chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 01Apr2021, 3rd dose on 07Sep2022; Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 7th September 2022, the patient received the 3rd dose of Engerix B pediatric. On 29th April 2021, the patient received the 2nd dose of Engerix B adult. On 1st April 2021, the patient received the 1st dose of Engerix B adult. On 1st April 2021, not applicable after receiving Engerix B pediatric and Engerix B adult and unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On 29th April 2021, the patient experienced overdose and adult product administered to child. On 7th September 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the overdose, adult product administered to child, overdose, adult product administered to child and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's comments: The reporter was patient's parent. The reporter reported that an 18 years patient received 1st and 2nd dose an adult dose of Engerix. She received a late 3rd dose (pediatric dose) at the age of 19 years old. The reporter stated the patient received the vaccinations at a different pharmacy. The reporter did not have the lot number and expiry date of vaccines. The reporter was consented to follow up. No symptoms reported. Additional Supportive Information: The patient received 1st and 2nd dose as adult dose of Engerix B, which led to overdose and adult product administered to child. The patient received a late 3rd Engerix B dose (pediatric dose) at the age of 19 years old, which led to lengthening of the recommended interval between vaccine doses.
Pt c/o pain, swelling up the right arm and neck, no respiratory distress.
Administered date: unknown, dose number = 3; Headache; Fever; Body aches and pains; Stomach upset; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had known allergies to latex sensitivity. 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 vaccination. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient had "administration date unknown, dose number=3". On 08Oct2021 at 17:30, the patient experienced headache, fever, body aches and pains, and stomach upset. The events 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 events headache, fever, body aches and pains and stomach upset. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, body aches and pains and stomach upset was recovering at the time of this report. The clinical outcome of the event "administration date unknown, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
On Sunday June 10, 2022 I got hives on my scalp and neck area that were very itchy. On Monday it had covered my neck and upper back. By Tuesday they had covered my back, I had a telehealth visit and my doctor called in a prescription steroid. By Friday I had to go in for a steroid injection as I was completely covered in hives and itching uncontrollably. The injection I got on Friday did not help, I went to the Emergency Room on Sunday and received both oral and injection steroids. I have am unable to work from being tired from the steroids I woke up this morning June 22, 2022 and discovered new break out on my left eye, lower back and left arm.
Scratchy throat approximately 15 minutes after injection. Benadryl 25mg administered by mouth. Patient began to feel better within 15 minutes.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Chest pain and tightness between my heart and left armpit.  Sporadic, elevated flushes of heart rate, high blood pressure, and several sharp episodes of pain going from my chest through my left arm to my left elbow.    I have a normal EGK and my CT scan was fine with no calcium deposits.  I still have pain and tightness with occasional flushes of my heart rate, felt specifically in my neck when I'm resting (sleeping). Blood pressure is still elevated.
Generalized hives (urticaria) after 1 hr-1 1/2 hr vaccination. No systemic symptoms. Resolved by 3 doses of BENADRYL (oral).
Client under the age of 18 at time of receiving vaccination.  Parent and client called. Both state: "feeling fine, except a sore arm." Medical Director Notified.
Heart was beating so fast as they were lying down they could almost here it pounding; Pain was irradiating from the shoulder to their breast; Terrible shoulder pain / pain was sharp and deep bellow the tissue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding), PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue). On 04-Aug-2021, the patient experienced PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding). On 05-Aug-2021, PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) had resolved. At the time of the report, PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Heart rate: 100 heart beats per minute (High) around 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported
This spontaneous report was received from a consumer reporting on herself as a currently 69 year old female patient with Codeine allergy. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling, musculoskeletal pain, muscle spasms, arthralgia, breast swelling and injection site pain. The patient received treatment with Flexeril. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. Additional information has been requested.
03/15/2021: Presented to the emergency department with shortness of breath and not feeling well. The patient was admitted with pulmonary vascular congestion on imaging and UTI. The patient is currently still admitted.
