chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anxiety; sore arm; stage 4 liver disease; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (stage 4 liver disease), ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIVER DISORDER (stage 4 liver disease). On an unknown date, the patient experienced ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm). The patient was treated with DULOXETINE for Anxiety, at a dose of 30 milligram twice a day. At the time of the report, LIVER DISORDER (stage 4 liver disease) outcome was unknown and ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: stage 4 liver disease.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not reported.  He had nausea and vomiting after second dose, then it went away like four hours. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.   This case was linked to MOD-2021-624828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Event verbatim and lower level term updated.
18  hours after vaccination woken up with chills .  Temp 100.8, severe body aches,  sore arm, fatigue.  Treatment :  ibuprofen, ice , fluids, sleep.  60% improved  48 hours after vaccine.
patient presented to ED with weakness, dehydration and fall, fever, UTI. Put into observation for IV antibiotics and fluids.
vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2022-580190 (Patient Link).
p/vax pt devel an inj site rxn characterized by redness, warmth & hives;tx w/DPH;
Hospitalization: admitted 8/29/22; discharged 9/4/22. Presentation to the ED: Chest pain, SOB, and HTN. COVID-19 + date: 8/29/22. Treatment: no steroids or COVID prophalyxis was given. Discharge to: home.
Patient tested positive for COVID 4/5/2021.  Pt was asymptomatic, testing performed prior to travel.
hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hives". The event "hives" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information: The patient had autoimmune disorder, had both Pfizer Covid vaccines, last March-April. She had been wanting a booster, but was concerned as she had reaction three days after second vaccine. She broke out in head to toe hives, with some appearing as very large welts, which were hot to touch, which lasted ten-twelve days. She went to urgent care at the time. They did not seem to know much about it. Benadryl was given. Her neurologist was made aware but also, had no recommendations.  Follow-up attempts made; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Vaccine EUA Raised rash around area of injection, itchy. Showed up 6 days after vaccination. Has not spread.
Intense diarrhea, stomach cramps and bloating. nausea, fatigue,  memory loss, incoherent, skin peeling over entire body including face, immobile and labored breathing (over and above her COPD).
FEELING WEAKNESS IN INJECTION ARM; TINGLING IN INJECTION ARM THAT GOES ALL THE WAY DOWN LEFT ARM; FEELS LIKE COULD SLEEP FOR DAYS THAT STARTED TO GET WORSE; BUMP UNDER SKIN ON ARM GOT INJECTION; LEFT ARM PAIN, EVERY DAY IT HAS PROGRESSED AND GOTTEN A LITTLE WORSE, VERY ARM SORE; PAIN AROUND INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. 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: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 18-DEC-2021 12:12 for prophylactic vaccination. No concomitant medications were reported.  On 18-DEC-2021, the patient experienced headache. On 19-DEC-2021, the patient experienced left arm pain, every day it has progressed and gotten a little worse, very arm sore, and pain around injection site. On 20-DEC-2021, the patient experienced feels like could sleep for days that started to get worse, and bump under skin on arm got injection. On 22-DEC-2021, the patient experienced feeling weakness in injection arm, and tingling in injection arm that goes all the way down left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm pain, every day it has progressed and gotten a little worse, very arm sore, bump under skin on arm got injection, feeling weakness in injection arm, tingling in injection arm that goes all the way down left arm, headache, feels like could sleep for days that started to get worse, and pain around injection site. This report was non-serious.
Heart fluttering and racing; Heart fluttering and racing; Itching; 31 weeks  pregnant at the time of vaccination; Facial tingling on right side; lips and tongue still tingle occasionally but duration of tingling is less than 10 mins; This is a spontaneous report from a contactable other healthcare professional via a Pfizer sponsored program . A 34-year-old pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration in left arm on 06Aug2021 10:00 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The Last Menstrual Period was in Dec2020. The gestation period was 31 weeks. The expected due date of the delivery was on 28Sep2021. The patient's medical history included Bell's palsy. The patient had no known allergies. Concomitant medications included VITAMIN D [VITAMIN D NOS], ZINC, prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Aug2021, the patient experienced itching (within 10 minutes of vaccine). On 07Aug2021, the patient experienced heart fluttering and racing (initiation 1 day after, duration about 4 days). On an unspecified date, the patient experienced facial tingling on right side (lips and tongue still tingle occasionally but duration of tingling is less than 10 mins). Therapeutic measures were taken as a result of events and included treatment with claritin. Seriousness of the events were reported as non-serious. The outcome of the event (itching, heart fluttering and racing) was recovered on an unspecified date in Aug2021 and event (facial tingling on right side, lips and tongue still tingle occasionally) was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event heart fluttering and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
I got shingles after the shot/Suspected vaccination failure; I got shingles after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included pain (horrible pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated horrible pain. The patient got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was not clear that horrible pain was occurred before or after the shot so, in worst approach it was considered as current condition not as event.
Day 1 (11/19)- Pain at the injection site in the late hours following vaccination.  Day 2 (11/20)- Pain at the injection site, redness at the injection site (dime size), sharp/intense lymph node pain in left armpit, fever. Alternated 100mg of acetaminophen and 400 mg of ibuprofen from 5pm to midnight. The pain did not subside.  Day 3 (11/21)- Pain at the injection site, redness at the injection site got larger (quarter size), intense achy lymph node pain in left armpit, fever.  Treated with 1000mg of acetaminophen at 5pm and 400mg of ibuprofen at 9pm. Fever did not break until the early hours of 11/22 and the pain did not subside.  Day 4 (11/22)- Pain at the injection site, redness at the injection site even larger (1.5in x 1in), intense achy lymph node pain in left armpit. Treated with 400mg ibuprofen at 8pm. The pain did not subside.
