chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all over her body in random places she feels pricks on her skin; on one side of her abdomen that she started to get a sensitive area; sensitive spot on her abdomen, felt like it was sticking to her skin, and then felt like she had pricks all over her skin; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 24Feb2021, in evening, she developed a sensitive spot on her abdomen, felt like it was sticking to her skin, and then felt like she had pricks all over her skin, on 25Feb2021 all over her body in random places she feels pricks on her skin, on 24Feb2021 she noticed last night on one side of her abdomen that she started to get a sensitive area. She did not have a rash. The outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Injection site pain Extreme tiredeness Severe chills entire night after injection Nausea  2 days after injection Bad taste in mouth Feeling unwell  Getting better, not fully recovered at time of this writing
Patient given Zoster vaccine instead of the Varicella vaccine she had requested. No adverse reactions noted and followed up with appropriate dose of VAR one month later.
Lewy body dementia with behavioral disturbance. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Note: Had light flu -like symptoms on February 23rd, the day after the vaccine. Rested all day. Then I awoke on February 24th feeling well (symptoms gone). Got out of bed and found myself extremely dizzy. Am continuing to experience dizziness. Have fallen once.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported by reporter.
was administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-month-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 31th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered an expired dose of the infanrix vaccine, which led to expired vaccine used. The reporter consented to follow up. Note: There was discrepancy in expiry date of vaccine captured as reported in narrative.
This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness and sleepiness. On 19th June 2018, the patient experienced skin reaction and skin discoloration. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the skin reaction and skin discoloration were recovering/resolving and the outcome of the tiredness and sleepiness were unknown. The reporter considered the skin reaction, tiredness and skin discoloration to be related to SHINGRIX. It was unknown if the reporter considered the sleepiness to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, (later that day) less than a day, the patient experienced skin reaction to her watch band, noted it was under the watch band that was colored red and less so to the watch band side colored blue. The patient had the watch over a month and had not had any reactions to it previously. The patient contacted the watch manufacturer and reported incident to them as well. The patient was using cortisone cream on the skin reaction and it was improving but not resolved yet. The patient experienced tiredness since getting the SHINGRIX. The patient had periods when riding the bus when she can barely stay awake and also she had slept about an hour later the past three days. The patient did not contact the physician. The patient had denied permission to contact their physician.
Expired dose- vial left in refrigerator for more than  30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-355908 (Patient Link).
Patient returned to office with 48 hours of vaccination with redness, tenderness, and bruising at the injection site.
Pt experienced red and swollen induration due to DTaP vaccine of about 3 x 4 cm in length. Very hot to touch, fever of about 100.
Patient reported feeling feverish on 3/12/2014. Local reaction at site: erythema, warmth, tenderness.
I got covid on August 8 2022 I had 4 shots total, two to complete the pfizer total and two boosters, both pfizer but you do not ask that question
Very sore arm Muscle pain over whole body Tired -weak Shivering *Only lasted one day * Rx # 1695155-13833 * MFG Glaxo Smith Kline * No reaction to first shot other then mild sore arm. * Zoster Vaccine (Recombinant) zoster vak * Called 4/26/19 FDA
Information has been received from a physician concerning a female with a history of non-specific viral illnesses and chicken pox, who was vaccinated on an unspecified date subcutaneously with her first dose of Zostavax (Oka/Merck).  Subsequently, "one week post vaccination" the patient experienced "a VZV like rash located all over her body."  Unspecified medical attention was sought.  The outcome is reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
I did have the localized soreness. I had a migraine that lasted for three weeks. They usually only last a day and missed two days of work. After two weeks, I sought treatment. I was given  five days worth of prednisone. That resolved the symptoms.
I tested positive for COVID-19 on 7/4/22. I had a runny nose, fatigue, and scratchy throat. I had a Tele-Health visit and we decided not to do Paxlovid. My symptoms lasted for about 3 days.
Exactly a week after the vaccine I noticed alot of bruising and redness all over my body and I also developed severe headaches and SOB off and on for about 2 weeks so my PCP advised I take a Bayer low dose baby aspirin for 2 weeks to prevent blood clotting d/t to the bruising and redness and I finally was able to stop the aspirin on yesterday
The booster dose was given to the patient, and after that, we found out that the time interval between the second dose and the booster is less than 6 months. No side effects or reactions happened to the patient.
I received the Johnson & Johnson COVID-19 vaccine at 8:30AM on Friday, March 26. The only symptoms I experienced until that evening were mild soreness at the injection site, mild stiffness/soreness in my left arm and my neck, and mild body aches. At 6:00PM that day, I was driving and experienced sudden-onset nausea and dizziness. I experienced tunnel vision and my vision began to black out. I was able to pull off the road and began retching and dry heaving. I also experienced tingling/numbness in my lips and then in my right hand, each of which lasted for about a minute. The nausea lasted for 5-10 minutes, after which it dissipated and I started experiencing chills. After returning home, around 9:30PM I experienced a severe headache and a return of sudden-onset nausea. I also experienced tingling/numbness in my right hand again, which disappeared after about 5 minutes. I retched and dry heaved again, and I took two Advil. The nausea passed and I was able to go back to sleep. The next morning, the nausea had completely disappeared,  and the only lingering symptoms were a mild headache and mild stiffness/body aches.
ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 2nd of two reports.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, strength: 0.3 mL, lot number: EH9899; expiry date was unknown), via an unspecified route of administration on an unspecified date at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. The patient had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that the patient continued to have the symptoms. The patient went to see the provider and tested positive for COVID virus. The patient was asking how to handle his/her second dose. The outcome of the event was unknown.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the COVID-19 and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516297 same reporter, same event, different patient.
Came down with double vision, poor balance and sensory symptoms. Diagnosed with Miller Fisher Syndrome, a subset of Guillain-Barre.
