chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced swollen lymph node in right arm about 2 days after the first vaccination on 1-25-21. Experienced swollen lymph node in right arm about 3 days after second vaccination on 2-22-21.
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD from lot # M044719 with expiration date on 07-MAY-2018; and lot # N014758 with expiration date on 08-NOV-2018 (strength, dose, route of administration or anatomical location were not provided); along with a properly stored sterile diluent (manufacturer unknown) with lot # N016189 and expiration date on 13-AUG-2019; both administered for prophylaxis. The storage temperature was -14 to -10 degrees Celsius (°C), for a timeframe of 26 minutes. There was a previous temperature excursion at -14 to -10 °C for 1 hour. No adverse effects were reported. No product quality complaint (PQC) was involved.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 26-JAN-2015 the patient was administered a dose of PROQUAD (Merck), 0.5 ml, subcutaneous, that underwent a temperature excursion (dose number, lot number and expiration date were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
inadvertently administered a dose of GARDASIL 9 to  60 years old patient; This spontaneous report as received from nurse refers to a 60-year-old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 14-SEP-2020, the patient was inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
other people who received the Moderna Covid-19 vaccine and got sick; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 an unknown date, the patient experienced IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick). At the time of the report, IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported.  The reporter was Retired Registered Nurse who mentioned that other people had gotten Moderna and gotten sick, no identifying information provided.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-624848 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non Significant Follow Up Appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624848:same reporter
Information has been received from an office manager concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, unspecified patients received doses of improperly stored VARIVAX (lot # M004330, expiration date 26-JAN-2018) (lot # M027343, expiration date 01-JUN-2018) (dose and route unknown). The storage detail was a temperature excursion for VARIVAX at 6.1 F for 96 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since there is no consent to contact the physician.
@ 0927 Patient received 0.3 undiluted dose of the pFizer vaccine on the left arm. This was the patients second dose of the pfizer vaccine. Patient was observed for 45 mins, no adverse reactions displayed.  Patient mother at the side of patient, fully aware of the error. This was the vaccinators first time at the site, the vaccinators did not have the proper training at the time prior to incident error occurring. The mother of the patient work at the site where she is familiar with the policy and procedures. There was no on-site manager at the site at the time the incident occurred. Patient remained in stable condition throughout the duration of stay in observation.
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
Patient felt very dizzy, complained of blurred vision and "seeing spots". Patient stated she felt like she couldn't stand and felt like vomiting when offered food or liquids. EMT's were onsite and took her BP which was normal both sitting and orthostatic. EMT's stated she had tachycardia which subsided within a few minutes. Patient was tearful and seemed nervous. Patient said she had chills and felt freezing, I oberved she was warm to touch (within normal limits). She stated that she had not eaten all morning but had drank a coffee. She was offered water and a granola bar - patient refused saying it made her want to "vomit". She was then taken by EMS to a local hospital because she was not feeling any better. Her vital signs remained normal. The hospital treated her for an "allergic reaction" and she was given Benadryl, Pepcid, and prednisone. She returned to work at 1:30 PM and is doing fine.
Information has been received from a nurse practitioner concerning an 18 year old female who on 24-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Tdap, given at the same time. On 24-MAY-2007 the patient was extremely nauseous after her vaccinations. Subsequently, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning an 18 year old female who on 24-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # unknown). Concomitant therapy included Tdap (manufacturer unknown), given at the same time. On 24-MAY-2007 the patient was extremely nauseous post-vaccinations. Medical attention was sought. On 24-MAY-2007 the patient recovered. Further information is not available.
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me.  About 9:30 my temp was 101.8F and they sent me home.  I just had the chills and fever.  I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
COVID-19; Pelvis pain; Painful hips; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PELVIC PAIN (Pelvis pain) and ARTHRALGIA (Painful hips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ARTHRALGIA (Painful hips). On an unknown date, the patient experienced COVID-19 (COVID-19) and PELVIC PAIN (Pelvis pain). At the time of the report, COVID-19 (COVID-19), PELVIC PAIN (Pelvis pain) and ARTHRALGIA (Painful hips) outcome was unknown.       No concomitant product was reported. Patient needed a hip replacement. No treatment information was reported. For Rinvoq, dechallenge was reported as yes. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Rinvoq for the event COVID-19 was a reasonable possibility and for the event Arthralgia was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient was given an undiluted 0.2ml dose of Pfizer pediatric dose.  Realized the error approximately 45-60 minutes after.  Contacted patient's parent and checked on patient's status. Per parent, patient is normal.  Parent will monitor patient and was instructed to take patient into hospital if symptoms are severe like chest pains, lethargy.
