chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck and shoulder pain two days after 2nd vaccine, on same side of body (left); Neck and shoulder pain two days after 2nd vaccine, on same side of body (left); This is a spontaneous report from a contactable consumer (Patient). A 50-year-old non pregnant female received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0187, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 25May2021 at 10:00 (age at vaccination: 50year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included escitalopram and bupropion taken for an unspecified indication, start and stop date were not reported. Patient had known allergies. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The patient previously took levaquin and experienced drug hypersensitivity and historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiry date was not reported) via an unspecified route of administration, administered in Right arm on 03May2021 at 16:00 for COVID-19 immunisation. On an unspecified date in May2021, it was reported that patient had Neck and shoulder pain two days after 2nd vaccine, on same side of body (left). Its persistent, doesn't come and go. Maybe lymph node in neck is swollen? Shoulder pain not only at injection site but back of shoulder and beneath shoulder blade. Patient was not prolonged hospitalization. No treatment was received for any event. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Skin rash - uncertain if vaccine related; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of RASH (Skin rash - uncertain if vaccine related) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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, the patient experienced RASH (Skin rash - uncertain if vaccine related). At the time of the report, RASH (Skin rash - uncertain if vaccine related) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 9 clinic days between 1/28/21 and 2/9/21, a staff RN made an independent decision to administer between .4ml and .5ml of the Moderna Covid-19 vaccine.  She believed this was correct and consistent with the instruction to give .5ml because she believed there was an additional .1ml of vaccine in the needle.  She administered the lower dose of between .4ml and .5ml to 506 patients.  On 2/9/21, a pharmacist who was working in the clinic followed the RN's recommendation and also administered .4ml to 33 patients.  No patient received more than 1 dose at the lower dose amount.   Lot #s affected include 032L20A and 007M20A.
Report described rash in a male vaccinee of unspecified age who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other healthcare professiona. Allergies, medical history, and concomitant medications were not specified. On 05/14/2001, the vaccinee received his second "adult" dose of Havrix. On 05/15/2001, he experienced a rash at the inejection site, chest, and trunk. As of 05/15/2001, the adverse event was unresolved.
cold chills; I got the shot and was so tired for two day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tiredness (Verbatim: I got the shot and was so tired for two day) and chills (Verbatim: cold chills).  The outcome of the tiredness was resolved (duration 2 days) and the outcome of the chills was not reported.   It was unknown if the reporter considered the tiredness and chills to be related to RSV vaccine.     It was unknown if the company considered the tiredness and chills to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-AUG-2023 This case was reported the patient via interactive digital media. The patient received shots of vaccine and was so tired for 2 days and cold chills. The follow-up could not be possible as no contact details were available.
Itchiness of hands, fingers, feet, ankles, lower arms. Ongoing as of 10/8/2021. Used Cortizone 10 which helped some. Itching can be intense at times. Non painful, though very annoying. Am going to try Calamine lotion.
It was reported that a 76-year-old female patient received a TD Adult vaccination adminstered in ER on 1/1/02. Within 24 hours the patient complained of no strength in both arms, which lasted a couple of days. Now symptoms have completely resolved, patient was not seen by health care provider. The lot # for the product is not known.
Pain in arm started within hours of vaccine. Fever, severe arm pain, erythema, induration, swelling at site occurred 24 hours later. Fever lasted approximately 24 hours, Pain, erythema, edema & induration improved 4 days after vaccine given. On visit 11/14 still had faint erythema, tenderness, induration & heat in area of left deltoid.
It was almost 24 hours when I had my effects, I just had a sore arm. Wednesday at 2pm I started getting a sore throat, then I started felling like I was getting a fever and got the chills and a head ache. I was tired and took a nap, my sore got more sore I though I had strep throat, and my fever was going up. My lymph nodes felt swollen. I went into the Dr. and he said it most likely a reaction to the vaccine, just sent me home. I think Friday morning I felt nausea, still had chills and my fever. I was tired and slept day and night, my throat was so sore. I had cold food or broth. This was on going till Sunday, I could tell I was feeling better, things were starting to change.  By Monday I was fine, it was almost like someone turned off the switch and I was better.
