chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable pharmacist via Pfizer Sales Representative. A 25-year-old male patient (nurse) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown as did not have this information), via an unspecified route of administration in Dec2020 (reported as received either 17Dec2020 or 18Dec2020) at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. One of the reporter's employees (patient) got the COVID-19 Vaccine. Ended up testing positive for COVID probably due to patient care. Patient was taking care of two to three people who were not positive for COVID while in the hospital, but tests came up as positive. Patient developed symptoms in Dec2020 and tested positive for COVID on 24Dec2020. Patient received COVID-19 Vaccine either 17Dec2020 or 18Dec2020. Began coughing three to four days after vaccination in Dec2020. Rapid test was negative in Dec2020. On 24Dec2020, the M20 test came back as positive for COVID. Only other symptom patient experienced was loss of taste and smell in Dec2020. Had been a stressful situation for the patient. The outcome of the events was unknown.  Information on the Lot/ Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
The patient got dizzy and fainted about 5 minutes after getting the flu shot.  He was fine immediately following the immunization, but after walking out of the room he got lightheaded and passed out.  He was only out for a few seconds, but fell and hit his head.   The patient appeared to be lightheaded and pale after fainting, but was responsive and could answer questions clearly.  The patient got his vitals checked and everything was within normal range.
Increased itching started in May, with no rashes. Muscle spasms, soreness increased. By June into July I started to have facial numbness, and symptoms that correlated as women's symptoms of mini strokes, to which I started autoimmune panels and testing for with my regular doctor in July. By July 18th reactions were so strong 5 minutes to 30 minutes after eating every single time of the mini stroke symptoms, it hit me hard and end up visiting the ER July 18th, 2021, 2pm as in my er visit history. After many ER visits of similar situations, I went through extensive food panel testing for allergies. I came back allergic nearly every single food out of nowhere, and was put on an elimination diet to focus on which allergies were true or not. Two and a half weeks into an elimination diet of wheat and gluten-free, with dairy added just to reduce inflammation, a life threatening anaphylactic severe allergy to Corn exploded. At the same time I was diagnosed with this allergy through food diets and blood testing, I found an allergist who did other extensive autoimmune testing and found out that I now had chronic Urticaria autoimmune, a type of mast cell diagnosis.   Now I have random anaphylactic reactions to everything in life- airborne, contact, and eating. I am severely allergic to corn and nearly all 180 derivatives. I find it unattainable to work in my condition due to no safe work environment and spontaneous need of medical attention. On top of that I'm now allergic to onions, wheat, gluten, tomatoes, strawberries, apples, bananas, pineapples, oats, goat, celery, purple pigmentation, with my original allergy to peanuts and treenuts, any many other foods, and still working on trialing foods IF I can source them corn free.   I also experience random chronic hives, throat pressure, GI symptoms, muscular and bone pain, random anaphylactic reactions with my autoimmune condition that was brought out and exposed in my life after the vaccinations happened.
About 24 hours after Moderna vaccine, patient developed severe rash in the groin/vulvar area that started as blisters and progressed to pustules and cellulitis with severe induration and exudates. The erythema progressed over about 3 weeks and did not respond to outpatient acyclovir and doxycycline. She required hospitalization for IV acyclovir, Zosyn, IV Vancomycin, fluconazole, dermatology consult with punch biopsy (pathology still pending at this time), gynecology consult, infectious disease consult. She had a pelvic CT that was negative for abscess. She is slow to respond to IV acyclovir/broad spectrum antibiotics and fluconazole was just added. She currently remains hospitalized (hospital day 7).
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported.  On 01-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L046897, 0.65 ml, subcutaneous. On 03-JUL-2016, the patient developed itchiness on both arms and bot legs two days after receiving ZOSTAVAX. No treatment was rendered. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention on 27-JUL-2016. Additional information has been requested.
This spontaneous report as received from a License Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently administered VARIVAX, that had been improperly stored (dosage, lot # and route of administration not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
Information has been received from a consumer concerning her mother who was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a small swelling under her jaw and was diagnosed with sarcoma. Unspecified medical attention was sought. It was noted that the pt's experience was still being treated. No further information was provided. Upon internal medical review sarcoma was considered an other important medical event. (OMIC) No further information has been requested.
Headache, intermittent chest tightness, "feeling faint" since vaccination (6/1 to current) Neuro exam normal.  Mild increase in heart rate with orthostatic testing; advised hydration and rest.  History of migraines but previously well controlled without medication; recommend follow up with patient's neurologist.
12JAN98 pt exp flu-like sx;20JAN98 pt exp sz which was dx as a febrile sz;24JAN98 pt devel a herpes zoster on face & mouth;18FEB98 pt exp pain form wearing clothes;23FEB98 exp ear infect;devel rash that itched;sick since vax;
Menstrual cramping, present on both sides of the body. I do not get menstrual cramps since being on the pill.
