chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Fever, Body ache, Shoulder pain, . Chills Narrative:
Vaccinated in left deltoid on Friday, November 5, 2021. Developed a large, red mass on Monday, November 8, 2021.
Case number PHEH2014US003636 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly at a dose of 0.5 ml on 27  NOV 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review  on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9262) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to dust" (unspecified if ongoing), notes: Allergies to dust, seasonal; "Seasonal" (unspecified if ongoing), notes: Allergies to dust, seasonal. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medication in 2weeks. Paxlovid used in COVID 19 Treatment. Treatment start date was 03May2022 and stop date was 07May2022. 02May woke up with sore throat and congestion. Body pain and fatigue. The patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.
Throat has been full of mucus; This spontaneous case was reported by a patient and describes the occurrence of SECRETION DISCHARGE (Throat has been full of mucus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-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 SECRETION DISCHARGE (Throat has been full of mucus). At the time of the report, SECRETION DISCHARGE (Throat has been full of mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Treatment medication were not reported.
BLURRY VISION; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurry vision, and dizziness. This report was non-serious.
Mother noted a rash on both arms after receiving MMR LD; DTaP (LD); VARIVAX (RD). On 8/18/08 no fever, some swelling, no erythema, no ischemia. Exam revealed papular non vesicular rash billious, no erythema. BENADRYL
"Patient with seizure this am during 1 assist transfer, resident passed out, lowered to shower chair next resident with incontinent episode and was sent to Emergency Department emergently and currently under evaluation with possible admission. "
Itching began 4 days before the red circular ring appeared on my left arm around the injection site. Ring diameter is about 2 inches.
Incorrect age-appropriate formulation administered to patient. Moderna 6 months to 5 years vaccine was given to patient as a booster dose who is ten. Patient has received two dose primary series of Pfizer 5 years to 11 years.  Patient was supposed to received Pfizer 5 years to 11 years for booster dose. Patient did not show any abnormal symptoms.
This spontaneous report as received from a certified medical assistant to an 14 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
A non-serious spontaneous report of "administration of expired product" was received from a registered nurse concerning a six-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The product expired on 19-Jan-2010. On 27-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
arm pain started the same day and next day fatigue, chills, body aches and temperature of 99.7 and moderate arm pain, could not put any pressure on the arm and could only lift it very little
Shortly after getting the vaccine, that spot on my arm started to hurt quite a bit, and I felt a bit worn down and headachy. Today I have a large red blotchy area at the site of the vaccine, about 3 or 4 inches in diameter, that's hot to the touch and hurts quite a lot. I've just been taking ibuprofen for it.
Patient in clinic for her 2nd dose of the Moderna vaccine. Using a 1.0ml Retractable needle/syringe?The needle retracted too early ((as soon as I pressed on the plunger)) prohibiting administration of the entire dose/content of the Monderna vaccine. Vaccine content leaked out onto the patient skin.  Dr. consulted and advised a new dose of the Moderna vaccine be given due to patient NOT receiving the entire dose. Patient given a new dose. Tolerated well.
elevated pulse (>100) and headache immediately following vaccine. redness, burning and swelling at vaccine site with in 10 minutes of administration. 25 mg oral Benadryl taken at that time. at 29 minutes pulse was over 120, full body shaking, respirations were elevated but shaky so unable to determine rate. temp was 100.1. bp was 152/92. redness and hives present on neck chest abdomen and arms. pulse reached 130 so epi-pen self administered to right thigh. within 2 minutes shaking was improving, pulse was dropping. rash and hives still present. 125mg solumedrol given IM in left glut. refused iv due to known adhesive allergy. within 5 minutes rash was improving. pulse was back down into high 70s. bp return to 120's/80's temp had returned to 99.0. another 25mg benadryl given orally. continued to monitor vitals over next 30 minutes and then was allowed to ambulate under supervision. at 1 hour went home to rest in care of family member. later that evening fever did return to 101.5. took tylenol ibuprofen and another dose of benadryl. temp returned to normal again. next day still having pain and swelling in injection arm and low fever returns when unmedicated.
Passed out post vax. BP dec, no pulse, thumbs turned inward toward the palm. Comfort measure given. Left health unit w/out problem after 30 min.
At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the next few days became severe there and moderate over other areas of the body with skin being very sensitive to clothes rubbing on it.  This had happened before with the shingles vaccine given 10/11/2012 which was reported to VAERS.  That resulted in two neurologist visits and an MRI finding nothing.  But symptoms continued and Lyrica 50mg and 75 mg was needed to function and sleep.  This lasted with varying degrees of intensity about the life of the vaccine and happened again with a Fluvirin given on 10/17/214 with symptoms starting on the 31st and lasting for quite awhile requiring Lyrica.
