chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patient were vaccinated with improperly stored PEDVAX HIB (lot#, expiration date, dose, frequency, indication, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a roughly 70 year old female patient. Information regarding concurrent conditions and pertinent medical history was not provided. On approximately 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (1 single shot, lot# and route were not provided). Concomitant therapies included "high dose flu shot" which was also administered on the same day as ZOSTAVAX. "About 2 weeks ago", on approximately 23-OCT-2014, "2 days after receiving ZOSTAVAX" the patient presented with a severe localized reaction as well as swelling within her shoulder and neck area which made breathing difficult. The patient also experienced flu-like symptoms. The patient had sought for medical attention. Treatment included prednisone and other unspecified medications (dosages/frequencies/manufacturers unknown) were given for the adverse events. The outcome of the events was not provided. Additional information has been requested.
blood shot spot in her eye; This is spontaneous report from a contactable consumer (Patient). This 65-year-old female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 0.3mL, Formulation: Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the right arm on 09Mar2021 09:30 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient medical history included high blood pressure. Concomitant medication included unspecified high blood pressure medicine, vitamins. On 09Mar2021, the patient reported of blood shot spot in her eye which worsened. The patient got her Pfizer Covid vaccine, she got done with her first shot. Yesterday(09Mar2021) the patient came home and nothing was wrong then at 6:00 in the evening her right eye, initially stated like where she got the shot at, it had blood shot in it, she put some eye drops in it for the redness of the eye.  She clarified she received the vaccine on the right side. She wanted to know what she needs to do about her eye, should she go to the emergency room or see an eye doctor. Patient height may be a little shorter than 5'2." No investigation assessment. Outcome for the event was not resolved.  No follow up attempts are needed. No further information is expected.
Fever seven hours after injection. Fever broke roughly 15 hours after injection. Migraines began 3 days after injection and have persisted through day 6.  They are ongoing.
COVID-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-015004, US-MODERNATX, INC.-MOD-2021-015004, US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015004:Reporter's co-worker case (male patient) US-MODERNATX, INC.-MOD-2021-014845:Reporter's female patient case US-MODERNATX, INC.-MOD-2021-015004:Reporter's co-worker wife case (female patient)
Pt received second dose of moderna. No reaction noted. Pt waited 15 in observation with son. Pt ambulated to parking garage and climbed 3 floors to parking 3. Upon getting to 3rd floor. Pt complained of feeling dizzy to son. Pt was placed on a wheelchair and code green called. Pt was checked by medics. Pt stated the dizziness started after the stairs and was subsiding while sitting. Medics arrived on scene. Vitals WNL pt declined transport to hospital.
Patient woke up on Sunday and could not open her mouth  without pain on her left side. She could not eat without pain.  Her pediatrician told us her lymph node in her neck was very swollen. She is currently taking 400mg of IB Profen every 6 hours until it resolves.
Per Providers office note "Patient had a syncopal episode after her COVID shot in the office today. This occurred within 1 min or less of the shot so it is more likely a vasovagal response that an adverse reaction. She fell forward out of the chair she was seated in and impacted the exam table and floor. She did hit her L brow area resulting in minimal redness. She had LOC for less than 1 minute and experienced minor trembling as she regained consciousness. Her mother, the nurse and I were all present during the episode. She felt well when she left the office. This is an isolated event for her."  Patient was sunburnt, wearing sweatshirt and sweatpants. Mom noted that she had not had anything to drink all day.  Patient was given Ice pack to cool her down as well as Juice. She did not have any Problems with the 1st and 2nd dose of the pfizer covid vaccine, She has not had any problems with any vaccines or blood draws in the past.
NUMBNESS IN LEFT ARM, FACIAL NUMBNESS, TRANSIENT ISCHEMIC ATTACK Narrative: 71 yo male with PMH tobacco dependence, hip pain, RLS, OA, COPD alcohol dep, depression, tension headache, HLP, GERD called triage line on 2/10/2021 to report that felt his equilibrium was off upon waking up on 2/10/2021. Per patient, his L arm and side of his face felt numb. He then took 2 aspirin 325mg and put them under his tongue. His numbness improved. Pt was advised to seek ED at the time of call. No records from local hospital but according to PCP's notes, patient was dx'd with a TIA at the ED. PCP's notes indicated pt's CTA and MRI were negative Pt was treated with clopidogrel daily. of note, patient received his note, patient received his first covid-19 vaccine dose on 1/12/2021 with no complication.
