chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness; Redness; Swollen Lymph Node; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMITRIPTYLINE, PANTOPRAZOLE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), MONTELUKAST, CYCLOBENZAPRINE, VITAMINS NOS (DAILY VITAMINS), CENTRUM SILVER +50 and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node). At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included ice.
I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye was puffy, swollen, red, itchy. I got a shot of dexamethazone and the next day I felt better.  I also had a script for prednisone.
Unknown lot number, immunization given at the hospital clinic. Booster immunization received 10/12/2021. Pt woke up on 10/14/21 with blindness of left eye. Diagnosed with central retinal artery occlusion.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by  pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event  was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
only thing out of range was his glucose; his second dose was 08APR2021/ his first dose was 21MAR2021; UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 08Apr2021 as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 21Mar2021 as single dose for COVID-19 immunization. On 28Apr2021 patient experienced UTI-like symptoms (irritation and burning). Patient stated that he had second dose of Pfizer COVID vaccine on 08Apr2021. He stated a couple weeks after the second dose he felt a twinge of urinary tract infection symptoms. At the end of April, clarified as 28Apr2021, he went to the doctor to see what was going on. He was prescribed "Ciproflaxin" to see if it was an infection. He confirmed the burning and irritation was still ongoing. Some days it was not bad, some days its annoying as all get out. Patient stated his urine had been tested and the test was negative. Patient stated he had blood tests and all the tests came back negative. Irritation and burning will be there for a day or so, then it quits, then it comes back. Some days it was not bad, some days its annoying as all get out. Patient required visit to physician Office. Patient confirmed full blood profile was completed on 28Apr2021 and the only thing out of range was his glucose because he didn't fast that morning and he didn't expect them to do the full blood profile. Patient stated he had every STI test done that one can think of and all came back negative. The patient underwent lab test and procedure which included Glucose 127 , STI Test negative and Urinalysis negative on 28Apr2021 The outcome of the event UTI-like symptoms (irritation and burning), dysuria was not recovered and only thing out of range was his glucose was unknown.  Information on the lot/batch number has been requested.
her arm that she got the injection in was sore/ like someone had punched her in her arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 23Mar2021 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medications included: QUINAPRIL; POTASSIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021 13:00, outcome "recovering", described as "her arm that she got the injection in was sore/ like someone had punched her in her arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Additional medications that the patient received within two weeks of vaccination included vitamins. She had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient took 2 NORLEX for pain in her arm at bedtime. On 24Mar2021 (one day later), her arm was not as sore as it was. Just a little sore but no medicine was needed for her arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles; patient that requested a second dose / First dose was given on 12Sep2019; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number X9GM4, expiry date 15th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for the 1st suspect vaccine. The age at vaccination was not applicable for 2nd suspect vaccine. The patient experienced shingles at some point between 1st dose and the day of reporting. The patient requested a second dose of Shingirx, till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The reported batch number for 1st dose was X96M4, however it was updated to X9GM4 as per sales datasheet. The reporter consented to follow-up.
4 days after vaccination (evening of 08/02/2022), a dry rash developed on the left wrist; hydrocortisone cream was applied. The following morning (08/03/2022), rash on the wrist was inflammed with 1.5 inch diameter red circuluar rash with oozing lesion in center. Several hours later, the space between index and middle finger of the left hand swelled up, presenting like an allergic reaction. Two sores broke the skin on forearm and hand. Over several hours, half-inch red bumps appeared one at a time in the direction up the arm, from wrist to forearm to elbow to bicep. Oral benadryl was taken that evening and no further reactions developed. All but one sore healed as of 08/14/2022.
exam of lt deltoid reveals obvious edeam there is a sl vesicular formation;there is erythema, tenderness to palpation;
Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 9-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Feverish, chills, lethargy, pain at injection site, diarrhea
Information has been received on 23-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a healthcare facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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 and pain and suffering and other damages. Additional information has been requested.
Ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, TINNITUS (Ringing in the ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   Reporter did not allow further contact
The pt developed redness, warmth and swelling (4"x6") on left arm after the vaccine administration. Pt grimacing when arm touched. Pt states that symptoms started 4 days post vaccination. Pt was able to move arm some how with less pain.
polymyalgia rheumatica ,  prednisone from 08/17/2021
Intense pain in every part of body.....every inch of my body engulfed in intense pain from 9am on day after vaccine until  next morning.  From head to toe.  Have never had an experience like this, I had taken my regular 5 mg Norco pill early that morning, so did not take any other pain relief.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAV (Havrix 1440 adult) (batch number 2ba99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th December 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 29th December 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 30-Dec-2022. Reporter's Comment: The reporter was a medical assistant. The patient received an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired dose which led to expired vaccine used.
Very itchy legs, arms, back with pink tiny pimple like bumps, acid stomach, and headache
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no drug reactions or allergies. On 29-MAR-2015 the patient was vaccinated with ZOSTAVAX (subcutaneous, 0.65 ml in the left arm, lot # K023624, EXP 19-FEB-2016) for routine vaccination. On 31-MAR-2015, the patient developed a red rash on both eyelids and on both eyebrows (rash) and redness around the injection site. The patient sought medical attention (seen at pharmacy) but received no treatment. No lab diagnostic studies were performed. The outcome of injection site erythema and rash was unknown. Additional information has been requested.
after first 2 shots headache and fatigue for 1-2 days.  After booster shot had headache and fatigue day 1-5, then on day 8 get red bumps/rash on face, acid reflux symptoms that resolved with Pepcid.  Day 10 rash was on bilateral palms as well as face (palms only, not whole hand), this is ongoing.  Was prescribed prednisone on day 10, I'm writing this on day 12.
Fever and lethargy within few hours then first time seizure with fever that lasted nearly 30 minutes and required 2 doses ATIVAN to stop it. Required ICU overnight stay.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Took Paxlovid for treatment of positive covid test; (Nov2022) Negative, notes: Started testing negative on day 6, after completing dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 12Nov2022 to 17Nov2022 for treatment  of positive covid test. Did have symptoms. Started testing negative on day 6, after completing dose of Paxlovid. Tested negative for 8 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was just swelling, redness, and heat at the site of the vaccination. After sending the picture to my Doctor he thought it was cellulitis and he prescribed me amoxicillin.
First shot was March 2021.  2nd shot was April 2021.  In July 2021 and continuing, started having severe rotator cuff pain.  Steroid injections and physical therapy did not help.  Next was stiffness in alternating hands.  3rd shot was November 2021In May 2022, I was finally diagnosed with RA.  Had final shot in September 2022.  Never had any RA symptoms/problems, prior to getting the covid vaccination.
Felt faint, improved after rest. No syncope. 140/77, 123/73
soreness in the arm and armpit of the left side where the vaccine was administered; soreness in the arm and armpit of the left side where the vaccine was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An 11-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "soreness in the arm and armpit of the left side where the vaccine was administered".  Additional information: The soreness started the day after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the morning after the vaccine, I had a episode of blurred vision which lasted between 1-2 minutes. I was laying in bed,just awoke and opened my eyes when this occurred. the blurring was as if the room was shaking and blinking my eyes did not clear ir. I closed my eyes for a minute then my vision returned to normal. i have never experience this before or since .
Powder component of Menveo with a Non-GSK supplied diluent; Powder component of Menveo with a Non-GSK supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received powder component of Menveo with a Non-GSK supplied diluent, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administred. No adverse event was reported. No patient identifier, no lot number, no expiiration date and no vaccination date was provided. The reporter consented to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 18-NOV-2014,  the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On 29-AUG-2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were reported as related to the therapy with ZOSTAVAX.
About five days after receiving first COVID shot I felt itchiness in left arm. Then I noticed large three large red blotches  from  almost shoulder to  about six inches from elbow.  They became a darker pink and outlined in red.  They were very itchy for several days, but otherwise I felt fine.  As of today I still have the blotches, but they seem to have faded a bit (red outline still visible) and the itchiness is much less.