Pfizer-BioNTech COVID-19 Vaccine EUA headache, swollen L tonsil and L ear ache for 4 days post-vaccine; symptom treatment with Dayquil and Nyquil. resolved without further treatment
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On  11-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Received H1N1 Nasal Mist on 12/24/2009. Red raised itchy rash to chest, stomach, back, chest, ears and scalp developed on 12/26/2009. Took 2-25 mg Benadryl po on 12/28/2009. Itchiness has not become worse.
At first just mild but by 09/23/2011 I could not lift my arm lateral of my body. Pain level was 9. I contacted pharmacy and 13 days later I went to doctor and received a cortisone shot. Pain level went down to 2 within 6 hours. I still feel pain in arm. Level 2 to 3 all the time.
muscle aches and pain; muscle aches and pain; dizziness; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Jan2021, 10:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 20Jan2021 at 21:00, the patient experienced muscle aches and pain, and dizziness. The patient wanted to know if these were common side effects and if she can use TYLENOL after her first vaccination with the PFIZER-BIONTECH COVID-19 VACCINE. The patient has not recovered from the events.   Information on the lot/batch number has been requested.
This unconfirmed, spontaneous report was received from a scientist via a company representative refers to a female patient of unknown age. The company representative heard a news story on television channel. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (dose, frequency, indication and route of vaccination were not reported). On an unknown date, the patient became blind after being vaccinated. The outcome of blindness was unknown. Causality assessment was not provided. Upon internal review, blindness was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected, because contact details were not provided.
Patient states she experienced extreme CNS effects like inability to form words, slurred speech, confusion. On 12/12/17 she was diagnosed with Laryngitis which she attributes to the vaccine.
The patient received  the Moderna covid 19 vaccine on 08/11/21.  From 08/12 to 08/14 she experienced what she described as normal swelling in the arm related to getting an IM vaccine which went away.  Then on 08/18  her arm turned red locally around the vaccination site after it had already been cleared of the initial symptoms.  She received mupirocin ointment from her primary care provider and now claims that it is clearing up.
This spontaneous report as received from a 26 years old female consumer refers to herself. The patient was vaccinated intramuscularly with her first dose of 0.5 ml GARDASIL (lot number not provided) in 2008. No other co-suspects were reported. No concomitant medications were reported. The patient was scheduled to receive her second dose in the near future. The patient explained that any subsequent doses after her next scheduled injection would occur after she had turned 27 years old. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Patient received vaccine on 4/19 Thursday. Patient started getting a bubble or water blister under the eye approximately 24 hours after getting vaccine. Symptoms developed fast. Eyes and mouth/lips became swollen. It hurt to swallow and patient had difficulty swallowing. Patient went to ER administered cortisone shot and given oral BENADRYL with PEPCID. Gradual decrease in swelling. By 4/23 Monday all swelling disappeared. Patient is now fine.
Patient noted severe arm soreness, along with redness down the arm to the elbow. These symptoms have persisted through today (10/6/17) but have slowly decreased in severity. The patient also stated she experiences nausea after receiving the vaccines for a few days.
p/vax pt had 3cmx3cm size area of redness, swelling; firmness; tenderness lt thigh; also mild rash over body mainly on trunk; neck & face; T101.5, rectal
Shingles on right side of upper face; nose, forehead, eyelid, and scalp.  I went to Urgent Care and received medication for Shingles and was referred to my Optometrist for eye exam and eye medications. This was on March 15, 2021.  I returned to my  eye doctor for follow-up on Tuesday, March 23, 2021.
Muffled /decreased hearing in both ears, voices seemed too loud and harsh. Very bad shorteness of breath, vertigo
Soreness in right arm; Fatigue; Stiffness with colder temperatures; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures), VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures) had not resolved and VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  In October 2021, patient had been having stiffness with colder temperatures. She said when she took the flu shot and COVID vaccine at the same time, she had soreness in her right arm and had fatigue.  Reporters causality of events with Rinvoq was no reasonable possibility.  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
Redness, swelling, at injection site 5AM Induration, possibly infected - placed on Keflex.
Chills; Nausea; This case was reported by a physician via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and nausea. On an unknown date, the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the chills and nausea to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The health care professional stated that, after vaccination with 2nd dose of Shingrix, the patient had chills and nausea. No other details were available since this was a friend of MD's patient. for the tolerence of 1st dose refer case US2019201138, reported by same reporter for the same patient.
Vaccine was: Influenza IIV4 (Quadrivalent) 0.5mL (90686) - This was from the visit form from the doctor. 7 hours after receiving the flu vaccine, Patients stomach started feeling weird, she then went to the bathroom and vomited. She vomited 4 times in a row, within two minutes. Then felt better and went back to bed.
