chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Metoprolol Tartrate, Mirabegron, Omeprazole and Rosuvastatin; for Post-traumatic stress disorder: Sertraline; for Mood swings: Sertraline. Past adverse reactions to the above products included No adverse event with Metoprolol Tartrate, Mirabegron, Omeprazole, Rosuvastatin, Sertraline and Sertraline. Concurrent medical conditions included Aortic stenosis (since about 5 years ago, pretty stable during that time.), Post-traumatic stress disorder and Mood swings.    On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches) and FATIGUE (fatigue). At the time of the report, PAIN (aches) and FATIGUE (fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747981, US-MODERNATX, INC.-MOD-2023-747999 (Linked Report). This case was linked to MOD-2023-747981, MOD-2023-747999 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747981:Same patient, master case (Spikevax 2023-2024 PFS) US-MODERNATX, INC.-MOD-2023-747999:Same patient monovalet dose
4:30 am on the morning of Saturday 3/20/21 I had used the bathroom and when I stood up I had ringing in my ears and when I went to grab the door handle I lost my balance and passed out.
From mom: patient had a fever (101F). Complained of sore are; Had hallucinated the night of the vaccine. According to patient "now acting OK, took the dog out" data from 7/28/07.
Red, splotch & ichy rash from neck to toes for 2 weeks. Doc gave steroid shot & antihistimin shot. RX of Prednisone & Hydroxyzine
This spontaneous consumer report (initial receipt- 25-Jun-2014) concerns a female patient. On an unspecified date, "one time years ago" the patient received miscellaneous influenza virus vaccine (batch number and manufacturer not reported). On an unspecified date, the patient developed an allergic reaction. She experienced a red bump at the injection site under the skin. Outcome was not reported.
No symptoms noted at this time. It was overlooked at time of administration and brought to our attention today that the patient is 16 years old. The Moderna vaccine should only be given to anyone 18 years and older.
Red, warm, swelling, pain, numbness. Onset 4/13/06 wrist/hand puffy. Hand clammy and just hurts.
dizziness, lightheadness, anxious, headache, observation done, water offered, symptoms resolved, pt went home
C/o palpitations, nausea, & near syncope within a minute of administration (PNEUMOVAX). Started to feel better apprx. 3 min after complaint. Given 25mg BENADRYL IM.
16 days p/lst immun pt devel fever over 102; on 18th day devel patchy dull red bumpy rash starting on back spreading to neck, trunk & arms; faded by 25th day; seen by MD who dx measles;
SORE ARM; TIREDNESS; LYMPH NODE SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 69 year old female. 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced lymph node swelling of left breast. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lymph node swelling of left breast, and the outcome of tiredness and sore arm was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 60-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units injection, via subcutaneous route for shingles prevention (dose, lot # and expiration date were not reported), reconstituted with sterile diluent (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date in 2017 (on or after 29-SEP-2017), the patient's arm was very red near the injection site. The size was smaller than a baseball but larger than a golf ball. It did not hurt or itch. The patient did not receive treatment for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the adverse event and ZOSTAVAX and sterile diluent (manufacturer unknown) was not reported. Additional information has been requested.
Dizziness, Nausea, weakness, fever, diarrhea, stomach cramps, tiredness, aches, severe lower back pain, lower extremity heaviness and weakness, hand tingling, shoulder and neck pain, headache.
08/11/08 14:05, received GARDASIL and MENACTRA. Walked to door to waiting area, LOC < 1 minute. No vomiting or seizure. Suspect vasovagal reaction.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster. On 5th October 2018, the patient received the 1st dose of SHINGRIX. On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient experienced injection site pain after receiving a dose of SHINGRIX. The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up.
09/02/2021 Patient was having breakthrough menstrual cramps and was already on Depo Trovera to treating the cramping.  I scheduled an appointment see provider, was able to get in 09/08/2021, provider had a verbal conversation and explained that the some vaccination like COVID and the HPV vaccination could cause the increase in her condition. Advised to take the recommended pain medicines that was pre- prescribed and advised in the future to not have her Depo Trovera and as other vaccination such as not the same day or time. HPV vaccination and HPV vaccination at the same time then she had the COVID 19. Improving, having an extra cramping cycle outside of her menstrual cycle.
At approximately 2:35pm on 1/7/21 I drew up 0.5mL of Moderna COVID-19 vaccine in a 3mL syringe attached to a 1.5 inch safety needle. The safety needle and syringe came already attached to one another in a sterile package. I had no difficulty drawing up the vaccine. I was able to inject the needle into the patient's right deltoid without difficulty and began pushing on the syringe plunger. Part of the way through administering the vaccine, the needle separated from the syringe and the remaining vaccine was sprayed from the syringe and onto the patient's arm.  Since I couldn't confirm how much vaccine was or wasn't administered, I informed the patient that giving another dose would not be indicated. I confirmed this with the clinic supervisor and the nurse practitioner working the clinic with me. I monitored the patient for 15 minutes after the injection and he had no difficulties or reactions. Discussed efficacy concerns with the patient and advised him to return in 4 weeks for his booster dose. Patient verbalized understanding.
