chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart attack; double pneumonia; Initial information received on 21-Oct-2020 regarding an unsolicited valid serious social media case from a consumer and additional information received on 25-Oct-2020.  This case is linked to case 2020SA300788 (same reporter).  This case involves male patient (age unknown) who had heart attack (myocardial infarction) and double pneumonia (pneumonia), while he received INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were unknown) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had serious heart attack (myocardial infarction) and double pneumonia (pneumonia) right after the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for both the events at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a male patient (age unknown) who had myocardial infarction and pneumonia just after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, medical condition at the time of vaccination, laboratory data and other ruling out etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Patient experienced weakened muscles, rapid heart rate, elevated blood pressure, dizziness, nausea
pt recv vax 27MAR97 9AM & 11AM pt fainted in the bathroom (about 30sec) was nauseated, chilled, lips dry, weakness;later had diff breathing;pt was taken to ER & given med;sl sore arm;
Case number PHEH2015US023187, is a spontaneous report initially received from physician on 06 Nov 2015 and follow up from Quality Assurance Department (QA, reference number: 1008467) on 10 Nov 2015 (combined report). This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on 05 Nov 2015. It was reported that during vaccination of the patient leak happened from where the needle was attached to the syringe. The case was assessed as non-serious. No adverse event was reported.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media through a company representative concerned (unspecified) multiple patients. The patient's weight, height, and medical history were not reported. The patients all had previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patients all received booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced covid (suspected covid-19 infection) who were vaccinated and had their boosters and still got sick (Dose number in series 2). It was reported as, "that's why I'm never taking one the booster that is all the people I know who had covid were vaccinated and they had boosters and still got sick sham they want to keep you sick with something". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000251788.
arm swollen larger than fifty cent piece;redness & severe tenderness & in 24-48hr;went to see MD & was given Lortab;MD stated rxn was not an adverse but severe rxn to vax;
Facial Swelling (Eyes,Lips,cheeks), itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, period flowing hard(came early), arm numbness, feeling like something running up my neck, felt weird right after, throat swollen, headaches, and fatigue.
First issue appeared to be a seizure while visiting a friend. Several seizures on 09/23/2011 resulted in being admitted to Hospital. Diagnosed as Complex Partial Seizures and took Gabapentin (anti seizure medicine) for 2 1/2 years. Second opinion but found no inherent cause for seizures. On 12/17/12 another Gardasil administered. Started having painful vulvar rashes and after many tests hospital and then at OB/GYN, a specialist diagnosed Lichen Sclerosis, an autoimmune disease. Subsequently diagnosed with Hashimoto's autoimmune thyroiditis.
Patient was administered his 1st Jynneos (MPX) vaccine, after the vaccine was administered the patient sat down in our post vaccination area. Within 10 minutes of sitting in post vaccination area the patient passed out and hit the floor face foward. When we flipped the patient over and he regained consciousness he was able to answer all questions asked. Patient was A&O x4. All vitals were in range patient did state he was dizzy, and patient looked pale and clammy. Patient stated he always passes out when getting his blood drawn and doesn't like needles. Paramedics were called and arrived on seen, when told he would be transported to hospital he denied and left AMA.
10 people received a dose from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Chest pain comes and goes all day starting from last night until 9pm today. Headache is also another symptom.
pt says she did not have any symptoms after taking the vax until several days later when she started falling with no warning.  She would get up in the mornings and could not walk.  She would have to bend over and bend her knees to be able to move.  When she tried to move she would fall.  When she fell she could not get back up.  Around 5/22/21 she went to the Hospital ER.  They did blood work and MRI.  All test were negative.  She was told to FU w PCP which she has not seen him yet.  Pt says she seems to be getting better but she is still very weak so she has take precaution when getting up. She has to take small steps when walking and she can only stand about 15 minutes at a time.
local rxn w/redness & swelling p/vax in rt arm;extended just above elbow w/28hr & w/in 2 days redness extended to lower part of arm;had low grade fever;vertigo;mild viral gastritis;
About 3 minutes after vaccination of Tdap, MENACTRA, HPV, respectively, patient fainted. Slumping slowly down from sitting position. Caught her and layed her down on table. Patient with loss of consciousness about 10-15 seconds with brief seizure activity towards last 5 seconds. I put smelling salt under patient's nose and she immediately awoke. Patient was monitored for 15-20 minutes afterward.
