chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurts moderate bad; 'm having bad body aches; Feel nauseated; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills). At the time of the report, LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
After two hours right thigh edema, erythema surrounding injection site. In 48hrs edema extending toward knee with erythma surrounding site and back of leg at leg approx 1" > leg. Treated with Augmentin and improved.
One week post vax, the pt developed an itchy rash on arms and upper body. Went to the ER and was told rash probably resulted from a soap/detergent. Client has been taking Benadryl daily. Rash reappears. Problem has persisted until this time without improvement.
6 hours after injection - began low grade fever - body, muscle aches- weakness- 12 hours after injection - high fever  102  for 3 hours chills sweats - all other symptoms persisted and I began to have a very strong METALLIC TASTE in mouth. Very ill; 3 days after Metallic taste still present still not feeling well. missed 3 days work; By Friday 4 days after- feeling much better - Metallic taste still present but seems to be a bit less.
The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine.
11-12 hours after vaccine I began to have a metallic taste in my mouth and nose. 24 hours later and there is still a weird smell in my nose and taste in my mouth.
On 6/8/2022 patient received two doses of Varicella, mistakenly. No adverse reaction has been reported at this time. Doctor has informed mother of event and informed to call office or go to ER with any site reaction, fever, HA, excessive fussiness, or seizure. Again at this time mother reports no adverse reaction.
Suspected vaccination failure/keeps getting them in spite of the vaccinations; keeps getting them in spite of the vaccinations; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Sept-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that the physician said in the 4 percent that just keeps getting them in spite of the vaccinations. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR129346:Same reporter
Information has been received from a pharmacist concerning a 16 year old male patient who was vaccinated IM with a single dose from a 5-dose vial of PNEUMOVAX 23 lot #655291/0985F. The reporter that the patient developed immediate swelling at the injection site. No other symptoms were reported. The pharmacist referred to this immediate reaction as "cellulitis". The patient was taken to the local emergency room for evaluation but details of the examination and treatment were unavailable. The outcome was unknown. The pharmacist has requested  A lot check for PNEUMOVAX 23 lot 3655291/0985F. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Vaccination site warmth; Vaccination site itching; Vaccination site swollen; Vaccination site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY PROVIDED).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication and treatment provided
sudden onset of fever of 102.4, very sore throat, rapid heart rate, headache, red and swollen eyes within 2 hours of shot. prescribed anti-histamines and advil.  symptons subsided after anti-histamines.
This spontaneous report was received from a pharmacist refers to 79 year old male of patient. On 20-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified dates, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
pt recv vax 18SEP97 & later that evening the pt exp a local rxn consisting of rash & itching all over the inj site;tx consisted of DPH, warm compresses & 1 doses of pred;
Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023; Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Environment allergies" (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 Oct2023, outcome "recovered" (20Oct2023) and all described as "Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Oct2023 to 18Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357547 same patient, different drug and event;
Experienced chills and fever starting shortly after the 24 hour mark after the vaccine and lasting roughly 8 to 10 hours.  Fatigue and severe headache starting around the 24 hour mark and continuing until the 72 hour mark.
Days 1-6 after receiving vaccine, arm developed a large (half-dollar sized), red, firm, swollen area that was hot to touch; it turned into a bruise and then was completely gone by day 6 (12/28/2020). On 1/1/2021, I noticed that my arm was again sore; upon inspection, I found that the welt had returned. It was again large, red, swollen, hot to touch and very itchy. As of today (1/6/2021), it is just a slight bruise.
erythema on forearm 3-4 diameter w/swelling & itchy; no systemic sx; last booster 2 yrs ago; 8SEP92 f/u no addtl event info; only pt details recovered;
Pt went to clinic on 9/15/17 at 8am reported he had received Tdap and PNEUMOVAX vaccines yesterday (9/14/17) at his annual check-up and last night developed fever, chills, nausea and body aches. Pt reported temp was 100.9 F this AM. Pt reported soreness in R arm and radiating pain across upper back. Pt reported rash, red bumps on the back of his neck and scalp. Pt assessed, treated and instructed to start promethazine, ibuprofen, TYLENOL, CLARITIN. Rapid influenza test was negative. Pt went to ER on 9/16/17 at 11:17 AM and reported fever, headaches, general aches. Pt assessed, treated and discharged for fever, dehydration. Pt went to office on 9/18/17 to follow up with PCP for ER visit. Pt reported at last communication with treating Provider that his symptoms are improving.
