chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shot, felt burning at time of injection. By the evening and the next day, arm felt stiff and she had difficulty moving it. At times has sensations of nerve pain down her arm. They come and go. Movement and pain has improved but is not completely resolved. Has not seen her physician-agreed to do so.
I haven't had a period since my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (I haven't had a period since my first vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (I haven't had a period since my first vaccine). At the time of the report, AMENORRHOEA (I haven't had a period since my first vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Itching rash on  both arms and legs.; This is a spontaneous report received from a contactable consumer (patient reported for himself). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EF8736, Expiration date: Unknown), via an unspecified route of administration, administered in Arm right on 07May2021 (age at vaccination: 54 years) as dose number unknown, single for COVID-19 immunisation. The patient medical history was none. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient received most recent COVID-19 vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021 the patient experienced itching rash on both arms and legs. Patient was no prolonged hospitalization. Patient visits emergency room, department or urgent care. Treatment was received for the event as steroid shot and hydrolyzed prescription as a treatment for itching rash on both arms and legs. The outcome of the events was reported as unknown.  Follow-Up (16Aug2021): Follow-up attempts are completed. No further information is expected.
swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that 'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
This report is concerning a 4 month old female who on 29-NOV-2001 was vaccinated with one dose of Comvax. Concomitant therapy that same day included Infanrix, Prevnar and IPOL. The next day, on 30-NOV-2001, the pt developed seizure and fever of 104 degrees F. The pt was taken to the local ER. Treatment of the events was not specified. The pt was improving as of 30-NOV-2001. This was originally reported by a LPN. The pt's seizure and fever were considered to be other important medical events. Additional information has been requested. Follow up info from the physician noted that the pt recovered. The pt's seizure and fever fo 104 deg F were considered to be other important medical events. No further info is available. This is an amended report. The adverse event term was changed from hyponatremia to hypernatremia.
shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergic to sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization), outcome "unknown", described as "shortness of breath".  The lot number for bnt162b2 was not provided and will be requested during follow up.
irritability/craby/bitchy; nose congestion; coughing; sneezing; couldn't sleep well; running/her nose is runny/blowing her nose; lack of appetite/not really hungry; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; Nausea/feeling a little nauseous; fatigue/She is just so tired and crabby; she does not feel good; This is a spontaneous report from a contactable consumer (patient). This consumer reported different event for 2 patients. This is the first report. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EY0584 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 18Jul2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GERD (gastrooesophageal reflux disease) and has had for about 30 years. There were no concomitant medications. On 18Jul2021, about 3 hours after receiving the first dose of the Pfizer Covid-19 vaccine the patient started having complaints of nausea/feeling a little nauseous, sneezing, running/her nose is runny/blowing her nose, coughing, couldn't sleep well and pain at injection site in left arm that was also swollen and warm. On the same day, the patient also experienced nose congestion, fatigue, irritability and lack of appetite. The patient wanted to know if these were normal reactions to the vaccine. On an unspecified date in Jul2021, the patient took off work because she does not feel good. She was tired and bitchy and crabby. It was reported that she does not want to be left alone also reported that wants to be left alone (discrepant information, pending clarification). The patient was not really hungry, and her nose was runny. The outcome for coughing, sneezing, nausea/feeling a little nauseous, and pain at injection site in left arm that was also swollen and warm was not recovered while the outcome for irritability/crabby/bitchy, nose congestion, couldn't sleep well, running/her nose is runny/blowing her nose, lack of appetite/not really hungry, fatigue/she is just so tired and crabby, she does not feel good was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100917618 same reporter/drug, different patient/AE
This spontaneous report as received from a physician refers to one unspecified patient. On unknown dates the patient were vaccinated with ZOSTAVAX (lot #:K000455, Exp date: 30-OCT-2014). 0.65 ml, subcutaneous. The physician reported 4 out of 10 patients were vaccinated with same lot of ZOSTAVAX and developed severe reactions. Multiple injection site reactions which included: angry red swelling at the injection site which cascaded down the arm to the elbow. Redness and swelling circumference around the injected arm. Blisters at the site, which physician confirms was not shingles. Physician stated the last 4 weeks was the most adverse effects she had seen with the ZOSTAVAX vaccine. Physician stated she had seen this change since the last batch label change from 3 piece label to one label. The physician stated one of her patients, who had the reaction to ZOSTAVAX, was scheduled to come into the office today. It was reported that this patient had recovered from the events. ZOSTAVAX Lot Check Request K000455 Exp 30-OCT-2014. This is one of several reports from the same source. Additional information has been requested.