Patient has Tourette's Syndrome, she forgot to take her guanfacine this morning.  Her grandmother brought her to get her 3 vaccine for Pfizer-BioNTech.   She did not have lunch or a good night of sleep according to the grandmother and patient.  After 5-10 minutes after receiving the vaccine, the patient started to feel dizzy so we brought her into the consultation room and sat the patient down.  She started to blink her eyes to keep from feeling dizzy and stay awake.  She had tics for a brief moment.  After the tics, she said she felt better but we kept her in the room for observation.
Child began exhibiting signs of seizure 2 hours after vaccine administered (07/22/2013).  His body stiffened, his eyes rolled and his nose and lips turned blue.  Called the doctor and doctor advised does of Tylenol and to call again if the condition persisted.  Child was drowsy and lost appetite for the following day until had another seizure on 07/24/2013 and was brought to the hospital around 6:30pm.  Child was admitted to the hospital following tests in the emergency room and after an EEG was diagnosed with infantile spasms on 07/26/2013 and discharged from the hospital with a treatment of prednisone and a followup EEG to be performed on 08/06/2013.
Information has been received from a registered nurse concerning a 19 year old female patient who on an unspecified date, when she was younger was vaccinated with two doses of MMR II. (Lot # and routes not provided). The nurse reported that the patient now had low measles titer. At the time of the report, the patient outcome was unknown. The patient sought medical attention by visiting the physician's office. This is one of the several reports from the same source. Additional information has been requested.
Patient admitted to hospital on 3/6/21 with sudden onset right-sided hemiplegia and aphasia. CT showed acute intraparenchymal brain bleed. Family chose palliative care over neruosurgical intervention due to sever neurologic impairment and inability to communicate. Patient was discharged to home hospice on 3/9/21.
Injection pain/tenderness at site, tiredness,  HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was feeling lightheaded and felt like she was going to pass out. This reaction occurred within 15 minutes of receiving the vaccine. Pt was pale, sweaty, diaphoretic, hypotensive and had bradycardia. Pt's systolic BP was in the 60s and her diastolic was in the 30s.  Pt was offered food but refused. Pt was immediately brought to the ER where her care was transferred to an ER nurse.
The evening after the vaccine I noticed I had big black dots floating in my vision in my right eye. The following day there were more floaters in my vision. The outside of my vision had a dark spot. I managed to drive to work but it was scary. Every day the vision in my right eye was getting darker. At Eye Center I saw an eye specialist and I was told that my retina was detached. I had surgery to reattach my retina 04/09/2021. I am still having trouble seeing and my vision is still blurry after four weeks after surgery for Retinal Detachment.
Patient hospitalized for Cesarean delivery indicated due to breech presentation within 6 weeks of receiving COVID vaccination.
Patient did not report any injection site reactions after getting vaccine, but 4 days post immunization she noticed a very large lump at the bottom of her neck near her shoulders.  She saw two physicians and had an ultrasound of the area done.  Physician informed her it was probably due to the recent vaccine she was given.  She also noted a lowgrade (99) fever four days post vaccine at the same time she noticed the large lump.  Vaccine was given sub-Q in the back of her left arm.  No redness or other reactions were noted after vaccine was administered aside from the lump on her neck.
"Blistery sores on the small of my back side itch and burn"; no treatment sought
Every joint in my body began to ache. I could not get comfortable. Some joints would hurt worse than others for a while and then the pain would subside and others would hurt worse. All night - did not sleep. Lasted most of 10/05/13 then gradually disappeared.
Friday (11/2/18) around supper experienced severe pain in left arm. Later same evening arm went numb down to fingertips. On Saturday (11/3) experienced entire body aches (not face). Sunday (11/4) was bedridden due to all the pain. Monday (11/5) called into work due to severe pain, especially left foot. Says had to crawl as she could not walk. Began taking pain medications. Tuesday (11/6) returned to work but still experienced some pain. Wednesday (11/7) reported information to Health Dept Immunization Clinic; not in as much pain. Says continues to take pain medication but pain is not as severe; gets still if she does not keep moving.
Flu shot 10/29/15. 10/31/15 pt reported fever 101 degrees, upset stomach, vomiting. 11/1/15 cough, self medicated with MUCINEX. Referred to private MD for evaluation and follow up.
Pt fainted in the waiting area and fell off his chair. He got right back up and sat back on the chair. The fall caused a cut on his chin and he was very lightheaded and thirsty. Symptoms did not progress. He waited a half hour and went home. His sister called and let us know he reached home.
Rash on arm Dr. gave patient KEFLEX. Pt. said it got worse and went to hospital. 10/5/15.
Racing Heartbeat started at 2:00AM. 120 beats per min.  Lasted 1 hour and then started racing again at 5:00 AM.