A medical student's first administration attempt resulted in < 50% of the dose administered to the vaccine recipient.  The medical faculty precepting the student observed vaccine liquid running down the recipient's arm, at which time the faculty member reported <50% of the dose was administered to the recipient. A second dose was administered in the vaccine recipient's opposite arm, per CDC guidelines. The student was counseled by the faculty member on how to confirm once the skin is pierced by the needle, and the remaining doses administered by the medical student were fully administered with no technical difficulties. Previous experience with VanishPoint® syringes from Lot G201116 resulted in difficult administration reported by 2-3 experienced vaccinators.  After the needle pierced the skin, the plunger stopped and required significant more force to complete administration of the full dose.  However, these doses were able to be fully delivered.  No VAERS report was required.  The lot number of VanishPoint® syringe used by the medical student on 3/2/21 was Lot #G201226. Immunization Registry was updated to decrement inventory for the first dose (<50%) administered by the student.  The full dose administered to the recipient was documented in the recipient's account and decremented from inventory automatically, per requirements for COVID vaccine administration.
Initial unsolicited report received from nurse on 03-AUG-2018. This case was linked to 2018SA216267 (same reporter). This case involves a 16 years old male patient who was vaccinated with fifth dose of IPOL (Batch number: N1K921M, expiration date: 14-Nov-2019, dose, route and site of administration was not reported) on 01-AUG-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Cough; Chills; Fatigue; Body aches; Joint pain / joints below waist ache; Low grade fever; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 25Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient had no past medical history as the patient was very healthy middle-aged man. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 04Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 (within 12 hours of vaccination), the patient experienced chills, fatigue, body aches, joints below waist ache and low-grade fever. On 27Mar2021 (36 hours of vaccination), the patient experienced slight cough. The patient did not receive any treatment for the reported adverse events. The clinical outcome for events chills, fatigue, general body pain, joint pain, low grade fever and cough were resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Devel hives over entire body; fever 2NOV & 3NOV91 to 101; MD called & recommended DPH x 24 hrs then ordered Pred;
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful  lymph node inflammation approx. size of a baseball. Right axilla.
4/8 Vaccination  4/14 7:30 in the morning, I was driving my son to school. I got this really bad HA on R side of head. Went away quickly. Left side of face was left numb. I quickly did a neuro check; I could move fingers, eyes, etc. I called nurse and told to go to the ER.  At the ER, Covid test; neg, CT scan, MRI, blood work; all normal. Something happened to the nerve on that side of my face, trigeminal nerve.  It took a couple days for the numbness to dissipate. But I do still have some pain on the L side of my face.  Told to follow up with PCM; scheduled for 429/2021
2 days later my left shoulder and clavicle became so sore I could not move my left arm; 2 days later my left shoulder and clavicle became so sore I could not move my left arm; Slight swelling at shoulder and clavicle.; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; At first, nothing but a sore arm.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Sjogrens" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB; "Other medical history: HPB" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB. Concomitant medications included: HYDROCHLOROTHIAZIDE; VENLAFAXINE HCL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2022 at 01:00, outcome "recovering", described as "At first, nothing but a sore arm."; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "2 days later my left shoulder and clavicle became so sore I could not move my left arm"; JOINT SWELLING (non-serious) with onset 12Sep2022, outcome "recovering", described as "Slight swelling at shoulder and clavicle."; NECK PAIN (non-serious), EAR PAIN (non-serious), HEADACHE (non-serious), BACK PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "The pain seemed to spread into my neck, ear and head, followed by severe low back pain". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, bone pain, joint swelling, neck pain, ear pain, headache, back pain.  Additional information: at first, the patient had nothing but sore arm. 2 days later, her left shoulder and clavicle became so sore that she could not move her left arm. The pain spread to her neck, ear, and head, followed by severe low back pain. She had slight swelling at her shoulder and clavicle. She had no other vaccine within four weeks of vaccination. She had no COVID prior to vaccination. She did not tested for COVID after vaccination. She had no known allergies.
Intermittent aching pain distribution. Right arriculotemporal nerve plus constant feeling of tightness, inability to take deep breath. Onset 24 hrs post Anthrax 1, duration 7 months, complete resolution w/o sequelae. No current findings.
Pt received SHINGRIX and PNEUMOVAX 23 on 3/20/18. A week later she developed pain in her chest. She presented to Hospital ER where Dr. diagnosed her with shingles underneath her breasts. Pt was given VALTREX 3/29/18.
Sinus Tachycardia started within 24 hours after vaccine.  Did have the expected headache, chills and body aches.  As these started to ease up, the Tachycardia started.  Called the Urgent Care Nurse and was advised to go to the hospital.  Went, they ran a preliminary EKG and immediately admitted me to the facility.  Three days later am still tired with headache.
received both seasonal flu and Moderna COVID 19 booster.  the patient c/o fever beginning late the same day/early am of the next day.  fever continued for an additional day.  102 at the highest. also c/o of swelling, itch and redness at injection site of the COVID 19 vaccine ( left arm), no c/o regarding the right arm ( seasonal flu).  my assessment today (12/6) showed a marked pinkish color and some swelling at injection site.  pt stated the area was still itchy and somewhat painful to touch.
Client reports that 2 days after the vaccination she woke up with bilateral swollen lower extremities. She states they hurt and the discomfort has progressed to where she needs to use a cane to walk with
Administered second dose of Pfizer 5-11 to patient that that turned 12 between doses.
One week after shot, experiencing an intermittent headache, tingling/numbness in left hand, pain in leg and arm that comes and goes, tingling/numbness in left foot. Chest discomfort that comes and goes
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule.  The child presented with influenza which later lead to death on unknown date.  The causality was not reported.  The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition.  Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion.  Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.