chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Their arm is  still very sore / arm is ache/ still sore), VACCINATION SITE RASH (Red rash has develop below  were they got  the shot/ the rash is approximately 3inch by 1inch) and VACCINATION SITE ERYTHEMA (Red rash has develop below  were they got  the shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PAIN IN EXTREMITY (Their arm is  still very sore / arm is ache/ still sore). On 01-Dec-2021, the patient experienced VACCINATION SITE RASH (Red rash has develop below  were they got  the shot/ the rash is approximately 3inch by 1inch) and VACCINATION SITE ERYTHEMA (Red rash has develop below  were they got  the shot). At the time of the report, PAIN IN EXTREMITY (Their arm is  still very sore / arm is ache/ still sore), VACCINATION SITE RASH (Red rash has develop below  were they got  the shot/ the rash is approximately 3inch by 1inch) and VACCINATION SITE ERYTHEMA (Red rash has develop below  were they got  the shot) had not resolved. No concomitant medications provided.No treatment medications provided., patient tried to move the arm a lot thinking it would help and was still sore, she put some ice.This case was linked to MOD-2021-403373 (Patient Link).
Throat Swelling, did not really affect breathing, also lymph node swelling, muscle weakness, tiredness.   Did stop at doctor's on way home and got high dose benedryl and steroid shot.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose or oral ROTATEQ (Lot # K015816, expiration date 29-MAY-2016; Lot # K023534, expiration date 22-MAY-2016; Lot # K016261, expiration date 23-JUN-2016 or Lot # reported as L008057, expiration date 01-DEC-2016) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 2016, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at the pharmacy. Subsequently, on an unknown date, the pt was treated by a healthcare provider at the hospital, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): shingles and other zoster-related conditions. The outcome of shingles and other zoster-related conditions was not reported. The reporter considered both events to be related to Zoster Vaccine Live (ZOSTAVAX).
Arm erythema, painful to the touch, sob, hoarseness, aches, pain, palpitations.
Swelling, redness, and heat in the injection site 7 days after the vaccination.
received only the adjuvant portion / without reconstituting the powder with the gE antigen; received only the adjuvant portion / without reconstituting the powder with the gE antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date 15th October 2022) for prophylaxis.   On 17th May 2021, the patient received Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant informed that the patient received only the adjuvant portion from the shingrix without reconstituting the powder with the gE antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with the case US2021114069, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021114069:Same Reporter
This child had acute disseminated encephalomyelitis (ADEM) involving inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to the conus.  He had bowel and bladder retention, lower extremity paresis and numbness.9/15/08-records received for DOS-8/2-8/10/08-DC DX: Acute disseminated encephalomyelitis. Presented with two day history of bilateral lower extremity numbness and tingling, awoke with mid upper back pain and later that night developed abdominal pain and difficulty breathing. Positive sick URI contact 2 weeks prior to presentation and two episodes of emesis the day of presentation. Constipation and urinary urgency but unable to void. Cough and rhinorrhea. Fever 102.  Foley catheter placed 800cc of urine removed which improved back and abdominal pain.Treated with high dose steroids.
placed it in the refrigerator unprotected from light exposure; This case was reported by a pharmacist via call center representative and described the occurrence of product storage error 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 product storage error. On an unknown date, the outcome of the product storage error was unknown.   Additional Information: GSK receipt date: 14-Jul-2022 Reporters comment: The pharmacist reported that nurse removed Menveo from its packaging and placed it in the refrigerator unprotected from light exposure. The reporter was unknown if any patients were involved. The reporter consented to follow up via email. Additional supportive information: The possible administration of unprotected vaccines to the patients, which led to incorrect storage of drug.
