chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccination Sequence 1st Dose COVID vaccination: 24-Mar-2021 (Moderna Lot 008B21A) 2nd Dose COVID vaccination: 21-Apr-2021 (Moderna Lot 001C21A) Booster COVID vaccination: 24-Nov-2021 (Moderna Lot 058H21A) Booster COVID vaccination: 21-Oct-2023 (Spikevax 12+ Moderna Lot 3032169) This was the first time I had the shot combined with the flu shot. Same as with the first 3 COVID vaccinations I felt very tired and "flu-ish", had a slight headache and couldn't sleep well, but the first time I did not get nauseous like I did with the first three shots. On the evening of Tu, 24-Oct-2023 (all other symptoms had resided),  I had a sudden onset of pain in my left jaw joint, which still persists today at the time of this report. Chewing still causes significant pain. I am reporting this based on some medical reports I found online earlier today that it could potentially relate to the COVID vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-MAR-2016, the patient was inoculated at a public health facility (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 24-JAN-2017, the patient was treated (by an unspecified health care professional) at a physician office/health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2017, the patient sought subsequent treatment at physician office/health center for ongoing and worsening shingles-related symptoms, which was diagnosed as post-herpetic neuralgia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
A KINRIX was administered to 6 month old patient, KINRIX is indicated for 4 year old to 6 year old. Patient was suppose to receive PEDIARIX instead which recommended for patients age.
Extreme lower back pain and shortness of breath. Breathing exercises for lungs and over the counter acetaminophen for body aches Outcome symptoms still the same.
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a  Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home.  The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
~11:30 pt c/o feeling warm, cheeks flushed, scratchy throat.  b/p 180/89, P 90, Zyrtec given at 11:43 am, Pt continued to appear flushed,  Benadryl given at 12:11 pm. 12:35 pm , patient transported to ED for further observation.
1:00PM 3/3 Freezing (could not get warm), general ill feeling 2:00PM 2 Ibuprofen 4:00PM 2 Tylenol Felt better 5:00-9:00 9:00PM 3/3 Freezing (could not get warm), body aches, teeth ached, 2 Tylenol 8:00AM 3/4 felt absolutely fine just a little tired
Patient reported significant pain at the injection site, loss of motion and decreased range of motion for the entire left arm, fever reached 101.5 degrees. Patient reported that these symptoms began approximately 7 hours after the injection and continued the entire following day (Sunday). Patient said that fever broke Sunday night and range of motion was better Monday. She was able to play tennis on Tuesday but the injection site is still painful.
Client received 1st dose of Moderna on 1/21/21, 2nd dose on 3/1/21 and 3rd was given Pfizer on 8/27/21. Client was monitored for 30 min after Pfizer dose give with no adverse reaction.
Given a Moderna vaccine at 17 years, when 18 years is required age. This is a vaccine administration error, not an adverse event. Patient did not report any side effects other than sore arm at injection site.
swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional.  A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination.  Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  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.
Nausea, fatigue, and headache followed by diarrhea and sleeplessness for 2 days.
recvd vaccine Wed, Sunday mom noticed rash at injection site which spread to generalized body area, becoming itchy with clear drainage from some of the sites where pt had scratched. Tactile fever present on Tuesday 9/26.  Pt was sent home from school on Thursday 9/28 due to rash presented to ED with c/o increased respiratory rate overnight that resolved and continued rash. ED determined  vaccine induced varicella.
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a nine-months old female patient who was vaccinated with third dose of PENTACEL with liquid part DTaP-IPV only and not the powder part lot number not reported via unknown route of and anatomical site of administration on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate reconstitution technique as patient was only given DTap-IPV. Patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
After 10 minutes of receiving shot I felt a cold surge in my left arm and  felt lightheaded. I felt sweaty, weak and faint. The EMTs quickly came to my side and administered my blood pressure and oximeter. When I continued to feel lightheaded they took me to a back room and hooked me up to an EKG with electrodes throughout my body. They retook my blood pressure and told me that my blood pressure had risen to 180/90 earlier! After sitting for a while they took it again and read 160/80. They told me to get it checked again, asked if I need go to ER, Walk-in or doctor. They walked me out to my husband, who was waiting in car. I went home and slept for 11/2 hours. Took my blood pressure the next day 3 times and averaged in the low 120s.
12/24/1999, developed "itchy rash, afebrile. Treated with Benadryl. On 12/31/1999, child had a grand mal seizure, duration unknown. Child did not stop breathing. 911 called and transported to the hospital. No further seizure activity since that date.
Pt woke with L leg pain, later swelling developed from thigh to knee and pt would not walk on L leg.  No localized swelling at the injection site, but swelling distal to that.
Initial misuse report received from health care professional on 23 Aug 2013. It was reported that the patient was administered a dose of Tetanus Toxoid vaccine on an unspecified date, which was expired vaccine. No adverse event was reported. List of documents held by sender: None.
Patient reported that a couple of hours after Prevnar administration, her arm became swollen and red.  She did get an headache, nausea, chills and was sick in bed for 2 days and felt like her body was on fire.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Left arm got a large red splotch a bit smaller than the size of my hand at injection site on Wednesday and got slightly bigger. Lasted 1 day then slowly disappeared on its own.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L039093, expiration date 06-OCT-2017; lot # L046885, expiration date 23-NOV-2017; lot # M006729, expiration date 08-FEB-2018; dose and route were unknown). The vaccines were stored under 5.1 F for 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effects were reported. No PQC was involved. Additional information has been requested.
