chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beginning in late April 2021 pain in middle of stomach; nausea; pain/beating in right shoulder and right arm. When I slept there was pain in my right side and moved to left and pain moved and when I tried to sleep on my stomach I had pain in my stomach. The main thing was that I felt nauseated. Currently I have begun to burp more than usual, enough to realize.
This spontaneous report as received from a pharmacist refers to a 76 years old male patient with vaccination. This is the second of two reports from this reporter; see SR # 1-5796715254 for the first report. The pharmacist reported that a patient developed an injection site reaction following vaccination with 1 DF ZOSTAVAX on 28-NOV-2012. On 30-NOV-2012 the patient experienced injection site reaction which was described as a small red area (exact size unspecified, but described as a small spot) 3 days after onset of therapy. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of injection site reaction was described as a small red area was reported as not recovered/not resolved. The relatedness for injection site reaction was described as a small red area is unknown for ZOSTAVAX. No other information to report.
9 days after vaccine I have redness and swelling near injection site along with being hot and tender to the touch. I have also been experiencing dizzy spells with heat waves for approx 24 hours (current time 1117).
After 5 minutes mouth had metallic taste, tongue and face started itching.  Temp 99.9 tympanic. Flushed, red, hives on face, trunk, severe Itching.
Client received first COVID  vaccine on 03/05/2021 about 1100 am, reaction noticed on 03/07/21 early in the day, exact time not known.  Client report vaccine given in left arm (deltoid), reaction on top of left shoulder.  Reaction is a lump, the size of "2 big marshmallows" on top of her shoulder, with left sided neck pain and fatigue.  No redness, pain or restriction with movement at reaction site.  Client has applied ice and taken Tylenol for reaction.  Client has an appointment with PCP tomorrow, 03/16/21.
pt recv vax 11AM & started crying @ 330PM;high pitched wail on & off devel fever 101 rt leg immun site devel hard knot, red & swollen;mom observed jerky movements that lasted approx 10sec;pt seen next day 2JUL97 appeared well;
Child fainted after receiving 5 immunizations. Immediately came to. Was given juice. Opened door to exam room and turned on fan in room to increased ventilation. Monitored for 15 minutes before was allowed to leave with parent. BP was checked up PHN and was normal.
Fatigue, Coughing, body aches all over, Headache, Chills, no fever
Pfizer-BioNTech COVID-19 vaccine EUA-  night of 1/5/21 began having joint and muscle pain with sore throat & HA. These symptoms continued and nausea, dizziness, fever and mild nasal congestion start 1/6/21
30 yo AD SSGT received his primary smallpox vaccine (VV04-003A, ACAMBISH/BAH) along with ANTHRAX vaccine #1 (MIP/FAV230) and TYPHOID Vi (PCM/B1026-2) on 01 July 2010. He denied any recent or past illness, exposures to illness (has 3 young children at home), or problems pre vaccination. He reported SPV site became red, tender with pustular formation (Robust take) reporting a small red lesion to posterior edge SPV Tegaderm dressing about day 5-6 that had similar characteristics to existing SPV site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He has kept this site covered and protected similar to SPV site. Day 11 (7/12/2010) while enroute for transport, this SM plane landed. SM advised he felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to edges of his tongue. He c/o a bad taste in mouth. He also noted onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, n/v/d, or shortness of breath. 7/13/2010. He afebrile (97.0-98.0 F) with no current complaints of headache, fever, chills or hand paresthesia/tingling...symptoms resolved <24 hours from onset. However he still had diffuse scattered single macules/papules to upper chest, back, neck and abdominal regions and a sore throat. Dx: non-viral pustulosis, pharyngitis.
Redness and itching around the site of injection spreading about in a 3 inch area, resolved after treatment with antihistamines.
Developed fever 101.4, body ache and headache, lasted 36-48 hours.
