chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15min developed double vision and blurry vision; Within 15min developed double vision and blurry vision; patient was immediately nauseated after the vaccines, then became dizzy.; patient was immediately nauseated after the vaccines, then became dizzy.; Information has been received from Food and Drug Administration (FDA) on 04-FEB-2022.  This spontaneous report was received from a consumer and refers to a male patient of unknown age. The patient's current medical condition included attention deficit hyperactivity disorder (ADHD) and allergy to ciprofloxacin hydrochloride (+) dexamethasone (CIPRODEX) ear drops. On 22-NOV-2016, he received influenza vaccine inact split 3v (FLUARIX) and fainted a few hours after while at school and 12 hours after vaccine. Received vaccine as part of a well child visit. He also received annual influenza vaccines prior to that dose. Have not received influenza or any vaccines since 22-NOV-2016 until present round of vaccine. Concomitant therapies included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL).  On 14-JAN-2020 at 15:30, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) first dose, administered intramuscularly into left arm as prophylaxis (strength, lot #, and expiration date were not provided), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), fourth dose, administered intramuscularly into right arm (strength, formulation, lot #, and expiration date were not provided) and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) first dose, administered intramuscularly right arm (strength, formulation, lot #, and expiration date were not provided).  On 14-JAN-2020 15:31, (immediately after vaccines) patient experienced nausea, then became dizzy. On the same date at 15:31 (also reported as within 15 min after vaccination) the patient developed double vision and blurry vision. The outcome of nausea and diplopia was not recovered. The outcome of dizziness and vision blurred was also reported as not recovered/not resolved (reported as not resolved after more than 12 hours later).  The relatedness between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was unknown.  Follow up information has been received on 25-MAR-2022 via telephone call from a licensed vocational nurse. She stated that the physician searched system in the office and was unable to locate any patients for this case. No further information was available.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (a little tenderness in the arm), pruritus (itching), induration (the arm is hard) and erythema (the arm is red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025L20A) for COVID-19 immunization. No medical history reported. On Jan 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 16, 2021, patient experienced pain in extremity (a little tenderness in the arm) and pruritus (itching). On Jan 18, 2021, patient experienced induration (the arm is hard) and erythema (the arm is red). At the time of the report, pain in extremity (a little tenderness in the arm), pruritus (itching), induration (the arm is hard) and erythema (the arm is red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In April 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter.  No treatment medication reported by reporter.  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.
Pt. was extremely weak in his upper and lower extremities. He had a 3 day IVig treatment and was diagnosed with Gillian Barre Syndrome. The event continued to happen over and over. We spent many nights in the hospital. He has since then been diagnosed with chronic Gillian Barre Syndrome aka CIDP. We go to the day medicine clinic 100 miles away every month for an IV treatment. I had no idea I could report this to anyone until last week. I had met someone with a similar scenario.
Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information about Lot/Batch number has been requested.
Around 12 hours post vaccination patient had severe soreness in arm. Woke her up from sleep painful. Around 24 hours patient arm pain was so bad she could not lift her arm. Had fevers (101) chills, lethargy. Today (3 days post imz) symptoms are much better and fever almost gone.
After 45 seconds pt c/o itchy throat "like she was getting hay fever" BENADRYL 25 mg.
Mother called health department on 12/11/2006 because she was worried that the child got a bigger dose of the influenza vaccine.  She states that he came down with a 102 fever on 12/6/2006, which was 2 days after the influenza vaccine was given and 104.5 temperature just under 3 days after the vaccine.  She states that my baby is not the same baby.  The child will only sleep an hour at a time and had been crying hour after hour up until 12/10/06.  She states that he was lethargic, fussy, not eating and constantly crying.  The baby also had a runny nose and slight cough.  Mother treated temperatures with Tylenol and did call the MD.  The MD told client it was a normal reaction from the vaccine.  She states that the client had a period of apnea after given Tylenol.  She states on 12/11/2006 the child had a vomitting episode as well.
