chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week after third Covid 19 vaccine shot she developed Shingles.    Approx 1 week later had a ruptured cholecystitis which required multiple surgeries.  After surgery she was unable to be extubated for an extended period.  Once extubated was on high flow oxygen and could not maintain sats on room air.   Was too weak to swallow or stand.  Had a feeding tube placed.  Never regained strength and on April 13 she chose to go on hospice and care was withdrawn.  She died on April 16th, 2022.
Information has been received from a nurse practitioner concerning a 19 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient tested positive as "high risk" HPV infection. The patient sought unspecified medical attention. At the time of the report the patient's outcome was not specified. This is one of several reports received from the same source. Additional information has been requested.
Back pain, chest pain, neck discomfort. Seen in ER 10/25/18. Chest CT negative for dissection, pneumonia or blood clot. Ruled out for an MI. Treated with morphine and TORADOL and went home. She reports ongoing shortness of breast.
10 days after receiving first dose of Moderna vaccine, patient developed a right arm nodule with right arm tenderness and erythema as well as a headache and dizziness.  She reports that the dizziness, headaches, and nodule have resolved, but she continues to experience right arm erythema. Small amount of right arm erythema noted on exam.  Small amount of tenderness noted at the injection site.  No streaking erythema or discharge noted. Patient started on prednisone and hydroxyzine for 5 days
HAD BODY ACHES, SCRATCHY THROAT, HEADACHE AND FEVER OVERNIGHT
Hallucinations; This serious case was reported by a nurse via sales rep and described the occurrence of hallucination in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant). The outcome of the hallucination was resolved (duration 1 hr).   It was unknown if the reporter considered the hallucination to be related to Arexvy.     It was unknown if the company considered the hallucination to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter reported that the patient received Arexvy vaccine accompanied with an unspecified flu vaccine and experienced hallucinations. The reporter stated that she did not know when the hallucinations started after administration of Arexvy vaccine.   The reporter stated that the patient thought she was on fire for an hour and then hallucinations resolved. It was unknown if the reporter considered the hallucination to be related to Influenza vaccine. This case was 2 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023152427:Same reporter US-GSK-US2023152421:Same reporter
A 10 month old male received an injection of Prevnar on 8/14/00 and within 24 hours, he developed a "very large" injection site reaction characterized by an 6cm by 8cm area of warmth, redness and a 5cm by 7cm area of induration. He was seen by the physician on 8/16/00. The reporter noted that the child received an IM injection of ceftriaxone on 8/11/00; however, he was unsure which arm the pt received the injection.
This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of RECOMBIVAX HB injection 10, which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. Therapy with RECOMBIVAX HB injection 10 was continued. The outcome of improperly stored RECOMBIVAX HB vaccine administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA011760 and MARRS # 1404USA011761 as same reporter link. Additional information has been requested.
Patient states at approximately 6:30pm on 6/14/21 about 6.5 hours after receiving her second dose her ankle started to itch while watching television.  The pt took off her sock and says the veins on he top of her foot turned dark blue (no other place) but subsided to normal with in 15 minutes.  She but topical benadryl on her ankle and it helped with the itching.  She still has a small rash on the arch of her ankle and a slight bump like a bug bite but the patient insists it is not a bug bite and would like the reaction reported.  She also experienced some flu-like chills yesterday.  Told the patient to call and speak to her doctor.
Rec'd vaccines 8/18/15 at WCE. C/O (Rt) arm/deltoid edema and erythema starting 8/19/15. Seen for same 8/19/15 at 1115 AM. Stated redness had increased since 8/18/15. > 4 x 4 cm area pink with warmth. No streaking; afebrile. TX > cold compresses-ibuprofen, BENADRYL.
4/5/21:  Office visit for myalgias, headache, and localized swelling/erythema to injection site (left deltoid).  Bactrim DS prescribed for possible infection with symptom management. 4/13/21:  Office visit for continued myalgia as well as chills, malaise, abdominal pain, N/V/D and dizziness.  Decadron 10 mg IM given in office and prescribed  prednisone. 4/14/21:  ED visit for headache and shortness of breath.  CTA chest, CT head, UA, urine pregnancy, D-dimer, Chem 14, and CBC done.  Diagnosed wtih episodic tension headache and abnormal CT chest (6 mm ground glass nodule to upper left lung). 4/15/21:  Office visit with c/o fatigue, dyspnea with moderate exertion, allergy symptoms, and headaches - follow up from ED for abnormal CT results - informed inflammation, infection - will repeat CT in 3-6 months.  Prescribed Z-Pak, medrol pak, and promethazine.