Patient suffered a lacunar infarct 9 days after 2nd Pfizer Covid shot. This required an inpt stay and resulted in blurred vision and an aspiration pneumonia.
NURSE HAD SHINGLES (ZOSTER) VACCINE SPLASHED IN HER EYE.  SHE IS ALSO PREGNANT.  SOME OCULAR IRRITATION ON FOLLOW-UP.  NURSE WANTED TO REPORT ACCIDENTAL EXPOSURE BECAUSE SHE IS PREGNANT.
SUFFERED SERIES OF STROKES BEGINING  ON 11/2/2022, SECOND STROKE ON 12/2/2022, THIRD STROKE 12/4/2022.
pt recv vax JAN96 & 2-3 wk p/vax pt exp a nodule @ the right thigh inj site;
Narrative:  FATIGUE STARTED LATER THE DAY OF THE INJECTION. SHE WENT TO BED EARLY AND WHEN SHE AWOKE THE NEXT MORNING SHE WAS BACK TO NORMAL. Symptoms:  & FATIGUE AND SORENESS AT INJECTION SITE Treatment:
Pt called her PCP for cough and chest pain associated with cough. Her PCP had informed her to go to the ER in view of her symptoms and chest pain. She was tested positive for COVID 19 in the ER and was admitted for further care. She remaind on room air. Not hypoxic. Cough and chest pain has improved significantly. In view of chest pain she had EKG done which was suggestive of A.fib rate controlled with no ST-T changes. Troponin mild elevation likely due to demand ischemia from infection. 2D echo was done.  Her cough has improved and chest pain had resolved she wanted to go home  She stated that since she is not hypoxic and no other on going issues, she insisted on going home. She was not a candidate for steroids or Rx as she is asymptomatic and is on room air.
Patient developed a large red, swollen and painful area around the injection site. The redness, pain and swelling are on the patient's anterior and lateral sides of her arm; approximately 2/3 of the patient's arm is swollen and painful.
Initial information was received from another manufacturer on 11 August 2008.  The initial reporter to this manufacturer was a health care professional.  A female patient received an injection of DPT (manufacturer, lot number, and date not reported).  The patient reported an anaphylactic reaction and a fever of 105 degrees F to the pertussis component of DPT.  No further information was provided.
Presented to ED 9/14 with C/O skin rash, erythema and itching on face and back. Swelling at injection site of varicella-zoster virus immunization that was given the day prior. Was given Rx for cephalexin and told to take BENADRYL (received first doses in ED) and stay home from school next day.
Moderna COVID-19 Vaccine EUA I got the 1st dose of Moderna vaccine in my left arm on 12/30/20 in the morning. I waited the mandated 15 minutes, went home later. i started experiencing pain in the arm. I took 400mg of motrin with lunch and another 400mg with dinner, I felt better and didn't have any issues until 1/17/21. It was a Sunday, I started experiencing pain in my left arm again in the evening. I took motrin 400mg with dinner. The pain continued on 1/19, by 1/20, I couldn't abduct my (L) arm, I couldn't put on my jacket. I took 800mg of motrin to no avail. The only relief was from applying warm compress. On Wednesday, 1/20/21, I took ketorolac 10mg with dinner, I got some relief. I took ketorolac 10mg with breakfast on 1/21 and with dinner. On Friday, 1/22/21, I took 10mg of ketorolac with breakfast, lunch and dinner, that relieved the pain. I got my 2nd dose of Moderna vaccine on 1/26/21 and have not had any problems so far.
had vaccine and still had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had vaccine and still had shingles. It did not prevent it. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in 2015 (reported as "within the last month"), the patient was vaccinated with a dose of ZOSTAVAX, dose: 1 vial (strength, route of administration, lot number and expiry date were not reported). On an unknown date in 2015 (reported as "within the last month"), shortly after receiving the vaccine, the patient experienced shingles like rash. The patient sought medical attention (no details were provided). Product quality complaint (PQC) was not involved. The outcome of shingles like rash was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I was having fatigue, aches and was feeling feverish with a cough. The next day I took a COVID-19 home test and it was positive. I called my health care provider and my husband had been positive three days before and been to the ER. I was given PAXLOVID, and I did get better. But I had loss of appetite, and I did lose a lot of weight. I did test negative after the five days. On March 11th I was not feeling well and was supposed to watch my grandchildren, so I tested and, I was positive. This time around I was achy and other than that I was not too sick.
