chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of chills in a 63-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included VITAMIN B COMPLEX, Pyridoxine hydrochloride (B6), CALCIUM, L-LYSINE, Selenium, SOYA LECITHIN, VITAMIN C, ALLEGRA and NEXIUM. On 17 May 2010 at 12:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, left arm). On the night of 17 May 2010, less than one day after vaccination with BOOSTRIX, the subject experienced chills, fever (over 100 degrees) and headache. The subject consulted the physician's office on 19 May 2010. At the time of reporting the fever had improved, and the chills and headache were unresolved. The healthcare professional reported that the physician considered the events were probably related to vaccination with BOOSTRIX.
This spontaneous case initially received from pharmacist on 24-Oct-2018, concerning a 71-year-old, elderly, female patient. The patient had no relevant medical history. The patient's concomitant medications included Lisinopril and Hydrochlorothiazide, Levothyroxine and aspirin. On an unspecified date, the vaccine was out of the refrigerator for 2 hours and maximum temperature of 70 Fahrenheit was reached, which was considered as first excursion (explicitly coded as incorrect product storage). On 24-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250802 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Patient presented anxious with reddening of skin around the neck/ upper chest and right forearm. No dyspnea. vital signs within parameters.
Localized reaction on (L) thigh. Presented with large, red swollen area to MD office. Approx 4x6".
5/9/2000 Soreness in left deltoid area with movement. Increased soreness in neck and shoulder blade area. 5/10/00 less soreness in arm. Denies activities that would be cause for soreness. Denies any swelling or redness visible.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medication information was reported. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Pneumonia that put her in the Hospital. Followed by brain,lung,kidney. & Death after over a month in the Hospital.
nodule; This is a spontaneous report from a contactable physician. A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date Apr2021 as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date Mar2021 as a single dose for COVID-19 immunization and experienced Hard spiderweb, Nodules. The patient medical history and concomitant medications were not reported. The patient took 7 months post Sculptra Aesthetic injection to temples, jawlines, cheeks, and chin. On an unknown date, the patient experienced hard spiderweb, nodule. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: she called that she had an ankle pain and swelling now in calf not recovering-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Severe
COVID-19 symptoms started 12/27/2021, tested positive 3-4 days after that. Symptoms included cold-like symptoms such like runny nose, sinus pressure, no coughing, achiness, and headache. Symptoms were very mild. I had ear ringing that started within a week after the other symptoms and it is still ongoing. The other symptoms lasted 3 days. I have an appointment with PCP for the ear ringing on 05/24/22.
My arm started hurting about a week after the shot.  It hurts to raise up. It sometimes feels"heavy". At times I have had pain going to my neck and to my shoulder blade. The pain has been  on and off for 2 weeks.
Patient had no adverse event or outcome. After administration, it was discovered that vaccine refrigerator was out of temp range. Pt is notified and offered re=vaccination.
on -03/25/21 I Injured my back doing an sitting dumbbell overhead press. The injury occurred while pulling the dumbbell from the ground into an overhead press position.  The injury felt muscular in nature, there was no pain after the first few minutes, I was able to complete my workout without any pain.    03/26/21 - Received Moderna Vaccine first dose  03/27/21 - Worked out again with no pain, avoided aggravating the area just in case.   03/28/21 - Woke up with debilitating back pain, unable to fully stand, dull stabbing pain shooting from lower back into hip and then into knee.   Following week I was unable to stand upright without intense pain, received Celebrex and muscle relaxers which did little to help with pain, Doctor then put me on 1 week of prednisone, an anti-inflammatory steroid which did not appear to do much.  Four hours after starting steroid use I decided to stretch my psoas muscle, despite incredible pain I managed to get it stretched out, I could walk upright with reduced pain afterwards.  For the next week the pain would gradually get better.    04/19/21 At this point pain had subsided to about 10% of pain at its worst point and has gradually gotten better, pain is almost non-existant at this point.  I noticed that my right quadriceps muscle had atrophied in comparison to my left quadricep muscle.  04/22/21  Began self-administered rehabilitation, slight increase of pain during workouts.  Noted that my right quadricep had gotten significantly weaker and had from visual inspection lost about 40% of it's muscle mass, left leg  feels hard to the touch while flexed, right leg is mushy to the touch while flexed, one month prior I could do squats of 285x8, now my right quadricep could only complete 5 reps of 15lbs on single leg extensions, my left leg could still do 40+ reps without failure.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender.     On 06-JAN-2017, 23-JAN-2017, 30-JAN-2017 and on 10-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L040054, expiration date: 26-DEC-2017) (dosage and route of administration were not reported) for prophylaxis. From 14-SEP-2016 to 22-MAR-2017, this doses were stored in the temperatures from 47 to 71 degrees of Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 1230PM & arm was sore about 530PM but did not see ( did not look in the mirror until 29OCT98) & saw an area of erythema, warmth @ site of inj;
Felt as if my heart was beating faster. flushing sensation all over along with the feeling of impending doom. Had tachycardia for the whole day. fluctuating heart rate all day with max recorded was 128. Intermittently noticed upper mid-right abdominal skin was rapidly moving up and down as if it was pulsating. Intermittently noticed a very faint feeling of numbness at one corner of my lower lip. Heart rate back to normal after 4 days. Should I take the vaccine second shot?
