chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/13/21: Admit Hospital.  COVID breakthrough.  Patient arrived at the ER due to shortness of breath and syncope. EMS were called by the patient's family after they found her unconscious on the floor. Her initial O2 saturation was in the 60's. Patient was brought to ICU and intubated. 8/26/21 remains in hospital intubated on vent.  CRRT started.   Diagnosed with: Severe ARDS, multifocal Pneumonia due to COVID-19, acute toxic metabolic encephalopathy, acute COPD exacerbation (likely 2/2 multi-focal pneumonia). Note: patient previously vaccinated with Pfizer COVID-19 vaccine in Jan/Feb 2021. 8/27/2021: patient died. Please note: Patient received first dose Pfizer vaccine on 1/23/2021 Lot # EL1283 and the second dose on 2/15/2021 Lot # EL9265
I had chills, just generally didn't feel good. It was like a real bad case of the flu. I went to bed well covered up. The next day I felt bad. I didn't have no other particular issues with it. I did have a lost of energy but gradually over the next 4-5 days I started to feel normal. Took COVID home test on February 23rd, 2022.
Pentacel (DTaP,IPV,Hib) vaccine given 5-17-23, vaccine expired on 5-4-23.  Called and spoke with Medical Information and was advised to repeat vaccine asap, vaccine not valid.  Called and informed patient mother of incident and rescheduled patient for repeat vaccination of Pentacel.  Mom verbalized understanding.
No adverse reaction.  On 4/11/08 pt. given DTaP rather than Tdap.  Pt is 17 yrs old.  Should have received Tdap.  All reported to state and district.
C/O pain in middle of arm well below the injection site. C/O pain in arm continuous since administration. No other symptoms. No treatment given. Patient did not seek treatment and did not report until today 3-13-18.
My 12 year old daughter has reported having twitching of the head and right eye. She reports it started last week and continues to this day. The twitching of the head happens as often as every hour or more. The twitching of the right eye is rare. Depending on how fast the twitch happens with her head pain is associated with it.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. In approximately 2012 (reported that at the time of the report "it had been two and a half years since the first vaccination"), the patient was vaccinated intramuscularly with the first dose of GARDASIL (0.5ml, lot# and expiration date were not reported). On 17-FEB-2015 (reported as "today") the patient was in the office for the second dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were not reported). Information about concomitant medication was not reported. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Delayed rash at injection site. Size of rash: 2" x 1". Onset: 11 days after injection. Treatment: hydrocortisone cream. Resolution: almost completely resolved 3 days after onset. Pregnancy: Due date: 1/27/21, have not given birth yet.
Red lump and soreness at injection site. Warm and sore to the touch. Itchy skin in  a 2-3 inch circle around the injection sits. Lump is injection point
extremely tired; left arm was killing her; injection site pain; Sharp pain in shoulder blade; Felt lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), ARTHRALGIA (Sharp pain in shoulder blade), DIZZINESS (Felt lightheaded), FATIGUE (extremely tired) and PAIN IN EXTREMITY (left arm was killing her) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site pain), ARTHRALGIA (Sharp pain in shoulder blade), DIZZINESS (Felt lightheaded) and PAIN IN EXTREMITY (left arm was killing her). On an unknown date, the patient experienced FATIGUE (extremely tired). At the time of the report, INJECTION SITE PAIN (injection site pain), ARTHRALGIA (Sharp pain in shoulder blade), DIZZINESS (Felt lightheaded), FATIGUE (extremely tired) and PAIN IN EXTREMITY (left arm was killing her) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a licensed practical nurse refers to a 18 year old male patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-JUL-2016, the patient was vaccinated with M-M-R II (lot # K008815 and expiration date 19-JUN-2016) subcutaneously (strength, dosing details and anatomical location were unknown). After giving the injection, the reporting nurse later realized that the M-M-R II vaccine had expired on 19-JUN-2016. The reporting nurse stated that, only one injection was given before the expiration of the vaccine was noticed. There has not been any adverse events reported with the patient. No treatment was given for the adverse event. The patient did not sought medical attention for the event. No product quality complaint was involved. Additional information has been requested.
My arm at injection site became very sore.  The pain/injury seems to be in the mussel tissue.    The pain is severe when I move the arm into certain positions.  It keeps me from sleeping in my normal sleeping positions.  After 7 months, the symptoms have not changed or diminished.
Patient received vaccine at 12:45pm on 9/6/18 with no incident. At approx 5:00pm at home she experienced red eyes and felt like she was having a reaction, so she drove herself to the hospital ER. Per the MD she presented with red eyes, sore throat, fever and myalgia; and a possible minor allergic reaction. He treated her with prednisone, ZOFRAN and BENADRYL and discussed the flu-like phenomenon vs a true allergic reaction with the patient. She was discharged with ZYRTEC, PEPCID, and a presription for prednisone.
