chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed reaction (noticed at 10:00 am on October 12 by patient).  An approximately 6 cm circular area of localized redness, mild pain, and increased warmth developed around the injection site.  Skin was flat with no hives, no itching, and no areas of abnormal firmness.  Patient was afebrile and denied any other symptoms.  Skin within the reddened area would blanch with fingertip pressure and quickly reperfused.  Pain was reported as a "1" on a 1 to 10 scale, described as aching with no radiation.  No treatment requested by patient or rendered.  Though the evening, no worsening of pain, redness, or development of new signs/symptoms reported by the patient.
1 week after having vaccines, increased temperature greater than 104 degrees causing febrile seizure, no previous history of seizures, second seizure 12-2003, third Nov 2004, no other seizure reported.
Swelling; Bruising and hardness; Tingling; Numbness sensations; Achy and uneasy feeling through the forearm to date; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 00:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient was not taking any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 11Mar2021, the patient experienced left hand ring finger, swelling, bruising, hardness, tingling/numbness sensations. The patient also experienced achy and uneasy feeling through the forearm to-date. The patient had continued swelling and hardness in the area and experienced rapid heart rate. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling, bruising and hardness, tingling, numbness sensations, achy and uneasy feeling through the forearm to-date and rapid heart rate was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling, soreness, hot to touch severe redness (R) arm (deltoid).
Fever (100.6) chills, very bad body aches, fatigue, dizziness  Lasted for about 18 hours. Woke up the next day feeling fine.
On 5/8/21 severe headache, extreme fatigue & (stiff neck (did go away after few days)) reported to Advice Nurse and Spoke to a Doctor. On 5/17 after the symptoms above worsening to include dizziness, shortness of breath, heart palpitations & constant headaches reported to Advice Nurse and video chat with doctor
Information has been received from a pharmacist concerning a 44 year old male with no past medical history who on 29-OCT-2006 was vaccinated IM with a first dose of Pneumovax 23 as part of a church immunization program.  There was no concomitant medications.  On 29-OCT-2006 the patient developed local injection site reactions that progressed over the next 48 hours.  On approximately 29-OCT-2006 the patient developed a 4 and a half inch, round rash at the injection site and the are was swollen and painful.  The patient was going to see his physician on 31-OCT-2006.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Information has been received from a physician concerning a male who on 29-JUN-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 656309/1393F).  Secondary suspect therapy on the same day included a dose of PREVNAR.  On 26-JUL-2007 the patient experienced fever and ear ache.  On 27-JUL-2007 the patient experienced another ear ache and had a fever of 101.8.  On 30-JUL-2007 the patient was diagnosed with coxsackie virus infection.  On 06-AUG-2007 the patient developed hives and was diagnosed with post-vaccination varicella.  On 24-AUG-2007 the patient experienced another ear infection and a fever of 101.  It was reported that no antibiotics were given.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  No further information is expected.
Swelling of lateral upper arm down to the lateral epicondyle, olecranon process.  Erythema, pruritis and heat.  She has no evidence of infection.  Warm to touch, erythematous and localized.  She has mildly excoriated area.  She has localized ecchymosis from scratching. Edema has started to resolve. No pain, no proximal symptoms, no symptoms of fever, no angioedema, no issues with lips, tongue, breathing.
sore arm post injection lasted 2 days. fatigue/grogginess the last of injection resolved next day. on day 7 developed stuffy/running nose and mild cough.
Severe shivering, muscle and joint pain, head ache, fever of 103.4 F
very sore arm, mild aches and pains, chills starting the same day and lasting until the next morning, abated with tylenol
Approx. 30 mins after receiving the flu shot, pt. reported pain and numbness in L arm, fingers, and hand.  Pt also fely VERY dizzy & light headed, to the point of nearly blacking out.  Patient also experienced rapid heart beat. There was no redness or swelling in the area the vaccine was administered. There was some decrease in mobility of L arm, fingers and hand. Pt. suffered extreme pain and soreness in the area around the injection for 6 days. Pt indicated she would take Aleve & come to the CHD for evaluation, but did not come in.
Patient called and said she noticed a raised and red spot that felt feverish the day after the ZOSTAVAX shot. I told her to monitor it and if it gets worse go seek medical attention.
periorbital swelling, facial flushing. Took benadryl 50 mg and swelling improved.
Increased fussiness, nursed x T post shots. 9:55pm called to office limp and difficult to arouse. Sent to ER parents later left ER child's behavior improved not seen by MD.
Pt received pfizer for 2nd dose instead of Moderna. Pt received 1st dose of Moderna.
Shaking, chills, fever, bone joint achiness next morning. All signs and symptoms gone in 24 hours.
Almost 3 months after my 4th vaccine, I was diagnosed with Covid. Mild symptoms lasted about 3 days.
