chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 20th December 2019) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (1st dose received on an unknown date). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX 0.5 ml. On 2nd April 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, muscle pain and sleeplessness. In April 2019, the patient experienced back pain, pain of lower extremities and pain in hip. On an unknown date, the outcome of the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any symptoms with her 1st dose. On 2nd April 2019 around midday, the patient had her 2nd dose of SHINGRIX in the right deltoid. By the evening, the patient's arm was very sore. She did not sleep well during the night and felt it was due to muscle aches she was experiencing. The next day on 3rd April 2019, muscle ache was worsened in her lower legs, back and hips. She did not feel like she had any fever. The patient consented to follow up. The patient stated, she experienced same event when she got a flu shot (refer case US2019GSK065517).
One week later after vaccination -  site was inflamed, hard and itchy. on about 1/3 of the upper arm.  Starts at the vaccination site and moves down to elbow.  Not very painful, but very red, swollen.   One week later was first  time of symptom.  Took Benedryl  and it stopped itching but swelling or redness is continuing.
FLU VACCINE. Doesn't know which type of vaccine. Doesn't know the LOT number.   Stomach and head was burning. My hand became numb.
I have had ear ringing constantly starting 24 hours after getting my booster shot and it has not stopped. It has been over 48 straight hours now.
inquires if they need to give them the third dose or start over; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (patient received the second dose on 15-NOV-2022).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: inquires if they need to give them the third dose or start over).  The outcome of the incomplete course of vaccination 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: 12-OCT-2023 The pharmacist reported that a patient received the 2nd dose of the Twinrix vaccine and inquired if they need to give them the 3rd dose or start over. The reporter consented to follow up. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
autoimmune disease fibromyalgia, raynods, numbness, flushing/sweats, anxiety,headaches, exhaustion to the point where its impossible to work, total body pain constantly,hair loss, vision problems,stiff and sore muscles,insomnia, trouble focusing and concentrating, memory loss, weakness, trouble breathing,and dizziness near syncope.           All the side effects happened and intensified during December through January so I had an anti nuclear antibody blood test that was positive revealing the autoimmune disease fibromyalgia and raynods. My ANA blood test has come back positive several times. The doctors put me through a ridiculous amount of tests to try to figure out a diagnosis and why this had come out of nowhere. They thought I had at one point every different type of autoimmune disease including lupus but settled on FIbromyalgia with raynods and the possible beginnings of Lupus. I have to frequent a rheumatologist, neurologist,and primary care doctor several times a month. The side effects have made me very weak and unable to live my life normally, its hard for me to work. I teach children which take a lot of energy when I have none what so ever. I used to be strong and able to work out and ride horses and live a healthy active lifestyle, now I cannot enjoy any of it. My body is in such pain all the time that its impossible for me to have a normal life. I wanted this vaccine to help prevent problems, when all it did was destroy my life.  5/18/09 Vax info received.  HPV#1 7/7/08 0847X.  HPV#2 9/8/08 0546X.  HPV#3 1/7/09 0546X. 7/15/09 Rheumatology consult rec'd dated 1/29/09 to 6/8/09 with final dx: Inflammatory arthritis,  arthralgias. Pt presented with c/o numbness and bluish discoloration of the feet.  Pt also has a blackish scab on the R 3rd toe. Pt reports feeling achy all over.  PE (+) for cold fingers and toes and bluish discoloration of toes. (+) fibromyalgia tender points. Assess: Raynaud's.  ANA (+).  Scoliosis.  Possible fibromyalgia. F/U 3/5/09 with dx:  fibromyalgia. Pt reporting poor sleep and feeling sleepy during the day, as well as SOB. F/U 5/12/08 for c/o rib cage pain and fatigue..  Pt reports after 3rd HPV vaccine sx began. Now with weakness, cognitive difficulties, H/A, dizziness, hair loss, balance issues, LUQ pain and extreme fatigue which disrupts ADLs. Occ blurred vision upon standing and canker sores. PE (+) for anxiosness, tenderness of trapezius and scapular border, joint tenderness of the MCPs and knees, ankles and feet as well as lower rib cage. Assess;  Arthralgias, fatigue and cognitive difficulties.
difficulty swallowing- felt like food was stuck in the esophagus approx 30 mins after vaccination was administered. i had a sip of iced tea and stopped eating.  This was resolved after about 45 mins.
The patient came to the pharmacy to receive the second dose of the shingles vaccine (Shingrix), since she received the first dose on 12/05/2022. At the pharmacy, we processed the correct vaccine but at the time of administration, the registered pharmacist gave her the wrong vaccine (updated bivalent booster 12+ of Moderna lot: as17ob, 0.5ml). This event happened on 02/10/2023 and in the same day, the patient was informed about what happened and she did not report any adverse event. She came back to the pharmacy on 02/11/2023 to receive the correct vaccine and was educated on possible side effects and was informed that we will be contacting her physician to let him know. We will also be contacting her for 5 consecutive days to check if everything continues to be ok.
