chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles / Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 17-SEP-2023, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient had two shingles shots several years ago from reporting and today (on reporting day) the patient finds out he/she had shingles. This case was considered as suspected vaccination failure since the detail regarding the laboratory confirmation of shingles was unknown at the time of reporting.
After about 10 minutes post vaccination, recipient felt itching on the back of her neck and to both of her eyes. There was slight redness noted to the back of neck. Recipient stated she didn't scratch the area but rather rubbed it. She denied SOB or dyspnea. Awake, alert and conversant. Observation physician notified. MD assessed recipient's throat and no swelling noted. VS monitored. She later verbalized that there was slight redness and itching to arms towards the back of her elbows. Skin blanches. Monitored closely. She verbalized sensation remained the same but not worsening. Recipient reported that she does have history of breaking out in generalized hives with IV and PO Phenergan but did not report to the vaccinator. Recipient stated she will take Benadryl once released. Advised to seek medical attention if symptoms becomes worse or have difficulty breathing. VS monitored and stable. Recipient remained awake, alert and conversant throughout observation period. No SOB or dyspnea. No throat swelling. Denied any other symptoms. Able to ambulate with a steady gait and without incident. Released from observation at 1:35 pm in no acute distress.
After 2nd. Vaccine my symptoms were fever, chills, body aches, headache, loss of right side arm and leg I?m a high risk and had previous stroke with minor paralysis on right side after shot loss of right side for 1 day slowly coming back
muscle twitch in his back and arms; This case was reported by a pharmacist via call center representative and described the occurrence of twitching of limbs in a 58-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2BB77, expiry date 30th June 2021) for prophylaxis.   On 18th August 2020, the patient received FluLaval Tetra 2020-2021 season. On 19th August 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced twitching of limbs. On an unknown date, the outcome of the twitching of limbs was not recovered/not resolved.   It was unknown if the reporter considered the twitching of limbs to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2020-2021 season and developed a muscle twitch in his back and arms that is getting worse. The reporter consented to follow up.
Patient reported that 7-10 days after receiving 1st VARIVAX having small red dots that were kind of like blisters and were very itchy that lasted for a week.
Sore throat Headache Runny nose Upset stomach General fatigue lasting for over 3 weeks
Local Reaction: Left upper arm from 2 inches below shoulder to just beyond elbow is reddened, painful, warm, slightly hard in areas, not circumferential.  Physician assessment reported local reaction.  Initially treated with warm compress, area became worse with heat.  Current treatment is cold compress, nurses report improvement.
Patient arrived to the COVID 19 vaccine clinic to receive first dose Pfizer vaccine. Mother present and gave verbal permission for the vaccine. Dose of Pfizer given was 6mo-4yo dose. Should have received the 5-11yo dose of Pfizer. Mother notified of dose error. Per guidelines patient was given 5-11 yo Pfizer vaccine dose same day.
Moderna COVID-19 Vaccine  0-15 min after shot - dizziness, slight headache, lethargy, heaviness 15-45 min after shot - roof of mouth felt like a hair on it then it started to spread to cover the left side roof of mouth and tongue. Lasted about 5 minutes then started to subside 48hrs after shot - arm still hurts all the way to the elbow
(+) Rt arm swelling at injection site- (+) soreness swelling decreased in 24hrs-1hr developed-fever 99 degrees. Sweating sensation, weak dizzy, shaking HA intermittently through out evening.
This spontaneous report was received from a pharmacy student concerning a female patient of currently 35-years-old. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On unknown dates, also reported "as a child", the patient was administered a two-dose series of M-M-R II subcutaneously (strength, dose, frequency, lot number and expiry date were not reported). The patient was entering a healthcare field and was required to have titers drawn on an unknown date, which showed she was negative for immunity to measles, mumps and rubella. Therefore, she received treatment (unspecified) for the event. Subsequently, on 06-MAR-2019, the patient was vaccinated with M-M-R II dose 3, subcutaneously (strength, dose, frequency, lot number and expiry date were not reported) for prevention of measles/mumps/rubella and with sterile diluent(MERCK STERILE DILUENT) (strength, dose, route, frequency, lot number, expiry date and indication were not reported). The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown.       The causality assessment between suspect therapies and the aforementioned events was not provided.
Patient developed a area of erythema and swelling to right deltoid area approximately 4cm x 4cm the day after receiving immunization.  Treatment is motrin and cold compresses to area.
This spontaneous case report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 16-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot number # K010967, expiry date: 06-NOV-2015 (dose not reported) via subcutaneous route. No adverse effect was reported. No further information was available. Additional information has been requested.