No ADR, timing ERROR, 2nd dose given 55 days after 1st  Narrative:  Timing ERROR only
Fever 100 Fahrenheit; Swelling on the injection site; She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever 100 Fahrenheit), VACCINATION SITE SWELLING (Swelling on the injection site) and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y) in a 15-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 19-Oct-2023, the patient experienced PYREXIA (Fever 100 Fahrenheit), VACCINATION SITE SWELLING (Swelling on the injection site) and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y). The patient was treated with PARACETAMOL (TYLENOL) (oral use) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100 Fahrenheit) and VACCINATION SITE SWELLING (Swelling on the injection site) had not resolved and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  It was mentioned that mother gave oral Tylenol and it was working. The fever was still going on. The patient has normal swelling on the injection site.   No treatment information was provided.
I had an odd smell sensation of an electrical burning smell (like that of an electric stove). It happened twice in the 2-3 days after getting the vaccine.
This case was reported by a sales representative via a healthcare professional and described the occurrence of sore arm in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. On or after 24 July 2007, the subject received unspecified dose of HAVRIX (1440 units, unknown). Immediately after vaccination with HAVRIX, the subject experienced sore arm. At the time of reporting the outcome of the event was unspecified. She was concerned that this event may be due to a particular lot number or due to the reformulation of the vaccine. The reporter considered that the event were probably related to the use of HAVRIX. Follow-up information received on 17 September 2007 indicated that the subjects experienced arm soreness immediately after the injection. Subjects noted that, "I can feel that all the way down my arm." It was noted that the pain and soreness at the injection site did not last very long. It was reported that when the subjects left the office they were no longer complaining of soreness at the site or with their arm. It was reported that this event occurred with both the 1st dose of HAVRIX administered to the subject as well as the booster dose. Vaccine was given intramuscularly in an unknown deltoid. Outcome of the events resolved. In the reporter's opinion, the events were related to treatment with HAVRIX. A statement was provided that this event occurred in multiple subjects over a 6 week period. The reporter also noted that she would be interested to see if these complaints decreased when the lot number changed.
Received nasal spray H1N1 vaccine on 10/21. Developed hives 10/26.
Pt received PNEUMOVAX and Influenza shots in left arm. 1 1/2 hr post immunization pt complained of pain and arm stiffness. The next morning family brought her to ER. ER MD says one of the shots too high. Treat with analgesics and ice. Patient called several days later to relate story.
7/19/2022-Presents to ED, c/o weaknessdifficulty ambulating leading to falls.  Had fever of 101.7 at home. Covid + not hypoxic. Ordered Vacno , betelovimab and and ceftriaxone. T: 102.2, HR-100. UTI-coverage with ceftriaxone. Admit SIRS with possible septic acute UTI vs covid.  7/21/2022-No acute resp distress. VSS Afebrile.  7/22/2022-UA positive with E Coli transition to Omnicef for 4 additional days. VSS. Asymptomatic covid. D/C to home.
This spontaneous report as received from a pharmacist refers to a 77 year old female patient with allergy to morphine and ACE inhibitors. The patient's medical history included seizure, chickenpox at age of 5, eczema, congestive heart failure (CHF), aortic femoral bypass (AFRB) and hypertension. On 20-JAN-2011 the patient was vaccinated with a dose of ZOSTAVAX (lot #06972) (0.5 ml in the left arm, route not reported). Concomitant therapies included warfarin, diltiazem hydrochloride, lisinopril and phenytoin. On 21-JUN-2013 (also reported as 3 days ago, on 23-JUN-2013), the patient experienced a severe case of shingles and was hospitalized in June 2013. The patient had a rash (vesicle/papule type) in clusters distributed in the right lower abdomen and in lower back (dermatome T8). On 23-JUN-2013, the patient also experienced pain and rash. It was reported that the patient did not experience a rash at the site of injection post vaccination. On 27-JUN-2013, a sample of VZVIP specimen was obtained from vesicle/papule and scab. The patient sought medical attention at hospital and on 24-JUN-2013 was treated with VALTREX 1000mg, three times a day for 7 days (also reported as concurrent medication). At the time of the report, the patient's outcome was not recovered. This case was considered serious due to hospitalization. Additional information has been requested.