Pain in injection site for first 2 days. 5 days after injection, site of the injection get hot, red, swollen, and itchy. It?s day 8 and it?s still like that.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293 and 2018SA267304 (Same reporter). This case involves Adult female patient (age not reported), who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA and expiry date: 30-Jun-2018) (dose in series and route not reported) in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant reported. It was a case of actual medication error due to expired vaccine used. No reaction 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. Documents held by the sender: none.
pregnant at time of vaccination On 5/25/21, patient presented to ED and was admitted O24.420 - Gestational diabetes mellitus in childbirth, diet controlled O42.02 - Full-term prem ROM, onset labor within 24 hours of rupture On 6/10/21, patient presented to ED: O99.893 - Other specified diseases and conditions complicating puerperium CHEST PAIN SHORTNESS OF BREATH BACK PAIN
This spontaneous report has been received from a registered nurse referring to an unspecified number patient of unknown age and gender. Medical history and concurrent conditions were not provided. The register nurse stated that an unspecified number of patients were vaccinated with ZOSTAVAX (lot # L000448 and expiration date 08-MAR-2016) (dose, and frequency were not provided), that were improperly stored. Concomitant therapies were not provided. The reporter reported that these doses were administered between December 2015 and 04-JAN-2016. No adverse effects were reported. Additional information has been requested.
Hyperpyrexia: 106.3. Treated with 1000mg Tylenol orally.
Approximately 5 minutes post vax, baby inconsolable, went from being red, head to foot, to white, head to foot. Some mottling, blotchy pink, then dusky in color. HR regular but increasing. Approximately 10 minutes later, pt sent to ER - crying and lethargic. Observed in ER 2.5 hours.
patient received his 3rd moderna vaccine - booster 3pm september 1 september 2 woke up with eyelid swelling
Caller states that she received her 1st vaccine today at 10:45 AM. Now with a red rash on both arms and her back.  Denies any other symptoms.  Denies shortness of breath or swelling.   Encouraged to apply cold compresses to rash, observe for an increase in symptoms and go to ED if symptoms worsen.  RN
On 10/17/2021 hands started to shake so bad that spilling hot things on myself, that lasted till this day. Fatigue, joint pain, both ankles and toes are stiff, all joints are painful, swelling in the top part of left foot-still ongoing as of today. My doctor is on vacation till 11/29, I have an appointment scheduled for 11/30 to get tests done.
Med Aide, administered 0.2ml of undiluted Pfizer Covid vaccine. Monitored patient for 30 minutes after administration and spoke with mom at length about s/s to monitor for. Will f/u tomorrow with phone call. Patient will seek emergent care if any severe reactions occur. At time of VAERS report, patient is having to adverse side effects.
This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc (Case Number: 00255117). Description: The primary reporter is Merck & Co., Inc. field representative, (Name), who is reporting AE information provided by nurse practitioner, (Name). The nurse practitioner reported a 90 year old patient experienced tachycardia, weakness, and feeling ill a few hours after administration of PREVNAR on an unspecified date. The patient's oxygen level decreased and she started to develop a fever. The patient subsequently recovered. No further details were provided. Physician Information: Product: PREVNAR. Product Circular#: NA. Lot Number: unknown by reporter. Expiration Date: unknown by reporter. Dose/Frequency: unknown by reporter. Please note that this information has not been reported to the FDA. No follow up attempts are possible. No further information is expected.
Patient had received her high dose flu shot at the PCP 4 days prior, and was administered the High dose flu again. will be calling patient to follow up on symptom, pt stated they feel fine at this time. MD is aware
i had a scratchy throat the night before. I tested the next morning. I was negative. I got on my flight and i felt bad but when i got off i felt even worse. I got to the hotel and couldnt eat and went to bed. I took a test the next morning and i was positive. I went to the wedding but sat far away. I had a headache the next morning the 6/26 but it went away with advil and i really just felt like i had a bad cold.
