chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client's mother provided incorrect last name when registering for vaccine appointment. Due to this inaccurate information, no client record was found in database. Patient asked parent to bring to record and reconfirmed when child last had vaccines. Per parent they were unsure, however it had been a "long time". After the appointment, when completing chart another last name was noted, Staff looked for record in database under this last name. Record found. Client received HIB and PCV when they were not indicated. Staff notified parent of error, child had no adverse outcome.
03/09/2021 at 1532  Pt reported that she was feeling dizzy, itchy under arms, behind ears, around mouth, and throat was feeling a little numb and tight. Pt denies SOB. No rash noted. Vitals taken at 1535 ? BP 118/72, 95 % O2Sat, 76 BPM, 20 resp. Pt reported that she still continued to have itchiness in throat, arms, and mouth. Vitals taken at 15:49 ? 132/98, 95 % O2Sat, 77 BPM, and 20 resp. At 1554 50 mgs of Benadryl was given on left deltoid. 1555 911 called. Dispatched directed us to lie pt supine and administer Epi SQ at 1600. Standing orders is 0.3 mgs Epi 1/1,000. 1602 vitals 132/90, BPM 65, 95% O2 sat, and 20 resp. 1605 pt reported that she was starting to feel a bit better. 1606 EMS arrived on scene for evaluation of pt. Pt was placed on cardiac monitor, pt placed in sitting position and evaluated by paramedics on scene. No visible rashes on back and extremities. Pt states that her throat tightness and numbness is gone, along with itchiness to all areas. Pt at 1612 signing out AMA with EMS. Pt further evaluated with clinic RNs and educated pt of possible adverse effects of epi administration of rapid heart rate or dysrhythmias, and told to contact 911 if any further symptoms arise. Pt educated about getting her second vaccine through her doctor due to further possible complications, clinic is not equipped to handle. Pt has sister in-law waiting in parking lot to take her home. Pt was observed for 1 hour and 10 mins, leaving facility at 1625.
She developed a DVT <4 weeks after receiving the vaccine (first became symptomatic 4/30).  She has a potential alternative cause in that she was taking oral estrogen but no other provoking factor.
gave Adacel to an 18 month old with no adverse event; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 month old patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel) by mistake (product use issue) (batch number: U6830AA and expiration date: unknown) 4th dose via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   This was an actual medication error case due to the event product use issue (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
A non-serious spontaneous report of FLUMIST "administration to six month old" was received from a registered nurse concerning a six-month-old of unknown sex. The patient's medical history and concomitant medication was not reported. On 30-Oct-2009, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/ sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up: Required follow-up attempts have been performed, requested information unable to be obtained.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001689 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *21-years-old (as reported) female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples. At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 21-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 21-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
11 days after receiving the booster I began having intense itching and hives on my body.  No other allergic factors could be identified (e.g. change in diet, detergent, pets, etc.). The hives have continued daily, and do not seem to respond to regular antihistamine use (Benadryl). The hives are highly reactive to touch (dermatographic) and can even be spontaneously generated - raised welts will appear after gently scratching an otherwise calm area of skin.  First and second dose of the vaccines were also Moderna, without this reaction.  Medical literature is very sparse on this condition, but I was surprised to find in social media community of 1300+ members reporting very similar symptoms to mine (delayed chronic urticaria after COVID vaccines).
Patient reported her arm was swollen, red and painful.  She reports a similar reaction to a previous flu shot.
Patient received Moderna Covid vaccine 6m-5y in our office today in error: Given 0.25 mL 6/18/2022 IM LEFT LATERAL Moderna AS1412B. The patient previously received the following: COVID-19 6M-4Y Pfizer-BioNtech 6/23/2022 Given 0.2 mL 6/16/2022 IM LEFT LATERAL Pizer FT9142
My period came a week early the day after my 2nd dose of the vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 04May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05May2021, the day after 2nd dose of the vaccine, the patient's period came a week early. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period came a week early the day after 2nd dose of the vaccine was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 210 pounds, and height was 69 inches. The patient's concurrent conditions included hypertension controlled by medication, social alcohol user, and non-smoker. The patient had known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient underwent COVID-19 SARS-CoV-2 Antibody (IgG), Spike, Semi-quantitative test, and it came back negative (confirmed immunological vaccine failure). The patient reported that according to the package, this particular test provides insight to antibody response to infection and exposure to the vaccine. The patient not discussed this results with her health care provider (HCP). The patient performed this test because of the recent discussion of boosters, and she wanted to know if she was still covered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191192.; Sender's Comments: V0. 20210855625-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
received call from patient's wife. reports received 2nd COVID 10 vaccine on 3/25/21 and 2 days later husband went deaf at 5pm on 3/27/21. Went to the ER, then regular physician. Was referred to audiology.  Wife states all physicians informed that cause of deafness was caused by the vaccine. Patient may or may not get full hearing back. Reports left hearing has partially returned and right hearing has not.
Patient was given Zostavax (lot1089U) and immediately felt tingles in arm.  Appr. 30 seconds later patient felt faint and stunned.  I laid patient on ground to prepare for CPR and EMT arrived. Patients wife said he had diabetes and that they had not been checking blood sugar.  EMT said they think his faint spell was due to blood sugar and not vaccine related.  EMT took him to hospital.
Patient lost unconsciousness for a few seconds a few minutes after receiving dose. Woke up in less than a minute.