Shivers, fever, body aches, headache. All last about 36 hrs.
Extreme pain in left arm from elbow to neck.  Pain began approximately 3 hours after shot and worsened to the point where I could only sleep sitting up for 4 or 5 nights..  The pain did not totally abate until 3/29.  I called my doctor due to the extreme pain on March 22 for pain reduction suggestions.  He advised alternating Tylenol and ibuprofen which provided some relief.  I had taken both previously but not alternating doses.  I had rotator cuff surgery several years ago and that pain was minimal compared to this pain.
Initial unsolicited report received from a nurse via (other company Pfizer manufacturer number 2015443993) on 21 December 2015. This case involves a (61-year-old) female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, route of administration were not reported) in arm and also received a dose of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (PREVNAR 13) (manufacturer Pfizer, batch number, expiry date, route of administration were not reported) in deltoid on 04 December 2015. Patient has medical history of rheumatoid arthritis. Patient had no vaccine given 4 weeks prior. On 04 December 2015, few hours "the same evening after getting the vaccine" following the vaccination patient experienced shortness of breath and feeling that she cannot get a lot of air. On December 2015, "after two or three days later" patient experienced headache, fatigue and increased joint pain. Patient did not required emergency room or doctors visit. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. Causality was reported as related "yes" for events shortness of breath and unknown for Headache, Fatigue and Increased joint pain. List of documents held by sender: none. Follow-up information received from a physician on 12 January 2016. Patient had received intramuscular dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone) (batch number- UI431AB, expiry date- 06-Jan-2016) in left deltoid and an intramuscular dose of prevenar 13 (batch number- L99271, expiry date- 03-Mar-2017) in right deltoid on 4 December 2015 at 11:55 and 11:56 AM. Patient had no illness at the time of vaccination. Patient had a history of allergy to sulfa (January 2001), allergy to atorvastatin (October 2014), mild renal insufficiency (December 2001), reactive airway disease (October 2008), respiratory problems, wheezing, decreased memory and work. Patient was vaccinated at private physician's office/hospital. On 05 December 2015, one day after vaccination, patient experienced increased joint pain, headache and fatigue. The patient did not require any specific tests and treatments. Patient stated that she was recovering from the events but the symptoms were not totally gone and she said that her lungs were clear.
I contracted the COVID virus after being fully vaccinated. With the symptoms of diarrhea, fever, massive fatigue, coughing and squeezing. I had to get an infusion 07/29/2021.
100.2 temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100.2 temperature) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D32M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PYREXIA (100.2 temperature) and CHILLS (Chills). At the time of the report, PYREXIA (100.2 temperature) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately 15 minutes after shot felt heart racing and pounding and was SOB .  No chest pain or other complaints.  Vitals stable.  Monitored and symptoms resolved with time.  Able to leave without problem.
had blood drawn at the Doctor's office to test for IgG COVID-19 antibodies and tested negative; This is a spontaneous report from a contactable pharmacist reporting on behalf of the patient via a Pfizer-sponsored program. A female (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date (unknown lot number and expiration) and second dose on 17Feb2021 (unknown lot number and expiration), both as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The pharmacist requested information on behalf of her parents who received both doses of COVID vaccine, both got second dose on 17Feb2021, her dad had a finger prick (at local pharmacy) and it came back positive, mom had same finger stick test but mom's was negative. They also both had blood drawn at the doctor's office to test for IgG COVID-19 antibodies and tested negative. The pharmacist further stated, "with my mother when she received second vaccine, she had no symptoms", the pharmacist wanted to know if this would mean a lack of protection/immune response for her mom. The pharmacist requested information on the vaccine coverage or vaccine efficacy in obesity population, and she stated her mom is on prednisone 5mg every day, and held it before vaccination. The pharmacist was concerned her parent negative antibodies test results could be due to a lack of efficacy. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy  and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None.  Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown.    Information about lot/batch number has been requested.
Breakthrough COVID.  Began June 14, 2022. Headache, muscle aches, fatigue, exhaustion chills, cough, shortness of breath, brain fog.  Acute symptoms lasted approx 10 days with ongoing fatigue, exhaustion, poor stamina, some shortness of breath with exertion, brain fog with some decrease going on 22 days since start of virus.
I noticed I was getting a lot of heart palpitations, so I called my doctor. She ordered a halter monitor. It came back normal, but she told me to get a kardia monitor. I took the results in to my doctor and she told me I had bigeminy.
The vaccine refrigerator went out causing a temperature excursion affecting the MMR and IPV vaccines. No adverse effects were reported to us.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE PAIN (Hurts around injection site) and VACCINATION SITE RASH ("Looks like a rash") in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PAIN (Hurts around injection site) and VACCINATION SITE RASH ("Looks like a rash"). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE PAIN (Hurts around injection site) and VACCINATION SITE RASH ("Looks like a rash") had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY-2021 Event details updated.
Pt. developed partial facial paralysis on her left side, around 1-2 weeks after her first COVID-19 vaccine injection.