The patient's past medical history included Hypertension since an unknown date. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy) and PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy). On 21-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site, which she felt). At the time of the report, SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20k) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy) and PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy). On 21-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site, which she felt). At the time of the report, SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
chest feeling heavy like she was swelling up with fluid; chest feeling heavy like she was swelling up with fluid; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced chest feeling heavy like she was swelling up with fluid on an unspecified date. Reporter stated that, "after receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine and then afterwards, while still at the vaccination site, she experienced her chest feeling heavy like she was swelling up with fluid. She did not need any treatment and before she left, the vaccination site told her to go to the emergency room if she started to experience trouble breathing or any symptoms that might indicate anaphylaxis. She does plan to consult with her physician about getting the second injection or not because of what she experienced. She inquired should she get second injection since she had a reaction after the first". Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HIGH FEVER UP 105.8, VOMITING, DEVELOPED RASH ALL OVER HIS BODY- SORT OF CHICKEN POX, SORE THROAT, LOST OF APPETITE- NOT ABLE TO LOWER FEVER UNDER 101. ON 11/2/09 TOOK PATIENT TO SEE DR., SHE EXAMINED HIM AND SAID THAT HE HAD CHICKEN POX. FEVER GOT VERY HIGH, CONCERNED CALLED DR. ON 11/3/09- NEVER RECEIVED CALL BACK, CALLED AND LEFT MESSAGE ON 11/4 & 11/5- CALLED MY INSURANCE NURSE ONLINE 24 HRS- BUT FEVER WAS STILL VERY HIGH- TOOK PATIENT TO EMERGENCY ROOM ON 11/06/09 1AM - TO ER DOCTOR STATED NO CHICKEN POX BUT A REACTION TO THE VACCINE HE RECEIVED ON 10/23 (FLU & H1N1 VACCINNE)- REQUIRED BLOOD TEST AND IV.  WAITING FOR RESULTS. WAITING IN HOSPITAL. 11/18 Medical records received fro DOS 11/6/09.  Final DX: Erythema multiforme, Viral illness ED visit. Fever rash x5 days. Larger erythematous lesions w/central clearing.  Chest, abd, legs. fever 102-105. Erythema multiforme poss s/to viral illness, poss bil OM. D/C to home on abx therapy. ICD9 Codes: 695.1, 079.99
received COVID vaccine #2 on 09 Jun 2021, and 4 days later began to have a rash that started on her arms and legs and has progressed to her shoulders, back, and thighs. Rash described as "raised red patches and welts", very pruritic ("itchy like chicken pox"). She reports areas where her skin is peeling, and that there are places where you can't see a rash but she can "feel bumps under the skin", and that the rash on her inner thighs is so sensitive it has made it difficult to walk. Caller states she had the same rash after COVID dose #1 (19 May 2021. Saw PCM given Zyrtec and Pepcid. Did not take regularly. Rash was not completely resolved before receipt of #2    Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
15-36 hours after:  headache, chills,  injection site pain 9 days after:  Hair follicle and or skin  tenderness  concentrated to the  back left  lower quadrant of head.
I got  my first Pfizer shot around 3 weeks ago, after the shot, like 3 days later,  I  found a big bruise on my right calf, on the outside side, pretty big, around 2.5 inches diameter, at that time I thought I bumped into something and did not realized it. Then I got my second shot on Saturday April 17th, on Monday 19 I was taking a shower and I felt a pinch on the back of my calf , right side again, and saw a big bruise developing I have varicose veins , but I never ever got bruises like that from nothing I feel the vaccine got something to do with this First time in my life this happening , and it is more than a coincidence after each shot appeared  After that shower I run to the hospital and did blood test , coming up good, thanks god, and also ultrasound on my leg , they did not find any clot. Im a Pro of vaccination , I want to help and inform my case , but also im really scared something could happened to me
Patient reported that the day after he received his vaccine, his left eye was very bloodshot.  He did not experience pain however his vision in that eye was a little hazy.  I attempted to contact the patient to ask how long this lasted or if it had cleared up but was unable to do so.
Received Tdap on 10/30/2007.  Later that evening, patient experienced extreme pain in her arm, fever 101 F, swelling, and redness.  Reports left leg pain, but has a history of backpain.  Today, no fever present, redness at injection site and area of Width 9 cm X Length 8 cm which is warm/painful to touch and swelling present below injection site.  Patient prescribed Cipro 500 mg one tablet twice a day for 7 days for cellulitis.
After having a sore throat and tightness in chest, took a home COVID-19 test and it was negative. Over the next couple of days I started having a fever with a really bad cough. Took another COVID-19 test and it was still negative. The next day I had a fever and started to lose my voice. Finally tested positive through home COVID-19 test. Called Dr. and was prescribed benzonatate 200mg. Only took one dose. Two days later I was attacked by a neighborhood cat and was put on doxycycline for 10 days. Took another COVID-19 test on 09/27/2022 and was negative.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.31 for dose administered on 11-Jan-2021.   No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
pt was given shot & immed fell to the floor, hit head & back & was unconcious; had a sl sz movement of head, face & arms, was put on oxygen & taken to hosp;
Patient received 1st dose of his Covid vaccine;  after~10 min, during observation period, he was noticed to become pale ,diaphoretic and with decreased level of responsiveness;  was put on the stretcher. Physician who was monitoring the vaccination area reported: "BP 110/64 HR 76 Sat 95%   Patient was feeling better upon being placed supine and was verbalizing as well.  Denied chest pain and shortness of breath. Just felt dizzy and weak." Patient was taken to ER; CBC,CMP,ECG- all normal and he was discharged after 2 hrs of observation with diagnosis of Vasovagal Syncope. Today, patient is well and went to work as per his spouse. Patient has history of similar syncope or near syncope events in the past during stressful situations, like seen blood .