fatigue, body aches, sneezing, scratchy throat. starting on 10/28/21
Low grade fever - 10 hours after vaccine skin sensitivity (not aches) - 10 hours after vaccine   both of these were present in first dose but not until 22 hours after vaccination
65 YEAR OLD MALE PRESENTS TO THE EMERGENCY ROOM COMPLAINING OF COUGH WITH CLEAR PHLEGM AND SHORTNESS OF BREATH ONSET 8 DAYS. HE REPORTS SOME CHEST PAIN WITH COUGH. PATIENT REPORTS HE WENT TO SEE HIS PCP ON 12-DEC AND WAS PRESCRIBED PROVENTIL AND PREDNISONE. HE HAD A NORMAL CHEST X-RAY AT THAT TIME. HE STATES HIS SYMPTOMS WORSENED ON 17-DEC AND HE WAS THEN GIVEN LEVAQUIN. PATIENT REPORTS HIS WIFE TESTED POSITIVE FOR COVID-19 ON 05-DEC, BUT HE TESTED NEGATIVE AT THAT TIME AND HAD NO SYMPTOMS.
4-16-21 STATES PT HAD HEADACHE AND NAUSEA YESTERDAY BUT SSTARTED VOMITING VERY EARLY THIS AM (X4) ABOUT EVERY 90MIN. HAS BEEN TAKING TYLENOL AND FLUIDS.  'FEELS VERY TIRED TODAY'.  NO FEVER. ADVISED TO CALL PC FOR POSSIBLE ANTIEMETIC TO AVOID DEHYDRATION. ADVISED SMALL SIPS OFTEN  - ADVANCE DIET SLOWLY.
Health Services received negative varicella titer on employee. Employee disclosed otezla use on health assessment given to Health Services, however when asked the vaccine screening questions answered "no" to all. She was given varicella vaccine by a nurse on 02/10/20. On 02/12/20 she called to report "really bad" chills as well as fatigue, body aches, and redness and swelling at the injection site that began 02/11/20. She disclosed to this writer that she takes otezla. Writer discussed with Health Medical Director who advised that employee notify her treating provider as well as watch for signs and symptoms of chicken pox.
Immediately after vaccine: tongue tingling and symptoms of panic attack. Anxiety and panic issues every day since the injection. Also, sore arm. Several days later, rash around injection site. Anxiety has still not subsided.
Patient Came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all.  The arm was warm to touch, no fever.  He was sent to the hospital by his doctor for x-ray and bloodwork.  The xray was negative but the bloodwork came back positive for severe infection.  He was given Tramadol and Cipro for treatment.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating profusely/her hair and body are so wet with sweat, she litterly have to change her clothes very often), PERIPHERAL SWELLING (swollen, painful left arm, heavy feeling, red and hurting), PAIN IN EXTREMITY (swollen, painful left arm, heavy feeling, red and hurting), LIMB DISCOMFORT (swollen, painful left arm, heavy feeling, red and hurting) and ERYTHEMA (swollen, painful left arm, heavy feeling, red and hurting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.  No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating profusely/her hair and body are so wet with sweat, she litterly have to change her clothes very often), PERIPHERAL SWELLING (swollen, painful left arm, heavy feeling, red and hurting), PAIN IN EXTREMITY (swollen, painful left arm, heavy feeling, red and hurting), LIMB DISCOMFORT (swollen, painful left arm, heavy feeling, red and hurting) and ERYTHEMA (swollen, painful left arm, heavy feeling, red and hurting). At the time of the report, HYPERHIDROSIS (sweating profusely/her hair and body are so wet with sweat, she litterly have to change her clothes very often), PERIPHERAL SWELLING (swollen, painful left arm, heavy feeling, red and hurting), PAIN IN EXTREMITY (swollen, painful left arm, heavy feeling, red and hurting), LIMB DISCOMFORT (swollen, painful left arm, heavy feeling, red and hurting) and ERYTHEMA (swollen, painful left arm, heavy feeling, red and hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant treatment medication not provided. concomitant medication not provided.
I started experiencing strange visual effects in my right eye, and I went to see emergency eye Dr, who referred me to the eye specialist because they believed I had a hemorrhage in my eye caused by a blood clot. He diagnosed that as CRVO Central Retinal Vein Occlusion. Referred back to my primary care Dr. to check for heart problems or diabetes and hypertension. However no Dr. will recommend that I get the booster shot, due to a risk.
Covid-19 vaccine was given to patient 9 years old. As per parent symptoms are pain in the injection site.
