chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 mins after patient received the Influenza vaccine, he began to have what appeared to be hiccups; when asked if he was "OK", the patient reported that he didn't feel right and was very diaphoretic and warm; he then began to have what appeared to be a seizure with jerking of upper extremities and his eyes began to roll upward; he seemed to become more alert after a few seconds and then repeated the activity; he had some residual confusion and thought that he was already at the hospital; 911 was called and the patient was taken to the hospital. Oxygen sat was 100% on 5LNC; blood glucose was 153; BP was 109/75 and pt slowly returned to baseline cognition prior to transport.
Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  Reportedly, patient had received all three doses including the booster were from Moderna and later the patient died.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'had been treated with a mRNA vaccine and that later the mother died'. The reporter confirmed that the patient received all three doses of the mRNA-1273 vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'had been treated with a mRNA vaccine and that later the mother died'. The reporter confirmed that the patient received all three doses of the mRNA-1273 vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
"Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccination was feeling more tender,  hot,  swollen,  and red.  In the night,  I couldn't lay on that side. Stayed the same throughout March 8th, until 7pm, became increasingly sore.  My entire arm is aching. The redness and swelling has also increased. I also have a headache started this evening.
severe weakness, dizziness, nausiated lasted 24 hours. I had to stay in bed. I fell to the floor when I tried to stand.
Case number PHEH2013US020873 is a combined initial and follow-up spontaneous report received from a medical assistant and nurse on 04 Oct 2013 and 07 Oct 2013: This report refers to an 18-year-old male patient. He was vaccinated with 0.5 ml of MENVEO (batch number: A12114 and expiry date: 31 Aug 2014) intramuscularly on 30 Sep 2013. On an unknown date after vaccination, he fainted and had to go to the hospital. It was reported that he fainted from the shot, not the vaccine. He was seen by a physician and completely recovered on an unknown date. No further information about seriousness was reported.
Approx. 15 minutes after receiving the booster dose of the Covid-19 vaccine the patient complained of dizziness and light-headedness. Patient was assisted to the cot and seated. vitals were obtained. Patient's skin was cold to touch. Patient was assisted into a supine position. Vitals reassessed, and found improved. Patient reported feeling nauseous. 911 called. Prior to EMS arrival, vitals reassessed. Patient care transferred to EMS.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received- narrative updated.
Red raised itchy area at injection site. On 2/16 ER provider diagnoses cellulitis and gave a course of CEFTIN. Patient seen again in ER on 2/22 for unrelated condition and reaction had almost completely resolved. Cefuroxime 250 mg bid.
Rash started on her neck, causes a pinprick sensation that develops to itching.   Pinprick sensation around eyes as well, but does not develop to itching.  Dry on either side of her chin, not responsing to lotion, cbd oil, natural creams.  Sometimes it lightens up but it comes back.   symptoms have persisted for over a month, patient has been fearful of going to a doctor due to covid, so I advised her to use a teledoc or call her PCP to see about getting oral or topical steroids to treat the rash.
Heavy clotting and menstrual bleeding, cramping, low back pain which started 4/20/21 and has not stopped as of today, 5/17.
After the 15 minute wait, I started to feel funny and was walking around the pharmacy parking lot for another 15 minutes. After that, I decided to go home and on the way home my neck started to get tight, not stiff, tight. I could still breathe but it was hard to take in a deep breath. I turned around and headed to the Hospital. I stayed in the hospital parking lot for about 30 minutes and the symptoms improved as well as my breathing improved but still felt tight in my neck. I went home started driving with plenty of water and was monitoring my breathing., and put on my machine for at least an hour.
Patient's skin was clear prior to vaccination. Within 6 hours of vaccination patient had a full body eczema rash covering abdomen, extremities, and face. No treatment was given by doctor. Parents used anti-inflammatory diet and probiotics to support patient. Rash cleared within 4 weeks.
Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. 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.
