chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Died the next day; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died the next day) 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.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on December 2021 The patient died in December 2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided. No treatment medications were reported.  The patient took the booster shot about 4 days ago and died the next day. The paramedics found the patient sitting upright dead with an oxygen mask on. This fatal spontaneous case concerns an unknown year-old, patient with no medical history  who experienced the unexpected fatal events of DEATH The event occurred unknown days after third dose of Moderna Covid 19 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed.    The rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an unknown year-old, patient with no medical history  who experienced the unexpected fatal events of DEATH The event occurred unknown days after third dose of Moderna Covid 19 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed.    The rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable other HCP (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021) (reported as COVID Vaccine), intramuscular in right deltoid on 18Dec2020 at single dose for covid-19 immunization. Medical history included had a fever on Monday and took Tylenol Cold and Flu (lot number: SHA101, Expiry Date: Jun2024) as the treatment; had an intra uterine device. There were no concomitant medications. Patient was a frontline health worker (a CNA, Certified Nursing Assistant) and received a vaccine yesterday (as of 19Dec2020) and since then she lost taste and smell, patient was not sure if this is due to the vaccination or if its due she had a fever on Monday and broke and was unknown if it's okay to get the vaccine, patient was not sure if it's like a bacterial infection or related to the vaccine. She still doesn't have taste and smell but its really congestion. The outcome of events was not recovered.
Pt called on 9/13/21 to let us know; that two days after receiving vaccine; she developed pain; redness; swelling and itching at the site of the vaccination.
Very painful injection site immediately following vaccine administration, hot/cold chills starting 10 hours after administration, extremely sore shoulder, chills for next 24 hours and excessive swollen bump on shoulder (3 inch bump) from 24 hours after receiving vaccine and still that swollen 72 hours later. Bump is extremely hot to the touch despite ice packs and heat.  Fatigued and headache for three days now.   Wrist on same arm is painful to bend on third day and slightly swollen.  I have been taking 2 200mg ibprofen every 8 hours since vaccine was received.
Hives all over body for 4+ weeks no relief from medications, antihistamines and steroids. flare ups worse at night. Hives extremely itchy burning stinging.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills. On 19th March 2018, the outcome of the injection site tenderness was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient was in her mid sixties and reported the presentation of all symptoms. At 15:30, the patient received SHINGRIX on the left arm. The patient experienced very red left arm and swollen at the injection site, which was hot to touch and tender. The arthritis flare up was in the joints of her fingers. The patient described it as similar to the reaction to an insect sting. The tenderness subsided after the 4 days but the swelling and itchiness lasted over 3 weeks before it resolved. The patient refused to provide the demographics or date of birth.
Within 30 minutes after the shot, my daughter had a headache and sore arm.  Other than that she was fine until midnight on Monday  morning  when her tremors increased and spread up from her legs to her torso and arms.  The tremors persisted all day Monday even through her cranio-sacral therapy at Medical Center.  Her therapist tried to calm down the tremors through frequency specific micro current with no success.  Her therapist could tell that her whole system was in "overdrive" which was vastly different than her previous session a week ago.  The tremors were so bad that my daughter wanted her wheel chair again.    I took a video of her tremors after her therapy session. Her therapist told us to contact her DO, Dr. about it.  I did.  She was able to crash around 10pm on Monday.  On Tuesday, when she woke up around 2:30pm, she still had the tremors but they weren't as severe.  We had a telehealth appt with her sleep neurologist, Dr. at 3pm and showed her the video but she doesn't recall ever seeing her tremors in the past.    When I spoke to Dr., I shared the video and she was going to discuss it with  the  therapist as they know each other.   My daughter's tremors have never been this bad.  She had one  major tremor episode in her legs  only over 2 years ago which we attributed to her meds at the time; but again, not this bad ever.
a patient who received a dose of V ARlVAX after the product was improperly stored; no adverse event; This spontaneous report was received from a unspecified reporter and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T006347 with expiration date on 20-FEB-2022, 1 dosage form (route of administration was not reported) for prophylaxis. Digital data logger was involved. The vaccine underwent the temperature excursion of -6.6 degrees Celsius or 59 minutes. No adverse events were reported.
I felt like I had a bad cold, I had a dry cough, nasal congestion. I always have complications when I get sick because of asthma, I was short of breath. I called the afterhours doctor's line. I was prescribed the PAXLOVID and started taking it immediately. Although my symptoms were not that bad, and symptoms went away as I was taking the PAXLOVID. The symptoms came back a few days after the PAXLOVID ended and I tested positive for COVID-19 again. This time my symptoms were stronger, it took another 14 days for me to get over those symptoms. I still have a lingering cough and fatigue. My leg was not healing during this time, I had to be put on prednisone and the doctor switched my antibiotics. I am now COVID-19 free but my stamina has not come back, my pulmonary function is down. My leg still has not completely healed.
Information has been received from a pharmacist concerning an approximately 58 year old patient who was vaccinated with a dose of PNEUMOVAX (lot# 661831/0310Y). Subsequently the patient experienced cellulitis at the injection site. At the time of reporting, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jun-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On 22-Jun-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 29.68 years. Concomitant products were not provided. On 27-May-2021, the vaccine with batch number 008C21A was moved to fridge. On 22-Jun-2021, four vials were moved to the clinic. On the same day, at 08 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Jun-2021. It was reported that the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Myalgia, Arthralgia, Fever, Chills,101.2, fatigue Narrative:
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number not reported) dose, start therapy date were not reported 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 subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
PCR test positive for COVID-19 but no signs of COVID-19; PCR test positive for COVID-19 but no signs of COVID-19; This is a spontaneous report from a contactable physician reporting for himself. A 70-year-old male patient received the 1st  dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 17Dec2020 at 09:00 AM, at single dose, for Covid-19 immunisation. Medical history included hypertension, high cholesterol, benign prostatic hyperplasia, drug allergy and food allergy all from unknown date and unknown if ongoing. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient received unknown medications within 2 weeks of vaccination. Historical vaccine included typhoid vaccine (unknown trade name) on unknown date and the patient experienced drug allergy. The day after vaccination with bnt162b2, on 18Dec2020 at 04:00 PM, the patient experienced PCR test positive for COVID-19 but no signs of COVID-19. The patient did not receive any treatment as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included: COVID-19 PCR test positive (18Dec2020), nasal swab positive (18Dec2020). Outcome of the event was unknown.  The information on the 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 PCR test positive  and suspected lack of efficacy due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  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.