Patient presented for a nurse care visit for her meningococcal vaccine. Nurse went and grabbed medication from fridge, checked to make sure medication is correct and expiration is up to date, reconstituted medication. Medication was logged, under patient's immunizations tab, searched through NDC. Medication given to patient, patient tolerated well and left clinic. Nurse then entered in site of injection then system prompted LOT #. Nurse tried typing in LOT # but was not able to find. Nurse looked at both bottles and realized powder bottle was expired (07/2022) but liquid bottle will be expiring in January 2023.
Body ache all over and pain. The next day bad muscle aches hurt to move pain meds did not help. 3rd day after shot big lump at injection site, hives, muscle aches improved. 4th day after shot little sleep, palm sized red and hot at shot region 9 inches long, hangover type headache. 5th day after shot no sleep, restlessness at bedtime. Day after shot rapid heartbeat in morning, pain and itching at injection site, Raynaud's feeling in fingers.
The day after vaccines, pt developed 12 cm redness at site of MMRV vaccine. Itchy, painfull and warm to touch. Given TYLENOL/MOTRIN and BENADRYL.
chest pain; rash on his neck and all over the body; itchiness/ rash developing on his skin and is itchy; pain in the injection site (right upper arm); This is a spontaneous report from a contactable Nurse. This Nurse reported for 12-year-old male patient (Reporter's son). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on Aug2021 (at the age of 12-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient has side effects of chest pain, rash on his neck and all over the body, itchiness/ rash developing on his skin and is itchy, pain in the injection site (right upper arm). The reporter wants to know what to do to alleviate itching and how long will it take to go away. The reporter questioned whether the Pfizer was like neurotoxins, like any of the chemicals that go inside the brain and was asking whether the vaccine was tested on animals, like mice. The clinical outcome for the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Moderna COVID?19 Vaccine EUA  Change in color and thickness of Vaginal discharge  Period started 2 weeks early, very heavy
Weakness, trouble breathing, URI, sinusitis, diarrhea, abdominal pain.
pt recv 1 dose of varivax in 10/95 & in 4/98 exp chickenpox w/approx ``500 pox on his body''
Swollen, hot, painful arm at injection site that started 3-4 hrs after administration and continued for 3-4 days
Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Crying, whining, can't get comfortable, won't eat, won't sleep, fever over 100.
Case fully vaccinated with COVID 19 vaccine. Dose #2 given on 2/5/2021. Tested positive for COVID 19 on 9/5/2021. Was admitted to Medical Center on 9/6/2021 and expired while still hospitalized on 9/14/2021.
This spontaneous report as received from a healthcare work (office manager) refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot# K007974, exp 03-JUN-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Following my second shot in my left arm on March 25, 2021, I am experiencing severe arm pain, especially when lifting my left arm. The pain initially began at the injection site, but has since spread to include the shoulder to elbow area.
Fever as high as 105.1 lasting 12-14 hours leveled out at 103 broke around 4 pm Chills, muscle aches Arm psin
Information has been received from a physician concerning a 57-year-old female with no pertinent medical history or allergies who on 11-JUN-2007 was vaccinated intramuscularly with (1 vial once) dose of Zostavax. Concomitant therapy included "FIORCET" and AMBIEN. On 06-AUG-2007 the patient developed "shingles like" symptoms after vaccination. The patient presented with sores in her mouth and pain on her right eye brow. She saw a nurse practitioner and then an ophthalmologist. The ophthalmologist prescribed VALTREX for the symptoms. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with an expired dose of VARIVAX lot # K002919, expiration date 26-FEB-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 4 month old female patient, with no known drug allergies and no pertinent medical history. On 07-JUN-2013 (on Friday) the patient was vaccinated with the second dose of ROTATEQ, orally (dose, was not reported) and a dose of Hepatitis B (Recombinant) (manufacturer unknown) (lot number, dose not provided). Other vaccines administered on 07-JUN-2013 included: IPV, PREVNAR and HIB (unspecified carrier). On 07-JUN-2013 the patient experienced two bloody stools with mucus since receiving ROTATEQ, as well as frequent bowel movements. There were no other side effects and no signs of intussusception. The patient sought medical attention. The patient was seen in the physician office on 10-JUN-2013 in the morning and a stool sample was obtained to verify that the bloody stools are not related to a bacterial infection. The lab diagnostics resulted: unspecified stool culture. The patient's formula was also changed to an unspecified formula to verify there was not lactose intolerance. The outcome of two bloody stools with mucus and frequent bowel movements was reported as not recovered/not resolved. Additional information has been requested.
big, huge, red spot; around her arm/ soreness/ arm was in such a condition; injection site hot; tenderness; severe flu-like symptoms; redness; chills; exhaustion; fever; achiness; dropped down two inches from injection site towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness) and INFLUENZA LIKE ILLNESS (severe flu-like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow). At the time of the report, RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
I tested positive for COVID-19 on 7/11/22. I had a mild fever of 100, and it lasted for about 24 hours. I also had a sore throat for about 4 days, and I had a cough that went on for about a month. Sometimes I had a spasmatic cough. I was prescribed Flovent, and she recommended that I take Mucinex, which I did. I took Nyquil initially for a few days before I went to the doctor.  We also talked about taking Paxlovid, but I decided not to take it.