Since 10/10/16, I have had dull throbbing pain on my left arm which radiates down past my elbow.  The pain is not excruciating however it is constant and bothersome.  I have taken Advil (400mg-600mg) since Monday in hopes of easing the pain; however it does not do much to elevate the pain.  The discomfort has made sleeping rather difficult since Tuesday of this week.  The pain feels as though it is intramuscular in nature and light rubbing does not seem to help much.  I am unable to sleep on my left side as this will cause the pain to intensify.  Nor can I put weight on this arm (i.e. leaning) as this will irritate and the pain will intensify as well.  Very limited use of my left arm as constant usage of the arm will increase pain and discomfort.
Pt (12 yo) received pedi pfizer by tech immunizer, when regular pfizer should have been given. No symptoms reported at this time.
Immediately after injection, patient bled from the injection site to soak a cotton ball.  She developed a raised area approx. 1.25 inch in diameter and 0.25 inch raised.  After approximately 30 minutes the raised area had returned to normal appearance and patient had no pain or tenderness from injection.
4-11-19 PT RECEIVED PNEUMOVAX 23, BY 4-13-19 PT WAS HAVING INCREASED DIFFICULTY BREATHING, CHILLS, ACHY, AND COUGH. PT WAS ORDERED CHEST XRAY AND WAS POSITIVE FOR MIDDLE LOBE PNEUMONIA. SHE WAS TREATED WITH LEVAQUIN 750MG DAILYX5 DAYS AND PREDNISONE 20MG TWICE DAILYX5 DAYS AND FOLLOW UP WITH PCP.
Initially no pain or discomfort at the injection shot.  Day two, a little soreness.  Day 10, evening, slight itchiness different parts of the body.  Slight swelling and itchiness in my face area.  The injection sight, suddenly felt very itchy and several nickel sized lumps developed in the injection sight area.  Both hands feel itchy and the right hand finger tips feel itchy and slight swelling.  The injection sight is sore and continues to  have the lumps, soreness and itching.
PT EXPERIENCED FAINTING, DIZZINESS, NAUSEA/VOMITTING AFTER COVID VACCINE. PARAMEDICS ARRIVED AND TOOK PT TO ER. VITALS: BP 105/68, RR: 22, HR 71, O2 99%
Arm became heavy and very painful within one hour of shot.  Went to emergency ward at 9:00 pm.  Gave me one dose of hydrocod .Did nothing for pain.  Went to doctor morning of July 30 and she put me on hydrocod and prednisone for 2 1/2 weeks.  Arm still hurt so she sent me to physical therapy.  It is 4 months later and my arm still hurts.  Also, at this time put me on Ibuprofen for 14 days.  It is dec 5 and arm still hurts.  Doctor referred me to an ortho and he is saying I should get a MRI.
PT. Was given the Janssen Vaccine on 03/22/2021 and Pt came for a 2nd dosage of the Moderna Vaccine on 05/13/2021. PT agreed on getting the vaccine, not telling the Medical staff about the previous vaccine from 03/22/2021. PT was left in observation for 30min after the Moderna vaccine was administer
Pulmonary emboli. History of J & J on 3/31/2021 and on 10/27/2021 (booster).
Febrile seizure 10/11 & 10/13 sent to ER. Was seen in office, pt still febrile and has herpes stomatitis.
A report has been received from a Health Professional concerning a patient, male subject who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 07-JAN-2015. Reporter stated that none of the six patients presented any adverse reaction after receiving expired FLUMIST Quadrivalent vaccine. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
This case was reported by a consumer and described the occurrence of sore arm muscles in a male subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent vaccination included Vaqta (Merck) given on the same date as Engerix B.  Previous vaccination included Twinrix (GlaxoSmithKline).  On an unspecified date the subject received a dose of Engerix B (unknown) and a dose of Vaqta in place of the combination dose of Twinrix which was unavailable at the time of vaccination.  At an unspecified time after vaccination with Engerix B and Vaqta, the subject experienced sore arm muscles.  The subject stated that his arm muscles were sore for 23 days following administration of the vaccines and the event remained unresolved at the time of reporting.
This spontaneous report as received from a healthcare professional refers to a 6 month old patient of unknown gender. Patient's concurrent condition and medical history was not known. On 01-OCT-2015 the patient was vaccinated with PROQUAD (Merck) dose 1. Concomitant medications were not provided. No adverse symptoms were reported. Product quality complaint was not filed. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified date, patients were vaccinated with improperly stored GARDASIL (dose, frequency, route of administration, lot#, expiration date and indication were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Good morning of March 21 tingling and numbness on the right side of the face went immediately into urgent care and was told I had on Covid vaccination supposedly woke up shingles in my system