I started feeling mildly nauseous and had muscle pains in my wrists and legs. Then the headache rolled in. By 9 PM, everything hurt. I was running a fever of 101.6. Over the next 12 hours it got as high as 102, and then dropped down when I took tylenol. It felt like the worst flu I've ever had. I did not actually vomit, but I didn't eat anything either so that might have helped. The muscle soreness was the worst--it felt like fine grit sandpaper was being rubbed between all of my joints. This went on until around 7 pm on April 7th, when all the symptoms lessened to some extent. I still had everything, it just wasn't quite as bad. As of 4 am on April 8th, the muscle soreness is pretty much gone (though I still feel weak) the fever is gone and all I'm left is this headache.
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-JAN-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX subcutaneously, lot # M041085 and expiration date: 03-JAN-2018 (dose and frequency were not reported). No adverse effects were reported for the patient. No causality assessment was provided.
p/getting immun pt began to cry uncontrollable; pt would not eat or sleep; mom unable to quiet until about 4PM; states pt did finally sleep; did not see MD mild temp; OK by 23JUL93;
Pt sts that shortly after her vaccine she became lightheaded and dizzy.  She had a similar issue when she gave plasma in the past (she passed out completely).  She did not tell staff ahead of time that she passes out with vaccines and was sitting in her chair at the time of administration.  Pt sts she immediately got lightheaded and dizzy and she passed out before she even knew what happened.  Pt did fall out of her chair and hit her head on the floor.  She was responsive within 10 seconds per bystanders and was AOX4. She does have a small amount of swelling to an approximate 1" hematoma to the R side of her head just into her hairline. She was treated and released by EMSA.  She refused transport to the hospital.  She did have pain at the site of the hematoma.  PMS was intact X4 and her neuro function was intact per EMSA during exam.  Pt left POV.
Red rash the size of 50c piece - 2/07 and sore.  2/12 - still red rash - getting better was sore & itchy but not any more.
Patient became bright red in her face and neck about 10 seconds after receiving her FLUZONE HD vaccine on 10/08/2018 at around 11:40 am. She complained of being unable to breath and was gasping for air. She also complained of a lower back pain that was a level 3 out of 10. Due to her inability to breath/taking a full breath, patient went into a panic-attack like mode. After about a couple minutes of gasping for air, the pharmacist decided to inject an epinephrine pen into the left thigh of the patient. The pharmacy called 911 and paramedics came and took patient to Medical Center. Patient seemed to improve in color and especially in her ability to breath post epinephrine pen injection. By the time paramedics arrived, patient seemed to have mostly recovered.
PATIENT DESCRIBED SEVERE (EXCRUCIATING) PAIN IN SHOULDER/ARM IN WHICH THIS VACCINE WAS GIVEN. LASTED SEVERAL DAYS., COULD HARDLY LIFT HER ARM.
This spontaneous report as received from a physician refers to a 62 year old patient. The physician reported that she had intended to administer ZOSTAVAX to a 62 year old patient, however, a dose of VARIVAX (Merck), (lot #, expiration date, dose and route unspecified) was inadvertently administered to the patient on 15-OCT-2013. No adverse effects reported. Additional information has been requested.
SORENESS, REDNESS, ITCHING, AND LUMP WHERE SHOT WAS GIVEN.  REDNESS AND LUMP APPROXIMATELY 3 INCHES LONG AND 2 INCHES WIDE.
temperature excursions/refrigerator door was not closed properly/was at 15.5 degree Celsius for 17 hours 30 minutes; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case involves a 4 years old female patient who received only Pentacel after temperature of vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot number C5560AA), HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (number: C5367AA), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot number: U6153AA), IPV (VERO) [IPOL] (Lot number P1A24MM/ N1K92;) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL) (lot number UI989ACA). The refrigerator door was not closed properly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was of actual medication error due to incorrect product storage. Temperature excursions was at 15.5 degree Celsius for 17 hours 30 minutes.  Pentacel was administered to a patient but it was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
mom reported that baby died yesterday AM @ some time between 7 & 10AM;pt was in bed w/mom;mom reported she wondered about the shots causing this;however was told by coroner that it was SIDS;reporter unsure whether autopsy done/complete;
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, route and lot # not reported) where it was a very long time between doses. This is one of several reports received from the same source. Additional information has been requested.
her mom has been delusional saying that "things aren't real and has been agitated/ Became extremely delusional; This is a spontaneous report from a contactable consumer (patient's daughter) via medical information team. A 84-year-old female patient (mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route on an unspecified date at single dose for covid-19 immunization. Medical history included dementia. The patient concomitant medications were not reported. On an unknown date, the patient received the first dose of the Pfizer Covid vaccine 2 weeks ago. It was stated since then, patient had been delusional saying that things were not real and had been agitated. It was also stated that patient was allergic to the pneumonia vaccine. Patient was older and had other medical conditions and took other medications, became extremely delusional after taking it. It was possible she was exposed to the virus because she lived in an assisted living facility. She never tested positive though. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.  Follow-up activities closed no further information expected.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient stated feeling fuzzy and hand tingling-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Began with gassy feeling on 4/14 that progressed to stomach pain on 4/15, then heartburn evening of 4/15 through the day on 4/16. Heartburn faded (did try taking Tums, with little effect), changed back to mainly stomach pain.  Stomach pain daily 4/19 - 4/29, mainly occurring (1) before & after breakfast, (2) late afternoon, (3) evening. Began taking Prilosec (omeprazole) on 4/30; stomach pain similar to previously described 4/30 - 5/1. Symptoms became more intense, heartburn and heart pain on 5/2, stomach pain 5/3, heartburn and heart pain 5/4. Stopped Prilosec 5/5, symptoms receded to mild heartburn and stomach pain 5/5 - 5/6.  Currently deciding next steps for treatment. Stomach pain can be soreness, occasional twinges, all located just below left ribcage.  Heartburn upper left, feels warm but also sore (kind of like someone punched me there).
