chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE WAS ADMINISTERED AT 9:33 AM. PATIENT WAITED 30 MINUTES AND LEFT AT 10:00AM. PATIENT RETURNED TO PHARMACY AT 10:45AM STARTING SHE STARTED HAVING A REACTION AROUND 10:30AM. PATIENT WAS TINGLY, BOTH ARMS WERE SWELLING AND HAD A RED RASH, AND SCRATCHY THROAT. PATIENT ALSO FELT WEAKNESS IN BOTH ARMS AND FATIGUE. BENEDRYL 50 MG WAS ADMINISTERED AT 10:45 AM BY MOUTH. PATIENT WAITED FOR 30 MINUTES DID NOT RESPOND TO BENEDRYL.  PRIMARY DOCTOR WAS PHONED AND HE RECOMMENDED ADMINISTERING EPINEPHERINE. EPINEPHERINE WAS ADMINISTERED AT 11:15 AM IN RIGHT THIGH. PATIENT WAITED 5 MINUTES AND STABILIZED. PATIENT LEFT PHARMACY AT 11:20AM
Fatigue 3/31-4/7  headache 3/30-4/2 extreme achy muscles 4/1-4/5 Fever off and on 4/2-4/8 painful upper arm and somewhat swollen 3/31-4/5
chills flu like symptoms weakness sore gums sore lips with sores painful bumps at injection site
Patient's arm swelled up as big as a bar of soap he said it felt hot and was hard to touch. The redness spread from site around arm to the inside of the elbow, (but was not as swollen on second day). He discussed with doctor, whom said he had never seen that type of reaction before. As far as I know it resolved on its own because he has not called or returned since reporting.
Strong flu-like symptoms for 48 hours after vaccination.  Neck discomfort began perhaps 1 month after vaccination .. eventually realizing there were one or more swollen lymph nodes.  This was accompanying by varying degrees of vertigo.    This has come and gone since the vaccination.  I have sought medical assistance though I have not been diagnosed with anything more than "swollen lymph node".   My medical "treatment" has included blood work in october and december, ultrasund of neck soft tissue and carotid arteries.  Xray of cervical spine.    These test as referred by my primary care physicial.   I have also seen an ENT specialist who believes the lymph node is resolving, but wishes to do additonal balance testing  in regards to the vertigo/dizziness I have experienced.
swelling at injection site, fatigue, pain and swelling on lower arm Narrative:  Other Relevant History:
This non-serious spontaneous (prospective) pregnancy case, initially received from other non-health professional on 26-Oct-2018, concerning a female patient of unspecified age. On an unspecified date, at 16 weeks gestation, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number, expiry date: not reported]. The patient reported that the vaccine was administered without prior consultation. At this time of this report, no adverse event was reported.
As per mother baby had subjective fever after vaccines yesterday, concerned about one of the injected sites that is mild red on left thigh.
Burning eyes, severe dry mouth, rapid heart rate, increased blood pressure, flushing, sweating.
Location around the injection site showed urticaria, rigidity to touch, warmth and difficulty to move entire arm. Urticaria spread over the next four days, while the other symptoms remained constant. Was prescribed an antibiotic 3 times a day for 1 week on 1/25/17. Reaction site is still rigid to the touch and shows bruising (as of 2/16/17). Ability to move arm without pain was regained a week after the antibiotics were finished.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of caution.
I started breaking out in severe hives. Several time my face swollen up. I had to go to the ER because I had a hard time breathing. They gave me an EpiPen. Twice around my injection site swelled up and had a red, circle of hives. I was very fatigue and had hot flashes. I gained weight. I went to an allergist specialist. He did blood work and an allergy test. I am on medicine and I then had another breakout.
Severe itching from scalp to top of legs on 14 th day after injection, preceded by itching of injection site on 7th day after injectin
Myalgia, Arthralgia, NauseaVomiting, chest pressure at 0700 on 2/2  Narrative:  Other Relevant History:
8.11.06 given Pediarix, Prevnar, Hib developed febrile seizures, seen at the ER. 12.4.06 given DTAP, HIB, IPV, Prevnar developed rash 1 day after vaccination.
Swollen arm within 2-4 hours; redness below injection site; patient was tired; bruise at injection site.  On 10/31 advised patient to take Tylenol and cold wrap the area.
Noticed right arm red after taking band aid off today. Received flu vaccine yesterday. No pain. "Right arm feels warm and hard lumps present".