Pt. states that after receiving the 2nd dose of Moderna 03/04/2021, started experiencing symptoms 07/07/2021 suffering from a Heart Attack (Stressed Induced Cardiomyopathy).
Patient requested HD flu shot due to misconception that she needed it because she has CHF. Mistake not caught by pharmacist who typed Rx and pulled vaccine from fridge. Vaccine administered by pharmacy tech. Patient informed. Patient should have received normal strength Fluzone rather than Fluzone HD.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild
Headache, Myalgia, Sore throat, chills Narrative:  Other Relevant History:
On Friday 09/13/2002, mother called 1pm stating that left arm was swollen fom top to elbow, red, warm, and itchy. No fever. treated with ice and possibly Benadrly.
woke up 01/07/2021 with a rash around the injection site. It is slightly itchy, red and raised.
On 10/31/19 patient developed fevers (Tmax 102.2 on 11/3/19) followed on 11/1/19 with papular/vesicular rash.  Rash was very itchy.  Subsequently developed malaise, sore throat, mild headache and mild cough.  No contacts with rash.  Pt treated herself symptomatically with tylenol for pain and fevers and hydrocortisone for rash.  Patient seen by this provider in the office on 11/4/19, had negative rapid flu test.  Low suspicion for strep throat, testing not performed.   Concern for possible varicella.  Recommended supportive care only and to avoid contacts at risk of varicella infection.
Patient started experiencing alot of pain and swelling in the arm the next day. States that she has had limited range of motion and cannot lift her arm above her wrist currently.
LOCAL REDNESS AND SWELLING OF LEFT ARM,  TREATMENT PLAN INCLUDES ICE, IBUPROFEN EVERY 6 HRS AS NEEDED, BENADRYL FOR ITCHING
Fever, chills, severe body aches and vomiting in first 24 hours.  Soreness in upper arm around injection site, loss of appetite, diarrhea, intermittent chills, and tingling in the fingertips from 48 hours on (still ongoing)
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of M-M-R II (lot number reported as M028130 (rHA) and expiration date 03-JUN-2018, dose and route were not reported) for prophylaxis.   The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved.   Additional information has been requested.  This is one of the several reporters received from the same source.; Sender's Comments:  US-009507513-1702USA003521:Original Case : 1702USA001003 US-009507513-1702USA003523:Original Case : 1702USA001003 US-009507513-1702USA003520:Original Case : 1702USA001003 US-009507513-1702USA003522:Original Case : 1702USA001003
Burning pain in chest on left side after 3rd day of receiving shot. 24 hrs after the shot fatigued,nausea, and headache developed. Those symptoms went away after 2 days. 18 days after the 2nd shot I had a heart palpitations and still burning pain on left side of chest. I continued to have heart palpitations for the next 11 days every other day. The severity of each one got less severe as time went. Emergency doctor gave me 6 days of steroids and Ibuprofen 800 MG 3 times a day. After 2 days of steroids and ibuprofen, the pain in my chest went away. It has been 16 days of bland diet and water and I still have not fully recovered. I still sometimes get sharp pains in my chest but the rapid heart beat has not come back.
"Not himself" Slept till 8-9 p, on day of shot. Not active. Little warm subjective. As of 2/4/2014 -> still not himself. Still warm.
serious neurological symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I had ever single one), for Covid-19 immunization. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms".  Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, I had ever single one, including the omicron booster. After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. I told my doctor shortly after and to my surprise, she said they were serious neurological symptoms and getting another would be dangerous. I'm very concerned about COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012028 same patient and event, different dose;US-PFIZER INC-202300012027 same reporter/pt/event, different dose;
Received Varivax 11/16/07 - Rash started 11/24/07 precede by runny nose/low grade fever. Rash - 5-10 areas entire body.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EB8737), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0172), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Adrenal Hyperplasia" (unspecified if ongoing). Concomitant medication(s) included: FLUDROCORTISONE, start date: 01Sep2021; HYDROCORTISONE, start date: 01Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021.  Information on the lot/batch number has been requested.