After receiving the vaccine, she complained of an allergic reaction. The onsite EMS was requested.  Her vitials were BP 172/84 HR 76  O2 99% on room air.  Patient refused additional evaluation and released home against medical advise
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced numbness, tingling, and pain at the injection site. The patient sought medical attention and on 02-DEC-2017 called the nurse practitioner. The outcome of numbness, tingling, and pain at the injection site was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA004514:
Initial unsolicited report received from a non- healthcare professional (office manager) on 15 October 2015. This case involves a 24-months-old male patient who was vaccinated with a fourth dose of DAPTACEL intramuscularly in left leg (batch no C4887AA, expiry date 16 July 2016) and a dose of FLUZONE intramuscularly in the right leg (Batch number- U5321CB, expiry date: 30 June 2016, dose in series was not reported) both on 13 October 2015. The patient's illness at time of vaccination was unknown, pre-existing physician diagnosed allergies with Amoxicillin birth defects and medical conditions and birth defects was not reported. Concomitant medication was not provided. On 14 October 2015, one day after vaccination, patient had red lump and rash which spread away from the shot down to the foot and into the diaper area. In the night patient had uncontrolled spasm like movements first with arms then legs. It happened at least 4 times in 1 hour. The patient had occasional uncontrolled movements of arms. During these movements he was alert, followed instructions including touching his nose but with difficulty. When legs were spasming he tried to hold them down and had "ouchies" on his arms. No fevers, eating, drinking and playin normal. The patient required ER/doctor visit. The patient's laboratory data was not reported. The patient received BENADRYL as corrective treatment and rash "calmed down". The patient had not recovered from the above mentioned events. Follow-up information received from a non-health care professional on 21 December 2015. No new information reported. List of documents held by sender: none.
Rt. arm, red bumps, swelling, 2 red spots, hot to the touch.
Around 5:30am I woke up feeling as though I had not slept well. I had chills, then I would sweat, then I would have chills again. I had severe fatigue, and muscle aches centering in my lower back. I took my temperature and it was 100 degrees. I took Aleve and laid back down. My fever subsided, but I continued to intermittently feel chills throughout the day. I took a warm bath and shower. I felt exhausted and the ache in my back continued. I laid back down from 5-11pm and continued to feel chills, though not as severe as they had been. In the evening, beginning around 7, when I would get up I felt a chill and a wave of paranoia, affecting my mental stability. These would subside when I laid back down. I retired to bed at 11 and woke up at 5am completely drenched in sweat. I changed clothes and returned to bed. When I woke up at 7:30am for work, I felt much better and have felt fairly normal, except for being dehydrated, since.
allergic rxn (urticaria) persistent x 5 days p/dose 1 hep B;
p/vax pt exp less than 50 lesions on stomach, back & head;pt sought unspecified medical attention;no fever was noted;
A few minutes after immunizations, felt ringing in her ears and dizzy, fell forward. Monitored for 15 minutes afterward and given juice and crackers. Stable vital signs. Dizziness and ringing resolved approximately 10 minutes after falling.
I was vaccinated on September 13th. During that month my menstrual period did not come. In the following month, my menstruation period was very light for 4 to 5 days (November). The next period in December, my menstrual period was very heavy and not end yet. (I'm bleeding for almost one month) I do not take contraceptives or any other hormonal medication.
Pt devel temp 1 day post vax persisted for 2 days; Admitted for Sepsis & expired the same day;
Severe chills, fever, nausea, vomiting, loose stools, muscle and joint pain
About 1.5 hours after second dose of Pfizer COVID-19 vaccine, patient was driving and experienced what she believed was a seizure. She has a past medical history of seizures, but had not had one for over 15 years after being stable on Keppra. Patient did have a minor motor vehicle accident and went to ER. At ER, she returned to baseline and it was determined it was either a seizure or syncopal episode. She was instructed to follow-up with neurology.
Approximately 5 min post vax, pt was in his chair in the classroom and slid out of chair from fainting. Teacher and school nurse took care of the incident. Mother took pt to MD the next day.
The patient inadvertently received their second shot in the serious early. The patient singed up for the wrong day for their second shot. Despite multiple checks the patient was able to receive his vaccine.