Redness and swelling of entire upper right leg to below the knee. Started about 12 hours, post vax. Resolved within 24 hours after Benadryl and Tylenol.
received vaccine, soon felt woozy, heart pounding, lips and fingers tingling, dizziness, reported to staff, brought back via wheelchair to obs at 0855. placed on stretcher in trendelenberg, states felt better moments after. snack and water given, instructed on hyperventilating and exercises to reverse this with controlled breathing. sig other at bedside, when symptoms resolved, patient and sig other escorted to exit without issues at 0920. 0855 intial/trendelenberg bp 139/85 hr 108 sats 100% on ra rr 22 0900 sitting bp 146/87 hr 106 sats 97% ra rr 20 0915 standing bp 130/85 hr 79 sats 98% ra rr 20
INTENSE HEADACHE. SCALE FROM 1 TO 10: 8 TOTAL INSOMNIA. IMPOSSIBILITY TO FALL ASLEEP ALL NIGHT VERY HIGH BODY TEMPERATURE NAUSEA DIZZINESS I TOOK ACETAMINOPHEN 500mg FROM 10 PM UP TO THIS MOMENT EVERY 6 HOURS SELF-PRESCRIBED REST. NO ACTIVITY OF ANY KIND
pt recv vax 130AM & slept until 430PM;wakened crying & cried non-stop until 830PM when pt calmed on the ride to DHS;on exam pt was WNL inj site was sl reddened;no tx;pt also rx for colic ;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE 1/18/2023,  2/6/2023,  1/15/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Headache, Myalgia, NauseaVomiting, Fatigue, chills Narrative:  Other Relevant History:
Exhausted since getting fist Vaccine,  itchy all throughout my body that has not gone away at all, random fevers
Day of shot: malaise/fatigue, headache, very sore arm began at 430pm.   Next day:  Severe  chills and shivering  at 1 am,  Total body aches, especially joints, at 4 am.  Burning sensation on skin, upper body at 630 am.  At this time (10am), aches,headache,sore arm and burning sensation continuing,  Regular strength Tylenol helping all symptoms.
Vaccine was administered on 8/25/21. I woke up on 8/26/21 with severe muscle aches and left arm injection site pain. The pain around the site of injection extended up into the neck on the left side and down to the elbow. The muscle pain was significant and progressed throughout the day. By the afternoon, I had a severe headache, nausea, exhaustion, and was running a fever. Temperature was 101.4 at 3:00 pm. I took ibuprofen 400 mg for the fever and pain at that time. On 8/27/21, the fever had resolved, but my left arm was significantly swollen from the shoulder to the elbow. A flat, red rash had appeared that covered approximately 75% of the skin on the upper arm. The muscle aches were improved, but still present. Lymph nodes in bilateral axilla were extremely swollen. They made it painful to sit with arms resting at my side. On 8/28/21, the rash and armswelling was slightly improved. The rash covered approximately 50% of the skin on the upper arm.  Lymph node swelling had improved, but was still present on the left side. The nodes were still painful to any movement or touch.  On 8/30/21, the lymph node swelling resolved. The rash fully resolved on 9/1/21.
Client c/o difficulty swallowing, chest pain and H/A. Client remained conscious throughout the entire event. Initial vital signs noted as B/P 155/87, o2 of 100% on R/A, and HR 96. Writer notified MD and MD authorized administration of 50 mg IM Benadryl. Staff called 911. Client refused service of 911 but agreed to remain in observation an additional 15 minutes. Clients last V/S noted as 146/93, O2 100% on RA, and HR 84. Client left with a continued complaint of slight H/A .
a 8 months old male patient was inadvertently given an expired dose of IPOL vaccine/No AE; Initial information received on 05-May-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves an eight months old male patient who was inadvertently given an expired 0.5ml third dose of IPV (VERO) [IPOL] lot P1A25 , expiry date: 02-MAY-2020 via subcutaneous route in the right thigh on 05-May-2019 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Patient reported swelling and redness at the site of injection. Also the site being itchy, achy and hot. Patient started seeing these on 10/4/16 and came in to our pharmacy to report on 10/5/16. She did state the symptoms had gotten better. She stated she applied ice to the injection site.
Arm muscle sore - never red, swollen or feverish. Sore as if it were a pulled muscle.
Pt received the vaccine at 1415 and started feeling "dizzy" at 1440. BP 118/72 and HR 820. SpO2 95% RA. She drank some juice. At 1445 she started complaining of seeing black floaters.
So a week later I saw that I had a lot of little red and swollen bumps on where I got my shot. I didn't think anything of it until, the next day, That my arm was burning and itchy. So, then that's when I went to my PCP and she said that it could been something I was allergy to and to take some Benadryl. So then the next day it was worse so I went back  and she said that it may have been poison ivy.  I told her that it was from the Covid injection and she said that it wasn't. I then went to the Urgent care the following day and they said that it wasn't from that and they gave me some steroid cream. But I believe  100% that it was from the injection. I am not an outdoor type person. So, I know  it was from the injection.
