chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fourth toe on her left foot is swollen and red; redness of her toes on her left foot; pain on her toes on her left foot; swelling of her toes on her left foot; toe is red and swollen/Left big toe swollen and red; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 08Apr2021 (at the age of 59 years old) (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Medical history included ongoing hypothyroidism. The patient's concomitant medications included Synthroid for hypothyroidism (has been taking the medication for about a decade). Patient was scheduled for the second Pfizer Covid 19 Vaccine on 29Apr2021. On 12Apr2021, our days after the first vaccine, the caller experienced redness, pain & swelling of her toes on her left foot. She reported she had developed a side effect of the Pfizer COVID Vaccine, she was supposed to have her 2nd shot today (date of reporting) but, put it off due to her experience. She reported her left big toe was red and swollen (at night). She also noticed her fourth toe on her left foot was red and swollen. She read on the CDC website that this is a documented side effect of the vaccine, she knew its related to blood inflammation connected to the vaccine. She said she needed to contact her doctor because she was not sure she should get her next shot. She was not sure she should get the next shot due her toes being red and swollen. Her event happened 5 days after her shot. 08Apr2021 was when she got the shot. No events required a visit to emergency room or physician Office. She had not had any treatment yet. She was going to call her doctor today. She got the COVID Test before getting her shot and the result was negative. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Apr2021. She received no treatment for any of the events. The outcome of redness of her toes on her left foot, pain on her toes on her left foot, swelling of her toes on her left foot, fourth toe on her left foot is swollen and red was unknown and toe is red and swollen/Left big toe swollen and red was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
diaphoretic, mildy sob and felt like he was going to pass out  Narrative:  RRT called to the scene. dx/ suspect vasovagal event per RRT.
Soreness at injection site (mild) and Fever 99.7 started about 6 hours after injection.  Still feverish at bedtime,  No fever next morning
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, unknown race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-AUG-2021, the patient had just come back from the doctor and the doctor had drawn the patient's blood to see where the patient's antibodies level was to see if the patient needed a booster. The patient's IgG (Immunoglobulin G), and IgM (Immunoglobulin M) were both negative. When the patient told the doctor that the patient received the Johnson and Johnson vaccine, the doctor said that he was prohibited from giving the patient a booster and that they had to wait to see what the CDC (Centers for Disease Control and Prevention) said. The patient asked about getting another brand of vaccine and the doctor said said that he would have done it, but he needed orders from a Johnson and Johnson doctor sent to him. The patient did not know how to get that. The patient stated that he was walking around without any immunity and he was told that the protection would last 8 months. The patient was planning to get a vaccine in November again, but without any antibodies, the patient felt that he needed a vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000190615.; Sender's Comments: V0: 20210846539-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
2 weeks post vaccine, 11/18/2021 hives, itching, hives all over my body and I started getting stomach pains. I went to several doctors and they did a lot of test. And an allergy test. The doctor said it was a probably a Moderna reaction or the theanine medication. They did not know. 01/10/2022 I have not recovered from the hives, they are still all over my body. The stomach pain resolved after a week. I was prescribed Zyrtec.
Following vax, the pt experienced sleepiness and a red injection site. The pt was treated with Tylenol. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl and monitored for 30 minutes and was better after administration of the benadryl
Initial complaint:  feeling lightheaded, couldn't see, diaphoretic, pale  12:10  BP 60 systolic   HR 64  Patient diaphoretic, "can't see".  Ice pack, granola bar and water provided.  12:15  BP 56 systolic    Second ice pack provided.  Reports "feel better"  Noted having  ringing in right ear 12:20  BP 98/42  HR 60  only complaint is  the ringing in his right ear.   Still Pale 12:25  Color improved.  Skin warm and dry.  Alert, continues to have ringing in ear.  2nd granola bar offered and encouraged to drink the water 12:30  BP 100/52  HR 64  Right ear "barely ringing" 12:35  BP 104/62  HR 68.  Reports ear ringing "gone" 12:40  Discharged with parent.  Instructed to inform vaccinator of incident when he comes in for his second vaccine  5/11  Unable to reach for follow up
Given varicella in Right arm. 9 days later arm has 2x2 red, hot, hard area with a "little bump" where needle pierced the skin. Complained of pain when moving arm also complained of itching in area.