Patient had swelling and bruising immediately after vaccination. A cold compress was applied and patient was observed. After 20 minutes, the swelling had reduced. Patient was called an hour after vaccination and she stated that she did not have any pain, the swelling had reduced, and there was no progression of symptoms.
BODY ACHES; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 01-SEP-2021, the patient experienced body aches. On 01-SEP-2021, the patient experienced chills. On 01-SEP-2021, the patient experienced fatigue. On 01-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fatigue, and headache on 03-SEP-2021. This report was non-serious.
The day after the shot I had fatigue, chills and body sensitivity. The chills and sensitivity went away by the second day, but the fatigue persists. I am moving slowly and my body feels very heavy. I cannot walk long distances without having to rest. Everything I do requires an immense amount of energy. I have been unable to go into work and my entire life has been consumed by my health struggles.
pt recv vax 17APR98 & 8MAY98 became tired,sluggish, & exp stomach cramps & diarrhea;the next day pt also devel low grade fever, rt quad soreness, body aches & was found to have elevated liver enzymes;
A syringe leaked, disassembling from the needle while being used to administer the first dose of the Moderna COVID-19 vaccine  to a patient; more than half of the dose being administered while the rest leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (A syringe leaked, disassembling from the needle while being used to administer the first dose of the Moderna COVID-19 vaccine  to a patient) and ACCIDENTAL OVERDOSE (more than half of the dose being administered while the rest leaked) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced DEVICE CONNECTION ISSUE (A syringe leaked, disassembling from the needle while being used to administer the first dose of the Moderna COVID-19 vaccine  to a patient) and ACCIDENTAL OVERDOSE (more than half of the dose being administered while the rest leaked). At the time of the report, DEVICE CONNECTION ISSUE (A syringe leaked, disassembling from the needle while being used to administer the first dose of the Moderna COVID-19 vaccine  to a patient) and ACCIDENTAL OVERDOSE (more than half of the dose being administered while the rest leaked) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported.  Treatment information was not provided by the reporter.
the pt was given a blank shot without med in it..the technicican realized about this and then gave the med  correctly
On left side of head, on same side as injection site, experiencing head that is painful/sore to the touch. The tenderness is in specific areas but only on the left side of head. Symptoms began about 6 to 8 hours after injection and persist currently over 24 hours later.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "hypertension" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Dose 1, 2: Pfizer/ Dose 3: Moderna" (unspecified if ongoing), notes: Dose 1, 2: Pfizer/ Dose 3: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 10-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
A 2 month-old given Hiberix, Pediarix, Rotarix on 1/30/2023 and again on 02/21/23; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 3-month-old male patient who received Hib (Hiberix) (batch number 7FZ57, expiry date 30th December 2023) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 959LS, expiry date 17th February 2025) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX) and PEDIARIX.   On 21st February 2023, the patient received the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation, Rotarix Oral Applicator Device, the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st February 2023, unknown after receiving Hiberix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 Information: GSK Receipt date: 21-FEB-2023 Reporter comment: The reporter reported that, the 2 month old patient was given Hiberix, Pediarix, and Rotarix on 30th January 2023 and then again on 21st February 2023. The reporter consented to follow up. Additional Supportive Information:  The patient received 2nd dose of Hiberix, Pediarix, and Rotarix  shorter than the recommended interval, which led to shortening of the vaccine schedule.