Pfizer-BioNtech COVID-19 Vaccine EUA symptoms time total @48 hours: mild nauseau throughout; overnight fever, gone by morning; headache, 24 hours after injection, severe at times, lasting about 24 hours.  No treatment sought.
Received DTaP, MMR on 9/24. Came to office on 9/26 c/o (L) arm a immune site red/swollen 8x6.5 cm redness (L) upper arm. MD ? reaction to DTaP.
Shortly after the vaccine was administered (pneumococcal 23 lot number J005067), the patient experienced a sharp ache throughout her back and up and down her entire arm. She is using Tylenol alternating with aspirin to control the extreme pain which is still lingering 4 days later. She also states she has a "dead arm" in which she can barely lift and move. She is now questioning whether she will need therapy to rehabilitate.
heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021.  An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack
Case number PHEH2011US008706 is an initial spontaneous report received from a physician on 02 Nov 2011: This report refers to a female child. She was given only the CYW-135 liquid component of MENVEO (batch number: unknown) intramuscularly on 28 Oct 2011. This was the second booster dose. No adverse event was reported following this medication error.
Mom called approx 1 1/2 hrs following immun reporting "nasty rxn" child c/o headache,being cold & vomiting. Recvd APAP q4h & liquids.
I had no reaction until the day after the shot, when a rash broke out on my chin. The following day the rash has spread to include my whole face. It's small red spots that itch and burn a little
AS MY CERTIFIED IMMUNIZING TECH WAS ADMINISTERING THE VACCINE, THE PATIENT'S HEAD LOLLED TO THE SIDE (SYNCOPE). IMMUNIZING TECH STUCK HER ARM OUT TO KEEP PT FROM FALLING FROM CHAIR AND HE REGAINED CONSCIOUSNESS ALMOST IMMEDIATELY (LESS THAN 1 SECOND). PT SAID HE FELT DIZZY AND WE HAD HIM STAY IN CHAIR WITH HIS HEAD BETWEEN HIS KNEES, TAKING DEEP BREATHS.  HE WAS WITH HIS MOTHER, WHO SAID HE HAD DONE THIS BEFORE AND SHE DID NOT SEEM ALARMED.
This is a spontaneous report from a Pfizer sponsored program "IBCC (Inbound Call Center for HCPs)" from a contactable pharmacist. A 18 year old male patient received the first dose of TRUMENBA on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the first shot of meningococcal group b rlp2086, the patient became ill. It was also reported that the second shot was pushed back due to the illness. At time of this report, the second dose was not received. The patient recovered from malaise on an unspecified date. The event adverse event, malaise, was classified as serious (medically significant) and assessed as unrelated to meningococcal group b rlp2086.; Sender's Comments: The company agrees with the assessment of the investigator and does not attribute the case to study therapy based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the event.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported.    On 07-Jan-2021 at 11:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 70.97 years.  On 05-Jan-2021, the vaccines were moved to fridge. On 06-Jan-2021, three vials were moved to clinic. On the same day at 03 PM, the vials underwent temperature excursion with temperature 35 degrees Fahrenheit. On 07-Jan-2021, six vials were moved to clinic. On the same day between 09 AM to 10 AM, the vials underwent temperature excursion with temperature 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 27-Jan-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Severe balance issues, dizziness, nausea, "spinning" at the time. I did not think about it being related to flu vaccine. However, it happened every October, for several years.
Pt. states that after receiving the 1st dose of Phizer 08/02/2021, started experiencing symptoms 08/05/2021 of rash, itching, hives, and swelling of the face/eyelids. ER visit 08/05/2021 prescribed Prednisone, Benadryl, and Famotidine.  Symptoms subsiding.
runny nose , post nasal drip, sore throat.   referred patient to urgent care for sx and possible covid test
After receiving the 1st vaccine, I was very ill for 3 days but then got better. (fever,h/ache, etc) I was in bed for 3 days.. I'm not reporting to you becasue Of that. I knew that might be a possibility and after 3 days I was better. Well, Everything got better except for one thing.  I cannot tell you the exact day or time that I felt it however, I developed chest tightness from the vaccine. I have never been asthmatic but the feeling of restricted airway and chest tightness after the first vaccine last a few weeks. It was an awful feeling. Walking up steps was challenging. I felt like I was lightly wheezing. It was audible. It went away a few days before I received my second vaccine. After the 2nd vaccine I again was bedbound for 2 days.. and partially on the 3rd one. Then I was better but the chest tightness came back. This time It lasted for a few months before mostly all subsiding. (Maybe 98 percent gone)  To be honest.. I am terrified to get the booster even though I fully support being vaccinated. I wonder If it was the Moderna vaccine.. maybe If I took the Pfizer vaccine booster I would not have the same issues. I'm scared to find out.I did not folow up with a doctor. I assumed as an EUA we take the risk when we sign for consent.
Tested NAAT positive for COVID 10/16/21 after being fully vaccinated.