chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; Chills; 101 degree fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, Chills, Vomiting and Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101 degree fever.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.; Sender's Comments: Based on the current available information which includes a  temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273 , a causal relationship with the event cannot be excluded.
Foster parent was feeding baby when half-way thru bottle the baby yelled out, went limp, turned very blue, stopped breathing and arched his head back and eyes rolled back in his head. This lasted 15 seconds and baby snapped out of it on his own. Foster parent says baby did not choke on the formula (Enfamil).
This spontaneous report was received from a medical assistant concerning four patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on 30-JUN-2016 and some doses were administered on unspecified dates), the four patients were vaccinated with PEDVAXHIB injection (lot number L042259, expiration date: 18-AUG-2018; and lot number reported as M010440, expiration date: 09-DEC-2018) (dose, route and anatomical location of administration were not reported), which were improperly stored at 32.7 F for 5 days. Additional temperature excursions reported maximum temperature 51.3 F for 84 hours and minimum temperature 27.7 for 314 hours. The PEDVAXHIB were back in range. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Swelling, induration and redness over injection site. No fever but pt is very fussy.
Blood pressue spiked. The systolic was in the 170 range. The diastolic was in the 110 range. This was obtained a doctor's office. Over the new few weeks it came down almost to previous levels. It got down to about 130/90. My cardiologist has since adjusted my blood pressure medication to bring it down even further.
5 minutes after the patient was administered flu shot "AFLURIA" she felt tingling sensation on both sides of her forehead. I checked her bl. pressure it was 206/110 with 85 pulse. She was rushed to her Dr who is at the same building who monitored her and told her it's from the flu shot.
MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported AE; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case is linked to cases 2023SA157204 and 2023SA157696.  This case involves a 18 years old and unknown gender patient who was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2023, the Meningococcal A-C-Y-W135 (T CONJ) vaccine underwent temperature excursion with low temperature of 0.5 degrees C (product storage error) and patient received a dose of 0.5 ml dose 1 of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) with unknown strength via intramuscular route in the left arm for Immunization with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
(L) arm pain since vaccine. Pain radiates from (L) shoulder to (L) elbow. Take Ibuprofen.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Medium
pt recv vax 4SEP96 & 12SEP96 pt devel a fever;13SEP96 pt devel a rash;
as it was taken out side the window (19-42 days); Exposure during pregnancy; Fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Oct2021 09:00 (Lot number: FE3592) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headaches", start date: 01Jan2020 (ongoing). Concomitant medication(s) included: KEPRA taken for headache, start date: 25May2021 (ongoing); PROPANOLOL BOEHRINGER taken for headache, start date: 25May2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 02Sep2021, Time: 08:15 am, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FE3592), administration date: 02Sep2021, for Covid-19 immunization, reaction(s): "First heart rate"; Bnt162b2 (Dose: 1), administration date: 02Sep2021, for COVID-19 Immunization, reaction(s): "Dizziness". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "as it was taken out side the window (19-42 days)"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Exposure during pregnancy"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "Fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccination (within 4 weeks) was none. Patient medical history included Illness/AE: Headches, onset date: 01Jan2020, stop date: Ongoing, pertinent: on treatment for chronic headches/migraines without. Still having effects of high/fast heart rate even on standing/staying still activity. Over 120bpm sometimes. It varies all the time. Doctor wrote or visits as adverse effects. Currently pregnant.  Follow-up attempts completed. No further information expected.
A report was received from a health care professional on 13OCT2003 concerning a 2 year old female vaccinee who inadvertantly received one dose of Fluvirin on 10OCT2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Red irritated circle at injection site with heat and itching.  Started off the size of quarter and at 8 days after vaccination is now approx 4 3/4 inches in diameter.  "Covid arm"??