DOS 10/23/22- 7 year old patient was given Pfizer Bivalent 12+. Patient's parent informed of the vaccine administration error.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL 9 lot # L007560, expiry date 15-JUN-2017. No adverse effects reported. This is one of the three reports received from the same reporter. Additional information has been requested.
aching; sore; feeling sick; fatigue; heaviness on the chest; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), PAIN (sore), MALAISE (feeling sick), FATIGUE (fatigue) and CHEST DISCOMFORT (heaviness on the chest) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (aching), PAIN (sore), MALAISE (feeling sick), FATIGUE (fatigue), CHEST DISCOMFORT (heaviness on the chest) and ARTHRALGIA (joint pain). On 17-Jan-2021, PAIN (aching), PAIN (sore), MALAISE (feeling sick), FATIGUE (fatigue), CHEST DISCOMFORT (heaviness on the chest) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Information has been received from a female consumer referring to her 12 year old niece. Information about medical history, concurrent condition and concomitant medical was unspecified. On 16-FEB-2016 the patient was vaccinated with her first dose of (a suggested 3 dose regimen) a "HPV vaccine". it was unknown if the patient received GARDASIL or GARDASIL 9 (strength, dosage, frequency and route unspecified). On the same day, the patient felt lightheaded and failed in the doctor's office. The patient sought medical attention as she was in physician's office. The patient also hurt her face and mouth and was unconscious for a few seconds. The outcome of the events was unknown. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL(GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758824A and A0758825A.
Starting the night, for a few days, injection site soreness, 104 fever, chills sweats, nausea, muscle soreness. Tinnitus- ear ringing happened a day or two later. It was really loud. Went to see the doctor 17March2021. Saw an audiologist. It could have been inflammation. No treatment plans.
had the vaccination and get shingles/Suspected Vaccination Failure; get shingles; painful; itchy; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccination and get shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: get shingles), pain (Verbatim: painful) and pruritus (Verbatim: itchy). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was a lot easier if you had the shingles vaccination and happened to get shingles anyway.  The reporter further stated that it was way less painful and itchy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
PT COMPLAINED OF DIZZINESS, RACING HEART, AND TIGHTNESS IN CHEST/ CHEST PAIN/ SHORTNESS OF BREATH  WITHIN ABOUT 5 MINUTES AFTER RECEIVING PFIZER VACCINE. I ADMINISTERED EPI-PEN IN RIGHT THIGH AND PT'S BREATHING OPENED UP QUICKLY.   CALLED 911.  PT BEGAN SHAKING AND FEELING VERY DIZZY/WEAK, BUT FULLY COHERENT.  I SAT WITH PT (AND HUSBAND) UNTIL EMS ARRIVED. THEY ASSESSED HER AND TOOK HER TO THE HOSPITAL.  PT WAS COHERENT AND ABLE TO WALK WITH AID UPON LEAVING THE PHARMACY.
Patient states that left arm was sore after shot (later that evening) the soreness spread down his arm and to his hips and shins over the next week and a half. Patient continues to have pain with increasing discomfort. He complains of no other symptoms and has no redness or swelling at the injection. Pt is also taking CRESTOR. Pt struggles to lift arm and is having difficulty walking.
FLUID IN THE HIP AREA BELOW THE SPINE; PAIN IN BOTH LEGS; EXTREME LOWER BACK PAIN; TINGLING IN FEET; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced extreme lower back pain. On 25-MAR-2021, the subject experienced tingling in feet. On 25-MAR-2021, the subject experienced pain in both legs. On 11-APR-2021, the subject experienced fluid in the hip area below the spine. Laboratory data included: Blood test (NR: not provided) No blood clot, CAT scan (NR: not provided) No blood clot but fluid below the spine, and Diagnostic ultrasound (NR: not provided) No blood clot but fluid below the spine. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, was recovering from extreme lower back pain, pain in both legs, and tingling in feet, and the outcome of fluid in the hip area below the spine was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 17-JUN-2014, (in approximately 2014, exact date was not reported) unknown number of patients were inadvertently vaccinated with GARDASIL (lot#, expiration date, dose not reported) that had been improperly stored (since unknown date). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness under left armpit on the second day of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9244), via an unspecified route of administration, in the left arm on 15Feb2021 at 17:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included haemophilia, congenital emphysema, pneumothorax, and allergy to adhesives on foot, all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 at12:00, the patient experienced soreness under left armpit on the second day of the vaccination. It got better, and then got worse on the 7th day following the vaccination. The patient did not receive any treatment for the event. The clinical outcome of soreness under left armpit on the second day of the vaccination was not recovered.
Tenderness in her forehead; Lymph node swelling in the base of her scalp on her right side; Pain in her forehead; Rash; Headache; Muscle pain; Joint pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 15-Feb-2021, the patient experienced TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Pain in her forehead) and RASH (Rash). The patient was treated with NAPROXEN (NAPROSYN E) for Lymph nodes enlarged, at a dose of 200 milligram. On 16-Feb-2021, LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved. On 20-Feb-2021, TENDERNESS (Tenderness in her forehead), HEADACHE (Pain in her forehead) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  It was reported that the treatment received on Monday but it didn't diminished the lymph node symptom.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-JUN-2021 contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
unable to move arm where vaccination was administered. Painful at night time, Throbbing, can't lift while laying down. Hard time putting coat, shirt, etc... on - Painful when putting across stomach, etc...
left underarm painful, center of chest hollow-feeling, leg cramp in right leg, one vertebrae in back of neck at shoulders (maybe C7 or T1) sharp pain comes and goes.