Two hours after vaccine, I had pain in the neck at my thyroid gland and what seems to be the lymph glands behind it on the right hand side.  It was tender.  I took tylenol to deal with it.  That pain persisted all the next day on Friday and again took tylenol and ibuprofen to deal with it.  Then Saturday AM I was awaked early with severe throbbing pain in same thyroid/lymph area, it hurt to swallow, turn my head, and the pain was radiating up to my right ear.  I was also having cold sweats.  I managed to get the pain down again with tylenol and ibuprofen.  On Sunday I spiked a temp of 100.8 and was having flu like symptoms, like body aches and more chills.  I got the temp down but my heart rate remained elevated and I found it difficult to catch my breath.  This went on for hours. I eventually had to go to the ER, where my pulse eventually came down.  Nothing like this has ever happened before.  The ER staff could not explain what had happened to me.  At the time of writing this on Tuesday, 5 days after vaccine, I again had a lot of cold sweats this morning and there is still some tenderness in the lymph gland area near above the right side of my thyroid gland, but I am feeling better overall.
The client stated he had soreness at the (right deltoid) and then 2-3 hours later he couldn't lift his arm above his shoulder.
patient in pharmacy today 4/27/2022 for cephalexin 500mg rx for cellulitis at injection site
46 YO LATINO F C/O FEELING AS IF SHE HAS RECEIVED ANESTHESIA. PT STATES THAT SHE FELT AN IMMEDIATE SENSE OF TINGLING IN HER UPPER ARMS AND LEGS FOLLOWED BY FATIGUE,  AND A FEELING SIMILAR TO WITHDRAWAL FROM CAFFINE. SHE DEVELOPED A CONSTANT, DULL 5/10 FRONTAL HEADACHE @3:59 PM. VS @ 3:30  BP 154/87 HR 88 SpO2 97%  REPEAT VS @ 3:48 BP 132/93 HR 88  PT APPEARS TO BE IN MILD DISTRESS WITH MINIMAL SWEATING IN FACIAL AREA. FACE IS SYMMETRICAL WITH NO APPARENT ABNORMALITIES. SPEECH IS "SLOWER THAN NORMAL". BREATHING APPEARS NORMAL. AFTER 10 ADDITIONAL MINUTES OF OBERSERVATION, REHYDRATION, AND FOOD HER SYMPTOMS RESOLVED. PT WAS STABLE ENOUGH TO CONTINUE THERAPY AT HOME. THE PT LEFT THE OBSERVATION SITE IN STABLE CONDITION WITH HER HUSBAND DRIVING. SHE WAS INFORMED TO F/U WITH HER PCP.
Developed redness/swelling/itching at site 6 hours after injection. Worsened overnight and next day, antihistamines improving.
Feeling extremely sluggish and fatigued, headache that won't go away, body aches
First pregnancy, conceived via IVF fresh 5 day embryo transfer. Male fetus. Vaccines received at 17w2d and 19w2d. At 23w6d (04/13/2021)an US at my local doctor's office with Dr. showed an interhemispheric cyst in the fetal brain. At 24w6d (04/20/2021) a fetal MRI and additional US were performed at the Hospital. According to Dr. (neurologist) and Dr's office the tests confirmed the presence of an interhemispheric cyst, as well as a near absent corpus callosum and malformation of cortical development. They advised these issues may result in seizures and moderate to severe developmental issues if we chose to carry the baby to term.
a nickel sized knot at the injection site on left deltoid; sore at the site; the patient was 30 weeks and 5 days pregnant at time of vaccination; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036190, 2020SA036199 and 2020SA036186 (same reporter).  This case involves a 31 year old female patient of unknown age who experienced a nickel sized knot at the injection site on left deltoid (vaccination site mass), sore at the site (vaccination site pain) and reported that the patient was 30 weeks and 5 days pregnant (exposure during pregnancy), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period was 30 week and 5 days.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's previous pregnancy was unknown.  On 06-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE prefilled syringes lot U6518AA and expiry date: 05-Nov-2021 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious nickel sized knot at the injection site on left deltoid (vaccination site mass) and sore at the site (vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that the patient had no redness and bruising.  On an unknown date, the patient had exposure during pregnancy.  Laboratory data was not reported.  Final diagnosis was vaccination site lump and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
10/14/2014 1745:Pt c/o rashes and itchiness on face and hands and confirmed by RN. 1755: Benadryl 50mg/ml IM given. 1900: Pt with diminished itching. 2200: Pt with diminished rashes on face/hands. 10/15/2014 0700: No rashes/redness noted on face/hands.
Bouts of tachycardia and arrhythmia while at rest. HR reaching 125 bpm. Commencing 36 hours post-vaccination, and lasting 78 or so hours post-vaccination. 3 bouts total. Resolved completely (cardiologist follow-up 11/2021 found no lasting damage).
day p/vax pt devel n/v;2JUL had fever of 101 & n/v persisted;presented to ER same day w/fever, chills, n/v & fatigue;hx of 1 episode of dysphagia & joint pain;VS BP was 110/60, t96.2, pulse 62;poss viral synd;
A few hours after vaccinations administered, patient had episode of tonic neck rotation, upper extremity extension and unresponsiveness with skin color change (pallor) lasting less than 1 minute followed by 45-60 min of sleep followed by 1 hr of inconsolable crying.  No treatment administered.