RTC R/T to irregular red circlar spots on both thighs more on right thigh than left thigh appears on lateral and inner and posterior thighs size ranges 4mm-30mm, Raised on right thigh laterally.  Areas of injection fading. Color brown. Mother noticed areas when she gave infant bath this AM. states infant ran temp 1-2 days post vaccines. 8/24/04: Mother denies any fever today. Mother instructed to take infant to pediatrician. Mother denies having pediatrician for infant. Notified nurse and CN for Health Dept that she was new to the county. Recommended clinic, If unable to see NP take infant to ER or any walk in clinic. A walk in clinic close by. Directions given. Instructed to give whatever is used for fever if needed. Report the outcome of doctor visit. The sites are not warm to touch no thighs. Mother verbalized understanding. Took numbers for health dept and clinic and put them in her wallet. 8/25/04 09:15 attempted to call mother to obtain report from doctor's visit.  10:45 called again. No answer. 8/25/04 4:20PM still not answering phone.
Rash on back/buttocks.  Itchy with no hives.  Patient called into practice 5 days after vaccine administered.  Vaccine administered monday, rash present 2 days later.
At 6 weeks on February 15, 2016 she got her first round of vaccines, she slept all day. Around 8 at night her fever had hit 103 and she would not wake up. Hospital admitted her and she spent three days there while they ran test. Spinal tap was performed along with a pee test. Results were negative. They said she must had, had a virus that the vaccines intensified or a reaction to vaccines. May 1st she had her 4 month shots. Once again her fever hit 103 almost 104. She began to breathe extremely hard. I called the nurses hotline and they told me to give her a warm bath. I undressed her to put her in the bath and she cried then her body went limp for like 5 seconds and I was screaming and she came out of it and started crying. I rushed her to the ER and we stayed till 5AM on May 2nd. That time was diagnosed as reaction to vaccines.
Received ADACEL, in Left delt and PNEUMOVAX in Right delt on 2/17/09- Called office 2/19/09 c/o swelling &pain came in for eval 2/19/09- Right upper arm with urticaria, tender to touch, mild eythema & slight warmth.  BENADRY 50 mg 1m given- Instructed to return if problems
Stared with headache, body aches (flu like symptoms). After a couple of days I started hearing a high pitch sound in both ears. It was not loud at the time. The ringing in my ears has gotten worse over the past couple of weeks to the point where I felt I needed to contact my doctor. The doctor feels this is related to the booster shot so I am preparing this report per his request. I also have pain in my arms and legs (where they bend). I don't know how to describe this in text. I have had no treatment, but it's getting worse!
Keratitis; Conjunctivitis; This is a spontaneous report from a contactable Physician reported for a 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient medical history included chronic granulomatous disease and recurrent immune mediated keratitis (recurrent immune mediated keratitis in the past).  Concomitant medications included azathioprine (IMURAN), itraconazole, piroxicam and sulfamethoxazole, trimethoprim (BACTRIM) On 30Jan2021, the patient experienced keratitis and conjunctivitis 1 day after vaccination. The events were resulted at Doctor or other healthcare professional office/clinic visit. The patient's father had exposure work (negative COVID19 PCR 10 days ago). The patient had no covid symptoms. Pending covid-19 test. The patient received topical NSAID as treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
RIGHT ARM SORENESS AT SHOULDER BLADE NEAR ARMPIT. HAD TO VISIT DOCTOR FOR SHOULDER PAIN AND WAS TOLD PAIN WAS RELATED TO ROTATOR BONE, REFERRED TO ORTHOPEDIC SPECIALIST. PATIENT WILL FOLLOW-UP. PATIENT USES HEAT-PAD AND SYMPTOMS ARE IMPROVING SINCE 1/10/2017.
sick, very sick; Initial information received on 05-Nov-2022 regarding non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who experienced sick, very sick after receiving vaccines influenza vaccine and covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine by unknown manufacturer (lot, expiry date and strength was unknown) via unknown route and unknown administration site as flu vaccination and on same day patient also received Booster dose of covid-19 vaccine not produced by Sanofi Pasteur (dose, expiry date and strength was unknown) via unknown route and unknown administration site as Covid-19 vaccination.  On an unknown date the patient developed sick, very sick (illness) (unknown latency) following the administration of influenza vaccine and covid-19 vaccine.  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Heart palpitations since the day after the injection. Happens randomly but several times per day and lasts for about 5 seconds each time.