Headache, Myalgia, Fever, NauseaVomiting, Chills, lethargic Narrative:
This case was reported by a health professional in on 29 September 2007, and represents one out of three cases reported as a cluster. The reporter is also the patient's father. A nine-year-old male patient received an intramuscular deltoid injection of FLUZONE (lot number 02449AA) on 20 September. Within 24 hours of vaccination, the patient experienced redness and swelling at the injection site. The area was approximately two inches in diameter, and was diagnosed by the reporter as cellulitis. The event was treated with antibiotic ointment, and resolved within "two to three days". This reporter also noted similar events in his daughter (2007-03238) and wife (2007-03240).
Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Dizziness and weakness. Onset was sudden 4 hrs go, onset followed Varicella vax given at 0900. Faint feeling.
I got an extremely bad headache, the headache is annoying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown) for influenza. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I got an extremely bad headache, the headache is annoying".  Additional Information: The patient reported that I got an extremely bad headache, the headache was annoying. The patient also was on blood thinner(Eliquis), that blood thinner might be a possible concern. The patient also had a flu shot (Name could be not clarified further hence, suspect captured as Unspecified Flu shot) both of them today. The patient also stated that I had the Booster, the new COVID Booster today, Pfizer Booster (Clarified as COVID-19 Vaccine).The patient had it around, about 3 O' Clock in the afternoon. The patient got an extremely bad headache and thought the pharmacist could had told one of the possible side effect could be the headache. So, the patient had  to go along with that, the headache was annoying but  was reading on the website that, told the pharmacist if one had been taking Blood thinners (Later clarified as Eliquis) and the patient didn't knew to tell him that about being on blood thinner. The patient enquired if the problem was due to taking the Pfizer Booster? And had a flu shot (Name could be not clarified further hence, suspect captured as Unspecified Flu shot) both of them  same day.  No follow-up attempts are possible. No further information is expected.
23MAR99 devel small red, raised rash on face that progressed to both arms & all over back;states stomach feels a little queasy;went to ER MD & given zyrtec;rash lasted 3 days;
CLINIC NURSE ADMINISTERED PFIZER VACCINE ON 11/29/21 THAT HAD A USE BY DATE OF 11/24/21.
Itchy rash, first on arms, then legs, then on chest, stomach, back. Looked like raised dots/pimples rather than widespread general rash. Very itchy. Prescribed prednisone which did not alleviate symptoms. Symptoms ended on their own about 4-8 weeks after onset.  Possibly unrelated, but stools have been soft, unformed, oily and stinky every since. This issue has not resolved.
Uncontrollable shivering, nausea, vomiting, diarrhea
Information has been received from a physician concerning his 20 year old daughter, who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, within a week after receiving the vaccination the patient developed a swollen mass/lymph node under the armpit, on the arm where the vaccination was administered. The physician believed that it could be "axillary mass adenopathy." The patient was seen by her primary doctor and was also going to be seen by a surgeon. An ultrasound was performed (no results provided). At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Patient had a positive COVID PCR test on 9/27/2021 after receiving both COVID vaccine doses
Pt given APAP then backed into a corner & screamed unconsolably for approx 1 hr fell asleep on moms lap for 1-hr-then awoke & screamed unconsolably for 2 more hrs; screaming subsided 1/2 hr p/2nd dose of APAP; no local rxn x/sore arm;
Day after Vaccine- Bilateral Calf Myalgia. Constant ache that increased to muscle spasms, and intermittent shooting pains over the next 2 days.  3rd day after vaccine- Bilateral bicep Myalgia with arm heaviness and tingling.
Body aches; severe headache; Bodytemperature of 102 -105 Fahrenheit; chills; Initial information regarding an unsolicited valid non-serious case was received from a consumer (Reference number- 00335714) and transmitted to Sanofi on 28-Oct-2020.   This case involves a 36 years old male patient who experienced body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 21-Oct-2020, the patient received a dose  of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number not reported) via intramuscular route in the right arm.  On 24-Oct-2020, the patient developed a non-serious body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test results included: Body temperature - On 24-Oct-2020: 102 Fahrenheit ; on 26-Oct-2020: 104 Fahrenheit ; on an unknown date: 105 Fahrenheit   Chest X-ray - On 26-Oct-2020:  (Unknown result)  SARS-CoV-2 test (COVID test)- On 24-Oct-2020: Negative  Final diagnosis was body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills.  The patient was treated with PARACETAMOL (TYLENOL) and IBUPROFEN (IBUPROFEN).  The patient was not recovered from the events at the time of this report.  There will be no information on the batch number for this case.
achy upon waking up on 2/13 (approx 7a).  At laundromat, started to get clammy, and sweaty.  Sat down, and next thing I knew I has fainted (approx 7:45-8a).  Police were called, then First Aid Squad.  Very pale, sweaty and nauseous (threw up 2x).  Went to Hospital.  Was evaluated in the ED for approx 6 hrs, then transferred to a room for overnight observation.