Temperature more than 100°F; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N concomitant medications reported. no treatment details provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
inflamed bumpy red patch approximately 2-1/2? x 2-1/2? just below injection site.  Red patch is warm to the touch and itchy
I just wanted to share that I had similar symptoms after my booster shot as I did with the first two. It's undeniable but things are back to normal now. Being a heart patient and being very active; I have been wearing a smart watch for years. I've gotten the craziest stats following these vaccines. I'm a former Nurse and not concerned, however, found this info to be worth sharing.  That said, overnight on the 11th (shot was on the 10th) my respirations registered at just 11 followed by 10 overnight on the 13th. My average is 18-19 with the one exception of 14. My resting heart rate was >65 for four nights. My normal is low 60's and high 50's.  My 02Sat was only 87 overnight on the 23rd, that's the first time I've EVER gone below 94. Average is 97-98. My temperature overnight on the 13th went up 4.4 degrees. That's a first, even with the first two vaccines.  My HRV went down to 14 overnight on the 11th also. This was a new low for me.
STROKE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. 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 not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke within12 hours of the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210926436- COVID-19 VACCINE AD26.COV2.S-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a 60 year old male consumer refers to himself with high blood pressure and high cholesterol. There were no drug reactions/allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported), 1 injection in the left arm. Concomitant medication included lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 27-AUG-2013, right after the "got the shot", the patient's arm swelled up like crazy and turned red around the injection area. Approximately on 10-SEP-2013 (reported as 2-3 weeks later), he started experiencing tingling and numbness in various parts of the body. This had not yet gone away. None treatment was given for adverse events. Blood test for lymes and thyroid were performed. The patient sought unspecified medical attention. The outcome of "arm swelled up like crazy" and "turned red around the injection area" was unknown. Additional information is not expected.
Sub-conjunctival hemorrhage, left sided. Never had  been observed before, according to the patient. Started 2 days after he got a second dose of COVID vaccine.
Fever, vomiting, numbness in the hands and legs started within 24 hrs after immunized. Fever 103 - 104.9. Fever for 4 days. Vomiting and nausea 4 days. Tired feeling.
profound dizziness; This is a spontaneous report from a contactable nurse.  A 54-year-old female patient received BNT162B2 (lot number: EK5730), intramuscular at the right arm  on 17Dec2020 18:00 at 0.3 mL for COVID-19 immunization at a hospital. There were no medical history and concomitant medications. The patient experienced which she described as bizarre side effect  of profound dizziness, almost like vertigo, states she was having to hold onto a wall, considered medically significant by the reporter on 20Dec2020 12:00. The patient recovered from the event on 21Dec2020, 10:00.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event dizziness cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Headache CHILLS AND FATIGUE Narrative: CAKLLED AND CLEARED TO WORK THAT DAY.
Red, warm, and extremely itchy walnut size lump below injection site, spreading down and around my arm to my elbow, lasting approximately two weeks. Pictures available on request.
Subsequently post vax, the child developed an afebrile generalized measles-like rash. The pt sought unspecified medical attention.
Pain; This is a spontaneous report from a contactable Other HCP ( Specialty Pharmacy). This Other HCP reported for a female patient that: A 47-years-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. Patient's past drug event history included Xeljanz XR at 11mg daily orally for Rheumatoid Arthritis in 2019. On unspecified date, the patient experienced pain. At the time of this report, outcome of the event was unknown.  Information on lot/batch number has been requested.  No Follow up attempts are needed. No further information is expected.
This spontaneous report as received from an office manager, refers to a patient (who is also a physician) of unknown age and gender. It was reported, that on 25-MAR-2015, the patient was vaccinated with a third dose of improperly stored RECOMBIVAX HB dose and route were not reported (lot # K012649, expiration date: 14-APR-2016). The temperature excursion for the RECOMBIVAX HB was found to be supported by in-house stability data. It was not known, when the patient received the first and second dose of the vaccine. No adverse symptoms reported. Additional information has been requested.
tested positive after receiving first vaccination; tested positive after receiving first vaccination; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the third of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive after receiving first vaccination in Jan2021. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if those who tested positive were still advised to get the second vaccine. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021058398 Same reporter/ vaccine, different patient/ similar AE
I was breastfeeding my son at the time. I pumped within an hour of receiving the shot. My 5 month old son nursed the night following the shot and later ate the pumped milk that I acquired the same day of the shot. 11 days later he was found unresponsive during his nap at daycare. It is not clear how long he was unresponsive for until found by babysitter. He was immediately rushed to the hospital and doctors were able to get his heart beating again with excessive effort. Organ damage was extensive and he had no brain function, he did not recover. He passed away 13 days after I received the shot.
Left delotid, red 5x9 cm area, warm to touch, firm, afebrile, dx sterile abscess. Ice.
