chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed that my heart rate was increased and it was very abnormal and alarming. I started having a sore throat and headache, and my body was achy. My spouse tested positive that Tuesday so I tested again since I had tested the two days prior and I was negative for COVID-19. I had severe joint pain, I was sneezing, I was coughing up yellow liquid. I was not interested in food not to the point of being nauseous but I was really turned off to food. I called my health care provider and I got prescribed PAXLOVID and a Z-PAK since I had a productive cough and I was given a steroid for my joint pain.
A vial of 10 doses was not diluted and given all 10 doses in vial.  Pt was observed.  After 2 hours still no problems.  VS's stable.  Pt not complaining of arm pain.  Talking up a storm like usual.
only the liquid portion of Menveo was administered to a patient; only the liquid portion of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA792A, expiry date 31-JAN-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2023 The reporter was a medical assistant. The reporter called to report only the liquid portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient who received liquid portion of PENTACEL (lot number, expiry date, route and site of administration were not reported) that was DTAP and POLIO but did not receive the ACTHIB portion, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. 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.
pt fainted, turned, blue & had a brief sz w/in 10 mins or so p/DT booster; pallor & sweating p/inject, BP 90/70 LA, sitting 35 mins p/vax;
About 16 hrs after shot (Tues AM) (arm was sore during day), I felt feverish and sore. Then within minutes my body was extremely hot and there was pain throughout my body.  Not the flu like aching but extreme joint pain all over.  Every inch of body was in excrutiating pain all the way to fingertips.  When I stood up the pain intensified from the bottom of my feet up my body.  With every step I took I just about collapsed from the pain.  Sobbed every step I took.  Live alone so had to hold on to furniture and wall to get to bathroom.  Again, excrutiating pain each step.  After I made it back to bed I fell asleep for two or three hours.  When I woke up, the extreme joint pain was gone, replaced with severe aching  and like a truck hit me.  Body was warm all over but not as hot as previously.  All of Wed my teeth and jaws were throbbing.  Did not feel better until Thursday, late afternoon. I was terrified.  Have never felt pain like that in my life.  My body felt like it was going to explode.  Scared that even if I called 911 I would not have been able to get dressed, etc.   If someone was with me I would've been screaming out loud.     I am terrified as to what to expect for any future vaccine for covid.
Developed pruritic rash at injection site 2 days post vaccination. Described rash as "mosquito bite" like. Only at injection site.
Delayed (~10 days) lump/swelling and itchiness at injection site.  Woke up yesterday and noticed it. Last night had a few drinks, and it seemed pretty itchy and swollen at the end of the night. This morning it is not really itchy and the lump seems smaller.
Pt was very nervous about receiving the shot. Right after its administration, pt noted that she felt her left arm hurt a lot, then the left side of her body felt numb - arm leg and left cheek. The left arm was pale as was pt's face. She was conversant throughout this event with no LOC no change in phonation, no lip or tongue swelling, no hives. She was asked to lie back down - her arm and cheeks pinked back up, her strength was strong and equal in her arms and legs and her face showed no asymmetry, tongue was midline, smile without a droop. Per NP in the room, this appeared to be a vasovagal reaction in an anxious pt -  pt recovered quickly once lay down, had sips of water and lollipop and was back to normal within 15 minutes. Initial skin pallor of left arm and left cheek pinked quickly once laying down. Per mom, an RN, this felt different, more like an allergic reaction. Mo noted three small pink dot rash on her left cheek a few minutes after pt was laying down. There were not raised like hives and did not itch, and resolved by the evening time. Given mo's strong concern that this is an allergic reaction, I am reporting this event to VAERS, with her knowledge.
hives; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included prednisone and unspecified antihistamine taken for an unspecified indication, start and stop date were not reported. The patient experienced hives on an unspecified date. It was reported that after the first shot, the patient had hives. It was reported that she went to the urgent care, her primary doctor and also, the emergency room as that had been so severe. She was not responding to the usual course of an antihistamine and prednisone. The patient was miserable and would like someone to call her back with some suggestions to help. The adverse event resulted in physician office and emergency room visit. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. Date of refrigeration include 07-May-2021.