Information has been received from a physician concerning a 30 y/o white female with no relevant medical history who was vaccinated  on 07Oct02 on "7A-3P days" SC in the left upper arm with a first dose of varicella virus vaccine live.  There were no concomitant medications. There was no illness at the time of vaccination.  Subsequently the patient developed a localized rash around the injection site. It was noted that when the pt returned for the second varicella vaccine on 20Dec2002, she stated that she had a "local reaction" which included pain, redness and itching. On 25Sep2002 varicella zoster antibody results were "not immune". It was noted by physician that it was a "very small reaction" but the pt did not want to get the second vaccine in the series. There was no treatment required. Unspecified medical attention was sought.  There was no product quality complaint involved. It was also noted that the rash did go away after a few days and the pt recovered. Follow up information indicated that the pt received a second dose of varicella virus vaccine live "without adverse experience". No further information is expected.
Pain on site of shot and entire shoulders area. Difficult to raise the arm. Followed by Fever of 102.7 F overnight, flu like symptoms, chills and fatigue.
Arm pain, induration, and erythema at injection site 1 inch appeared 8 days after vaccine.
tested positive for Myocarditis; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 13:00 (at the age of 58-year-old) as single dose for covid-19 immunization. Medical history included gastrointestinal (GI) bleed, murmur and high blood pressure. Concomitant medications included metoprolol and lisinopril. The patient previously took penicillin and acetylsalicylic acid (ASPIRIN) and both experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Apr2021 at 12:45 (at the age of 58-year-old) as single dose for covid-19 immunization. Patient ended up in the hospital and tested positive for myocarditis on 08May2021 at 14:00. The adverse event resulted in emergency room/department or urgent care. Treatment received included blood transfusion and antibiotics. Patient hospitalized 5 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 on 09May2021 and was negative. The patient was not pregnant. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Injection was given Wednesday 10/18/23.  Arm was sore 10/19/23.  Late evening 10/20/23  had a chill for 2-3 hours,  hands very cold, headache, runny nose,  congested sinus, very cold hands.  Headache lasted 3 days-took tylenol to lessen it and eventually it went away.  Arm continued to be sore but very light;  then noted on  Saturday 10/21/23 band of pinkness accross my left arm where injection had been given-this was very pronounced and very warm.  This lasted till today 10/24/23
approximately 11 hours after the vaccination was given, I would go from freezing to hot, could not get comfortable in bed, super tired.   the hot to cold went on for almost 24 hours.  When I woke up on the second day after receiving the vaccine, I woke up with a great amount of pressure in my head and a massive headache.  On the 3rd day after the vaccine, I got up and ready for work.  about 45 minutes into work, I was short of breath and light headed.    I did have a positive Covid result on Dec 31 so I still have the antibodies.
I had my vaccination for Dose 3 12/23/2021, I began to feel unwell on 12/25/2021 and went to tested location at Medical Center and tested positive for COVID on 12/26/2021 and you directed for CDC directive for the 5 day and quarantine protocols. Health Department contacted the participant and gave the directives for care and quarantine after receiving the positive COVID diagnosis. Participant is still having chest discomfort and since the COVID diagnosis and this is the lingering effect. Slight methodical type sensation in chest.
Chest pains, loss of conscious, extreme headache  Heart palpitations, facial numbness, bloody nose, rash, bone pain in legs, pain in back that extends to jaw. Major fatigue. Muscle burn in legs, ti fling in feel legs arms and hands. Fever of 102.1
varicella-9 lesions;no fever less than 50 pox on whole body, rash gone in 6 days;
J96.00 ACUTE RESPIRATORY FAILURE 1/10/2023 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2022 CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 5/1/2023 CHF EXACERBATION, UNSPECIFIED
chest pain (pain scale 6-7); sweating; hard breathing; pain in arms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain (pain scale 6-7)), HYPERHIDROSIS (sweating), DYSPNOEA (hard breathing), FATIGUE (fatigue) and PAIN IN EXTREMITY (pain in arms) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022V21A or 02ZVZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced HYPERHIDROSIS (sweating), DYSPNOEA (hard breathing), FATIGUE (fatigue) and PAIN IN EXTREMITY (pain in arms). On an unknown date, the patient experienced CHEST PAIN (chest pain (pain scale 6-7)). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain (pain scale 6-7)), HYPERHIDROSIS (sweating), DYSPNOEA (hard breathing), FATIGUE (fatigue) and PAIN IN EXTREMITY (pain in arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.