I started having light head. More further, It does happen when I lie down and rise up. I feel like I may loose my balance.
Large (several inches in diameter), swollen, hot, red welt formed at sight of injection.
Clinical Summary Hospital Course:    Patient is a 88 y.o. male patient of MD with a history of small bowel obstruction was transferred to a HCF on 11-2-2022.  I saw and evaluated patient in the emergency department and subsequently recommended a laparotomy as he had been dealing with a bowel obstruction for approximately 6 to 7 days.  The patient did require open lysis of adhesions and resection of the small intestine with primary anastomosis.  Postoperatively the patient was sent to a general medical floor.  Nasogastric tube was left in place and he was started on TPN as he had already been n.p.o. for a lengthy period of time.  We did keep him on TPN.  He did suffer from intermittent episodes of delirium and pulled at lines and drains.  His PICC line required replacement as well as the nasogastric tube.  The patient had a steady decline from a respiratory as well as to cognitive standpoint.  He began having bowel function on approximately 11-8-2022.  Due to his respiratory concerns a respiratory panel, viral, was checked and he was found to be positive for COVID.  Patient was placed in isolation.  After long discussion with the family they opted to transition the patient to comfort care as they felt that he would not want to continue with aggressive measures.  The patient passed on 11-11-2022.   Discharge Diagnoses:   Small bowel obstruction COVID-19 pneumonia Protein calorie malnutrition  11/2/22 EXPLORATORY LAPAROTOMY, POSSIBLE BOWEL RESECTION, POSSIBLE OSTOMY
Severe diaphragm spasm that lasted for a few days after. I am not sure what it triggered because I?m still being tested but I now have upper gi issues and cannot really eat solids. It?s so crazy, I?ve never had stomach problems in my life and now they?re saying I have Dysmotility. The severe spasm in my diaphragm is a link.
Patient noticed approximately 6 hours after receiving vaccination that she had itchy, painful red bumps starting at injection site near shoulder all the way down to her elbow.  I instructed her to take some benadryl for a possible allergic reaction and either tylenol or ibuprofen for pain.  I also instructed her to seek urgent care if she notices any swelling in mouth or throat.
Dose 1 09Mar2021/Dose 2 09Mar2021; Dose 1 09Mar2021/Dose 2 09Mar2021; Headache; body pay elevated fever; body pay elevated fever; Pain on site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 17:00 (Lot number: EN6207) as dose 1, single and administered in arm left, administration date 09Mar2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Maigrain" (unspecified if ongoing), notes: other medical history : Chronic Maigrain. The patient's concomitant medications were not reported. Past drug history included: Augmented antibiotics sulfur, reaction(s): "Drug allergy"; Augmented antibiotics sulfur, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body pay elevated fever"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain on site of injection"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset 09Mar2021, outcome "unknown" and all described as "Dose 1 09Mar2021/Dose 2 09Mar2021".  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient had 3 days of Headache, body pay elevated fever. Pain on site of injection.  Follow-up attempts are completed. No further information is expected.
13APR94 pt cranky; 24 hrs later; 14JAN93 fits of crying, not eating, arching back; sleeping when exhausted-no fever elevation;
Chills; he started throwing up; wants to receive the Johnson and Johnson vaccine instead; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter (patient's wife) reported for a male patient (reporter's husband) that:  Is the Reporter a Healthcare Professional (HCP)? Unknown Is the reporter's contact information available to you or a sub-contracted party? Yes Is the reporter the prescribing HCP? Unknown  Suspect Product(s): Covid-19 Vaccine  Verbatim and Event Description:  No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Swapped from program. Caller husband received first dose from Pfizer and had lots of side effects some which are Chills, he started throwing up and she stated that he almost got all the side effects that were listed on the Fact Sheet. He was too concerned to receive the second dose from Pfizer and wants to receive the Johnson and Johnson vaccine instead. They wanted to know what are our recommendations on that. Read ISI and transferred to PMI.   Medical Information (MI): Where any medical questions adressed by this program forwarded/referred to medical information? Yes: Customer and/or medical inquiry forwarded or referred to MI  Information on the lot/batch number has been requested.
Fever Tmax 102.4 axillary; macular rash neck (L); (L) arm; (R) ear. No hives; decreased po intake; increased irritability, increased sleep. No lesion at injection site. Tx: supportive care; antipyretics.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 09-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
2 weeks following vaccinations pt presented with small vesicular rash on right thigh, as well as papular rash with erythematous base all over trunk.