I had my second dose on 02-21-21. On March 6, 2021, I started getting palpitations and I was not doing any physical exercises. I started to feel my heart race, my heartbeat was over 100. I took my blood pressure, and it was also high. I called my insurance company provider and she told me to be on safe side for me to go to the ER. I did not want to go at first but then my symptoms started to get worse and about noon time on my daughter took me to ER. They kept me for 25 hours or so at the ER. They did a lot of testing and sure enough my blood pressure and heart rate were really high then they sent me home the next day. On that Sunday 03-07-2021, it was the two week mark that I had rec my second vaccine. At the ER they told me there was no correlation with the vaccine. I also got a nuclear exam study. When I went to see my cardiologist, he said there is a possibility there was a correlation with the vaccine and my symptoms. I took my medications prescribed and I started to feel better after 4-5 days.
Headache, Body aches, fever, diarrhea for 3 days no energy and sleepless nights
I have received all of the HPV vaccines. HPV 1_ 08/06/2007 HPV 2_ 10/08/2007 HPV 3_ 05/05/2008
severe local rxn to lt forearm w/erythema & pain from deltoid to elbow;tx included DPH & heat packs;
Cellulitis left arm, extreme swelling left arm and fever of 100.4. Discomfort lasted approximately 1 week. Note: reported 10/10/02 to us.
Jittery feeling and feels like heart palpitations and slight pressure/tightness in chest area. Thyroid levels were checked and were normal. EKG normal. I have had open heart surgery in 1990 for Wolff-Parkinson White syndrome (WPW). Was corrected with surgery but get EKGs yearly. Currently wearing holter monitor and scheduled for echocardiogram next month. Symptoms have been consistent all day since the shot.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 15-year-old, adolescent patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804101 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Mod info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a adult patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site reaction, injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site reaction, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site reaction, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed injection site reaction including injection site swelling, injection site redness and injection site pruritus. The reaction size was like a quarter diameter (25 cents coin). On 4th May 2018, the symptoms were still present. It was unknown if the reporter agree to follow up with GSK.
First shot I was sick, tired, and in a fogg  Second shot day after I was in Pain, cold/Hot,  sick, crying, fever dont know what it was.
Pt received the Johnson and Johnson COVID-19 vaccine on 4/1/21. Pt had fever (hot to touch) with delusions (talking to self as reported by husband) within 24 hours of vaccine. No further fevers nor delusions since then. Within 2 to 3 days after vaccine, she developed midback (right side) pain which radiated around to RUQ abdominal, pain was sharp. It hurt a lot to sneeze. She denies nausea, vomiting, diarrhea, constipation, hematochezia, melena, or dysuria. Pt reports she is getting stomach acid reflux in her month. RUQ abdominal pain was initially 10/10, now it is constant 4-5/10 pain, 14 d after vaccination. Food does not impact abd pain or reflux. She denies heartburn. She has frequency of bowel movements (6 to 8 per day) for the last 2 days.
Body aches, runny nose, fatigue, headache about 24 hours after receiving the vaccine. Symptoms persisted. Then on Tuesday, 2/16/2021 when I woke up I could not taste or smell anything.  I had video visit with the doctor and was told to take Motrin, hydrate and rest. I stayed out of work the next day.  These symptoms continued. I stopped taking my Leflunomide as advised by my Rheumatologist on 2/19/2021. I contacted my PCP on 2/24/2021.  Fatigue and cold symptoms better. Had green mucous and sinus fullness. Still no taste or smell. Started on Doxycycline 100 mg daily and had COVID test done on 2/25/2021 which was negative. Completed 10-day course of doxycycline. Fully regained taste and smell  on 3/2/2021. All symptoms had resolved by this time.