89 y/o female w/ history of syncope presented to RX for 1st dose COVID-19  vaccination. Patient buckled in wheel-chair, unable to walk, assisted. Requested vaccine be administered without moving patient from wheelchair. After administration, patient remained in waiting area for recommended 15 minute observation time, then patient's wheelchair was moved nearby, but still waiting area. Approximately 20 minutes after vaccination, granddaughter called me over to help. Patient was unconscious and appeared not to be breathing, but pulse was palpable. Called for code white. Pharmacist asked granddaughter to hold patient's head up. Pulse remained palpable, pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. Patient quickly regained consciousness, spoke to family, said she didn't feel well. EMS arrived. Patient began to vomit, was placed on stretcher by EMS and left with EMS. A few hours later the granddaughter reported to us that the patient had a UTI and physical exam by ER attributed her experience to untreated infection.
Patient received vaccination in the left arm and in the evening noticed the side affect , that he had difficulty moving arm above the chest line. We advised the patient to contact his doctor to make him aware of this side effect and his symptoms.
No adverse event; Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine; Patient received 0.5ml of the 6 month to 5 year old vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine) 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 INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine).    No concomitant medications were reported.    The patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose. Patient received 0.5ml of the 6 month to 5 year old vaccine. The reporter (nurse) did not give permission for Safety to contact.  No treatment information was reported.   Reporter did not allow further contact
MILD STOMACH ISSUES; SOME DISCOMFORT ON THE ARM OF ADMINISTRATION; HEADACHE; This spontaneous report received from a patient concerned multiple patients. 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild stomach issues. On APR-2021, the subject experienced some discomfort on the arm of administration. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild stomach issues, headache and some discomfort on the arm of administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417098.
Treatment of COVID-19; Treatment of COVID-19; dose 4:Pfizer/ Dose3,2: Moderna/ Dose 1: Janssen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 10Oct2022 as dose 4 (booster), single (Lot number: GH96935) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 2, single (Lot number: 048F21A), in left arm and on 11Jul2022 as dose 3 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "cic" (unspecified if ongoing), notes: cic. Concomitant medication(s) included: LEXAPRO, start date: 01Jun2021; TRULANCE, start date: 01Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown", described as "dose 4:Pfizer/ Dose3,2: Moderna/ Dose 1: Janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
My ribs are killing me, my bruises are bigger and darker after a week of me getting them.  I can't bend over, turn, raise my hands, stretch without being in serve pain.  It's hurts to breathe and feels like my ribs are being crushed.  My left side is in pain but my right side is fine.  I have been unable to work or do any daily activities without pain
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old female patient who experienced stopped breathing, eyes rolled back, face turned purple, went limp, crying, hives, otitis media, and temperature axillary 98 deg. F. At 15 months of age, the patient received the first dose on 07-Apr-2010. Additional suspect medication included PREVNAR. On 07-Apr-2010, prior to receiving her PREVNAR vaccination, the patient was fussy, but a physical exam was normal and the patient was afebrile. After vaccination, the patient immediately began crying, she stopped breathing, her eyes rolled back into her head, her face turned purple and she went limp in her mother's arms. The nurse blew in the baby's face for several seconds and the patient spontaneously started breathing again. The patient also developed hives and was treated with BENADRYL. The patient was examined and nothing else seemed to be wrong. The hives were resolving by the time the patient was leaving the office. On 08-Apr-2010, the patient was seen for a follow up visit. Her temperature was 98 degrees axillary. That same day the mother reported that the patient's temperature was up to 102.2 degrees. The child was subsequently diagnosed with otitis media. The outcomes for the events of otitis media, crying, fever and eye rolling were not reported. The other events have resolved. No additional information was available at the time of this report.