Pt was administered lot EW0151 that had expired 7-31-21.  He had been in ultra cold freezer until a few hours prior to administration.  The Pfizer manufacturer and the state CDC were notified.  The recommendation is that the patient be revaccinated. Pt has been notified and given this information.
I had been traveling and my significant other tested positive upon our return. I then started getting some slight symptoms- it was all very mild- congestions, headache, cough, and a sore throat. I talked with my Doctor and they put me on Paxlovid for treatment and now am feeling pretty normal. I do have a lingering cough. I had started with a home test but then tested with our county health department this past Saturday and all were positive as well.
Information has been received from an office manager concerning a female who "a very long time ago" was vaccinated with a dose of GARDASIL vaccine (yeast) and "that evening felt very strange, had trouble with vision, and just did not feel well". The father of the patient was concerned and the patient contacted doctor for medical attention. Additional information has been requested.
Presented to ED 4/16/21- Patient states she woke up today with blurred vision in her right eye.  This improved over the course of the day but she feels like it is not quite normal. Diagnosed as irritation of right eye and given bacitracin eye ointment. Patient also reported body aches and congestion.  Patient reports her eye never felt better so she saw an ophthalmologist who stated she had a stroke in her right eye. She continues to have a body sensation in her eye from the stroke and her vision is slightly altered. Patient reports there has been no resolution or improvement of symptoms. No prescriptions or other interventions occurred as a result of the ophthalmologist appointment.
Daily headaches; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 13:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy to avocado. The patient did not receive any medication within two weeks of vaccination. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 20:00, the patient experienced daily headaches. The patient did not receive any treatment for event. The clinical outcome of the event daily headaches was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Presented with severe weakness, lower back pain, and inability to ambulate to DCH ED 10/12/08. Hx stroke 1 yr. ago and has had progressive weakness since that time .  Approx. 2 weeks ago she was unable to get up, swallow, and SOB with minimal activity. Seen by neurologist who felt presentation consist with Guillain Barre Syndrome. Influenza vaccine given on 10/01/08 records received 11/17/08-for DOS 10/12-10/20/08-DC DX: Guillain-Barre syndrome. Presented with severe weakness lower back pain, unable to ambulate. PMH: stroke 1 year ago and since that time has had weakness which has been getting progressively worse, 2 weeks ago became suddenly worse to point unable to get up, unable to swallow, shortness of breath with minimal activity. Transferred. 11/24/08-records received for DOS 10/21-10/29/08-DC DX: Guillain Barre. CAD. Diabetes Mellitus Type II, HTN, hypothyroidism. Treated with IVIG.
Case number PHEH2014US014771 is an initial spontaneous report from a nurse received on 21 Jul 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not provided. On an unknown date, the nurse administered MENVEO (batch number: unknown) subcutaneously to a patient instead of intramuscularly. No adverse event reported following this medication error (wrong route of administration).
A few hours after receiving the influenza vaccination, started to experience pain in upper left arm. At physician visit five days after vaccine administration, patient described pain as constant soreness, worse and sharp with movement. Patient stated trouble lifting arm and states arm felt warm. Two episodes of sweating occurred, one four days and the other five days after receiving vaccine. Pain improved with lifting and stretching. Denies neck, check, or jaw pain, nausea, or palpitations.
Initial and follow-up information has been received from a certified medical assistant concerning a mother who reported her 16 year old daughter with no pertinent medical history, who on 05-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included ADVIL and CLARITIN. Subsequently the patient developed an injection site reaction. She developed a red "knot" on her deltoid arm, "not even big as a penny". Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient's recovered from the red "knot". It was reported that the patient had no reaction to the first injection and that the third dose will be given in the future. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a certified medical assistant concerning a mother who reported her 16 year old daughter with no pertinent medical history, who on 05-JUN-2007 was vaccinated IM with a second dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included ADVIL and CLARITIN. Subsequently the patient developed an injection site reaction. She developed a red "knot" on her deltoid arm, "not even big as a penny". Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient's recovered from the red "knot". It was reported that the patient had no reaction to the first injection and that the third dose will be given in the future. On approximately 19-JUN-2007 the patient developed a rash all over the body. The patient was examined by a dermatologist. The dermatologist reported that the rash was not related to the GARDASIL but viral in origin. At the time of the report, the outcome of the rash all over her body was unknown. Additional information is not expected.
Vaccinated 11/15/03 for Varicella. Had Varicella 10/06/04. I.e. Disease despite vaccination.