First dose given was Pfizer on  5/23/2021. Moderna was given for second vaccine on 6/13/2021
Fluorouracil cream; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Fluorouracil cream) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Fluorouracil cream). The patient was treated with FLUOROURACIL at an unspecified dose and frequency. At the time of the report, UNEVALUABLE EVENT (Fluorouracil cream) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  Consumer received the first shot of the Moderna vaccine on Tuesday. He has been put on Fluorouracil cream by his doctor and wants to know if he should hold on until he gets the second shot?
This spontaneous report as received from a pharmacist refers to a female patient of unknown age (reported as "in her 40's"). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration and Lot number not provided). No adverse events were reported. Additional information has been requested.
swollen face, eyelids, gen erythema, temp 99.2, BP 110/60, pulse 108;wheezing;rx w/epi, ventolin, DPH;
pt had fever 103 & mom reported given APAP a/shots; also addtl APAP & ice bath; confirmed reaction w/MD ; MD states pt allergic to pertussis to give DT only in future;
Left side of face extremely swollen did not go to throat subsided some 12 hours later.
patient came for COVID 19 vaccine today while in observation she got up to walk and felt dizzy. MD on site assessed patient, No SOB, speaking in full sentences, Complained of  heaviness in bilateral ears.  Patient rested, given crackers and water patient verbalized she did not eat breakfast.  Patient has BP machine at home and will monitor BP in morning and evening and bring those readings to onsite appointment on 03/23/21.  Nurse called patient also in the evening to check in. Patient reported all symptoms resolved and feeling back to normal with no concerns
Pt vaccinated with Engerix-B experienced star burst effect on vision in lt eye.
Patient complained of tongue tingling/numbness and feeling of swelling at 6:58pm.  No shortness of breath or other symptoms.  Vitals at 7:01pm HR 89, BP 125/85, O2 98%.  At 7:11pm patient still felt tongue as numb but not worsening and not other symptoms.  Provided Benadryl 25mg.  Patients HR 92 and O2 98.  AT 7:25pm patient stated she felt fine and HR 95, O2 99.  Patient released to husband to drive home.
pain, redness, spreading redness at injection site - lasted 4 days.  Felt like wasp bite, changed from about 1x3" to about 4" round, worse at evening.  Not severe enough to prevent sleep.
Pt was given PEDIARIX at 4mo. WCC, HEP B was given too early, must re-vaccinate to insure immunization.
A female patient received one dose of H1N1 vaccine (batch and manufacturer unknown) on an unknown date. The patient had a medical history of hypogammaglobulinemia and primary immunodeficiency disease (PID). The patient was on concomitant medication VIVAGLOBIN since ??-NOV-2009. The dose was 13ml (2.08g) weekly in 2 sites over 1-1.5 hours. The patient premedicates with TYLENOL and BENADRYL. Her last infusion was 10-OCT-2010. The patient had previously had a bad cough and was on a nebuliser for 4 weeks with an ongoing mild fever daily for the past 2.5 months. The patient's family had been dealing with a respiratory infection and they all had been on a course of antibiotics recently. On an unknown date, the patient had pneumonia with the H1N1 vaccine. The event outcome was unknown. The reporter did not make a causality assessment. The case was reported as serious due to medical significance. The company considered events unassessable due to lack of information regarding time to onset. This case is related to WAVES case 2010026637 (VIVAGLOBIN adverse event case). Information derived from this AE report does not change the current safety profile of the product.
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Acute headaches, chills, tight chest pain, fever  With in a few hours after receiving the vaccine. Dealing with headaches for 6 days, making difficult to rest at night and concentrate.
