chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in right ear; Pinpoint pupils; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in right ear) and MIOSIS (Pinpoint pupils) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM (MELOXICAN) and VITAMINS NOS for an unknown indication.    On 28-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced TINNITUS (Ringing in right ear) and MIOSIS (Pinpoint pupils). At the time of the report, TINNITUS (Ringing in right ear) and MIOSIS (Pinpoint pupils) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included a high cholesterol medication and herbal supplements. No treatment details provided.
administered Pentacel incorrectly described as the DTap-IPV portion was not given/no AE; ActHib portion was reconstituted with sterile water/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] incorrectly described as the Dtap-IPV portion was not given/no AE(product preparation issue) and ACT-HIB portion was reconstituted with sterile water/no AE(product preparation error).  Medical history, medical treatment, vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A).  On 20-Feb-2020, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ226AAA via intramuscular route at the right thigh for prophylactic vaccination. Lot number and expiry date of DTAP-IPV was reported as UJ315AA and 04-Apr-2021 and ACT-HIB as UJ226AA and 04-Apr-2021 respectively.  It was of actual medication error case due to inappropriate reconstitution technique and wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
I went to my regularly scheduled appointment, at the appointment, my doctor listened to my heart and she noticed a heart murmur. I had an echocardiogram on 6/4 and the results came back 06/07/2021. The indication for the study was a cardiac murmur. 1) The final conclusion is a normal left ventricle size, mild concentric LVH and normal systolic function LVES 65-70%. Ruled out small regional wall motion abnormality with limited endocardial definition secondary to body habitus. 2)There is normal RV size and function. Moderate left atrial enlargement. 3) Mild mitral regurgitation. Trace tricuspid regurgitation normal RVSP of 20MMHG. 4) Grade 1 diastolic dysfunction. 5) Normal IVC size and respiratory variation. The person that did this report is a doctor, MD, Cardiology and Vascular Medicine.
arm (on the side of the injection down to her wrist) still hurts from it; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date in Jun2021 at the age of 58-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date in May2021 at the age of 58-years-old as dose 1, single for covid-19 immunisation. It was reported that she received first shot of pfizer covid vaccine in May2021 and 2nd shot in Jun2021. Stated that since receiving her second shot on an unspecified date in Jun2021, her arm (on the side of the injection down to her wrist) still hurts from it. when she wakes up she can hardly move it. Adds before receiving the vaccine, she had no issues with her arm. She asked, why would her arm still hurt? The reporter asked, why should she have to pay for costs associated with side effects of the vaccine. The case was reported as non-serious. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Wheezing, chest pain, chills within 3 hrs after shot, next morning swollen upper lip, low grade fever. Tingling hands and feet.
The arm sore for about two days and a week after the injection site swelled up again; The arm sore for about two days and a week after the injection site swelled up again; A spontaneous report was received from a consumer concerning a 79-years-old male patient who experienced events arm sore for about two days (pain in extremity) and a week after the injection site swelled up again (injection site swelling).   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 031620A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) arm sore for about two days and a week after the injection site swelled up again.   Treatment details included cold compress and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, arm sore for about two days (pain in extremity) was recovered/resolved  on an unknown date, The outcome of the event, and a week after the injection site swelled up again (injection site swelling) was not recovered/not resolved at the time of reporting.
PATIENT EXPERIENCED THROMBOPHLEBITIS AND SWELLING ON HER RIGHT ARM. STILL IN A LOT OF PAIN.
GAVE KINRIX FOR THE 3 RD DOSE OF DTAP; This case was reported by a nurse via sales rep and described the occurrence of inappropriate schedule of vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was 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: 26-OCT-2022 Reporter's Comments: Nurse gave a dose of kinrix for the 3rd dose of dtap. Additional supportive information: The patient received kinrix as the 3rd dose of dtap, which led to inappropriate schedule of vaccine administered.
