chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four days after receiving the vaccine, patient experienced re-activation of Shingles symptoms - pain & blistery red rash.  Patient had her first bout with Shingles earlier in the year - from January, 2021 until May 2021, when the rash and pain had finally subsided.
Progressive ascending stinging pain starting in the feet and hands, loss of 4 or more hours of sleep every night due to pains, myocardial infarction resulting in triple bypass surgery.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient. On 25-AUG-2014 the patient accidentally received an expired dose of PNEUMOVAX 23 (frequency unknown, dose, route reported as injection, lot # J006921, expiration date 09-AUG-2014) (reported as for an unknown indication). Concomitant therapies included XANAX, diazepam (manufacturer unknown), gabapentin, REGLAN and VALTREX. The patient's relevant tests or laboratory data was unknown. As of 25-AUG-2014, it was unknown if the patient would receive PNEUMOVAX 23 again. This is one of three reports received from the same reporter. Additional information has been requested.
I was getting ready for work on Sept. 24th, 2021 and then I started to get pains in my heart and my blood pressure went up to 194 over 190. The pains in my heart persistent. I called my nurse friend,  for help to take me to the doctor or hospital.She is an LPN. She kept taking my blood pressure and tired to calm me down. We were going to go to the hospital, then my heart stopped hurting after a couple of hours. She thought since I have so many allergies, that I was allergic to something in the vaccine.
Pt. developed same redness around injection site following administration. Ice applied to site x 10 minutes. Redness subsided. Mother advised to give pt. Benadryl
Soreness at injection site with slight swelling. Fatigue on day 1 following administration.
Patient complained of severe pain in arm that lasted for a couple days after the vaccine. She still has a lot of pain up until today and feels like she can't move her arm.
She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.; Sore arm; She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.; Throat is dry; nasal passage down my throat it is sore from dryness.; Dont have saliva; Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.; Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), NASAL DISCOMFORT (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.), SWELLING FACE (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.), CHEST DISCOMFORT (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.) and DYSPNOEA (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breathing difficult and Thyroid nodule removal in January 2018. Concomitant products included DOXYCYCLINE HYDROCHLORIDE (CONTIMYCIN) from 19-Feb-2021 to an unknown date and METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced NASAL DISCOMFORT (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.) and SWELLING FACE (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.). On 28-Feb-2021, the patient experienced CHEST DISCOMFORT (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.), DRY THROAT (Throat is dry), NASAL DRYNESS (nasal passage down my throat it is sore from dryness.) and APTYALISM (Dont have saliva). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and DYSPNOEA (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.). At the time of the report, VACCINATION SITE PAIN (Sore arm), NASAL DISCOMFORT (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.), SWELLING FACE (Swollen nose. Skin swell there and went across my cheek and down a little bit and was swollen.), CHEST DISCOMFORT (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.), DYSPNOEA (She is experiencing chest tightness and difficulty breathing since 4 or 5 days ago.), DRY THROAT (Throat is dry), NASAL DRYNESS (nasal passage down my throat it is sore from dryness.) and APTYALISM (Dont have saliva) outcome was unknown.        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.
Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine administration while still under observation. Two oral Benadryl tablets were given (50mg total) and epipen was administered in the left thigh. 911 was immediately called and patient was taken away in ambulance
ActHIB(unopened), Fluzone High Dose(unopened), Thyphim(unopened), Ipol(Opened) and unopened) and Tubersol(unopened), lowest temperature was -17C degrees for 63 hour and  45 minutes, did not know the cause of the excursion with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00315997) was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case was linked to cases 2020SA288477, 2020SA290000, 2020SA290005, 2020SA288639 and 2020SA288639.  This case involved 15 months old female patient who was administered with a 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ391AAA, expiry date: 10-Aug-2021), on 07-Oct-2020, via unknown route in left upper thigh for prophylactic vaccination, which had a temperature excursion along with the vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], IPV (VERO) [IPOL], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported for all), at lowest temperature was -17 degrees for 63 hour and  45 minutes. The cause of excursion was unknown.  It was reported that 6- patients received vaccines that were not suitable for use post a temperature excursion. 5 received Fluzone Quadrivalent High Dose and 1 received Act-HIB.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   No adverse event was reported at the time of reporting.  It was a case of actual medical error due to product storage error temperature too low.  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 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.
5/5/09 Pt was brought into ED by EMS. Pt was pulseless and apneic. Pronounced dead in ED. History was that pt was put on sofa for a nap at 7 AM. At 915, EMS was called because pt was not breathing. Pt in foster care. Coroner's case. Possible SIDS.   9/4/09 Coroner's Investigative Report DOS 5/5/09. Decedent found on stomach, not breathing by parent. Parent called 9-1-1 and started CPR.
Right after tetanus vaccine administered, donor felt nauseous, warm, and later sweaty. Donor was instructed to lay down and feet elevated, and ice packs applied to forehead, back and chest. After nausea went away, water by mouth was given to donor.