Mom reports baby woke 2hr later fr nap w/fever 103F refusing po, irritable recurrent vomiting, no hoarseness, dypnea, cough, rhinorrhea;
swelling & redness on arm where recv vax;severe arthritic rxn;rash-3 days;fever, h/a, joint pain-began on 27MAR & lasted 2wk;difficult in walking;given Motrin & children APAP for pain;family MD dx rubella vax
Site where injected swelled up to the size of an orange, had 102.7 temp from 2/6/21 till 2/8/21, extreme sweating while freezing, severe headache, body aches to the point I could not walk, nausea/vomiting, shakes, dizziness and lightheadedness along with shortness of breathe. On 2/8/21 fever broke and now extremely cold to touch, temp is at 96.4  continued shakes, shortness of breathe, lightheadedness, dizziness and arm is still swollen( Size of an orange) at the site. 2/9/21 continued adverse effects.
Patient experienced arthralgias and fatigue. No medical treatment was needed. Patient took a sick day off of work to recover.
Had dizziness after first shot on 5/11/2009. My daughter had mild dizziness and headaches on and off after shot but the first week of July she had severe dizziness and nausea. Taken to emergency room for treatment. Treated with antibiotic and antivert. 10 days after this visit, taken back to emergency room with 103 degree temp, severe abdominal pain, dizziness, nausea and vomiting. Also had asthma attack that required rescue inhaler. Had not had asthma attack for over 10 years. Treated at ER  with IV fluids, IV antibiotics, IV pain medications and IV antiemetics. CT of abdomen showed infection of the colon. Sent home on Flagyl, Cipro, Lortab and Phenergan. Had some blood in stool and rectal pain for 3 weeks after this visit. Continues to have dizziness, nausea and left upper quadrant abdominal pain. Has bleeding between periods and fatigue. Prior to the Gardisil shot, my daughter was healthy and had not been in emergency room for over 5 years. She was scheduled for her second shot on 7/13/2009 and we did not get it. 11/3/2009 records from ED visits 7/2 and 7/11/2009.Dc Dx Vertigo, abdominal pain, Colitis Patient presented on 7/2/2009 with c/o's vertigo and dizziness. Tx'd with antivert, medrol dose pak. On 7/11/2009 patient presented with c/o's nausea, vomiting, fever and LUQ abd pain. Tx: IVF, IV ABX, IV Zofran and Dilaudid.
On 13AUG92 pt found choking & gasping in bed white-warm & diaphoretic; taken to ER; fever to 106; poss febrile seizure; pt recvd vax 3AUG92; dx encephalitis unk etiology-suspect HSV;
Patient presented to health department to receive second dose in COVID vaccine series. Informed COVID contract nurse she had received Moderna as her first dose primary series. Was given Moderna by COVID contract nurse for her second dose of the primary series. When completing her vaccine card, COVID nurse noticed she had received Pfizer as her first dose and not Moderna. Patient was made aware of the error. Was monitored for 15 minutes without any reactions or incidences.
CONTACTED AND INFORMED PARENTS OF ISSUE AND GAVE THEM THE OPTION TO REVACCINATE THEIR CHILD.  THEY WERE ALSO CONSULTED TO CONTACT THEIR PEDIATRICIAN.
Noticed bulge on groin area and called doctor's office. Bulge was tender to touch. Took him to pediatrician in morning and was told he had swollen lymph nodes in the area and also in the neck as a result of the vaccine he received. A day later, he said his cheek hurt and it appeared swollen. It got worse the next day and was painful.
Father states child began favoring leg yesterday. Today, child's leg has 3 1/2 x 2 1/4" area of redness, swelling and warmth. MOTRIN given.
Patient presented to Pharmacy on 11/08/ 23 and  requested a FLU shot . We administered FLUAD shot on 11/08/23. Subsequently     when checking database for patient to determine eligibility for COVID booster, We discovered patient had already received  FLUAD  from other pharmacy on 09/07/2023 . Patient did not experience any adverse events.
Difficulty breathing, injections was red with a big bump and a rash formed around it, tiredness, weakness, rash traveled from injection site to shoulders and scalp