chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT STATES HAD 2ND PFIZER COVID VACCINATION ON 5/27 (CANNOT LOCATE IMMUNIZATION IN REGISTRY ALTHOUGH 1ST DOSE IS SHOWING).    5/31 TO ED WITH SHORTNESS OF BREATH AND FATIGUE.   CARDIAC CATH DONE.  PER PHYSICIAN NOTE:  Takotsubo Cardiomyopathy - dilated cardiomyopathy. LVEF of 25%.  LHC showed nonobstructive CAD only.  Recommend optimized medical therapy per core measures and monitor for 90 days. Discussed with patient and will order lifevest to monitor and protect against SCD. She is agreeable. Re echo 90 day.  If LVEF does not improve, may need to consider ICD implant after 3 months of treatment.
1 week (7 days) after receiving vaccine developed 3" x 2" localized redness/erythema and itching. Has had 5/8" wide bruise since the day after the injection.
began crying @ mid noc would calm for 5 mins 1/2 hr only cont' crying all noc til 630AM; remained fussy all day; t100.6 ax during noc elevated to 102.5 22OCT92; lt thigh warm to touch 22OCT92, no redness or swelling 23OCT92;
arm hurts very bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts very bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts very bad). At the time of the report, PAIN IN EXTREMITY (arm hurts very bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Headache & Fever Narrative:  EMPLOYEE STAYED HOME IN BED MOST OF THE THE DAY FOLLOWING HER VACCINATION  Other Relevant History:
I got moderna COVID19 vaccine on 12/26/2020. Day 1-3 local pain and swelling, no redness. All resolved after day 3-4. Very tired all week post vaccine,.  Day 5-6 noticed ipsilateral axillary lymph node swelling.  On day 7 post vaccine I got a localized area of itching swelling and redness as if I had been bitten by a few mosquitoes at injection site that was new. Milder on day 8, less itchy and swollen, but still red and a little raised.  Mild shortness of breath.
headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Bells Palsy - right sided facial weakness since yesterday afternoon.  B/P - 128/76, Pulse - 80, Temp 97.8.  Prednisone 20mg BID x 7d, Valtrex 500mg TID x 7 days.
sick; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   The patient was treated with VITAMIN D NOS [VITAMIN D NOS (not otherwise specified)], ZINC (ZINC) and a lot of vitamins for Illness.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Fever to 102.7 degrees F and headache overnight after vaccination. By morning she was feeling better and temperature was down to 100.1 degrees F.
Onset of generalized urticaria with severe puritus2 hours after injection. I have been getting them 40 years with no problems. Within 24 hours fever, joint swelling and nausea. I took benedryl and a Medrol dose pack I had for a neck injury in the past. Took the full 5 days and  the symptoms have resolved.
This spontaneous report has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. Information regarding drug reactions, allergies, pertinent medical history and concomitant medications was not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, route of administration, dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. A previous temperature excursion was reported with a temperature of 62F during 17 hours. Subsequently, another recent excursion was reported with a temperature of 35F during 1hour and 14 minutes. The total amount of time of the temperature excursion was 18 hours and 14 minutes. The information of excursion was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information has been requested.
Woke up with sore arm, tachycardia, chest pain, dyspnea
Pt vaccinated on 3/28/2005 in am and then that evening developed joint pain, muscle pain, stiff neck, and headache. No relief with Tylenol.
Rash on left arm from shoulder to elbow. Warm to touch, itchy, painful near injection site. Slight swelling for two days. Took Benadryl and Advil for two days and pain, itch stopped, but redness persisted for one week.
Patients first KINRIX and second PROQUAD, but it is his 5th dtap and 4th polio. Patient began experiencing pain and ithching and swelling of the left arm as well as fever last night around 2 am according to mother. Mother gave child Tylenol for pain and fever. When child came to clinic arm was swollen with no hard lumps and very mild tenderness of the area. gave the child benadryl in clinic, Dr.  gave the child a prescription of ibuprofen and benadryl to take at home, we will follow up with him 1 week and for the meantime gave mother ER precautions.
A report has been received from a Health Professional concerning a child, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced Stomach virus (Preferred Term: Gastroenteritis viral). The patient recovered from the event of Stomach Virus on an unspecified date. The report was considered to be non-serious.
9:00 PM began coughing, sore throat, fatigue, 10:30 PM mild chills, sore throat, 11:00 pm to 12:00 pm severe chills & rigor, profound weakness, nausea, Temperature oral=99.4, by 12:30 am able to sleep.  4 am awoke & felt "normal" 8 am feel "normal" T=99.1.  I am an RN and have never experienced chills and rigor & profound weakness like this with any illness or vaccination.
Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female with no pertinent medical history and no drug reactions/allergies who on 01-SEP-2009 was vaccinated with the first dose of GARDASIL (0.5ml, IM, 662229/1497X). There was no concomitant medication. The patient was 3 weeks pregnant when she was vaccinated. The patient had ultrasound to confirm pregnancy. The estimated due date would be on 21-MAY-2010. At the time of reporting the patient was pregnant. Follow up information has been received from the physician assistant concerning a 19 year old female with no significant past medical history, no concurrent medical conditions and no previous pregnancies who on 01-SEP-2009 was vaccinated with a dose of GARDASIL (lot# 662229/1497X) in her left deltoid. Concomitant therapy include prenatal vitamin daily for pregnancy in September 2009. On 15-OCT-2009 ultrasound was performed to confirm the pregnancy and the result was normal. The patient's LMP was reported as 11-AUG-2009 and the EDD was reported as 21-MAY-2010. No adverse event known. At the time of the report the outcome was unknown. Follow up information has been received from a physician's assistant concerning a 19 year old female who had one previous pregnancy and one full term delivery (40 4/7 weeks from LMP). There was no birth defect and no infant complications in previous pregnancy. On 01-SEP-2009, the patient was vaccinated with the first dose of GARDASIL (lot# 662229/1497X). Concomitant therapy include prenatal vitamin daily for pregnancy on 12-OCT-2009 (also reported as September 2009). On 15-OCT-2009, ultrasound was performed with normal result. On 04-NOV-2009, MSAFP was performed and the result was negative. There was no diagnostic test during pregnancy. During pregnancy, the patient experienced cholestasis and profound anemia. On 11-APR-2010 (reported as 04-NOV-2010) the patient was treated with ferrous sulfate 325 mg 3x1day for anemia. On 26-APR-2010, the patient was treated with BENADRYL Q6H for cholestasis. On 29-APR-2010, the patient was treated with ACTIGALL 300mg 2x1day for cholestasis. On 03-MAY-2010 (37 3/7 weeks from LMP), the patient delivered a female infant (weight 7 lbs, length 51cm, Apgar 8+9, head circumference 35.5cm). The infant was reported to be normal. There were no congenital anomalies. During labor/delivery the patient was inadequately treated for a group B strep bacteria. The patient experienced slow weight gain. At the time of the report, the patient recovered from slow weight gain. The baby's experience has been captured in WAES 0910USA02157B1). No further information is available.
lt arm indented @ site;redness about the size of silver dollar;red dots on inner aspect of upper arm;warmness to such;hardness above the inj site;
mother noted facial "breaking out." No itching/redness. Pt stated she can "feel it."
Case number PHEH2014US002953 is an initial spontaneous report received from a nurse on 10 Feb 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of MENVEO (batch number: A13013, expiry date: Sep 2014) intramuscularly on 07 Feb 2014. On the same day, post vaccination, he experienced swelling, pain, hardness and redness at the injection site. Outcome of the events was reported as condition unchanged at the time of this report. Seriousness and causality of the events was not reported.
Got really sick after 2nd vaccine; Swollen feet and ankles after 2nd vaccine; Malaise for 4-5 days after 2nd vaccine; Upset Stomach for 4-5 days after 2nd vaccine; Flu Like Symptoms for 4-5 days after 2nd vaccine; Pain in the Lymph node for 2 days after 2nd vaccine; Pain on the Injection site for 2 days after 2nd vaccine; Headache for 4-5 days after 2nd vaccine; Fever 101 F for 2 days after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder NOS and Osteoarthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine). In April 2021, PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine) had resolved. At the time of the report, ILLNESS (Got really sick after 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101 F.   No treatment information was provided Concomitant medications included Heart medications and Arthritis medications
Large red circle at injection site - swollen, somewhat itchy, and sore Reaction occurred a little more than a week after the shot.  Pregnant, although unknown at time of shot.  Est. date of delivery is October 17, 2021
I started experiencing breathing difficulties in May, 2021, which increased in severity until, on 06/29/2021, were so bad I had to see a doctor. I went to a clinic, was sent to ER, admitted to hospital, & a large pulmonary embolism was found. A blood thinner (Eliquis) & high blood pressure meds were prescribed. On 07/07/2021, I was transferred to a rehab center to rebuild strength & breathing endurance. I was discharged on 07/27/2021 with supplemental O2 required for any exertion. To date I still require prescribed meds & supplemental O2 for exertion.
Gave patient pfizer dose without diluent.   Patient is fine aware of increase in side effect.   MD aware also.
Mother stated pt had some redness at site of tetanus injection site.  States the same side of his chest appears to have fluid under the skin.  Appointment offered to patient for today but mother states they are not able to come in due to pt having a basketball game.  MD aware.  Complained of swelling underarm and right chest.  The day after pt. received his DT booster in the right deltoid area, he developed redness within a day or so, swelling in the right arm, all symptoms are subsiding.  He has had no weakness or numbness.  He is playing basketball, but cannot recall any specific injury. Neck:  No massses. Right shoulder:  Now, very slight generalized pinkness, proximal humerus.  He has a slightly tender fingertip size, freely moveable subcutaneous mass in the right axilla which probably represents a reactive node.  The chest wall is otherwise clear.  No crepitus. Chest: clear. Probable local reaction to DT. Mild lymphangitis, note no history of cat bite or other injury. I will report the reaction properly to the vaccine registry.  Recheck in a month, sooner if necessary.