Tdap and VARIVAX administered on 11-29-11. Child noticed painful, warm bump back of arm on 11-30-11, worse on 12-1-11. At O.V. area of redness, induration and tenderness. Back of (L) upper arm 3 1/4" x 4". Prescribed KEFLEX x 7 days. Outlined redness. To RTO if increased size.
no adverse event; HCP states that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior.) and NO ADVERSE EVENT (no adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior.).    Concomitant medication details not reported by the reporter. Vial size was reported as 2.5 ml. Vial did not go any temperature excursion. Vial was initially stored in refrigerator on 21-MAR-2023. Treatment details was not reported by the reporter.
Client in to health dept with rash on body, swollen hands, temperature 102 - 105 F.  Rash started one day post vax, turning into whelps two days post vax accompanied by swelling of hands and feet, hands turned purple and began to peel on 02/16/2001 and fingernails on right hand middle finger and index finger came off. 02/20/2001 right side of face and right eye swollen, pt seen in ER where blood was drawn and was WNL, pt treated with a steroid injection and sent home with prednisone, Benadryl and hydrocortisone. No school until 02/26/2001, heart echo done on 02/26/2001 was WNL.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 2nd November 2018, the patient received the 1st dose of SHINGRIX. On 2nd November 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, shivering, pain in arm and swelling arm. On 28th November 2018, the patient experienced shingles. On an unknown date, the outcome of the fever, muscle pain, shivering, pain in arm, swelling arm and shingles were recovered/resolved. It was unknown if the reporter considered the fever, muscle pain, shivering, pain in arm, swelling arm and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the unknown arm. The patient experienced a sore and swollen arm where she received the injection, fever of 103, shivering and muscle aches on the day of vaccination. On 2nd November 2018, the patient's body temperature was recorded as 103 degree F. The symptoms were most severe the first 2 days but took approximately 5 days to resolve. The reporter gave consent to follow up.
mild body ache; feverish; This is a spontaneous report from a Non-contactable Pharmacist. An adult female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left arm at single dose on 31Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. 1st dose gave mild body ache and feverish for 2 days. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The outcome of both events was resolved.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Eczema around the mouth and hands; Hives around the mouth and hands; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands). At the time of the report, ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included mometasone 0.1% ointment and triple antibiotic.
chest tightness; heart rate was very high; fever; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever) in a 38-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     There was no history of COVID-19. There was no history of Myocarditis/pericarditis. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if the patient had experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Pfizer COVID-19 vaccines (All Pfizer COVID-19 vaccines previously). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccines. Concurrent medical conditions included Hypertension, Hypercholesterolemia (high cholesterol) and Drug allergy (sulfa medications.).    On 19-Oct-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023 at 2:00 AM, the patient experienced CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever). At the time of the report, CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Heart rate: high  it has been ranging from 130s-150s bpm.         No concomitant medication was reported. The dosage text was reported as Unknown. The patient woke up this morning at around 2 AM with a really bad fever and the heart rate was very high. It had been ranging from 130s-150s bpm and had not gone down in these last few hours. The patient does not think he had a fever anymore. The patient had received all Pfizer COVID-19 vaccines previously and this was his first Moderna shot. The patient was not sure but says that this was the fifth or sixth dose in the series of COVID-19 vaccines. The patient was not sure if it was anxiety or something else, but his chest does feel tight. At this time as the patient was at the ER waiting to be seen for the increased heart rate. ECG, cardiac test, cardiac enzymes tests were not done. No treatment medication was given to the patient.
Diagnosed with shingles on 1/21/21 at age 38. Started symptoms about 9 days after receiving the second dose of the covid vaccine.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache. This report was non-serious.
Approx (or up to, I don't remember the date) 1 week after vaccination, I began experiencing limited range of motion and pain in my left arm, between the shoulder and elbow. This issue has persisted for over 2 months now. At the time, I was seeing an occupational therapist for a different issue in my right arm (was at end of treatment) and he suspected shoulder impingement possibly due to the vaccine.