Pt has been short of breath for one week. Pt has chronic asthma and is on 3L home oxygen. Pt admitted for COVID-19 and asthma exacerbation.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
The next day after the vaccine around 3PM, I felt my heart beat really fast and was getting light headed. I checked my smart phone and my heart rate was 170. I called my cardiologist office. I checked my phone again that indicated was A-fib. I went to ER, they were about to shock my heart but the and a cardiologist was there to say no. I started a medication called diltiazem which was an IV drip. I could not tolerate it due to dropping my blood pressure really low. I was kept to monitor over night. The next day I went into Ventricular tachycardia. I was kept another night and it did just stop and was discharged next day. I spent a total of 2 nights in the hospital. I was seen by a cardiologist. I had a stress test and CT angiogram which was fine and cleared. I have had a change in medications which is metoprolol and a blood thinner for a month. I also take an aspirin. I do have a routine visit in May.
I was suddenly hit with severe muscle and joint pain; I was suddenly hit with severe muscle and joint pain; Patient received first dose of vaccine on 01Mar2021 and received second dose of vaccine on 06Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 79-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration in Arm left, on 06Mar2021 at 12:00 PM, as a single dose for COVID-19 immunization at hospital (Age at vaccination was 79 years old). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on 01Mar2021 at 12:30 am, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient medical history included RA (rheumatoid arthritis), ISBC (irritable bowel syndrome), GERD (gastroesophageal reflux disease) and moderately high blood pressure and allergies to codene. Concomitant medication included immunosuppresent SULFASALAZINE for RA (rheumatoid arthritis). On 06Mar2021, the patient had Inappropriate schedule of product administration. It was reported that patient received first dose of vaccine on 01Mar2021 and received second dose of vaccine on 06Mar2021 and stated that on 14Mar2021 at 12:00 PM, after second vaccination she was suddenly hit with severe muscle and joint pain. It lasted for 36 hours and then gradually began to improve and the only immunosuppresent patient take was Salfasalazine for RA. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any treatment for the events. The patient underwent SARS-CoV-2 test Nasal swab with the result of negative on 26May2020. Outcome of the events muscle pain and joint pain was recovering and outcome was unknown for the event of inappropriate schedule of product administration.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness  Unsteadiness Fainted and fell backward hitting head and both arms when blood pressure bottomed out 10/26/2010.
Immediate: None; Within several hours: Arm pain/discomfort.  10 hours later (c. 7:30pm): Intense chills, body aches 12 hours later (c. 9:30pm): intense chills, body aches, skin ache, fever (approx. 100.3F), joint pain, exhaustion, lightheadedness, migraine Symptoms lasted approximately 24 hours; Slowly dissipated starting around noon on 3/27. Exhaustion persisted.  Monday, 3/29: Woke up with nausea, minor headache, fatigue.
Case number PHEH2012US018053 is an initial spontaneous report received from a pharmacist on 09 Sep 2012. This case refers to a 40-year-old female patient. She was vaccinated only with the MenCYW-135 component of MENVEO vaccine (batch number: not reported) intramuscularly on 09 Sep 2012. No other information was available at the time of this report.
Numbness, tingling from ear to right arm at injection site. At ER complains of right cheek tightness and tingling continually down to right shot area.
Patient stated arm is still sore after a month. Patient reported to doctor.  He still has range of motion just stated arm is sore.
REDNESS, LUMP, WARM TO TOUCH AND SORE AT INJECTION SITE.
I had cough, congestion, achy, fatigue, and running nose. I tested positive for COVID-19 at home. I emailed my doctors office and was sent a prescription for Paxlovid.
Left arm pain, red, warm to touch, swollen. Left arm swollen 4 inches below injection site.