NO FEELING FROM THE WAIST DOWN, SHAKES, DIZZY, LIGHT HEADED, CANT WALK, AMONG OTHER THINGS.
Redness, swelling, heat at injection area. Subsided some w/ hot compress & soaks, subsided a lot better w/ BENADRYL. Lasted 6 days.
pt recv vax & did not feel well & pt head down on table;pt rested;pt was pale & hands were very cold (pt says they always are);BP 80/70, P100;in 10min color was better & pt felt much better;
Varicella Information has been received from a physician concerning a 6 year old female described as healthy who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Within the last few weeks, in August 2005, the patient developed breakthrough varicella with about 10 lesions. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved.
About 6 hours after vaccine administration patient started experiencing extreme headache, joint pain, says she felt "sick to her stomach" and nauseous, and had chills along with a fever of 104 degrees. All of those symptoms lasted a full 24 hours into the next day she said by Wednesday morning 12/18 she woke up feeling that the symptoms resolved and she was returning back to normal.
Vasovagal syncope - occurred about 3-5 minutes after administration.  Patient slouched in chair, eyes rolled back slightly and patient was snoring. Patient was guided to the floor by pharmacist and significant other and regained consciousness after just a few moments.  Patient was unaware of what happened. Patient was given water and remained lying on the floor for a few minutes and then was able to sit up and recover.
LOSS OF TASTE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; HEADACHE; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcohol use, and other pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced loss of taste. On 20-MAY-2021, the subject experienced cough. On 20-MAY-2021, the subject experienced body aches. On 20-MAY-2021, the subject experienced chills. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 20-MAY-2021, the subject experienced headache. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste on 25-MAY-2021, body aches, and muscle aches on 22-MAY-2021, chills on 24-MAY-2021, fever on 27-MAY-2021, and headache, and nausea on 26-MAY-2021, and was recovering from cough, and fatigue. This report was non-serious.
Arm feeling like shot with a gun; Whole body was sore radiating; Felt like the flu, most of the day in bed, horrible; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: Arm feeling like shot with a gun), radiating pain (Verbatim: Whole body was sore radiating), influenza-like symptoms (Verbatim: Felt like the flu, most of the day in bed, horrible) and headache (Verbatim: Headache). The outcome of the arm discomfort, radiating pain, influenza-like symptoms and headache were not reported.   It was unknown if the reporter considered the arm discomfort, radiating pain, influenza-like symptoms and headache to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort, radiating pain, influenza-like symptoms and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-Mar-2023 The patient had his/her first shingles vaccine, the next day was horrible.  Aside from his/her arm feeling like he/she was actually shot with a gun, his/her whole body was sore radiating from my shoulder/ neck down, felt like the flu, headache, most of the day in bed. The patient had to get a second shot.
Initial case report received from a consumer via a local health agency on 30 NOV 2009. A female patient (age unknown), was vaccinated S-OIV-FOCETIRA (batch no. 102046P) on 12 NOV 2009. On the same day, 45 minutes after vaccination, the patient experienced total body paralysis 3 times over 3 hours having consciousness during the paralysis. Since then, the patient had been experiencing chest pains, dizziness, and high blood pressure and had been out of the work for over 2 weeks. The patient performed electroencephalogram (EEG), brain magnetic resonance imaging (MRI), echocardiogram, with all results negatives. At the time of this report, the outcome of the events was unknown. Total body paralysis, high blood pressure, dizziness and chest pain are unexpected after vaccination with S-OIV FOCETRIA. On a case level, this case is considered unlisted. No change in benefit-risk-ratio. No measures necessary. Agency reference no., NA09-008970.
expired vaccine administered to 14 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  Patient not actively experiencing side effects.
