chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hubby suffered 6 times after shot/Suspected vaccination failure; Hubby had 6 times after shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-JUN-2022 Reporter's Comments: This case was reported patient's wife via interactive digital media. The patient suffered 6 times with shingles even after shot.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked to the case US2022AMR089766 reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR089766:Same Reporter
Patient came in for covid vaccine. Before injecting I asked patient has she ever received any covid vaccinations and patient answered no. Patient was elderly and stated she was very nervous so I gave the injection before adding all info into the rover. After administering the vaccine and staring to input information I then noticed patient had previously been vaccinated in March . When the patient was asked about previous vaccination she denied ever being vaccinated. Patient sat for the required 15 min and an additional 15 min for a total of 30 mins and NP on site monitored patient and there was no reaction. Patient was discharged.
More pronounced swollen lymph nodes in neck; Prominent left side of neck swelling; Rash behind ear and nape of hairline that itches; Rash behind ear and nape of hairline that itches; Swelling on left side of jaw extending to lip and down into neck, like a toothache; Swelling on left side of jaw extending to lip and down into neck, like a toothache; Aching in arm down to hand; Achy muscles on back and behind left breast; Swelling in the left breast that has not gone down; Swelling on left side of jaw extending to lip and down into neck, like a toothache; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.  A 74-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 26Mar2021 as dose 1, single  for covid-19 immunization. Medical history included Swollen lymph nodes, patient had swollen lymph nodes for a year and a half or two years from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. On an unspecified date the patient experienced more pronounced swollen lymph nodes in neck, prominent left side of neck swelling, rash behind ear and nape of hairline that itches, swelling on left side of jaw extending to lip and down into neck, like a toothache, swelling on left side of jaw extending to lip and down into neck, like a toothache, aching in arm down to hand, achy muscles on back and behind left breast , swelling in the left breast that has not gone down, swelling on left side of jaw extending to lip and down into neck, like a toothache. Therapeutic measures were taken as a result of rash behind ear and nape of hairline that itches. The outcome of the all events was unknown except for the events Swelling on left side of jaw extending to lip and down into neck, like a toothache, Swelling on left side of jaw extending to lip and down into neck, like a toothache it was recovered on unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Extreme fatigue, muscle and joint pain, headache, low grade fever, enlarged lymph nodes along neck and under arms
Moderately uncomfortable headache non-stop for 2 1/2 days so far, during waking and sleeping hours. Nausea at waking up, for several hours, all three mornings. Occasional nausea in afternoons/evenings.  Feeling in throat like I have a cold or flu.
Became dizzy, lightheaded for about 5 minutes. BP 102/60. States didn't eat lunch and was hungry.
Woke up scratching chest area.  Noticed blister like bumps on chest.  Noticed new waves of blister rash severe itching and low fever.  Later diagnosed with chicken pox likely caused from vaccine given 3 weeks previous.
Adverse events not known. Patient lied to get his 3rd Covid vaccine. After facts he said he wanted a booster and will take full  responsability for it.
Info has been received from a health professional concerning 2 adolescent pts who in 1997 were vaccinated with doses of varicella virus vaccine live. "Recently", in approximately January 2005, the pts experienced mild cases of chicken pox. The children were recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Follow-up info has been received regarding one of the pts, an 8 year old white male with no medical history or allergies, who on 8/26/98 was vaccinated SC in the left upper leg, with a dose of varicella virus vaccine live. It was reported that on 1/2/05, the child had pruritic lesions scattered about the scalp, chest, thighs and scrotum. All were in different stages of development. It was noted that the child was exposed to a classmate that had chicken pox. It was also noted that the pt recovered. No additional info is expected.
Fever of 100.8; Tired; Achy; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced fever, tiredness and pain. On an unknown date, the outcome of the fever, tiredness and pain were unknown.   It was unknown if the reporter considered the fever, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the afternoon of day before reporting. In the morning of the day of reporting, the patient had fever of 100.8 degree farenite, achy and tired. The patient asked, if it was ok to take Advil for Shingrix related fever.