10 minutes after receiving covid vaccine, rapid  heart rate, hard to breathe, and metallic taste in mouth. Advised to go to emergency after been checked out by allergist on site. At emergency, was given Pepcid, steroids, IV fluids, Benadryl intravenously. Also, did bloodwork and chest X-ray. After bloodwork came back, doctor felt okay to release me. Over the week, still felt heavy chested and I could not return to work until a week later. The emergency doctor, sent me home with steroids, Pepcid, and Benadryl to take for the next 3 days. I only took the steroids and Pepcid because the Benadryl made me feel so out of it. I also started to get fatigued couple days after with some body aches. On Saturday morning,  I woke up at 4:00 am to vomit. Had an appointment with my PCP that Monday, told me to take Claritin and Albuetrol inhaler.
Information has been received from a registered nurse concerning her 17 year old daughter with a sulfonamide allergy, migraines and "2 months of periods" who on 18-JUL-2007 was vaccinated with a dose of 0.5 ml intramuscularly in the deltoid with Gardasil. Concomitant therapy included ibuprofen, acetaminophen (TYLENOL) and sumatriptan succinate (IMITREX (sumatriptan succinate). On 21-JUL-2007 the patient developed a headache that hurt behind her eyes and on 22-JUL-2007 the patient developed a fever lasting 3 1/2 days. On approximately 25-JUL-2007 the patient developed nausea and dehydration. On 25-JUL-2007 the patient visited her physician where she was given IV saline for dehydration, ketorolac tromethamine (TORADOL) for the headache, 1 GM IV of ceftriaxone sodium (ROCEPHIN), promethazine hydrochloride (PHEERGAN) for nausea, and amoxicillin (+) clavulanate potassium (AUGMENTIN). The physician thought that the patient might also have had a sinus infection. A complete blood count (CBC) and thyroid panel were completed, but the results were not reported. At the time of the report the patient had not recovered from nausea, dehydration, eye pain, headache, and the sinus infection. The physician considered headache, fever, sinus infection, nausea, and dehydration to be other important medical events. Additional information has been requested.
Fever, chills, tachycardia for appx 24 hours and subsequent palpitations
Sore Throat, Headaches, Fever, Fatigue, Aches, Coughing, Hoarseness, Itching, Weakness and Hair Loss.
This spontaneous report as received from a consumer refers to her child, a patient of unknown age and gender with no reported medical history. On 04-SEP-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 1. On 04-NOV-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 2. On 20-FEB-2008 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 3. No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced first dose given on 09-04-2007, second dose on 11/04/2007 and third dose 2/20/2008 (Inappropriate schedule of vaccine administered). Additional information is not expected.
Patient had emesis following J+J vaccine and has been notified he will be flagged for any future potential boosters. Patient verbalized understanding.
Adverse reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction to vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No relevant concomitant medications were reported  No treatment information was provided.   Reporter did not allow further contact
Patient got flu shot 10-13-09.  Presented to local ER 10-14-09 w/symptoms vomiting & dizziness.  Was admitted see discharge summary.  Viral syndrome.
Pt recvd vax & devel flushing following vax w/Hep B vax; No further details were provided;
Patient reported severe swelling, that was abnormal for the typical response, for a few days at the site of injection.
Patient reported to emergency room at local hospital experienceing diarrhea, dry throat, muscle ache & chest pain. Negative findings. Discharged to home with follow up with PCP 8 Nov 02.
PATIENT COMPLAINED OF DIFFICULTY BREATHING 10 MINUTES AFTER VACCINE.  PUT PULSE OXIMETER ON PATIENT - OXYGEN WAS AT 99.  PATIENT SAID THEY ARE HAVING ANXIETY.
Nausea for 24 hours, threw up overnight.  Headache for 24 hours.  Some swollen glands.  Excessive aching around hips.
4-20-16 Left arm, back of arm, VZV site, red, swollen, using cold compresses.
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Apr-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. This was 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y). Subsequently, the patient developed injection site reaction after receiving PNEUMOVAX 23. The patient developed arm swelling, redness and pain. It was unknown if the patient sought medical attention. The patient was not hospitalized. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 92 year old male patient with hypertension, degenerative joint disease, osteoarthritis, peripheral neuropathy, Restless Leg Syndrome, chronic obstructive pulmonary disease, gastrooesophageal reflux disease and allergies to penicillin, aspirin, sulfa and erythromycin and a history of prostate cancer and gastrointestinal bleeding who on 04-FEB-2003 was vaccinated with previous dose of PNEUMOVAX 23 vaccine without problem. Recent dose of PNEUMOVAX 23 was administered in his left arm on 06-JAN-2010. Concomitant therapy included PROTONIX, COMBIVENT and FLOMAX. There were no other vaccines given at the same time. It was reported that there was no serious criteria. At the time of the report, the patient was fully recovered. This is one of several reports received from the same source. No further information is available.