+ exposure on 4/22, recieved second dose of the covid vaccine on 4/27, pt presents with fever and mild sore throat
LIP SWELLING; VOMITING; LOW GRADE FEVER; CHILLS; NAUSEA; BODY ACHES TO UPPER THIGHS; This spontaneous report received from a patient via a company representative concerned a 74 year old female. The patient's weight was 116 pounds, and height was 155.44 centimeters. The patient's past medical history included hives, and concurrent conditions included anxiety, waldenstrom, alcohol use, non smoker, sulfa allergy, dog allergy, and cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use, no illness at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included ibrutinib. On 09-MAR-2021, the subject experienced body aches to upper thighs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced lip swelling. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip swelling, and vomiting on 10-MAR-2021, and had not recovered from chills, nausea, low grade fever, and body aches to upper thighs. This report was non-serious.
Pt arrived this morning upon opening the center; pt reports having a "bad reaction to the pneumococcal vaccine" she received here 2 days ago. Pt immediately taken in to a triage room to assess. R-deltoid noted as being very red and hot. Pt c/o of the R-deltoid having localized "itching, but no pain". Dr. came in to assess. Pt was walked in to schedule and s/s were tx'd accordingly.
No fever. States tongue was slightly swollen 2-3 days after injection. Taste buds were swollen for about 5-6 days. Saw doctor in office. Strept test done at that time 11/18/02; was better 11/19/02. Had told doctor that he had a yellow fever shot prior to onset. Doctor reassured him that he was ok. No difficulty breathing. We suggested that before considering getting another yellow fever shot after 10 years that he confer with physician at that time.
This spontaneous report was received from a physician via company representative refers to a 13 year old patient. The patient had parasympathetic tingling sensations. There was no concomitant medications or drug allergies reported. On 10-DEC-2015, the patient was vaccinated with GARDASIL, dose 1 lot # K006960, 19-FEB-2017 and on 11-FEB-2016, the patient was vaccinated with GARDASIL K005881, 14-JAN-2017, dose 2 right leg intramuscular. On an unknown date, the patient experienced increased tingling sensations in the right leg after the first and second dose. The patient was referred to a specialist in pain management for unspecified treatment. Therapy with GARDASIL was discontinued. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
A 2-year-old female patient with no concurrent illness and no pre-existing medical conditions had received an intramuscular right thigh injection of ActHIB, lot number UF568AA (Sanofi Pasteur, SA lot number D0050-1) on 15 June 2009 and four days later, she refused to hear weight on and refused to use her right leg, had difficulty walking and had a fever (temperature not reported). She had not experienced any adverse vents following prior vaccinations. The patient recovered from the event (date of recovery not reported). Follow-up information was received from the health care professional on 03 August 2009. The patient began experiencing symptoms one day post-vaccination, on 16 June 2009 (previously reported as 19 June 2009). Symptoms included fever of 101 degrees, and difficulty walking. Her mother was advised to administer Tylenol, and to rest her legs. The following day, the patient's grandmother reported that the patient's fever had broken, and that she was feeling better.
03/23/21: Patient presented and was admitted through Emergency department for generalized weakness x 2 days. The patient was recently discharged from the hospital on in December 2020 and was treated for covid pneumonia, he also had a small PE and started on warfarin. He reported pain to his bilateral knees and left arm. had a fall on 3/2021. on admission, BUN/Creatinin was 32/1.61, EKG was tachycardic with nonspecific st changes.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
blurred vision, confusion, room spinning  fever  excessive sweating  left side facial drooping  glazed eyes (rolling up ) altered mental status, unable to stand/walk vomiting
18 year old male no medical problem received meningococcal for college 0.5ml, given in left arm SC.  Immediately after vaccine administered (1-2 sec), patient pale, tachycardiac, syncope occurred.  While this was occuring, patient was placed on floor and regained consciousness but was disoriented.  It took about 20 minutes before patient able to site up without dizziness and resolution.  Patient observed total 45 mm with no other problems and no vital signs.  Patient denies any anxiety symtoms or nervousness and had recovered vaccinations in past without problems.  Called patient later that evening-only felt tired, no improving symptoms of fatigue.
The morning following vax, the pt developed a fever. The pt presented that afternoon to physician with a fever of 103. No abnormality noted. Pt also experienced loose stool.
Approximately one week after first Pfizer vaccine, I developed pronounced and constant high pitched  ringing in my ears(tinnitus).  It never stops. Surges louder.  Hearing test shows unusual partial  loss of hearing on left side as well. Oral steroids did not help. Steroid injection into ear drum has not helped.
Headache & Myalgia Narrative:  Employee reported began experiencing symptoms of headache and body aches approximately 6 hours after receiving COVID-19 vaccine. No medications were reportedly taken. No further information provided.
On 12 December 2006 the subject received unspecified dose of Influenza vaccine. On 12, December 2006, less than one day after vaccination with Influenza vaccine, the subject experienced an unspecified adverse event. At the time of initial reporting. 12, December 2006, the event was worse.
Pt reports painful left arm right after her vaccine was administered.  Nine days later, patient noticed arm was swollen and red and remained very painful.  Called clinic 3 days later as there was no improvement.  Pt was prescribed doxycycline 100 mg  twice daily for 10 days
Patient lost consciousness. Presumed seizure activity. Patient had low BP. Paramedics took him to the hospital.
