactions and allergies. On 06-JUN-2018, the patient was vaccinated with a second dose of GARDASIL 9 injection, lot # N019104, expiration date 02-MAR-2020, intramuscularly, for prophylaxis. After the vaccine was administered, the patient had a urine pregnancy test done which was positive. The patient reported her last menstrual period (LMP) was in February of 2018. The pregnancy outcome was outcome pending. On the same day, the patient also had a Papanicolaou test (reported as "pap smear") done, a urine test for chlamydia and a blood test for human chorionic gonadotropin (HCG) but results were not available. The patient sought medical attention. No adverse effects were reported. The outcome of exposure during pregnancy was unknown.
Pt developed a rash all over body with low grade fever of 99.8 for 2 days. Pt also had watery eyes. Physician diagnosed erythematous  dermatitis and treated with Benadryl.