Running Nose; Cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 26-Mar-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 RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches). At the time of the report, RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Systemic symptoms; Bruising after vaccination; Limited range of motion in arm and struggles to lift arm; Tender arm; Vaccine inadvertently injected into the bursa; A spontaneous report was received from a nurse concerning a unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and vaccine inadvertently injected into the bursa/incorrect route of product administration, experienced tender arm/tenderness, systemic smptoms/general symptom, bruising after vaccination/vaccination site bruising, and limited range of motion and struggles to lift arm/injected limb mobility decreased.  The patient's medical history was not provided. No concomitant medications were reported.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient reported that she received her first vaccine, and it was inadvertently injected into the bursa.   The patient later reported that she experienced a tender arm, systemic symptoms, bruising after vaccination, limited range of motion and struggles to lift the injected arm. She stated she will seek medical attention. No treatment information was provided. Consent given for Safety to follow up.   Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccine inadvertently injected into the bursa, was recovered on 06 Jan 2021. The events, tender arm, systemic symptoms, bruising after vaccination, and limited range of motion and struggles to lift the injected arm, were not resolved at the time of this report.; Reporter'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
The day after received vaccine in morning her right eye started twitching got worse felt tingling and like it started to go numb then I went to Urgent care walk in was told as long as it does not spread it will be ok to check back in 2-3 weeks if it did not get better and within 2 and a half weeks it was gone.
Expired Vaccine administered to  patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable
This spontaneous report has received from a physician assistant referring to a patient to unknown age and gender. On 16-FEB-2016 the patient was vaccinated with an expired dose of VAQTA (50U/1ml, lot # K010195, expired date 15-JAN-2016), 1 DF. There was no adverse event reported. Additional information has been requested.
flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer with unknown formulation, strength, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination. Batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency).  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Mother reports extreme left arm discomfort from time of injection for 3 days.   Day after injection had temp of 101.2 for 4 hours.   2 days after injection arm bright red, hot area 3" x 3";  lasted 48 hours.
On 12/7/10 received DTaP, HIB, IPV, PREVNAR & ROTATEQ. On 12/12/10 devlp. blotchy rash all over - self resolved. On 2/4/11 received DTaP, IPV, HIB, PREVNAR & ROTATEQ. On 2/11/11 developed erythema multiforme rash.
INITIAL SIDE EFFECTS OF REDNESS/PAIN TO SITE, FEVER, BODY ACHES, VOMITING, HEADACHE SUBSIDED WITHIN ONE WEEK. ON 3/6/2021, I WOKE UP W SEVERE PAIN/TENDERNESS TO INJ. SITE WITH SHOOTING PAINS DOWN ARM. HOME TREATMENT WAS TYLENOL AND ALTERNATE W IBUPROFEN, WARM PACKS ALT W COLD PACKS  OFF AND ON FOR 2 WEEKS. PAIN INCREASED WITH MORE FREQUENT "WAVES OF PAIN ACCOMPANIED BY  ELECTRICAL SPURTS SHOOTING DOWN MY ARM AND NUMBNESS TO INDEX FINGER AND THUMB.  ER MD ON 3/19/21 COULD NOT DETERMINE CAUSE AND PRESCRIBED MUSCLE RELAXANT AND FOLLOW UP W PCP.
Pt. came to pharmacy showing the site of injection (ZOSTAVAX) has swollen red looks like infected with a dime size wound-she said it is painful and sore. She noticed it on 7-19-15 and reported it on 7-20-15 at 12.12PM.
Chills and fever, terrible headache, extreme sleepiness or tiredness, loss of bladder control.,
Patient reported onset of swelling, redness and pain in left upper arm. The erythema measured 11cm x 15 cm and the induration measured 4 cm x 7 cm.  This area of erythema and induration was significantly distal to the injection site in the left deltoid.