SINUS CONGESTION; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE; This spontaneous report received from a patient concerned a 52 year old white 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 had no daily medications or medical conditions. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1821287, and expiry: unknown) dose was not reported, 1 total administered on 21-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, patient developed some symptoms, in the evening patient experienced scratchy throat and sinus pressure (Confirmed covid-19 infection). On 11-SEP-2021, the patient tested positive for Covid-19 (Confirmed clinical vaccination failure), Laboratory data included:COVID-19 PCR test (NR: not provided) positive. On same day, she experienced fever, Laboratory data included: Body temperature (NR: not provided) over 100.4 degrees Fahrenheit and recovered on (Tuesday) 14-SEP-2021. On unspecified date, the patient experienced a little bit of a cough, a bad headache, loss of taste and smell. The patient stated that her overall condition was improving and was feeling okay, but other than feeling tired and a little bit of sinus congestion, also the smell hasn't came back and the taste came back slowly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus pressure, had not recovered from confirmed covid-19 infection, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194180.; Sender's Comments: V0: 20210940995-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Muscle aches 9:00 am. Dizziness 1:00 pm. Fatigue 9:00 am. Sore throat 4:00 pm.
Had the original vaccine / After / gave me 1st of 2 part new vaccine, got shingles; rib cage pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received original vaccine on an unknown date and got awful case of shingles 5 years later).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and rib pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the shingles was unknown and the outcome of the rib pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rib pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of 2 parts new vaccine and got shingles almost right away. The patient still has rib cage pain occasionally. The patient was not going to take 2nd dose in series.
fever; severe body aches; fatigue; This is a spontaneous report from a contactable Other Health Care Professional (HCP) (Patient) via in response to HCP follow-up letter sent in cross reference case. A 53-year-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via intramuscular route of administration at left arm on 29Jan2021 13:00 (at the age of 53-year-old) (Lot Number: EJ1685) as single dose for COVID-19 immunisation. Patient Medical history included HBP (hypertension) and concomitant medication included hydrochlorothiazide with a daily dose of 12.5 mg for (HBP) hypertension. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration at left arm (at the age of 53-year-old) on 08Jan2021 08:15 (Lot number: EJ1685) for COVID-19 immunization and experienced headache, myalgia, chills, pyrexia and fatigue on 08Jan2021 at 12:00. On 29Jan2021 13:00, the patient received 2nd dose of vaccine and symptoms started around 30Jan2021, 03:00 (AM) early and developed severe body aches, fatigue, 100-100.2 fever which lasted until 02Feb2021. Fatigue lasted until 03Feb2021. Then all symptoms subside. The patient underwent lab tests and procedures which included body temperature: 100 - 102.2 on 30Jan2021. Patient did not visit the emergency room or physician office for the events. Patient was not admitted in the hospital and did not received any treatment for the events. Patient was not deceased. Outcome of fever and severe body aches recovered on 02Feb2021 and fatigue recovered on 03Feb2021.  Follow-up attempts completed. No further information expected.
This study case was received from the investigator in a trial on 27 November 2013. A 29 year-old male subject had received on 13 November 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Typhoid (lot number, route, site and date of administration not reported) and three days later, experienced shortness of breath, dry cough and was diagnosed with possible myopericarditis. On 20 November 2013, the subject had a normal Troponin and an abnormal ECG that showed a first degree atrioventricular (AV) heart block. The subject was referred appropriately. No treatments were received. No further information was available at the time of the report. The subject's outcome was still present (not recovered). According to the investigator, the event of possible myopericarditis was considered mild, an other important event and possibly related to vaccination. Documents held by sender: none.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for 13 days before the administration. There were no adverse reactions reported after the administration. Pfizer has provided temperature excursion data to determine that the vaccine was still viable.
feeling down; Initial information received on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case is linked to case 2022SA120789(CLUSTER).  This case involves 63 years old female patient who experienced feeling down after receiving COVID-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer, and COVID-19 vaccine not produced by Sanofi Pasteur (strength, form, dosage, frequency, lot number and expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was feeling down (depressed mood) (unknown latency) following the administration of vaccines.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Around 8:15/8:30p on 10/1/21  first 3 bumps seen on arm 6a 3 on leg and just kept coming, 10/2/21 3 bumps on stomach  and upper back, around noon had fever 100.9, slept for 20 hours between noon and Sunday evening, 10/3/21  found 3 more on lower back and 3 on face, 10/4/21 7 new ones just on hands, 10/5/21 6a found 3 on face 1 on neck, 1 on right upper arm.
Patient received flu shot around 8:30 this morning.  This afternoon around 4:00pm after awakening from a nap she noticed a rash on face and stomach.  Patient has never had the flu shot before.  Advised to take benadryl and if it does not get better to visit the ED ASAP.  Advised of symptoms of servere allergic reaction.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 09-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient called pharmacy 12-10-11 to report muscle and joint pain that started on day after vaccination and has continued since then.
adverse events- constant and consistent pain every day, difficulty sleeping, wakes me up several times a night, low range of motion treatment - doctor visits, physical therapy, acupuncture, massage, ice, heat, rest outcome - no change
Additional information received on 03-NOV-2003 provided patient demographics, product details, concomitant product details, and outcome (recovered). Information regarding Prevnar (penumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a two year old male who experienced a large scar at the site of Prevnar administration. The patient experienced vaccination site reaction (injection site reaction) and injection site scar (injection site scar) on 26-OCT-2002. No additional information was available at the time of this report.