chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 045B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.  The vial was stored in refrigerator on 05-Jan-2022 and administered on 06-Jan-2022. the vial did not undergo any temperature excursion
FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.
became flushed, feverish, chills, body aches and headache shortly after arriving to work this AM
no adverse event; Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (no adverse event) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE from 27-Sep-2023 to an unknown date for an unknown indication.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route).    Treatment medications were not reported.   This case was linked to MOD-2023-742767 (Patient Link).
Patient described onset of symptoms 10/18: Fever (101.7), muscle aches, flulike symptoms, aches and pains, spinal aches, right ear pain, right arm pain and is hot itchy and swollen, loss of appetite. Still has taste and smell so doens't think it's COVID.
Patient received vaccination with TdaP and hepatitis B vaccine in left deltoid at same visit. The night after injection she developed injetion site soreness, fatigue, body aches, HA, chills, generalized weakness, nausea. Worsened over the next day and developed per patient up to 105F and on 4/4/18 early am she presented to ER for eval.  Labs revealed WBC 20, slight elevation of serum bili. Patient felt better after IVF and analgesics/anti-pyretics. Rapid flu test neg. Patient was feeling improved but still slight malaise by evening of 4/4.
Patient received the vaccine on 8/31/21 and developed hives on both of her legs on the evening of 9/6/21. During the early morning hours of 9/7/21 the rash proceeded to go up her buttocks and both upper arms. The patient took Claritin and it improved her symptoms.
tested positive for COVID 11/9. admitted for COVID PNA, COPD exacerbation and bronchiectasis exacerbation
I had severe chills that started around 10:00 PM that night and continued until 1:00 in the morning. I slept 14 hours that night - I did sleep. Got up at 2:00 in afternoon. That fever when I woke up was 100.5. That fever lasted most of that day 2/9/2021. My temperature went anywhere from 99.7 to 100.5 and I had a fever until 11th of February. I also had muscle aches like the flu. I had fatigue, too.  I had the sore arm, too, and that lasted until about the 13th or so. No dr. appt.  I still have a little fatigue lingering - still need to take a nap sometimes which is unusual for me.
Throughout the holidays, I kept feeling like I was dizzy and would faint. I went to shovel snow and had a pain in my side that felt like I had pulled a muscle. I had a friend drive me to the emergency room and they did x-rays and cat scans and told me that I have pneumonia and blood clots on my lungs. I was admitted to the hospital and stayed for 5 days. The doctor seems to think that I had the blood clots. I was given IV medications and antibiotics to treat what was identified as acute pneumonia. I had to take 3 rounds of antibiotics and it still did not clear up the pneumonia. All the pain is on the right side. The doctor also put me on blood thinners. I have follow up with the cardiologist and pulmonologist throughout the month of July. I also experienced pain the  area of my breast where I had a lumpectomy. I am still having the pains daily.
Patient fully vaccinated to COVID-19 with Pfizer vaccine 2/3/21 and 2/24/21. On 8/26/21 patient developed progressive weakness, poor appetite, fevers, and cough with occasional green phlegm. He presented to urgent care on 8/29 where COVID was confirmed. Given Augmentin and azithromycin for concern of coexisting pneumonia. On 9/4/21 his 02 stats dropped to 80s and admitted to reporting hospital. Chest Xray showed worsening patchy opacities in L lung base. 02 requirements quickly rose to 6L. Currently admitted to ICU.
This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and injection site pain. On an unknown date, the outcome of the injection site reaction and injection site pain were unknown. It was unknown if the reporter considered the injection site reaction and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacy intern. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that the patient experienced a bad reaction, clarified as a severe injection site reaction which was sore. No additional information was available.
Mom took child to ER for fever 103.9 purple feet. Had given TYLENOL. At ER, (mom told me) given MOTRIN, instructed to give warm bath, massage legs, can't MOTRIN. Left ER about 5:15 PM. Was there about 1 1/2 hours. Follow up 3-1-07 mom says still has fever, no other problems.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-MAR-2018, 07-MAY-2018 and 16-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# M022173 and expiration date 15-MAR-2019; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Developed dot-like rash to the R side of belly button after 3rd dose of oral typhoid.  "I have eczema".  Began typhoid 3/28, finished the doses on 4/4.  Saw the rash on 4/3/08.  Rash now size of 2 quarters blended together.
The patient received the injection, was monitored for 15minutes. He returned to his station at work. He had a sensation that he could not get an adequate breath. He says this started about fifteen minutes after the shot and observation had been done. He was assessed at 5:55pm on Friday (4/23/21). The pt had his vitals done at the area of injections. He was found to be stable. The pt walked under his own power to the medic clinic. There he was placed on a stretcher and vitals performed again. He was given a epic-pen injection in the left thigh, per author. This was a 6:35pm, approximately. He had no adverse effects from the epinephrine shot, with vitals still monitored. An ambulance arrived, report given and he was to be taken to the medical center for further observation.
parent called @ approx 1720- pt screaming unconsolably since immun administered leg red & swollen @ site of inj;
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored doses of GARDASIL intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a gynecologist, concerning an adult male female patient of unknown age. On an unknown date, the patient was vaccinated with the wrong RECOMBIVAX HB vaccine. It was reported that the patient received a pediatric dose (5 mcg) from a RECOMBIVAX HB lot had expired on 09-NOV-2012 (lot # not reported). Additional information has been requested.