I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Brain aneurysm", start date: 2020 (unspecified if ongoing), notes: Brain aneurysm; "Quadruple heart bypass" (unspecified if ongoing), notes: Quadruple heart bypass. Family history included: "My dad committed suicide" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash that began @ site of vax & spread to chest, abd, & upper arms & between legs which itches which began Thursday evening;tx took DPH for itching;
Pt had focal seizure. Evaluated by EMS- Transported to Emergency room/department or urgent care
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 10:00 as dose 2 (booster), single (Lot number: FE3592) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 25May2021 at 09:00 as dose 1, single (Lot number: 1802070), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroid" (unspecified if ongoing); "vitiligo" (unspecified if ongoing); "hx of urticarial vasculitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Dapsone" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM, start date: 14Mar2019; LEVOTHYROXINE, start date: 18Mar2021, stop date: 27Sep2022; VITAMIN D [VITAMIN D NOS], start date: 12Jul2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (unspecified date) Positive; (20Sep2022) Negative; (21Sep2022) Negative; (22Sep2022) Negative; (23Sep2022) Negative; (24Sep2022) Negative; (25Sep2022) Negative; (26Sep2022) Negative, notes: Became symptomatic; (27Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Drug ineffective, Covid 19 and suspect drug BNT162B2 cannot be excluded.
pericarditis; severe chest pain; It was worse when laid down; It felt like angina, like heart attack; I'm still short of breath; dry cough; This spontaneous case was reported by a nurse and describes the occurrence of ANGINA PECTORIS (It felt like angina, like heart attack), PERICARDITIS (pericarditis), CHEST PAIN (severe chest pain), CHEST DISCOMFORT (It was worse when laid down) and DYSPNOEA (I'm still short of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus and Renal disease (Genetic).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced ANGINA PECTORIS (It felt like angina, like heart attack) (seriousness criteria hospitalization and medically significant), CHEST PAIN (severe chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (It was worse when laid down) (seriousness criterion hospitalization) and COUGH (dry cough). On 25-Jun-2021, the patient experienced DYSPNOEA (I'm still short of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, ANGINA PECTORIS (It felt like angina, like heart attack), PERICARDITIS (pericarditis), CHEST PAIN (severe chest pain), CHEST DISCOMFORT (It was worse when laid down), DYSPNOEA (I'm still short of breath) and COUGH (dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: textbook for pericarditis (abnormal) cardiologist described her EKG as textbook for pericarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details was provided. The Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Approximately a week after my first dose of Moderna COVID-19 vaccine, I developed a red welt at and around the site of injection on my left arm. The welt is very firm and slightly tender to the touch, blanches when pressure is applied, and occasionally itchy. My arm is also sore I am still experience extreme fatigue. No treatment or medications have been taken to alleviate these symptoms at the time of this report submission.
Was walking out to car and became suddenly dizzy and shakey and fell to the ground. Unknown but believes was briefly unconscious. Denies hitting head. Afterwards was still shakey but went indoors and rested and felt better.
received a dose  that was exposed to a low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 2-May-2022 Reporter's comments: The patient received Boostrix that was exposed to a low temperature excursion of 28.8 degree F. The vaccine was no longer viable. The consent to follow up was not given. Additional Supportive Information: The patient received Boostrix that was exposed to low temperature, which led to incorrect storage of drug. This case was linked with case US2022072584, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072584:same reporter
Two days after receiving the second Moderna COVID-19 vaccination, I developed tinnitus that still persists after one month.
This spontaneous report as received from a pharmacist refers to an approximately 59 year old female patient with Macrobid allergy (unknown reactions) and penicillin allergy. The patient's medical history included two cases of shingles one year ago in 2012 and herpes simplex. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J003796, expiry date 28-JUN-2014) subcutaneously. No concomitant medications were reported. On 05-NOV-2013, the patient developed a welt at the injection site. The patient was advised to apply ice compress to the site of the reaction and to take an unspecified antihistamine (manufacturer unknown). The patient had sought medical attention and called the pharmacy to report the symptoms. The pharmacist adds that the patient's symptoms have improved but the patient still has a lump at the injection site and had also developed a recurrence of cold sores. The outcome of developed a welt at the injection site, cold sores and lump at the injection site was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
pt reports pain in back of arm that goes to her back  started 2 days after receiving the shingrix injection , she states goes down to elbow as well
Pt reports he was sick with the flu. Reports coughing, sneezing, feeling ill, and tearing from his left eye.
Patient reported they had never received a COVID-19 vaccine in the past nor was there any vaccine listed in the medical system. The state vaccine registry later notified health district of the fact that the patient is listed as having gotten a Pfizir vaccine 01/2021.
Sunday night - fell asleep on the couch - looked like he was "dead" per RN wife, and she had trouble waking him up.  He  woke up feeling confused.  Was dizzy and was urinating and was lightheaded, stumbled to the couch. Wife is a nurse - called 911 - looked like a ghost, profusely sweating.