I have had almost a non-stop migraine since my first dose of the COVID vaccine.; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7533), via unspecified route of administration in the right arm, on 02Apr2021 at 10:15 AM, as 1st dose, single for COVID-19 Immunisation. Medical history included chronic migraine. Concomitant medications included rizatriptan benzoate (MAXALT), Naproxen sodium (ALEVE), gabapentin. The patient had no known allergies. The patient was not a pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW6170), via unspecified route of administration in the right arm, on 25Apr2021 at 02:30 PM, as 2nd dose, single for COVID-19 Immunisation. On 03Apr2021, the patient experienced non-stop migraine, suffered from migraines for decades, but this was noticeably worse. It was reported that normal preventative measures do not helped like they did before. The patient stated that her triptan drugs (rizatriptan or naratriptan) do still provide relief. The patient received neurological treatment. 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 4 weeks prior to the COVID vaccine. The outcome of the event was not resolved.   Follow-up attempts are completed. No further information is expected.
The symptoms I had was fatigue and slept for 2 days.  I also had headache pains, nausea, and a weird pain on the sides of my head to my eye and my ear.  I also had pain in my upper jaw.  I also had swelling in my temples on my head.  It did not hurt all the time it was off and on.  I went to the doctor, and she did not know what the swelling was for, but I did have an ear infection in my left ear.  She prescribed antibiotics and I took all of those, but it did not go away.  It took a few more days past the antibiotics to go away.
severe migraine, light headedness, fever, nausea, vomiting, extreme fatigue, arm soreness, twitching fingers in hand of arm Vaccine given, low blood sugar, chest pains through into the back, abnormal heart rate, fainting
Intense full body aches, starting 10 hours after shot. Fatigue, weakness. Chills. Fever.  Heart racing. Body aches and fatigue lasted 24 hours. Chills and fever lasted 12 hours.  Redness, swelling, and itchiness at injection site starting 48 hours after shot.
Patient was in for his 12 month well exam with Dr. He was to be given MMR, Varicella, and HIB per Dr. CMA got a Proquad, Varicella, and HIB. She did not follow the correct process to pre document prior to giving vaccines and administered the incorrect vaccines. Because of this patient received two doses of the Varicella vaccine. Proquad was also given and has increased risk for fever and seizures in this age group.
Rash and and redness on the arm and it's tender to the touch; Rash and and redness on the arm and it's tender to the touch; Rash and and redness on the arm and it's tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005387, 202005389 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment:The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
it almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the first injection of vaccine almost killed him/her, so doctor told to not take the 2nd dose.  The patient stated that he/she wont take this one either, if they ever even come out with vaccine. No other information was reported.
Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness.
Patient came to an in store clinic for a second dose. Patient did not report that he had received a first dose pfizer on 3/27/21 at a different location.
PATIENT HAD CHILLS AND BODY ACHES AT NIGHT AND WOKE UP NEXT DAY 7/27/20 WITH REDNESS, PAIN IN ARM ALONG WITH IT BEING SWOLLEN AND HOT. PAINFUL TO SLEEP AND IT ALSO BECOME ITCHY THROUGHOUT THE DAY THEN
Vaccine was first punctured at 9:05 am, and vaccine for this patient was administered at 4:25 pm, 20 minutes past the 6 hour vaccination window. This mistake was later noticed by the provider who collected vaccines at the end of the day, and was investigated at 5:30 pm the same day. The patient has not reported any adverse effects, and the manufacturer was contacted for guidance.
Received part of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Shingrix. On 13th January 2023, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's comments: Pharmacist had stated during administration of a Shingrix dose to a 50 year old patient,  the needle had dislodged and part of the product had leaked out.  The patient only had received a part of the vaccine, and the amount actually received was unknown.  This was the patient's first dose in the series. The reporter consented to follow-up. Additional supportive information: At the time of reporting, the needle had dislodged and part of the product had leaked out, which had led to Incomplete dose administered.
Right after the injection, I felt flushed. For the following 2 days, I felt: chills, headache, a light/dry  cough, light nausea, balance was off, concentration was off, fatigue, and joint pain (esp. in hands and  fingers). Symptoms cleared by 2/15/2021 except for headache, which remained present every day and  Intesified. i told my wife for the first time about it on 2/22/21, then told her that I worried it was a  symptom of a stroke on 3/1/2021 and she told me to call my doctor. I met with PA  on 3/3/2021 and had a CT scan on 3/9/21. I met again with PA on 3/9/21 and  was told that my CT scan indictate normal brain abnormalities due age and an inflamation in the  sinuses.
Pt describes soreness, intermittent numbness and pain along shoulder and down left arm since receiving Hep-B vaccine.
Lumps on her chest; Pain moved under her arm; Fever of 101.1 degrees F; Tired; Sleepy; Arm was painful; Extreme pain on her upper back; Back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful) and BACK PAIN (Extreme pain on her upper back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN and FAMOTIDINE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BACK PAIN (Extreme pain on her upper back), MUSCULOSKELETAL DISCOMFORT (Back was hurting) and PAIN IN EXTREMITY (Pain moved under her arm). On 06-Mar-2021, the patient experienced BREAST MASS (Lumps on her chest). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 08-Mar-2021, PYREXIA (Fever of 101.1 degrees F) had resolved. At the time of the report, FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BREAST MASS (Lumps on her chest) and PAIN IN EXTREMITY (Pain moved under her arm) outcome was unknown and BACK PAIN (Extreme pain on her upper back) and MUSCULOSKELETAL DISCOMFORT (Back was hurting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pyrexia: 101.1 Degree F..
Change in medications. Increased doseages. Ozempic shots for diabetics in addition to increased level of oral meds. TSH elevated. Increased medication  dose. Uncontrolled blood pressure. Increased meds and addition of second medications.