The pt developed swelling, redness and hives at injection site approximately 24 hours later. The whole leg is swollen and hot to the touch. Mom iced the area and gave Benadryl. Area has gotten better over two days.
Information has been received from a registered nurse concerning a 45 year old male with babesiosis disease from an infected tick bite, Lyme's disease, and no known allergies who was vaccinated when he was a child with MMR. Concomitant therapy included azithromycin, cefuroxime axetil, and atovaquone. Since the patient had no written vaccine documentation, an antibody titer was drawn on 2/21/05. The range for the equivocal test was .91 to 1.09. The result was equivocal at .97 for rubeola. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Tiredness Headache Muscle pain Chills Fever Injection arm : Pain Redness Swelling Treatmemt: Took 2 pills of motrin Took 2 gelcaps  tylenol Outcome: Recovered
pt recvd vax 23JUL93-rash appeared on 25JUL93; frontal portion macule more on rt thigh; itching; states only applied alcohol; knot noted @ lt side of abdo? insect bite; advise see MD;
The patient said within 30 minute to an hour she developed a headache and the next day she had flu-like symptoms including fever and chills.  After about 3 days her symptoms went away but then she has started having headaches on and off since then.
This spontaneous report was received from a pharmacist referring to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 06-MAR-2016, the patient was vaccinated with an expired dose of VAQTA lot # K001296, expiry date 15-JAN-2016, 1 ml, intramuscularly in the right arm (reported as right deltoid). No adverse event and no product quality complaint (PQC) were reported. Additional information is not expected as the reporter did not wish any further contact.
she knows someone who is vaccine injuired who had severe neurological injuries; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of unknown age received bnt162b2 on unknown date (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller seeking information regarding legal differences between Pfizer BioNTech covid 19 vaccine and Comirnaty. Caller stated that the media said the vaccine was only 39% effective. Caller also stated that there were studies in other countries who were far more advanced in their vaccination rates that support this. Caller stated that the media said the vaccine was 100% safe but she knew someone who was vaccine injured who had severe neurological injuries who was not receiving any help from Pfizer. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Body aches; Chills; Tired; low grade fever of 99.9; Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Body aches), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever of 99.9) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced MYALGIA (Body aches), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever of 99.9). On 04-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, MYALGIA (Body aches), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever of 99.9) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Events updated.
I haven't been treated, but wanted to report the following: redness around injection site, mild swelling in face area, fatigue that is intermittent, mild rash on chest, a feeling of burning in the feet with a feeling of pins and needles. The redness and rash are gone.  The swelling is no longer visible, but I did feel like I had a generalized bee sting within my skin.
Patient called the office stating that the area where the injection was given was "fine" for 3 days and on the 3rd day she developed a raised, spotted, red rash. Patient was seen and DX: with cellulitis and given an antibiotic.
Second Moderna shot; uncontrollable shivering, skin painful all over body, prolonged and severe headache, nausea, vomiting. Lasted about 24 hours.
A week after the vaccine 4/10/2021 I started extremely heavy periods. I'm already anemic and I'm still bleeding excessive 11/2/2022. I've had multiple iron infusions since then.
Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), as DOSE 1, SINGLE, then as DOSE 2, SINGLE, both at the age of 31-years-old, via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain on 06Jul2021. There was no treatment received for the event. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Booster; Nausea; Sleeplessness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:00 (Lot number: FH8027) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "SLE" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 19Nov2021; METHOTREXATE; FOLIC ACID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09May2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Dose number:1 02May2021 Dose number:2 09May2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Dose number:1 02May2021 Dose number:2 09May2021". The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:00, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 26Nov2021 01:00, outcome "not recovered", described as "Nausea"; INSOMNIA (non-serious) with onset 26Nov2021 01:00, outcome "not recovered", described as "Sleeplessness". Therapeutic measures were not taken as a result of nausea, insomnia.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Client received the vaccinations. Her father said following the shots she began to feel alot more tired. (The next day). He said since then there has been an increase in sleeping. She has been following asleep in class. Also she has flushed cheeks. He planned to take her to the doctors for her lethargy.
Patient went to bed on 9/24 with headache and nausea, and woke up at midnight with severe sweats and fever, changed clothes drank water and returned to bed. On 9/25, patient woke up with severe headache and disorientation/dizziness, and her underwear showed menstrual blood, described per patient as "medium, like a first day of" menses. Patient is aged 67 and reports not having menses in roughly 10 years. Patient aggressively hydrated and ate soft food, and napped several times. Headache and dizziness/disorientation continued all day. 9/26 and 9/27 showed slight symptom improvement, but headache and disorientation remained. Menstrual flow did NOT occur after first instance on morning of 9/25. 9/28 and 9/29 showed significant symptom improvement, and by 9/30 no symptoms remained, patient was "back to normal"
Fever and nausea started about 3 hours after receiving the vaccine and continued for about 12 hours. Diarrhea started about 13 hours after vaccination.  No treatment was provided.
Pt recv vax on 8/26/98; on 8/27/98 pt exp swelling, itching, pain at vax site
20MAY96 pt recv vax & rash noted 5min later on upper arm 2"x3" rash disappeared-phone call to home 2hr later
I am 8 weeks pregnant and my estimate delivery date is August 10, 2021 . I felt numbness on my right left and could barely walk. Some nausea, dizziness ,and fatigue .