3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg About an hour later I was able to walk a little. Stayed off my feet. Right foot became very cold. 3/30/21 Saw my primary care physician at med center. She sent me for an ultrasound at medical arts. From there I was sent to the emergency room at hospital. I asked the attending physician assistant about a correlation between the blood clot and the Covid vaccine because I had read about it being a concern in other countries. He stated that was a bunch of baloney. Was told to have a repeat ultrasound in a few days and was prescribed a 30 day starter pack of Xarelto and released.  3/30 repeat penis ultrasound of right leg showed the same results. 4/1 appointment with hematologist. Prescribe Xarelto for three months and ordered a repeat ultrasound in three months and bloodwork at that time.
The patient did not experience any symptoms; The patient was administered improperly stored VARIVAX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.   On 09-JAN-2020, it was identified that on an unknown date, the patient was inadvertently administered with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/Merck)(VARIVAX) 1 dose each for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported) (lot number R034394 had been verified to be a valid number; expiration date 27-NOV-2020), who was administered with sterile diluent (DILUENT MRK) as concomitant. The temperature excursion was at 6 degrees Fahrenheit (F), for a time frame of 20 minutes, and not had the previous temperature excursion. It was reported that the call was due to data logger, and the patient did not experience any symptoms.
Received Heplisav-B 4 weeks ago, Received 2nd Dose of Engerix-B; Initial Report Received on 22-Feb-2023.  A pharmacist reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization.  The patient received Engerix-B as the second dose for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Jan-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.    On 17-Feb-2023, 29 days (4 weeks) after having been vaccinated with HEPLISAV-B, the patient came back to receive the second dose.  There was a mix up at the pharmacy, when the patient came back, the patient received Engerix-B as the second dose.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Neck Pain, Sinus Pain, and Tinnitus - Sinus Medication and Antibotics did NOT work.  Prednisone worked.
had a bad rxn to MMR shot; exp a fine red rash on face & arms; was afeb
Contracted Covid in July. I woke up in the middle of the night with a scratchy throat and my right ear was hurting. The next day my throat was feeling was a bit better, but I had dinner plans so I took my temperature and a Covid test to be sure and the test was negative and I had no temperature. The following day, my throat was scratchy again, and my temperature was slowly rising. By that night, on July 15th, I had temperature, chills. aches, and fatigue. I took ibuprofen and the next day I called my doctor, however when I called my doctor all my symptoms were gone and I felt fine, but my doctor still gave me an antiviral. At night that same day my temperature spiked again and I was hit with severe fatigue. The following morning, I felt fine but I did start coughing and it was the only symptom I had.
This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received the first dose PREVNAR 13, on 22Jan2018 in the afternoon, in her right arm at single dose for immunization (she had some problems with coughing and her doctor didn't want her to get pneumonia at her age). Medical history included allergy to penicillin and some problems with coughing. There were no concomitant medications. She said she had a pneumonia shot in the past and it was reported that history of all previous immunization with pneumococcal 13-val conj vaccine was none. The patient previously received vitamin B12 injection in left arm (she has been taking it once a month for maybe over a year-as reported). On 22Jan2018 around 14:00 or 15:00, the patient had a reaction to pneumococcal 13-val conj vaccine in right arm: she couldn't move her arm for several weeks, it left that arm hurting all the time and when she laid down at night, and put her arm under her head, her arm killed her. She said it hurt off and on, not constantly, but it hurt when she used it too much, like she had a lot of trouble lifting things. She didn't have the strength she once had, like it hurt if she mopped the floor. Her right arm was affected, which was the arm that she got the shot in. Her doctor said she had a reaction said she did something to the muscles in her arm. She tried to exercise her arm to get strength back in it, but it didn't seem to be doing anything. She said it was about six months before it started getting better, but it has gotten to a certain stage and it doesn't get worse or better. Outcome of the events was recovering. Information on the batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with immunization. The patient was vaccinated with, .65 ml ZOSTAVAX on 29-NOV-2012. Product Lot # H017449 exp 12/20/2013. No other co-suspects were reported. No concomitant medications were reported. On 29-NOV-2012 the patient experienced pain and warmth, 1 day after onset of therapy, injection site warmth and red raised welt on the injection site which measures 2 inches in diameter. No treatment information was reported. The outcome of pain and warmth, injection site warmth and red raised welt on the injection site which measures 2 inches in diameter is unknown. Additional information has been requested.
Patient's soft spot swelled up and so did his temples. I was told by the ER staff at hospital his brain swelled due to a reaction of his vaccinations.
In March and April 1998 the patient received his first and second injection of Engerix-B, with no untoward effects. In September 1998, he received the third dose and thereafter experienced muscle pain in his opposite arm. The information received on March 10, 2000 reports the symptoms are ongoing.
I received the first dose and have tested positive for Covid; I received the first dose and have tested positive for Covid; chills; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:  unknown), single dose, dose 1 via an unspecified route of administration in 2021 for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose and tested positive for covid and had chills in 2021.  The patient was scheduled to be tested again on 28Apr2021 and to get the second dose of the vaccine on 30Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of tested positive for covid and chills was unknown.  Information on the lot/batch number has been requested.