Erythematous rash that started 2 days after the vaccine in the area of injection and lasted 2 days; 1 week after injection developed hives over the injection site that resolved; 8 days-present blanchable erythematous rash surrounding injection site. No systemic symptoms.
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
Intermittent tachycardia; headache; left shoulder pain, increases when lifting elbow above pectoral; This is a spontaneous report from a contactable nurse, the patient.  A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left arm on 16Dec2020 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunization.   The patient's 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 vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 16Dec2020 at 21:45, the patient experienced intermittent tachycardia, headache, and left shoulder pain (which increased when lifting elbow above pectoral). Therapeutic measures were taken as a result of the intermittent tachycardia, headache, and left shoulder pain and included treatment (self-medicated) with acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of intermittent tachycardia, headache, and left shoulder pain were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Arm swelling, about a 2 inch x 4 inch lump at injection site that's hard and hot to touch, arm soreness, flu-like symptoms including headache, body aches.  Patient took acetaminophen and seems fine now.
Powder component was reconstituted with sterile water; Powder component was reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA417A, expiry date 30th September 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not reported. No patient initials provided. The nurse reported that a patient was administrated with Menveo and powder component was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  No vaccination date provided. No adverse event was reported. The reporter consented to follow up.
Red, swollen and tender/ warm left arm.  Swelling started 21 Jun 04.
SEVERE neck/upper back muscle spasm C7-T2 radiating through to throat and Lt clavicle, neck weakness. Physical Therapy x2, complete bed rest x3 days, drugs: FLEXERIL and NORCO, heating pad helped. Today is the end of day 3 and I can get out of bed with some pain and sit in chair - big improvement..  Not fully recovered but I hope by the first of the week I can return to work.
Significant soreness and some swelling in left deltoid, maximizing on Sept 7th, and mostly resolved by evening of Sept 9th.
Arm pain (moderate, resolved within 48 hours.) Dizziness (mild, resolved within 48 hours.) Fatigue (severe, resolved within 72 hours.) Arthritic hip pain flare up (moderate, when bearing weight, unilateral. Began 72 hours post vaccination, resolved within 5 days of vaccination.) Exacerbation of GERD and nausea (mild, began 72 hours post vaccination, resolved within 5 days of vaccination.) Low grade fever (mild, 2 degrees F above normal basal body temperature for patient, or less - began within 12 hours of vaccination, resolved within 72 hours.) Somnolence (moderate, excessive sleepiness e.g. 3 or 4 hours beyond normal 8 hour sleep requirement daily - began 4 days post-vaccination and resolved within 1 week of vaccination.)
I had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago/ Suspected vacination failure; Shingles; Red patch on my stomach; Itched; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's sister suffered from shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago/ Suspected vacination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), skin red (Verbatim: Red patch on my stomach) and pruritus (Verbatim: Itched). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin red and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, skin red and pruritus to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, skin red and pruritus to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 22-JUN-2023 The case was received from the patient interactive digital media. The patient had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago of a dollar bill that barely itched.  The patient thanked god his/her sister as she strongly urged him/her to take the vaccine after she suffered from shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a retired pharmacist, referring to a 70 year old male patient. Prostate cancer was reported as pertinent medical history. The patient with no reactions or allergies. On approximately 2006, when the patient was 60 years old, he was vaccinated with ZOSTAVAX (lot #, expiry date, concentration, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date in 2016, when patient was 70 years old, he developed a case of shingles. The patient sought medical attention through the office visit. Labs diagnostics studies not ask if were performed. The reporter stated patient was treated with valacyclovir and unspecified anti-inflammatory medication "for pain" and patient was "getting better with time" (recovering). Additional information has been requested.
Menstrual cycle began 3 to 4 days early. Very heavy bleeding and clots. Uncontrollable pain even with over-the-counter pain relievers. Not typical period.
At 5pm began coughing, producing increasing phlegm. Continued for 30 min. then took 2 puffs Albuterol inhaler. 5:30 throat began to hurt, painful then tight to swallow even liquids. 6:30pm Felt body aches, extreme chills...took 500mg Tylenol. Went to bed. Awoke 8pm with facial tightness and lips swollen, heart rate 100, resp 26. Took 50mg Benadryl. Facial tightness and lip edema decreased after 1 hour so did not go to ER. Felt aches chills and headache for total of 3 days.