15 YO received Pediarix; 1st  TDAP Oct2021, 2nd Feb2022; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe (batch number B4722, expiry date 17th February 2024) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Hepatitis B (1st dose received at age 14 years), Hepatitis B (2nd dose received at age 15 years), Polio (1st dose received in 2021), Polio (2nd dose received in 2022) and TDAP (1st dose of TDAP in October 2021).   On 24th February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. In February 2022, the patient received the 2nd dose of Tdap Vaccine. In February 2022, unknown after receiving Tdap Vaccine, the patient experienced drug dose administration interval too long. On 24th February 2023, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The nurse reported that Pediarix was administered to a patient as a catch up vaccination. All reported adverse event information contained within adverse event report. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of TDAP later than the recommended interval, which led to lengthening of vaccine schedule. The patient received a dose of Pediarix at inappropriate age, which led to inappropriate age at vaccine administration. The case was processed in worst approach with inappropriate age at vaccine administration for Pediarix and lengthening of vaccine schedule for TDAP due to limited information was provided and further clarification request was raised.
RECEIVED 0.3 ML OF JNJ VACCINE AS A BOOSTER THIRD DOSE AFTER TWO DOSES OF PFIZER VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .3 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced received 0.3 ml of JNJ vaccine as a booster third dose after two doses of pfizer vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 0.3 ml of JNJ vaccine as a booster third dose after two doses of pfizer vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211045172 and 20211045143.
PATIENT PRESENTED TO MEDICAL CENTER ER ON 8/9/2021 WITH APPROXIMATELY 5-6 DAYS OF GENERAL ILLNESS TO INCLUDE NASAL CONGETSTION, COUGH PRODUCTIVE WITH WHITISH SPUTUM. SUBJECTIVE FEVERS AND CHILLS, GENERALIZED WEAKNESS AND DECREASE APPETITE, MULTIPLE SYNCOPAL EPISODES, SOME DIARRHEA. DENIES ANY KNOWN SICK CONTACTS OR RECENT TRAVEL. TOOK HOME COVID TEST REPORTED IT WAS POSITIVE. RETESTED AT HOSPITAL. COVID19 SARSCoV2 = DETECTED ON8/9/21
Administered 1st dose of Moderna COVID-19 vaccine to 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old) 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.   No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from a certified medical assistant who reported that on unspecified dates one unspecified patient received improperly stored RECOMBIVAX, lot # L038018/exp. 13-SEP-2017; three unspecified patients were vaccinated with VAQTA, lot # L015460/exp. 20-JUL-2017 and three unspecified patients were vaccinated with VAQTA, lot # M011839/exp. 13-SEP-2017 (MARRS# 1610USA003123). It was reported the vaccines were improperly stored. Temperature was reported as 35 degrees Fahrenheit. Time frame was reported as 15.5 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Lump/swollen lymph node at left clavicle; This is a spontaneous report from a contactable other hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: 301358a) dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 12:30 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (at the age 42 years). No known allergies were reported. Medical history included covid-19 and hypertension from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: ER2613) dose 2 via an unspecified route of administration, administered in Arm Left on 22Mar2021 as DOSE 2, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not written on card) dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced lump/swollen lymph node at left clavicle on 09Oct2021. No therapeutic measures were taken as a result of event. The clinical outcome of the event was not recovered.  Follow-Up (21Oct2021): Follow-up attempts are completed. No further information is expected.
Was given Adacel 8/12/06 patient had positive pertussis test 11/3/06. office visit 11/6/06-pertussis exposure, treated with Zithromax. treated for leg laceration. On 11/22/06 continues to cough, treated with Histussin HC.
Patient reported GI symptoms after 2nd dose. Fatigue, ongoing abdominal pain.
pt recv vax to lt leg on 26OCT95-mom reported crying for 4-5 days afterwards
Fever 102 degrees swollen Lt foot, vomiting, loss of appetite & fussiness.  No treatment.
Immediate fever, 102.5, aches, flu-like symptoms for 7 days.
Sx : Pt left arm (vaccinated arm) shows red rash an back of arm from elbow to shoulder. 2" radius around injection site is dark red. Rash area is itchy. Tx: Topical Hydrocortisone.
Recieved 3rd Gardasil shot on February 28, 2008. On 3/10/2008 site where shot was administered still sore.  To touch it feels as if the site is bruised.  To rotate arm (i.e. such as crossing arms to pull shirt off) - upper arm where shot was administered in terrible pain.  Sore if sleeping and roll over on it.  The pain has been there around the shot site since the day of the shot and has not lessened.
Fever up to 104.0 within 12 hours of TWINRIX & ADACEL vaccines given.