pt recv vax SEP96 & approx 10 days later in SEP96 pt devel abd pain, fever, & diarrhea;lab test include colonoscopy & endoscopy showing positive results for erosion;pt was hosp in 1997 for 4 days;pt also exp weight loss;
headache; fever; pain; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), intramuscular on an unspecified date in Jan2021 as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced headache, fever, pain for 24 hours after receiving the vaccine. The clinical outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
SWELLING; ALLERGIC REACTION TO THE VACCINE; RIGHT SHOULDER WAS TOO HOT; RIGHT SHOULDER WAS BEET RED; CRYING PAIN; COULD NOT SLEEP; RIGHT SHOULDER WAS ACHING AND HURTING AND HALF-WAY DOWN TO ELBOW; This spontaneous report received from a parent concerned a 47 year old female. The patient's weight was 150 pounds, and height was 68.5 inches. The patient's past medical history included tattoo in left arm, and concurrent conditions included non alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no know allergies and no drug abuse or illicit drug usage. the patient never had any issues with her shoulder or has taken any regular medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced crying pain. On APR-2021, the subject experienced could not sleep. On APR-2021, the subject experienced right shoulder was aching and hurting and half-way down to elbow. On MAY-2021, the subject experienced right shoulder was beet red. On MAY-2021, the subject experienced right shoulder was too hot. On 07-JUN-2021, Laboratory data included: X-ray (NR: not provided) did not see anything, nothing wrong. On an unspecified date, the subject experienced swelling, and allergic reaction to the vaccine. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right shoulder was beet red, and right shoulder was too hot on MAY-2021, had not recovered from right shoulder was aching and hurting and half-way down to elbow, crying pain, and could not sleep, and the outcome of swelling and allergic reaction to the vaccine was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to a currently 15 year old male patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, lot number L016429, expiration date 09-AUG-2017, (dose, route, anatomical location were not reported) after temperature excursion (incorrect product storage). There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Symptoms.. fever chills headache dizzy vomiting for several hours lasted until 2 pm on 3/18/2021
Patient said the day after the injection (roughly 24 hours after) her arm was swollen in about a 3 inch area.  The area was sore, hard to the touch, and very red.  The area was raised up and quite painful.  This lasted for approximately 1 week and then the area went back to normal.
patient experience fluid-filled blister at injection site in the evening after receiving immunization, immunization site was red and swollen; blister popped during the night.    Patient inquired about it and showed pharmacist the area on Tuesday.  Area was no longer red or raised, a scabbed area approximately 1/8' was visible
Patient was feeling a little lightheaded after the vaccine. The patient was able to walk to the waiting area and have a seat and then became pale, laid back in the chair and closed her eyes. She said she was feeling light headed. Pulse and breathing were normal at the time. Patient stated they were feeling a little better after a couple of minutes and needed to use the restroom facilities. I helped the patient along with her mother to the bathroom. After closing the door to the bathroom the patient's mom called for help and stated the patient had passed out. A pharmacy technician called 911 as I attended to the patient and parent. The daughter was responsive (alert and oriented) when I got there and stated she was feeling better. After a couple of minutes laying on the floor the patient was able to sit up on the floor. After a couple  more minutes the patient was helped up and was able to use the restroom and returned to the waiting area and sat in a chair until the paramedics arrived. The patient was still a little lightheaded and had not eaten or drank anything that day. The paramedics arrived and checked vitals. The patient was taken to the emergency department for further evaluation - I would assume the ED did a VAERS report on this potentially too
The pt was exposed to other children who had the vaccine and developed small chicken pox like spots on trunk and extremities.
Headache, nausea, and rash on neck and below neck (rash still present today). Headache and lasted only one day, the day after vaccine. I have an appointment with my doctor tomorrow for the rash as it still itches off and on.
Information has been received from the mother of a 4-year-old male with no pertinent medical history, who "at the age of one" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. "In the winter of 2004", the patient developed chickenpox. "It was a mild case". There were no laboratory or diagnostic studies performed. The son had a booster of varicella virus vaccine live (Oka/Merck) in April of 2007. On 01-Jan-2008 her son had bright red cheeks and a fever. On 03-Jan-2008 her son had one or two spots on his back. On 07-Jan-2008, the mother noticed more spots on the back, one on the neck, one on an unspecified cheek and on "the front". The spots were itchy. The school nurse put an unspecified medicine on them but did not feel he had chickenpox since he had been vaccinated twice and had gotten chickenpox in the past. The son was seen by the pediatrician at an unspecified time who diagnosed him with having chickenpox. The mother mentioned the second outbreak was even milder than the first outbreak. The outcome was reported as not recovered. No product quality complaint was involved. It was also reported that two of the patient's siblings developed adverse events following vaccine administration (WAES numbers: 0801USA02225 and 0801USA02100). Follow-up information was received from the physician's office which indicated that they were unable to provide follow-up information because they could not identify the patient. This is one of several reports from the same reporter. No further information is available.
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a  facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date.  The following information on the batch/lot number has been requested.
Shots administered at 10:30 AM on 8/3/15. On 8/4/15 mom called to report that child had rash all over. Advised mom to bring child in for assessment. This nurse notes tympanic temp of 97.6 degrees F, rash of small red pimple sized dots from about waistline and down bilat legs.
Patient reported being dizzy then became unconscious, his eyes rolled upward to the left, he begun to shake, especially his right hand and had an episode of urinary incontinence, this happened 3 times. EMS was activated his blood sugar was tested result was 116 and EKG done which showed normal sinus bradycardia. He refused EMS transport to ED.