Swelling from shoulder to elbow - began 2 days after getting flu and pneumonia vaccine - referred to immediate care - told to ice arm for 2 days - unable to which vaccine.
a lot of inflammation in the middle and right side of his neck; a lot of tightness in his neck/ could barely move his neck; neck pain  like severe muscle strain in the middle to the right of the neck; could not sleep; temperature of 99.1 degrees; body aches all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), SWELLING (a lot of inflammation in the middle and right side of his neck), INSOMNIA (could not sleep) and PYREXIA (temperature of 99.1 degrees) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle strain. Concurrent medical conditions included Seasonal allergy and Drug allergy (advil). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.   On 29-Mar-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021 at 2:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), INSOMNIA (could not sleep), PYREXIA (temperature of 99.1 degrees) and MYALGIA (body aches all over). On an unknown date, the patient experienced MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck) and SWELLING (a lot of inflammation in the middle and right side of his neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CYCLOBENZAPRINE (oral) for Muscle relaxant, at a dose of three tablets. On 28-Apr-2021, MYALGIA (body aches all over) had resolved. On 29-Apr-2021, INSOMNIA (could not sleep) had resolved. On 30-Apr-2021, MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck) and SWELLING (a lot of inflammation in the middle and right side of his neck) had resolved. At the time of the report, PYREXIA (temperature of 99.1 degrees) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) pyrexia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Patient took Tiger balm and ice pack for treatment   This case was linked to MOD-2021-116556, MOD-2021-116556 (Patient Link).
It was reported that a 53 year old female received Fluzone 98-99 on 10/7/98. Reportedly sometime post vax, the pt experienced a large local reaction at the injection site.
Patient admitted to the hospital on May 5th 2021 with acute on chronic right knee pain, found to have a septic right knee for which she had a washout 5/7. Patient had a negative COVID PCR on admission (5/5). Subsequently on 5/14 she had a repeat COVID PCR for discharge planning which came back positive. On 5/16 patient was noted to have a new oxygen requirement of 4L NC, though her imaging appears more consistent with fluid overload than COVID. She currently remains hospitalized. She is fully vaccinated.
Symptoms still persisting today, missed two days of work. Diagnosed Gastritis, gastric diverticulum and multiple ovarian cysts. Treated with Maalox, morphine and zofran.
Information has been received from a physician's assistant concerning her 2 month old daughter with no pertinent medical history or drug allergies, who in February 2007 was vaccinated with her first oral dose of Rotateq. Concomitant therapy included Hib conj vaccine. In February 2007, within 24 hours of vaccination the patient developed severe diarrhea and fever of at least 102 f. Unspecified medical attention was sought. No other labs or diagnostic studies were performed. Subsequently the symptoms persisted for 48 hours and then the patient recovered while on therapy (unspecified). In 2007, the patient received her second oral dose of Rotateq and only developed a little diarrhea. There was no product quality complaint. Additional information has been requested.
Started to have pain and throbbing in upper arm that sometimes traveled down the arm and up into the shoulder.  When it persisted for more then 2 weeks I went to an ortho who thought it might be bursitis and received a cortisone shot and anti-inflammatory.  2 weeks of the anti inflammatory did not reduce the pain.  Still have a follow up to come.
Patient inadvertently received a MMRV and a Varicella on the same date. This was reported to Coordinator, PCP, DON of facility. No known reaction has occurred. Instructed to file report.
On 10/3/12 patient reported to Dr. that several days after receiving flu shot on 9/16/12, she experienced tingling and numbness in the arms and legs. Then it spread to her abdomen. No fever. Advised her to see her primary care doctor who subsequently referred her to see a neurologist.
Narrative: COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/09, Pfizer, dose #2 08/30 COVID SWAB, Result: detected 08/30 pt cc: exposure: unknown 08/30 SARS-COV-2 Variant Sequencing result: pending
Left upper arm pain at times, mostly when raising arm above shoulder or reaching behind back. The pain gradually became more prevalent and after 4 to 6 weeks the pain increased in area up including left shoulder, with increasingly limited range of motion.  I visited the doctor on 1/20/2023 and was prescribed Methylprednisolone 4mg oral.  After about a week my range of motion increased and my shoulder pain gradually decreased. I am still experiencing upper arm muscle pain when reaching rearward and above my head.
Vaccine injected too low, causing redness, warmth, swelling and pain at injection site.
The night after taking the vaccine, she couldn't move her right hand. It was swollen. She stated her throat was also swollen. Went to the doctor.
Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-103413 (E2B Linked Report).; Sender's Comments:  MOD-2021-103413:Cluster case for other people who took second shot and fell ill
A report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 15-Dec-2014. The patient had expired FLUMIST which started on 15-Dec-2014. FLUMIST (INTRANASAL) was discontinued on 15-Dec-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 28Sep2022; Pfizer / BioNTech, Date: 05May2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Oct2018, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Moderna, Date: 28Sep2022; Pfizer / BioNTech, Date: 05May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Jan2023) Positive, notes: Positive antigen test 10 days after end of Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.