Information has been received from a registered nurse concerning a 16 year old female (126 lbs., 62in.) student with no known drug allergies, who on 20-AUG-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included MENACTRA, ADACEL and ACCUTANE.  There was no illness at the time of vaccination.  Approximately 10 minutes after vaccination, the patient fainted for approximately 1-2 minutes in the office parking lot, struck her head on the pavement and was taken by EMS to the emergency room of a hospital.  The patient experienced hematoma on the scalp of the right back side of the head and contusion due to the syncope from getting "3 shots".  The patient's ECG was "normal" and a CT scan of the head without contrast revealed soft tissue swelling in the right parietal occipital region suggestive of recent trauma and no evidence of intracranial hemorrhage or parenchymal contusion.  On the same day, 20-AUG-2007, the patient was discharged from the emergency room as "improved".  Additional information is not expected.
I felt like I had the flu but had no fever. My daughter tested me and I had COVID-19. My wife and daughter had it at the same time. I also had a dry cough. I was given cough syrup and pearls. I still have the dry cough today.
After the vaccine I had a reaction on my arm. It itched a lot and was red and bumpy like I had a rash. I applied cortisone to it to reduce the inflammation because it was getting worse.  In early May, I contracted Covid. I thought the vaccine was supposed to prevent this. I had a runny nose, sinus congestion. I took Paxlovid, Mucinex and lavender. I took some vitamins to help fight it. I used Flonase and Claritin. And took a probiotic.  My symptoms were just not going away with the Covid. Low energy, congestion of the throat, and leg weakness.
I got a rash on my chest and it progressed to my neck and face. I went to the doctor on 4/7/2021. I was prescribed Methylpred and Clobetasol. I took the medicine as directed. The rash stopped spreading and got better. This morning 4/13/21,  the rash is back and spreading .
Vaccines provided at 9:30a on 10/20/11. Generalized tonic clonic seizure, lasted approx 40 sec at approx 12:30pm. Temp 100.4 at the time. Temp 101.5 in office one hour later. Generalized tonic clonic seizure on 10/28/11 for less than 1 minute. Temp 102.2 in emergency room.
Lost memory for remainder of day. The night of the 5th and through approximately 9pm on the 6th I was incapacitated. Couldn't walk, talk, move. Semi unresponsive. No recollection of those hours.
Pt. was very itchy, swelling and redness at site, some soreness. Applied cold compress and took BENADRYL and ADVIL.
Approx 48 hrs after vaccines administered child developed hives, swollen lips & tongue also an aching stomach. Episode lasted 72 hrs. Mo had given child BENADRYL, child taken to PMD. Symptoms subsided - more BENADRYL given. Hives off/on.
PT STATES THAT HE WOKE UP ON SATURDAY (<24 HOURS) FROM RECEIVING VACCINE WITH MILD ITCHING ON RIGHT ARM THAT PROGRESSED TO SWELLING, ITCHING, AND REDNESS REACHING ALMOST TO THE ELBOW JOINT. PAIN AT 2/10 AT THE VACCINATION SITE BUT NOWHERE ELSE. NO TENDERNESS TO PALPATION AND FULL RANGE OF MOTION TO ELBOW/SHOULDER. GOING TO ER FOR FURTHER CARE.
This is a 70y.o. female with uncontrolled type 2 diabetes, hypertension, history of non-compliance with medications, and gait instability who presents following a mechanical fall. She describes she was ambulating to her car using her cane when she lost her balance and fell forwards onto her right arm. She had immediate pain in the right shoulder. She denies head trauma or loss of consciousness. She admits to falling several times over the last few weeks. She denies any focal weakness, visual disturbance, paresthesias, chest pain, or palpitations. No fever, chills, shortness of breath, cough, or known exposures. She admits she does not take her medications as prescribed.    On arrival to the ED, BP was 180/87, HR 87, RR 18, SpO2 100% on room air, no fever. CT head and C-spine negative. X-ray of right humerus reveals a mildly shortened right humeral neck fracture. She did incidentally test positive for COVID-19; no acute process on chest x-ray. Labs remarkable for random glucose 459, WBC 13.5, CRP 30.4, LDH 310, ferritin 349. The patient was referred for admission. Orthopedic surgery evaluation