Pt recvd 3 doses of Engerix-B & determined to be a non-responder;
8MAR94 pt mom states pt was drowsy & limp but arousable for 12 hrs p/vax; MD examined pt 6PM 8MAR93 & had a nl exam & pt was listless 2 hrs prioiito exam dx poss vax react;
Patient is a 74 y.o. female patient of local MD with history of fibromyalgia, depression, lumbar degenerative disc presented to Hospital with diffuse body aches.   Patient presents today from her senior living apartment for diffuse body aches and fatigue and inability to care for herself.  She has been to the emergency room 3 times since 11/26.  She initially presented with pain everywhere and was found to have a URI and musculoskeletal pain.  Today she tested positive for COVID in the ED.  She also reports having a dry cough that is occasionally productive of mucus.  Mucus used to be white, now is yellow.  She reports nausea without vomiting.  She reports night sweats.  Denies diarrhea but reports loose stools.  She just quit smoking 1125   Diffuse body aches and failure to thrive Covid-19 Virus Infection Date of onset of symptoms: 11/26 Symptoms present on admission: Body ache, loose stool, cough Date of covid positive test: 12/5 Vaccination status: vaccinated Imaging: None on admission Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: none Anticipated special isolation end date: 12/15 IV hydration Tylenol for fever and symptomatic pain control Flexeril for diffuse body aches as needed Lidocaine patch   Hypokalemia Very mild in the setting of COVID Replete and monitor   UTI Diffuse body aches Follow-up urine culture Continue cefazolin   Depression Continue home citalopram     General weakness PT OT
pt recv vax & devel lumps @ the inj site 2 to 3 wk p/vax;the lumps needed to be drained several times;the resulting fluid was clear in color;this is 1 of 2 pt who exp this event;
Pt started with low grade temps up to 99.2, rash on trunk on and off last week but in the last day the rash has spread to the rest of the body from head to toe with little itching. Parents were using calamine lotion to help with itching.  Parent advised by Dr. to use hydrocortisone 1% cream as needed for itchy areas.
This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were reported as follows: This case was reported by the former retired GlaxoSmithKline (GSK) employee. The patient did not receive 2nd dose of SHINGRIX by the 6th month and a week deadline. The patient stated that his 6 months period since his first SHINGRIX vaccine was 13th October 2018. The patient had his name on list at several locations as well as his general practitioner (GP). The patient was asking about the supply that was it going to get better. The representative stated to the patient that, to monitor the ongoing safety of our medications. The representative asked the patient to provide his physician's contact details. To address the current high demand, GlaxoSmithKline (GSK) had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. Individual medical guidance for patients like himself should be provided by medical professionals and was not something GSK provides to patients. As the patient might know the Food and Drug Administration (FDA) approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The representative stated that he could share with him that the CDC has provided guidance that if it had been more than 6 months since you got the first dose, the patient should get the second dose a soon as possible and you did not need to restart the vaccine series. The patient was advised that he should talk to his doctor or pharmacist about this guidance and your individual situation. If the healthcare provider needs additional information for our products, they can call the GSK Medical Information department. Many of the pharmacist in his were quite frustrated. The locator on the website was not accurate. The patient thought that he would rather see not available than list locations that when he called they did not have any in stock. The patient gave permission to follow up with his healthcare professional (HCP).
I have been suffering for about 1 year with hot flashes. Approximately 5-8 per day and 3-4 at night that were awakening. I took my 1st Moderna vaccine and nothing happened until after the 2nd dose of Moderna. The effects were almost immediate, that same night I slept completely though the night (minus my bladder and PTSD issues) without 1 hot flash!!!!! I am so happy and spreading the news.
The pharmacist injected the SHINGRIX vaccine into my left deltoid tendon (insertion), not into the deltoid muscle. This was evident by both the area of pain and tenderness and the placement of the band aid. There was a large air bubble in the syringe, and I do not know whether or not she tapped it out prior to the injection. Since the injection, I've had pain and tenderness in the left deltoid tendon. On day 2, the pain and tenderness spread to the left brachialis and triceps muscles, and I still (on day 4) am not able to lie on the left side because of the pain. On day 3, the pain spread into the left teres major and minor muscles. All the areas of pain have persisted. There was mild induration of the brachialis, but no obvious erythema nor swelling in the arm. I have had NO pain in the deltoid muscle itself.
Two nights after first vaccine she felt unwell. Was too dizzy to get out of bed in the morning, had to hold on to things. Was getting out of breath with walking. Came to see cardiology and was found to have a pericardial effusion and bilateral pleural effusion. She was in SR. started ibuprofen and colchicine. On 2/25 she returned and had afib with RVR. converted to SR. Ibuprofen stopped due to eliquis being started for afib. Rheumatology started prednisone and stayed  colchicine. COVID PCR was negative. She elevated ESR and CRP.  Also seeing rheumatology who ordered multiple studies.
Slightly sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 61-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced slightly sore arm. It was reported that no treatment was required.   The outcome of the event was recovered on the same day (25-Oct-2018).  This case is linked to 201804954 (same reporter).  Non-significant follow-up received on 02-Jan-2019: The reporter's county was added in the general tab. The reporter did not give permission to contact the patient. Med info number SEQ19-00015 was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 61-year-old female patient (under 65 years) was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event painful arm as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event inappropriate age at vaccine administration as not related to suspect vaccine due to accidental nature of the event.
This spontaneous report was received from a pharmacist refers to a unspecified patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU, lot# N009167 with expiry: 02-FEB-2018, for prophylaxis. Concomitant included MERCK STERILE DILUENT. No adverse effect reported. The vaccine was stored at 6° F to 14° F for 45 minutes. It had no previous temperature excursion and the excursion was detected by digital data logger.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2015, the patient was treated for a vesicular rash, which was diagnosed as shingles. The patient was prescribed prednisone, LIDODERM, and VALTREX for the management of his painful symptoms and chronic pain. 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Whole body contractions like it turning to rock, Pain as # 10 in scale, fever for 3 days,  chill an shaking, sleeping a lot  headache and allucination.