HYPOTENSION SHOCK, UNSPECIFIED 10/28/2022  --  RECURRENCE OF SAME SYMPTOMS
1. Moderate frontal  head ache started 6 hours post vaccination and lasted for 24 hours , relieved by advil  400 mg 2. Mild Chills began at 20:00 day of vaccination and continued intermittently at night for 2 days 3. Mild injection site tenderness began  immediately after administration and continued for two days
Initial report received on 18 October 2006 from a health care professional. A two-month-old female patient, with a past medical history of torticollis, had received a first dose, left thigh injection of ActHIB, lot number C2650AA; a first dose, left thigh injection of IPOL, lot number Z2001-2; and a first dose, right thigh injection of Prevnar, manufacturer reported, lot number B08646E; on 17 October 2006 at 3:30 pm. Immediately post-vaccination, the infant was crying and screaming, then quit crying, put her head back and turned pale. Her lips were not blue. The patient was still without any abnormal movement. The length of the episode was not reported. At 11:00 pm, the parents took the patient to an emergency room for evaluation. No description of events that precipitated this visit were provided. Blood and urine testings were performed, but no results were provided. Per the reporter, "no spinal tap done." The patient was re-examined by the pediatrician on 18 October 2006 and was noted to be well. On the same day, the patient received a first dose, oral administration of Rotateq, manufacturer reported, lot number 0849F. At the time of this report, the patient had recovered.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (typical flu-like symptoms after receiving the first two doses) and LYMPHADENOPATHY (lymphadenopathy after second dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, METHYLPHENIDATE HYDROCHLORIDE (CONCERTA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LEVOTHYROXINE, SPIRONOLACTONE, LEVETIRACETAM (KEPRA), TRAZODONE, MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE (PEPCID [FAMOTIDINE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MELATONIN and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (typical flu-like symptoms after receiving the first two doses) and LYMPHADENOPATHY (lymphadenopathy after second dose). At the time of the report, INFLUENZA LIKE ILLNESS (typical flu-like symptoms after receiving the first two doses) outcome was unknown and LYMPHADENOPATHY (lymphadenopathy after second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication use was reported. This case was linked to MOD-2021-406115 (Patient Link).
recently had a blood titer drawn and it was negative for immunity; Information has been received from a consumer referring to a male ptiant of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient never had chicken pox.  In approximately 1995, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were unknown) 2 doses for prophylaxis.    On an unknown date (also reported as recently), the patient had a blood titer drawn and it was negative for immunity. The outcome of the event was unknown. The causality assessment was not reported.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump on my forehead), RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-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. In May 2021, the patient experienced RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red). On an unknown date, the patient experienced SKIN MASS (lump on my forehead). At the time of the report, SKIN MASS (lump on my forehead) outcome was unknown and RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: result not provided Result not provided and non-canerous (normal) Non-canerous. Patient took an unspecified 1% lotion for the rash, then a different lotion after seeing the dermatologist which helped with his symptoms. No concomitant medications were reported. Patient's rash started to clear up in October and in the same month he saw a dermatologist.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 06-DEC-2015 at time- 22:13, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.7 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Heart palpitations; pulse felt stronger on my wrist when I checked it. It was "pounding sort of".; Sore and swollen are where she had the injection; Sore and swollen are where she had the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 07Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "Heart palpitations"; PULSE ABNORMAL (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "pulse felt stronger on my wrist when I checked it. It was "pounding sort of"."; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "Sore and swollen are where she had the injection". Therapeutic measures were not taken as a result of palpitations, pulse abnormal, vaccination site pain, vaccination site swelling.  Additional information: The caller stated she has had no symptoms yesterday and today. These side effects lasted 10-11 days. She didn't treat it; she took more deep breaths to try to relax about it. She said that she hadn't had them for the last two days, so she guesses it got better, but it took a while. She had concerns about getting the second dose. Caller was due for 2nd vaccine dose on 28Oct2021 and asked if other people had these symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 11:04 AM, RN administered 0.1cc dose of Jynneos vaccine Lot # FDP00015 exp date 12/3/2022 via intradermal route to right forearm to Patient. RN noticed leakage out of the arm. The full 0.1cc dose was not received. RN notified clinic lead nurses PHN regarding incident and was instructed to give a 2nd dose to left forearm. Educated patient that because the full dose was not received, a repeat dose must be placed to the other arm or 2 inches away from the 1st dose. Patient verbalized understanding. RN re-administered another dose of 0.1cc of Jynneos Lot # FDP00015 exp 12/3/2022 to the left forearm and the full 0.1cc was received. Patient was educated to observe for adverse reactions.