A non-serious, spontaneous report of "got H1N1 and now feeling like she has the flu" and nausea has been received from a consumer concerning an 16-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like she had the flu and nausea. Neither outcome nor causality has been reported for these events.
weakness, pharyngitis, upper resp infect, sweating, achiness, sensation of warmth, lightheadedness, chills, flushing abd pain, diminished appetite, cough, arthralgia,myalgia,neck & shoulder pain, stiff neck, lymphadenopathy, disturbed;
pt was found dead in crib on 19APR96;pt recv vax 18APR96;pt was laid on belly to sleep
Started to feel dizzy while driving around 11pm. Got home and headache came on. Started feeling nauseous around 1pm. Felt like I was having palpitations in my chest but pulse checked with pulse oximeter showed 60-80bpm. Eyes became blurry for about 15 minutes. Increased urination without any pain. Felt dizzy and had major chills. Sx lasted for 1-2 hours. Took 2 exedrine pills as well as checked blood pressure which was 160/100. Rechecked blood pressure at 6pm and was 180/99. No fever just intermittent chills. Normal blood pressure 120-130/80.
I am submitting this VAERS report in the possibility that others may benefit from the information I am providing.  As one of the vaccine nurses at the hospital, I administered several hundred influenza vaccines to both children and adults between the dates of 29 Oct through 14 December, 2007.  Shortly following the administration of the vaccines I became sick with flu like symptoms.  I initially tried to self treat myself with Tylenol and chicken soup, as I felt sure what I had was viral.  My initial symptoms were headache, mild fever, and an achy feeling all over.  These symptoms persisted for more than a week and were later followed by a bronchitis type cough and lung pain on inspiration.  I saw the physician on November 26th and was given some antibiotics for my bronchitis.  However, my lung x-rays appeared normal.  Now 4 months later I continue to feel fatigued with mild reactive airway type symptoms.  In addition, I had a Respiratory Viral Panel done in January that did not show any respiratory, or influenza virus.  However, that test was frozen and mailed out late.  There were two other nurses at our hospital facility that administered hundreds of influenza vaccines and experienced some of these same type symptoms.  Therefore, their VAERS Report and statements are included in this envelope.  Please do not hesitate to call me should you have further questions, or concerns.  The vaccines I administered are as follows: FluMist Manufacturer MedImmune Inc Lot 500488P Exp Dec 25, 07; FluLaval Manufacturer GlaxoSmithKline Lot AFLLA040AA Exp July 08; Flu Zone Manufacturer Sanofi Pasteur Lot U2490AA Exp 30 Jun 08.  When trying to complete PDF VAERS Form on the computer it appeared to be a read only.  Therefore, completed by hand.
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
57 y/o with Past  Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication completed her 15 minute observation period post administration of her 2nd Pfizer COVID vaccination.  As she walked out and she began listing to the right side. She sat down, confused, and complaining of chest pain. She also noted pruritus over her face and scalp. No c/o Shortness of Breath, wheezing or nausea. She was immediately evaluated by me and EMT's . Vital signs demonstrated a HR of 74 in sinus rhythm, O2 Sat of 98% and BP was 192/104. She did not have a rash but was scratching at pruritic areas on scalp and face.  See continuation page...
Large swelling and muscle tenderness - limited use of arm. Injected in same arm due to other arm involvement with breast surgery.
other zoster related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      In or about 2012, the patient was administered zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by various healthcare providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown. The reporter considered events to be related to Zoster Vaccine Live(ZOSTAVAX).
From initial info received on 2/18/04 from a nurse practitioner, regarding an adverse event, it was reported that a 33 year old male pt received Fluzone (u1137HA), administered IM in the left deltoid on 10/29/03. During December 2003 (exact date of onset is unknown) the pt experienced pain in his arms and legs, and extreme fatigue. The pt was hospitalized in December. The pt partially recovered from this event and was able to go back to work in January 2004. From additional information received on 01Jun04 from a health care professional it was reported, No additional information at this time. From additional information received on 21Sep04 from a registered nurse, it was reported that there is no additional information at this time. It was not reported whether the pt recovered from these events. No further information is anticipated, this case is considered closed. Follow up 01/06/05: Medical Assessment: File to be completed.
DELAYED SYSTEMIC UTICURIAL REACTION. THROAT SWELLING/HIVES, ELEVATED HEART RATE. PATIENT TREATED WITH OMEPRAZOLE 10MG,  PREDNISONE 10MG, TRAIMCINOLONE 0.025 % CREAM, AND HYDROXYZINE 25MG TAB