Initial report received from a patient on 31-August-2005. A 44 year old, female patient, developed injection site inflammation 48 hours after she received an injection in the right deltoid of Adacel (lot number C2151AC, route of administration not reported) on 24-August-2005. She had "localized redness, warmth and swelling 3" diameter." A "golf-ball sized nodule and redness are still present." At the time of reporting, the patient did not recover. Follow-up information received on 17/Oct/2005: The patient who was the reporter precised that she did not take any other medications and she did not presented with illness at time of vaccination. She recovered on unspecified date. Case is closed.
PATIENT FAINTED . He has an history of fainting according to grandmother. he was sweaty and pale. paramedic came and his blood pressure was 120/70   heart rate 70. no problem now
Patient states she had a rash 2 days after vaccination lasting 2 days. She reportedly applied a cold compress to alleviate the itching. The raised rash around stomach. She said looked like hives.
Information has been received from a 64 year old female with no known pertinent medical  history or no known drug reactions / allergies, who on 06-Oct-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included SYNTHROID. The consumer reported that on 07-Oct-2008, she experienced headache, stuffy head and muscle pain in her arms and legs after receiving ZOSTAVAX. The consumer reported that her symptoms resolved on 10-Oct-2008. The patient did not seek medical attention. No further information is available since the patient declined to provide physician's information.
After receiving the vaccine I had a stoke since the stroke I had several visits to the hospital for stomach issues as well as being admitted for low platelet count
Sinusitis for 2 days. Treated with Entex, Tessalon Perles and Zithromax.
body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
No Adverse event; Patient received 0.25ml of Bivalent booster instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. This case was reported for 11th patient out of 20 patients. It was reported that none of the patients were pregnant. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665494:
Initial  and follow-up information has been received from a healthcare professional and a pharmacist concerning an 85 year old female patient. Information about concurrent condition and medical history was not reported. On an unspecified date the patient was subcutaneously vaccinated with PNEUMOVAX NP injection (vaccination date, lot number, dose and indication not reported). On an unspecified date (from about 35 years ago), the patient had no health issue  originally, she was continuously administrated with FLUITRAN and PERDIPINE as blood pressure medication. On an unspecified date (from about 15 days after vaccination), the patient suffered poor health suddenly. On an unspecified date (within one month after vaccination), the patient developed bleeding suddenly. The patient visited the hospital and found bladder cancer. On an unspecified date (within half a year), the patient died. The cause of death was bladder cancer. Information on autopsy was not reported. Reporter's comment: The cancer primary doctor considered the vaccine was not the cause of death and considered the cause could not be identified. But the patient's family did not agree and considered there was no other reason except the PNEUMOVAX NP. The reporting pharmacist considered that the bladder cancer was serious due to death. The reporting pharmacist did not assess the relationship of bladder cancer to PNEUMOVAX NP. Upon internal review, the event of bladder cancer was considered to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted.  Updated information received on 07-NOV-2016 from the pharmacist has been marked with double caret.
She received her first smallpox vaccine in the LUE on 5/5/2011. On 5/10 she had throbbing and tingling at the vaccine site with LUE pain. On 5/12 post vaccine day (PVD) 7 she developed edema of the right leg. On 5/13 the site had blistered with a few hours of severe pain (7/10) in her whole left arm and in the lymph nodes of the left axilla. Also on 5/13 she developed edema of the left leg, abdominal pain, severe back and neck pain, headache, fatigue and fever/chills 100.2. On 5/14 edema of the right arm occurred. Began to feel better on 5/17 with some decrease in the severity of the edema, headache and upper back/neck ache. The edema was impressive, non-pitting and in the abdomen, both LE's and RUE. Neither elevating legs nor applying ice changed it. Weight increase of 5# occurred from 4/11 to 4/16. The abdominal pain is diffuse with more in the RUQ, LUQ and perumbilical area with intensity of 4-5/10 at rest and 7/10 with palpation, lying on her stomach or with activity. Abdomen is distended. Poor appetite and loss of sense of satiety. No change in BM's or N/V. Lying on her back increases back pain. She was seen at the ED on 5/14 where there was concern for DVT in the RLE, but ruled out and cellulitis was suspected. She went to the ED on 5/15 where DVT of the RLE and RUE were ruled out with diagnosis of lymphedema. Over the next few days she was followed closely. Tender and enlarged liver with edema raised concern for cardiac involvement, but was ruled out. On her 5/19 visit there was significant decrease in the edema with ecchymosis on the dorsum of the feet and an "erythema reticular pattern on all extremities." Her liver remained enlarged with the edge palpable. Later that day labs revealed C4 of 6. On 5/20, post vaccine day 15, the SM developed a rash. She sent a photo that is consistent with hypersensitivity reaction to smallpox vaccine sometimes described as non-viral pustulosis. On 5/24, PVD 19, Derm and PCM visits...still c/o mild burning and swelling of LE's. Mild fatigue and HA. Abd pain, fevers and most of edema resolved. Mild edema and pustules on back on PE, No other rash. Back rash likely heat rash/miliaria. Punch biopsy right calf and right dorsal foot with neg Immunoflorescence testing. Neg testing with anti-IgG, IgM, IgA, C3and fibrin.