Pt recvd vax on 21AUG92 & several hrs later pt exp urinary retention. subsequently urinated 100cc of dark brown urine; sx subsided w/in 24 hrs;
Sore left arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 15:45 (Lot number: EJ1685) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin; "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC. Past drug history included: Cephalosporins for Drug allergy, reaction(s): "Drug allergy"; Mastisol for Drug allergy, reaction(s): "Drug allergy to antibiotics"; Bactrim for Drug allergy, reaction(s): "Drug allergy"; Known allergies: cephalosporins, reaction(s): "known allergies: Cephalosporins"; Known allergies: mastisol, reaction(s): "known allergies: Mastisol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 19:00, outcome "recovered" (Mar2021), described as "Sore left arm at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The most recent COVID-19 vaccine was administered at Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. While the AE reported was not resolved at the time the report was made, the AE was later resolved.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Very Sore arm for four days and couldn't raise arm at all for two days. Shivering and fever for one day.  Tired and achy for three days.
SWELLING AT INJECTION SITE REDNESS WHOLE THIGH AREA WITH WARMTH AND PAIN.
Day 2 - fatigue, body aches, chills, headache, extreme arm soreness, nausea.  Symptoms subsided Day 3 but headache continued and large red circle appeared on arm, just below shot site, itchy and hot.  At Day 6, arm is finally only moderately sore, redness gone, itchiness gone.
pt recvd vax;t & fever of 105 R on & off from 6pm to 5am screaming all noc long, crying all noc & next day; gave warm bath all next day;very pale & stopped eating x 12 hrs;to MD 2x's next days;
As stated by the employee, MA, who gave the vaccine - "The patient came in with her grandparents for their COVID vaccines. Upon arrival to the office I advised that they would be receiving the Moderna vaccine as we are out of the Pfizer at this time. Patient and grandparents agreed. After administering the vaccines, I noticed the patient was under the age of 18. Once I realized what I had done, I went directly to another employee, MA, and then together we reported the incident to (Family Medicine provider) who advised that there wasn't anything life threatening connected with administering the vaccine. The information was then given to (Pediatrician) who stated he would contact the patient's parents."  No treatment course indicated by Dr.  To date, the patient/parents have not reported any serious side effects or symptoms. As indicated in the patients, Dr. spoke to the parents on 5/2/22 documented as "spoke with mom - she had no fever but was achy yesterday.  She felt better today and went to school. I apologized for patient getting the Moderna vs. the Pfizer and we did address the issue with the MA who gave it and will proceed to have our clinical manager review the process to make sure it does not happen again. Mom voices understanding and will call me with any questions."
Flushing and shortness of breath immediately after receiving vaccine  Lasted approx 5 minutes
Knee injury; This case was reported by a consumer via call center representative and described the occurrence of knee injury in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced knee injury. On an unknown date, the outcome of the knee injury was not recovered/not resolved.   It was unknown if the reporter considered the knee injury to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix, and had knee injury. The patient asked that after how many days after 2nd dose of Shingrix could he/she take a 6 days course of methylprednisolone for a knee injury. The follow-up could not be possible as no contact details were available.
This pm she became dizzy and lightheaded. started itching all over. bp 129/83 p.75. she took 25 mg. of Benadryl and was feeling better.
pt recv vax;highly distraught p/ vax; passed out twice; nl heart rate, BP & glucose
Swelling started almost immediately after injection about 2 inches below the injection site on the thigh. The swelling started slowly spreading up and out towards the injection site increasing in an odd irregular fashion. Within 30 minutes the swelling had reached the injection site and continued to spread outward. The skin became red and was warm to the touch about 2 degrees difference in temperature than other areas of the body. (Temporal temp was 99.2/ Off site thigh temp 96.7/ onsite red and swollen areas of the thigh temp 98.7/) Administered a homeopathic remedy and applied essential oils 2.5 hours later the swelling decreased dramatically. However, swelling resumed the next day upon rise. Patient complained it was sore when touched.
On 3/1/10 infant ran a temp of 103. On 3/2/10 now afebrile, pt started having seizures lasting about 1.5 hours. Pt was put on Kepra for about 6-8 weeks and was weaned off of medicine in 5/10 and has been seizure free since. Mother states that infant began holding his head often, was irritable and crying uncontrollably at times after receiving his 1st series of vaccines at 2 months of age (12/17/2009) which continued until pt had the seizures and was hospitalized 8 days after receiving vaccines on 2/22/10. No other symptoms or health problems reported.