ER report attached, autopsy report will not be read for about 1 month. 5 month old pt was brought in by his mother and a babysitter screaming through the door that the child was unresponsive. It was difficult to obtain the exact history but apparently they were down tending a game and they were coming back. The baby was in a car seat and they were talking and they thought the baby was maintaining normal activity. By the time they got to their destination, they thought that they didn't hear the baby in the back seat anymore, so they investigated and found the baby not breathing and unresponsive. They drove immediately up and rushed into our facility. Physical examination revealed a 5 month old totally cyanotic dilated pupils. No response to pain or verbal stimulation. One of the nurses began mouth to mouth resuscitation. CPR was started. About 1 or 2 minutes later a pediatric mask was applied and the child was bagged which resulted in good breath sounds bilaterally. Compression was continued. There was no pulse or blood pressure. Within a few minutes,  the anesthesiologist arrived and intubated the child with much difficulty. IV access was obtained. The child was given 2 doses of epinephrine, 1 dose of Atropine. CPR was continued. The child then began to respond and developed a pulse of about 120. The blood pressure of 62/34. Dr's arrived shortly thereafter. The child was given sodium bicarb. The child continued to have no response to painful stimulation but continued to have pulse and blood pressure as noted. Air care was consulted. They arrived. After some discussion the pt was transferred to another health facility after receiving Rocephin 525mg. The pt had initially received a 100cc bolus of normal saline. The pt continued to have good color, pulse and blood pressure. Blood gases were obtained. The pt had pH of 6.5, PCO2 of 99, PO2 of 128, BE of minus 30. The second blood gases pH was 6.7, PCO2 40, PO2 388, BE was minus 27, HCO3 was 6.3. This was done approx the time that the pt left. Final Diagnosis: Code blue, full CPR, resuscitation with pulse and blood pressure. Pt sent to ICU. Discharge Summary received on 2/16/2005 states encephalopathy, acidosis, hyperglycemia, hypokalemia, hypoalbuminia and hypocalcemia. Autopsy report received revealed the COD was undetermined but likely SIDS.
11:41 AM. Pt c/o chest tightness. Brought patient to triage room. V/S 167/89, HR 66, Temp 97.4, RR 16, O2 SAT 98%. Provided water to drink. She stated she felt better. No other associated symptoms. Pt stated she felt better. Continued to observe. Advised when to seek medical care, AACC #, and ED precautions. Instructed parameter of BP and O2 Sat to report to clinician. Pt verb understanding.
Dizziness onset 10/9. First noticed the morning of 10/10 a hot, red, rash on left arm below shot administration site. Rash slowly moved down arm over the course of several days and is still present as of 10/11.   **Did not receive information from workplace clinic on vaccination manufacturer, lot number, etc.** Please contact clinic for that information.
Patient asked for Pneumovax. Denied ever getting one. Vaccine was given. Patient did receive one in 2013 according to chart.
Pt. reports an ER dx of cellulitis due to administration of a flu shot too low on the arm. Below the deltoid muscle.
Has typical side effects, headache, body aches, nausea, mild fever but I did have one I could not find when researching. Around 1PM my face felt warm so I touched it to see if I felt feverish. My finger literally stuck to my face because face was sticky. I was nauseated so I hadn?t eaten since vax , only drank non flavored spring water. Washed my face and checked it hour later. Checked and my face was sticky again. Cleaned it and it happened two more times through course of day. Best way I can describe the stickiness is when a young child eats a lollipop or freeze pop and you have to clean it. Washed my face before going to bed and woke the following morning not sticky. But counties with nausea, body aches, and headache though out day which o know is normal.
Patient received J&J vaccine for 1st dose. As per CDC, eligible individuals may choose which vaccine they receive as a booster dose. Patient chose to received Pfizer vaccine booster about 7 months after initial vaccine. He reports about 1 week later he began experiencing right arm numbness and mild chest discomfort, as well as upper back pain, nausea, dizziness and malaise. Today he felt a little improved with no right arm numbness
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received dose from vial beyond 30-day use by date) in a 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (patient received dose from vial beyond 30-day use by date). On Jun 16, 2021, administered expired product (patient received dose from vial beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021.  This case linked to MOD-2021-363753 (patient link).
Immediate wheal on skin at administration site with red area about 1/4" - 1/2" around. Patient applied ice x 10 minutes and Benadryl prescription written. Parent to call if worse.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was over the age of 65 years. The events took a month to fade. The patient wanted to remain anonymous. For further tolerance, refer case US2018GSK195450.
11:42 patient complained of headache and stiff neck. NP and on site EMS evaluated patient. No medications given. VS @11:24 BP 148/100; HR77; SAT 98%  on RA VS@11:30 BP 165/111;HR 87;  SAT 98% on RA Patient education- recommendation to follow up with PCP regarding HTN, which he states is a new problem for him.  Stated his headache is better and less intense. Discharged home @ 11:42
The MMR vaccine given to the patient on 06/14/22 expired on 05/29/2022. Patient was notified immediately when the event was discovered and told to call if she noticed any adverse reactions.