I was fatigued the first couple of days, I was more fatigued this time more than before the first shot. I thought this was a normal reaction for people. I didn't think that I had a reaction but as time went on I realized that I had been fatigued for months (6mos).
Periodic episodes of itchy skin in different parts of body.  Area of body such as arms, legs, neck will itch intensely for 10 minutes then will subside.  Occurs several times a day & night in various areas.  Sometimes accompanied by rashy/red skin but rash doesn't linger.   Has been occurring for 2 weeks.  Taking Benadryl and Claritin control the itching.
After the Gardasil, pt. felt dizzy, passed out for a few seconds. Pt did not lose consciousness. No incontinence. No frothing on the mouth noted. No rolling of eyeball. Had jerking movement of upper ext. Pt did not have breakfast that AM. This is the 2nd episode.
Irregular heartbeat. Sometimes my heart stops for a second or two and then restarts with a large kick. This is especially felt while resting or even sleeping and will shake the bed.
Severe constipation for greater than 2 weeks, had pain which reminded her of her history of cecal volvulus pain, resulting in emergency room visit 2/10/2020.  Dx with UTI and constipation.  Prescribed antibiotics at that time and advised to take Miralax and docusate.   Patient has had small "mushy" BMs since then but continues to feel that she has not fully evacuated her bowels.   Scheduled to see gastroenterologist 3/11/2020.
About 12 hours after my vaccine I got sick. I experienced nausea, headaches which progressed. My left arm was red, I felt feverish and I also had red rash radiating to my left breast and nipple. I placed a bandage under my left breast because I could not have anything brush my breast and nipple area since it was very sensitive. I talked to my doctor through telehealth and he prescribed antibiotics for ten days. My left breast was very sensitive and tender to the touch. I had tiny little red blotches under my breast, they kind of look like little warts. I will see a doctor next month to check the little red blotches I have under my left breast and nipple. Do not have lot number to provide.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received FLULAVAL QUADRIVALENT (batch number XZ3SP, expiry date 30th June 2015). Concomitant products included PNEUMOVAX-23. On 30th October 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In October 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL QUADRIVALENT was continued with no change. In 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL QUADRIVALENT. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL QUADRIVALENT. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Per nurse patient was gripping her right wrist with her left hand when the vaccine was administered into the left arm. Immediately after the vaccine she began complaining of right wrist pain. Mild appreciable swelling noted of right wrist, no color change. Patient continued to complain, normal radial pulses. Ice pack applied to right wrist. Patient was observed for an additional 15 minutes and during that time vitals checked (Temp 37.1, BP 109/74, HR 113). Tylenol was administered by mom after. Patient was interactive with child life during this time but also appeared nervous and shivering in the chair. Child stated that was because she was nervous. No other signs or symptoms. At end of 30 minutes child still with limited ROM of right wrist and hand compared to left. No previous injury per family. Discussed with family that if pain or swelling increases or fails to resolve within 2 hours mom is to seek immediate medical care. Also discussed seeking immediate medical care for appearance of any other symptoms. Patient remained A/O, smiling intermittently when distracted by staff throughout visit.
Lightheadedness and 5/10 chest pain. Hx of HTN and sarcoidosis. Bp was 168/86. HR 64 and 100% spo2 on RA. CP resolved within 5 min of initial vitals. Evaluated by ems and released home in stable condition. Patient advised to follow up with PCM as soon as possible.
dizziness; fall; weakness; This is a spontaneous report from a contactable consumer (patient). An 89-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. Medical history included post polio syndrome and myasthenia which compromise immune function. The patient experienced dizziness and weakness which stated as severe side effects of the vaccine. Patient received his first dose of the Pfizer covid vaccine and about 1.5 hours later experienced dizziness which resulted in a fall.  He wanted to know if he should get the second vaccine. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax; devel redness, swelling, tenderness at inject site; lasted 2 days;
This spontaneous report was received from a female nurse reporting on herself. In August 2012 "two weeks ago", the nurse was administering subcutaneously a "standard" dose of VARIVAX (merck) (lot # not provided) to a patient and when the patient moved, the remaining portion squirted into the nurse's eye. The nurse developed two red, fluid-filled bumps around her eye, which lasted for two days and had since resolved. No treatment was given for the event. The nurse did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient has been experiencing intense ongoing phantosmia. "Smell strong smoke for months nonstop and it wont go away."
Pt given KINRIX (DTAP/IPV) at 6 mo of age. Pt's mother reports no adverse events.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Cholesterol. On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.