after 10 hours since the shot i experience extreme fatigue. then very painful muscle aches in my lower back and legs. as well as my rib cage and neck. uncontrollable shakes and chills. no fever. it lasted 24 hours.  after that time i am still experiencing fatigue and nausea throughout the day. i am improving since the start of my symptoms.
Patient reported he has been having sore arm since over 4 weeks after the vaccination  which affects his ability to raise  his arm up fully and is currently undergoing physiotherapy .
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (Strength, dose, lot numbers and route were not reported). No adverse effects were reported. The patients did not seek medical attention. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Oka/Merck) VARIVAX information (patients identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time.  Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provided and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Acute hypoxic respiratory insufficiency: Due to Atelectasis and Asthma exacerbation  No actual pna / Infiltrate on CTA  Tobacco use  Hx of DVT / PT  Factor 5 Leiden heterozygous  Super Morbid Obesity Covid symptoms began on 10/15. Hospitalized 10/19. Patient reluctant to start solumedrol since it makes her incredibly anxious and she doesn't tolerate it.  She is agreeable to decadron.  Will schedule albuterol inh 4 puffs q 4 hours + q 2 hours prn.  Try to avoid aerosolizing nebulizers if able.  Monitor covid labs.  Encourage tobacco cessation Continue home xarelto CTA thorax done on admission with no PE (atelectasis - no infiltrate)   Essential HTN: DM2: Hold home metformin - Start low dose corrective (likely will need inc. Given steroid use).    Vte prophy: Cont home Xarelto    Diet: General per pt preference    Code: Full    HISTORY OF PRESENT ILLNESS:   Patient is a 37 y.o. female who presents today with covid-19 symptoms and exertional hypoxia.    She lives with a friend and she has covid also. She was vaccinated against Covid (in July - J&J). She has been feeling unwell for at least 5 days since 10/15/21. She has been checking her temp and having fevers up to 102.7 last night which was the highest. She has been taking tylenol and ibuprofen. She feels sore all over. She has chest pain that she describes as achy or sore. She has been having a dry cough. She hasn't brought up phlegm. She has had poor po intake.    She has hx of DM on metformin.    She has a history of asthma. was last hospitalized with asthma a few months ago. She has noticed wheezing in the past few days as well. She is reluctant to try any solumedrol since it makes her really anxious and crawling out of her skin.    She has a hx of DVT and PE and takes Xarelto for that (factor 5 leiden hetero).    She had nausea and vomiting 2 days ago - that was bilious but no N/V since then. She hasn't had any diarrhea.
Weight gain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, WEIGHT INCREASED (Weight gain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Medical history, Lab data, Concomitant medications and Treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up document received on 24-JUL-2021, contains no new information.
13 year old female patient after the administration of the first dose of pfizer vaccine in the observation area she star to feeling  dizziness.  We take the vitals  O2% 98, Blood Pressure 140/90, Heart rate 100.  We give 10 more minutes in observation.  After 30 minutes the mother patient tell to the nurse that patient suffer to Vasovagal.
Patient developed a high fever to 105 degrees with temperature staying 102 degrees for 12 to 24 hours. Note: Patient had similar febrile response to first set of immunizations on 11/09/2000. Temperature went up to 103 degrees and lasted 24 hours.