Patient reports red, swollen painful area around injection site. Area was also warm to the touch. Patient is icing the area at home and I recommended she use BENADRYL tonight as she states each day the reaction gets worse. She is going to call me tomorrow to report how her arm is.
muscle spasms in her thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasms in her thighs".  Additional information: The patient due to take second dose tomorrow. Has been experiencing muscle spasms in her thighs and wants to see a physician. Wants to know if she can delay getting her second dose of Covid Vaccine for a week or so.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client had received flu vaccine at hospital 9-8-23. When nurse asked client, she did not remember getting a flu vaccination.  Nurse did not check MICC for vaccination status prior to vaccinating.
Patient received 2nd dose at 6 week interval instead of 2 month; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received 2nd dose at 6 week interval instead of 2 month).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The reporter asked that what should office do or the patient need to be revaccinated. The patient received 2nd dose of Shingrix at 6 week interval instead of 2 month, which led to shortening of vaccine schedule. The case was linked with case US2023135132 and US2023133827 reported by the same reporter.; Sender's Comments:  US-GSK-US2023133827:Same reporter US-GSK-US2023135132:Same reporter
Information has been received from a 64 year old female with neurology problems, carpal tunnel syndrome and a history of right wrist surgery who on 28-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included NASACORT, SYNTHROID, allergenic extract, methyltestosterone, montelukast sodium (MSD), NIASPAN, ATROVENT and CLARINEX.  On 30-JUN-2007 the patient experienced numbness in both feet.  That same day the physician did an adrenal insufficiency test in which something was injected, possibly cortisone (results not reported).  On 02-JUL-2007 a strength test was performed on her feet where she was stuck with pins (results not reported).  Additional information has been requested.
Patient developed rash after 10 hours ,had to ice her leg afterwards; This case was received via another Manufacturer on 27-May-2022 and was forwarded to Moderna on 27-May-2022. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards). At the time of the report, RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Reported that after 10 hours of vaccination patient developed rash due to which she had to ice her leg afterwards.
Patient admitted with left sided weakness on 4/21/21. First covid-19 vaccine (Moderna) received on 3/23/21. MRI/MRA shows acute infarcts of the right caudate body and striatum. H/o HTN, hep C with cirrhosis, COPD, tobacco abuse, alcohol use disorder, GTC seizure disorder. ECHO on 4/21/21 which was normal. Patient thought to be actively overusing alcohol at home. Patient was treated for stroke and discharged on medications to help with alcohol withdrawal symptoms (clonidine, gabapentin) as well as aspirin, plavix, and atorvastatin for new stroke. Thrombocytopenia noted (platelets 50K), however patient?s platelets have historically been low likely related to alcohol use. Per hospitalist discharge summary, low suspicion for vaccine induced thrombocytopenia. HIT Ab test ordered on 4/21/21, resulted negative. It seems to be coincidental that stroke occurred about a month after patient?s first covid-19 vaccine but reported to VAERS for completeness. Did not add covid-19 vaccine to patient?s allergy list. Patient received second covid-19 vaccine (Moderna) on 4/28/21.
Patients mother called clinic and states her son received vaccination last week in clinic and still has a lump in his right arm.  Patients mother was notified during phone call of the "After the Shots" information including, use of tylenol or motrin prn, cool wet washcloth for comfort, and to notify his healthcare provider or go to urgent care if symptoms do not improve.  Also instructed to call healthcare provider or go to urgent care if the child has temperature greater than 101.9, child pale or limp, crying more than 3 hours, strange high pitched cry, childs body shaking, twitching or jerking or any decrease in activity or responsiveness.
felt hot; mine itched terribly/itched for weeks; a red line around the injection site./I can see a red line; Raised; red round welt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA (a red line around the injection site./I can see a red line), VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-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 VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She is scheduled to get her second dose on 21Dec2021,   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
COVID toe; Toe swollen and red around nail bed; It had pus; A lot of icky pus; Toe swollen and red around nail bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed). In September 2021, VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The pus was absorbed back about in a week and all around the area is healed. No treatment medications was provided.
11/03/23: Rash developed at injection site 11/04: Pain developed at injection site 11/05: Shoulder pain developed 11/08: Pain in shoulder area, described by patient as a 10/10   Treatment: Tylenol with codeine, muscle relaxor, injection for pain and inflammation  Patient is feeling better now after the treatment was initiated by prescriber.
6 x 9mm with edematous, reddened area to upper left arm. Treated with Benadryl 25 mg TID.