Started being tired all the time even when getting enough sleep, loss of muscle tone, couldn't walk normally.
fever up to 98.5; Rash on the upper right side of my body; Chills; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731/ZR8731) via an unspecified route of administration in the right arm on 09Apr2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy (thyroid remover) on an unknown date in 2012, heart murmur, blood pressure high, allergy to latex and sulfur. Concomitant medications included nifedipine (PROCARDIA) 60mg and levothyroxine sodium (SYNTHROID) 112mg; all for an unknown indication and from an unknown start date. Prior to the 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 four weeks prior to the COVID vaccine. On 10Apr2021, the patient experienced chills. Chills became more intense, the patient slept under two blanks and turned on the heat. On 11Apr2021, the patient had rash on the upper right side of body and at 21:00, the patient had fever up to 98.5 (units unspecified). Therapeutic measures were taken as a result of events and included treatment with two BENADRYL and two TYLENOL, on an unknown date in Apr2021. The clinical outcome of the event fever up to 98.5, chills and rash on the upper right side of my body were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling, erythema at injection site approximately 3 inches, painful at injection site, temperature 100.6, felt heart racing.
Symptoms - ?at approximately 8:00 pm began with nausea, chills and fever (Tmax 100).  At time of call still with body aches, chills, and HA.  Patient reports she called into work today. Last day of work and shift - ?unknown, called into work today Home remedies? -  rest  Any improvement? - none Recommendation?  Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in the paperwork and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy.  Patient verbalized back understanding and denied further questions at this time.
Bilateral pain in lower extremities below the knees.  11/30/09 ED notes received for DOS 11/20/09 - Final DX: Rhabdomyolysis and presumed postviral myositis. On 11/19/09, Pt c/o lower leg pain bilaterally, swelling and macular rash. On examination: bilateral edema with tenderness to deep palpation below the knees bilaterally. Pt developed difficulty urinating, inability to walk due to pain; tx: IV D5 normal saline. Pt discharged.  12/01/09 H&P and MR received DOS 11/22/09  11/24/09. DX: rhabdomyolysis, myoglobinuria, possible viral infection or post vaccination associated myositis. Pt continues c/o pain in legs and arms, which is described as pressure pain. Pt c/o fevers, rash in arms, swollen legs. On examination: no fever, Pt ill-appearing, swelling of LE, tachycardia. According to Dr. this event was not of oncologic origin. tx: Tylenol, morphine, IV fluids. Pt's condition improved. Pt was able to ambulate. Pt discharged with ibuprofen prn and scheduled for physical therapy. 12/29/2009 DC summary for 11/22-11/28/2009, patient transferred to this facility after increased need for O2 and decreased urine output, CXR noted fluid overload and was tx'd with diuretics, Infectious Disease could not find etiology for rhabdomyolysis, work-up for reoccurrence of ALL was negative, Rheumatology work-up was negative, PT consulted to assist in ambulation DC Dx Rhabdomyolysis
tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 14:30 as dose 4 (booster), single (Lot number: EW0150) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "long covid from presumed infection", start date: Mar2020 (unspecifie d if ongoing), notes: long covid from presumed infection in Mar2020 (intestinal); "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022 at 12:00, outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative; (25Jul2022) Positive, notes: after 11 days of negative antigen tests; (25Jul2022) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient have no known allergies.
Severe hives on ankles and lower leg, relieved by antihistamine. Itching at injection site for 24 hours.
had COVID like months ago/ But she said that this was worst; had COVID like months ago/ But she said that this was worst; Shaking; Throwing up; Cannot remember conversation; she feels like horrible; This is a spontaneous report from a contactable consumer (patient's son).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, he was calling for her mom. She got the Covid-19 Vaccine and she got it at approximately 13:30. By 5 O' Clock she was shaking, throwing up and she cannot remember conversation she had around at that time. Now she doesn't remember what they spoke, and she feels like horrible. She already had COVID like months ago. But she said that this was worst. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on an unspecified date 2021. The clinical outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
not feeling well; Chill; Fever; Injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain). At the time of the report, VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        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 information provided. Treatment included Tylenol and Ibuprofen
SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sore arm. On 2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sore arm was not reported. This report was non-serious.