COVID diagnosis; Soreness in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID diagnosis) and ARTHRALGIA (Soreness in shoulder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to COVID-19 and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, MELATONIN and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRALGIA (Soreness in shoulder). On 01-Jan-2021, the patient experienced COVID-19 (COVID diagnosis). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN (since covid-19 diagnosis)) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID diagnosis) outcome was unknown and ARTHRALGIA (Soreness in shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Scheduled for 2nd vaccine on 28Jan2021. Information I have researched says you should wait 90 days after COVID to receive the vaccine but no information on if you have received the 1st vaccination already.; Sender's Comments: Due to biological implausibility, the event of COVID-19 is assessed as not applicable to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event of Arthralgia, a causal relationship cannot be excluded.
My husband and myself received my 2nd SHINGRIX shot on March 5, 2019. The day after we both ran low-grade fevers and had flu-like symptoms. I continued to be sick each day after that. Was dizzy and that continued to get worse until yesterday when I got up (3/9/2019) the dizziness was awful. Room was reeling and I was vomiting each time I moved my head. Had to call an ambulance and go to hospital. They did an MRI on my head and diagnosed me with Vertigo. I have never experienced this in my life before. Today I came home, still dizzy though not as bad. I definitely believe this is caused by the SHINGRIX shots.
3rd COVID vaccine (booster) administered by Pharmacy patient says vaccine administered on L arm and was too high (proximal) into shoulder joint. she presents with L shoulder pain and limited ROM. I suspect injection was possibly intra-articular not in deltoid muscle. she has frozen shoulder from this and was treated with sling, immobilization, nsaids, pain meds, and ortho followup
exposed to temperatures out of the recommended storage temperature range / no AE; 8 months old infant received IPOL in deltoid / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA301600 and 2019SA301577.  This case involves a 08 months old female patient who received 0.5 ml dose of suspect IPV (VERO) lot N1K93 (Expiry date 18-Nov-2019) via intramuscular route in the right deltoid on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a actual medication error case due to incorrect product storage and vaccine administered at inappropriate site.  It was reported that temperatures out of the recommended storage temperature range.  At a time of reporting No adverse 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.
Patient received first dose of COVID-19 vaccine on 2/18/21 and received the Moderna COVID-19 vaccine. When patient came back for second dose on 3/25/21 patient was given Pfizer COVID-19 vaccine.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 14-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, vomiting, fever, headache 8 hours after shot that lasted about 12 hours
Woke up with chills, mild headache, tiredness..... continued throughout the day, temp of 100.4  at 8:00 pm, took ibuprofen. Symptoms gone by the next day.
Moderna- COVID 19 Vaccine EUA Tingling and numbness in hands and feet
I was at the hospital and stayed 60 minutes after vaccine a week after I noticed I had severe headaches, leg pain, issues breathing, and headache one week and half after Janssen. Primary care physician wanted to send me to the hospital but I declined and asked for another alternative.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Arm became increasingly sore and stiff by the time I was going to bed (about 11 PM) I was unable to move my arm in any direction more the 3 or 4 inches and was in a lot of pain.  I was unable to move my arm for the next 3 days.  My arm began to ease up a little but as of today (April 15, 2010) I am still unable to lift more than a couple of pounds with that arm or I will have a great deal of pain and I am unable to reach behind my back or raise my arm above my head.  I am in frequent pain even when I don't move my arm.  I am unable to sleep on my left side.  I am unable to hold my arm up (as if holding a book) more than a couple of minutes without being very painful.