Erythema rash, slight burning.  Treatment: gave 1 BENADRYL 25mg capsule.
pt recv vax 11OCT96 & pt devel rash that looked like chickenpox w/approx 10 marks scattered on body;it was reported that the rash did not consist of  raised bumps, did not itch & was not accompanied by a fever;
sore arm/most painful shot; Couldn't hardly lift it; This case was reported by a consumer via interactive digital media  and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on unknown date, for tolerance refer case US2021AMR183231).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injected limb mobility decreased and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine and the patient stated that it was the most painful shot he/she had but well worth it. One day after the vaccination, the patient had sore arm and did not able to lift arm but it was better 24 hours later. The reporter stated that he/she had heard so many reports about how awful shingles were and patient did not wait to get 2 course vaccine. The reporter stated that did not want darn shingles. The case was linked with US2021AMR183231 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183231:Same reporter
I was vaccinated with my 3rd COVID booster 1 week ago. I still have purple lips, a swollen face, headaches, and body aches since receiving the vaccine. Something is definitely not right.  I have not been seen by a medical doctor yet.
After receiving the vaccines, the patient stood up and experienced some syncope, then passed out.  She was quickly woken up and was guided to a chair.  She was not injured from the fall and it was discovered that she had not had anything to eat or drink that day.  The step father went and grabbed some orange juice that seemed to help.   Another potential contributing factor may have been that she had been holding her breath.  I followed up with the family about an hour after.  Patient reported a very mild headache and mild sore neck muscles.  I again followed up with the parents the following day and she seemed to be doing well.
Information has been received from a registered nurse concerning an 8 year old female with no known allergies or pertinent medical history who on 19-AUG-1999 was vaccinated with a 0.5 ml first dose of Varivax (lot # 629257/1851H). There was no concomitant medication. On 23-AUG-2006 the patient developed a "chickenpox like rash with over 50 lesions". The patient had no other symptoms. Medical attention was sought and the patient was treated with an unspecified antihistamine and calamine. No labs were performed. No further information was available. There was no product quality complaint involved. Additional information has been requested.
When woke up 12/2/2015, had hives (1/2 to 2 inch diameter) scattered all over body and face. Afebrile; no other symptoms or problems noted except slight runny nose.
5 days after injection my right shoulder area at site of injection started itching. The next day there was a swollen red like rash. VERY itchy and caused some aching in arm. Currently happening now. I put hydrocortizone on site to relieve itching but, it did not work.
Burning sensation with administration Deep depression with suicidal thoughts no attempts were made - resolved severe diarrhea for 5-8 weeks
Rash is at 10 centimeter round, red and hot touch; Rash is at 10 centimeter round, red and hot touch; Whole arm was sore down all the day down to finger; Flushed; Fever; Tired; Rash of 3 centimeter; A spontaneous report was received from a nurse, concerning herself, a 63-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed flushed; rash is at 10 centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all the day down to finger.  The patient's medical history was not provided. Concomitant medications reported included apixaban, bupropion, venlafaxine, simvastatin, levothyroxine and montelukast.  On 04-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04-Jan-2021, after the shot of vaccine, the patient developed a rash of 3cm at the site of injection and additionally developed low fever and became flush and felt tired. The next day, on 05-Jan-2021, patient's whole arm was sore down all day down to her finger. However, after 4 days, on 07-Jan-2021 the patient was out of tiredness, but on 12-Jan-2021, her rash had increased to 10cm, red and hot to the touch. Treatment medication included acetaminophen.     Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever and whole arm was sore down all the day down to finger were considered unknown. The event, tired was considered to be resolved on 07-Jan-2021.; Reporter's Comments: This spontaneous report concerns a 63-year-old female patient who experienced flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all day down to finger.  The events occurred the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown).  Treatment reported was acetaminophen and the outcome is resolved. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of fever, injection site rash, redness, muscle soreness and tiredness are consistent with the known safety profile of mRNA-1273 vaccine.
Patient received COVID booster shot on 9/29 started symptoms on 10/2 and when she obtained a COVID test the PCR test result was positive.
7/30/08 Client's mother reports fever, headache, body aches and neck pain continuing from day after these immunizations given (5 days).7/31/08  Symptoms have improved, no fever, continues to have headache but not as bad.  Did not seek MD.  8/4/08 Spoke with mother. Still with soreness at injection site of Tdap, but no more fever, headache, or bodyaches since 8/1/08.
Patient received vaccine and stood up to go to observation when patient appeared pale and experienced an episode of syncope. Patient stated he felt the need to vomit. Patient's mom at side. She stated that in the past he has been known to have these episodes after venipuncture. Patient redirected back to seat. Staff directed to call 911. Emergency kit at side and vital signs and pulse ox taken. Assessment of patient, alert and oriented x4 and vitals within normal limits. EMS came to site and patient refused further evaluation after clearance.
Fatigue; Headache; Pain at the injection site; Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-367477 (Patient Link).