HYPOXIA 12/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
EXTREMELY SORE ARM (UNABLE TO LIFT ARM), FEVER, CHILLS, UNABLE TO STAND LONGER THAN A MINUTE
slight upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 18:30 (Lot number: En6202) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL; ESCITALOPRAM; VITAMIN D NOS. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "slight upset stomach". Therapeutic measures were not taken as a result of abdominal discomfort.  Additional information: A 40-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 25Feb2021 at 18:30 (at the age of 40-years-old) as single dose for COVID-19 immunisation. The patient experienced slight upset stomach on an unknown date in 2021.The clinical outcome of upset stomach was unknown. Patient had not been tested positive to COVID-19 prior to vaccination. Since the vaccination, the patient had not undergone test for COVID-19. It was not known if patient had other vaccine in four weeks and other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Weakness, loose stool, cough, ST, runny noise, loss of taste and smell.
pt taken to ED at a local Medical Center with SOB; required intubation emergently; transferred to another hospital for higher level of care; transferred to ICU; able to be weaned from ventilator and extubated; work of breathing increased and pt declined; transitioned to DNR/DNI, comfort measures; pt passed away in the hospital
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-OCT-2014, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 15-JUN-2016, the patient was treated by a physician at an internal medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Upon awakening the next morning I had  profound fatigue, Body ache, joint pain, nausea and diarrhea.  Rested most of the day, took Ibuprofen 800 mg once, and feel tired but improving. This is still Day 1 post injection
After receiving vaccine 10:15 AM pt states "she noticed her eyes "burning", "blurred" & "red". Also c/o lower lip feeling "numb", "tightness" in throat. Symptoms began 2 hours after receiving flu shot, seen and treated in ER at 1515 PM with prednisone and BENADRYL.
HCP called to report AE for supported VARIVAX TE administered to patient.; No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot #W034708, expiration date 01-NOV-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown days, the suspect vaccine experienced a temperature excursion of 6 up to 14 degrees Fahrenheit for 597 hours. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event). No previous excursions.
My scheduled appointment was 2:30pm on Dec 18 2021, but I arrived earlier due to the snow storm, so the pharmacist gave me the shot around 12:15pm (the first person of the day received the vaccine in that store). In the afternoon, I felt a bit tired, mild reaction, then around 11:00pm when I went to bed, I started to have fever, headache, muscle pain (the whole body), injection site pain, too, extremely tired, the symptoms get more severe by the hour, grade 3-4. On Sunday 19th/Dec, I was in the bed for the entire day because of the exhaustion, fever and headache, which lasted 30 hours till Monday (20th) morning, at which point I began to feel myself. During the first 24-48 hours, I drank 1.5 gallon water, and ate very little. I even didn't have the energy to take a shower till this morning (20th).
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 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: En6201), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: 2553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure and no spleen" (unspecified if ongoing); "High blood pressure and no spleen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Patient received treatment with Paxlovid on 28Jun2022 and stop date was 01Jul2022. Patient had no known allergies. It was reported that "Adverse event: 2 days after feeling well all the covid symptoms returned and tested positive for covid. I'm still ill today. My wife has the same".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 20-DEC-2007 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-MAY-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
patient woke up with redness around injection site and swelling that progressed to underarm as well, sore arm and neck and two days after complaints of bad headache but swelling going down
Vaccine given, 20 min later chest tightening, cough, breathing difficulty. EPI-Pen administered. Chest still tight, nebulizer treatment. 30 min later ambulance to the Emergency Room. Received IV benedryl, IV steroids. Observation x 2.5 hours then discharged home.  Fatigue x 3 weeks and counting. Asthma flare ups daily x 2.5 weeks. Increased need for Albuteral inhaler, now using Alvesco inhaler daily.  Sporadic dizzyness upon standing since 09/09/2021 after vaccine. Dull headache. Noticed small area of swelling and pain in lower left leg, no bruise or injury to that area.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions and medical conditions was not provided. On an unspecified date starting on or after 31-MAR-2016, the patients were administered an unspecified number of improperly stored doses of VAQTA, intramuscular injection, (lot # L043209, its expiration date: 17-SEP-2017; lot # M003011, its expiration date: 05-NOV-2017) (route, dose and frequency were not reported). Information regarding the patient's concomitant medication was not provided. The temperature was 33 degrees F and the time frame: 13 hours and 30 minutes. Therefore, there was not a previous temperature excursion and the call was not because of a data logger. Additionally, no adverse effects were reported. This is one of several reports from the same reporter (MARRS # 1604USA017966 and MARRS # 1605USA008486) Additional information has been requested.