Patient had flu symptoms for 24 hours after receiving the vaccine. Thereafter, she developed a rash that started around the head (eyes, ears, neck) and then progressed down towards the feet and took about a week. She went to the urgent care on day 4 after start of rash and was suggested to use Benadryl to help with the rash. She did not take any medications for the rash. One week after receiving the vaccine, she developed diarrhea that lasted about a week. In total, her adverse effects from the vaccine lasted about 2 weeks consisting of rash and diarrhea. Patient states that she thinks her puffy eyes and rash around the eyes is because of the shingrix vaccine and has been to the doctor for which she got Maxitrol eye ointment prescribed today.
Information has been received concerning a pt who has been vaccinated from 1994 to 1999 with the pneumoccal vaccine 23 polyvalent on an annual basis. the physician reported that the pt no significant effects, only transient low grade fever, myalgias, and tenderness at injection site. the physician reported that the patient will not receive any further dose of pneumococcal vaccine 23 polyvalent until age 65.
Heartrate increased; Could not eat; Sleepiness increased each day; Loss of appetite; Tiredness; Headache; Fever off/on; Nausea kept me from eating; Vomit; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right leg on an unknown date in Apr2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included born with Pallister-Killian tetrasomy 12p, history of physical and cognitive delays, seizures, GERD (gastroesophageal reflux disease). The patient had known allergies to wheat, squash, cats and dogs with long fur. Concomitant medications included KEPPRA, lamotrigine (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN) and clorazepate (MANUFACTURER UNKNOWN)for an unknown indication, from an unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unknown date in Apr2021 at 08:00, the patient experienced heartrate increased at times, could not eat, sleepiness increased each day, loss of appetite, tiredness, headache, fever off/on, nausea and vomit. It was reported that nausea was worst and kept from eating. The patient did vomit twice and could not eat for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of heartrate increased, could not eat, sleepiness, loss of appetite, tiredness, headache, fever off/on, nausea and vomit was recovering.    No follow-up attempts are needed. No further information is expected.
DIZZINESS; TROUBLE SLEEPING; ARM SORENESS; CHILLS; FEVER; HEART PALPITATIONS; BODYACHES; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included asthma, and high cholesterol, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 21-MAR-2021 (vaccinated on left arm at 15:30 p.m.) for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced terrible headache. On 21-MAR-2021 22:00, the subject experienced heart palpitations. On 21-MAR-2021 22:00, the subject experienced bodyaches. On 21-MAR-2021 22:00, the subject experienced arm soreness. On 21-MAR-2021 22:00, the subject experienced chills. On 21-MAR-2021 22:00, the subject experienced fever. On 21-MAR-2021 23:00, the subject experienced dizziness. On 21-MAR-2021 23:00, the subject experienced trouble sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, arm soreness, fever, dizziness, bodyaches, terrible headache, trouble sleeping, and heart palpitations. This report was non-serious. Additional information was received on 22/Mar/2021. The following information was updated and incorporated into the case narrative: (Patient name spelling was changed and mail address was corrected). No new information available.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
severe itching from her legs down; a rash that has gone away; had the Covid arm for 7 days; her whole body is itchy where the hives was, especially her legs; her whole body is itchy where the hives was, especially her legs; her skin is crawling; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs) and PRURITUS (her whole body is itchy where the hives was, especially her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable). At the time of the report, PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
SORENESS ON THE ARM FROM THE ELBOW UP; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was not reported and height was 65 inches. The patient's past medical history included colonoscopy, rheumatic fever, and whooping cough, and concurrent conditions included penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfur, and tetanus vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 22202A, and expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced soreness on the arm from the elbow up. Treatment medications (dates unspecified) included: magnesium sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness on the arm from the elbow up. This report was non-serious.
pt recvd vax; joint pains, n, redness, pain, swelling, warmth, itching at site p/ dose 1; pre tx w/ dph dose 2 & 3;
This spontaneous report was received from a medical assistant referring to three unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, lot # L035510 and expiration date 13-MAY-2017, orally, for prophylaxis (dose and frequency were not reported). The vaccines were stored under temperatures between 32 Farenheit and 36F for 888 hours and under >46°F, but <77°F for 39 hours. There were no previous temperature excursions, no data logger was involved and no adverse effects had been reported. No product quality complaint was involved. Additional information has been requested.
Chills, fever, severe body aches, 3mm erythema at injection site (left deltoid).