-Burning nerve pain, crepitus, muscle tightness to where chest wouldn't expand fully for breathing - Resolved on own by next morning
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date unknown) for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and rash. On an unknown date, the patient experienced shoulder pain. The patient was treated with Physical Therapy (Nos), Anti-Inflammatory and Pain Medication. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the injection site pain and rash to be related to SHINGRIX. The reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient arm was sore at the injection site right after getting the shot and less than a day after receiving SHINGRIX, the patient developed a rash that went up about 1 to 2 inches above the injection site. Later, less than a year after receiving SHINGRIX, her right shoulder started being really sore. On 14th December 2018, the patient went to get the 2nd shot of SHINGRIX (batch number D9P5X) and her right shoulder was still very sore so she got it in her left arm instead. The shoulder pain had not gone away so the patient saw an orthopedist who said the pain was due to a reaction to SHINGRIX. The patient had been ordered physical therapy and was taking an anti-inflammatory and a pain medication. This was the potential legal case. The reporter consented to follow up.
Severe reaction to the first one; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Severe reaction to the first one) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Severe reaction to the first one). At the time of the report, IMMUNISATION REACTION (Severe reaction to the first one) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient had a severe reaction to the first dose of Moderna Vaccine.  No treatment medication was reported.   This case was linked to MOD-2022-677887, MOD-2022-677886 (Patient Link).
Around 8PM I started having chills. Within an hour I was achy and the chills were terrible. I wore freezing winter weather clothing under 4 blankets and was still freezing. I experienced shortness of breath and started using my CPAP even when awake about half the time. I walked with a hunch very slowly and my knees and feet crunched. I couldn't sleep for more than about 30 minutes at a time and it took a lot of energy to roll over or get up. By 6AM, I couldn't even try to sleep anymore and started drinking constant hot black tea with a splash of milk. I had lost my appetite and only ate small amounts until Tuesday, July 31. The extreme chills started alternating between bad chills and burning up for about 12 hours but most of the time I was chilly and wore layers. My joints and bones felt loose and I still walked with a hunch and around 4PM on Aug 27 I was walking on a hardwood floor when I felt a crunch in the instep of my right foot and it started hurting bad. To this day (Sept 17) it still hurts although not as bad but occasionally I'll be walking normally and I'll feel a pop and it hurts like crazy for a few seconds. The chills started to die down slowly and the hot flashes became less often for the next two days and by dinner time on Sunday, Aug 29 I was only slightly chilly and no longer walked with a hunch but did walk slightly slower than normal. Normally I feel fine in temperatures between about 60 and 80 degrees Fahrenheit but by this point I wasn't comfortable outside of about 70-75. Over the past 3 weeks my comfortable temperature range has widened a bit and as I write this my house is 68 degrees and I'm slightly cold when I normally wouldn't be. My appetite restored by Tuesday and the only night I had a hard time sleeping thru was the first night. As of Wednesday, Sept 15 I'd say I felt close enough to my pre-vaccination self to say I've fully recovered. I'm not achy anymore but my energy level is only about 85%-90% of what it was pre-vaccination and my right foot still hurts sometimes when I walk. I've noticed that I still get winded quicker than I did pre-vaccination and fatigue quicker when walking but I'm no longer shallow breathing and haven't since the day after my vaccination. I think that's about as thorough as I can be.
Suspected vaccination failure; Patient got the flu after getting the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had one and only flu shot and it was not as bad as what the other person went through, but the patient did get the flu after getting the shot.  The patient then decided to never take the vaccine again because they believed that they were filled with things that ppl would otherwise, never put in their bodies. This case was considered as suspected vaccination failure as the exact time to onset and confirmation of lab test was unknown.
body and joint pain, loose stool, Intermittent moderate to severe head pain,  swelling and pain at injection site,  Chills, fatigue, fever 100°.  exact symptoms for approximately 24 hours after the first shingrix vaccine administered March 30, 2019.   same facility, no difference in health;  first vaccine administered right arm.