TDaP given instead of DTaP. Patient received 4 doses of DTaP all at the appropriate times. The 5th dose, TDaP was inadvertently given when the patient should have received the final 5th dose of DTaP. Intradermal flu shot given instead of age appropriate flu shot. Patient inadvertently received intradermal 0.1ML ID FLUZONE instead of VFC-Child age appropriate 0.5ML IM FLUARIX.
Since the third day, every night I felt a hint of chest pain/distress, which becomes more clear during a deep breath, for around 1.5 weeks. It dispear during the day and after 10 days, but reappears indefinitely later. I went to see a cardiologist, and the doctor listened to my heart and lung and said that may be asthma. My asthma was asymptomatic before the vaccination and only appears during extremely hard exercise. After the vaccination I also found my asthma got worse (noticable during long fast walking/slow running, and sometimes at rest).
Patient requested seasonal flu and shingrix vaccines.  When documenting the Shingrix vaccine, noted patient had received 2 doses already and therefore the Vaccine given on 9/16/22 was not required resulting in an extra dose of the shingrix.   She has received Shingrix on 2/11/22 , 4/29/22 and 9/16/22.  Pt informed and provider APRN informed.  Pt denies side effects as of 9/16/22.
increased stiffness and pain worse; increased stiffness and pain worse; tired; pain in feet and knees.; pain in feet and knees.; This is a spontaneous report from a contactable other health care professional. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 (at the age of 52-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (rheumatoid arthritis symptom including increased stiffness & pain worse following missed Xeljanz XR 11 mg dose; Frequency: Daily; Route: Oral Date of use: May2021 to current) from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 2021, patient reports stiffness that was worse after immobility or when awakening in the morning, pain in feet and knees. Xeljanz XR held for a couple weeks since Aug2021 due to having COIVD vaccine. Rheumatoid arthritis symptoms including increased stiffness and pain worse following missed xeljanz XR doses. Patient continues to be very tired at night. Patient did some cleaning 08Sep2021 that had caused increased pain. Advised to update md with new/worse symptoms. The outcome of the events were unknown.
PT EXP PAIN AND STINGING AT SOI AFTER ENGERIX-B INJECTION.  TREATMENT:  PT COUNSELING.
The patient had a swollen arm for 6 that spread to under her breast and her lymphnode was swollen as well.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with RECOMBIVAX HB (thimerosal status was not reported) that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1403USA012181, 1404USA004082 and 1404USA004083 via same reporter link. Additional information has been requested.
I became nauseous early on prior to dinner. When I went to be around 10 that evening, I fell asleep early on and then woke up with shivers and then sweats. I felt like I was hallucinating all night. When I woke up the next morning I spent the entire day on the couch going in and out of sleep. It was awful
Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, a health care professional (HCP) prescribed hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for a patient who was over the age of 45 (product prescribing issue - product administered to patient of inappropriate age); therefore, the pharmacist refused to administered the vaccine. No other information provided. No additional adverse events.
not immunocompromised people received 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (not immunocompromised people received 3rd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised people received 3rd dose). At the time of the report, OFF LABEL USE (not immunocompromised people received 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Strange red almost rash like large mark appearing weeks after vaccine that matches ?Moderna rash?. Injection site still sore weeks later
Vomiting light brown stomach bile consistently for three hours, cold skin while sweating, and feeling like I was burning from the inside out while still having cold skin.
Began having chills and felt achy around 5:00 PM.  Took some Motrin and Benadryl and began to feel better between 7:30 and 8:30 that night. Next day (11/3/2010) noticed a non-itchy red rash on torso and forearms around 11:00 AM.  At unknown time on 11/3 noticed the rash was also on her lower back.  She continuted with Benadryl.  On 11/4/2010 contacted me (vaccine provider) and the rash was no longer on her back and was beginning to look less red.
Had fever, body aches, chills and headache 12 hours after the vaccine was given, that lasted almost 24 hours. Then subsided. About 8 hours later I developed a migraine headache that lasted 5 hours.
Information has been received from a certified medical assistant concerning a 31 year old female who on 10-OCT-2005 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#649739/0121R). Subsequently, on an unspecified date the patient received a second dose of varicella virus vaccine live (Oka/Merck). The patient had positive titers in 2005, but now the patient presented with low antibody titers. Unspecified medical attention was sought. No adverse events were reported. No further information was provided. There was no product complaint involved. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child and unknown gender. On 02-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient and Parent lied on pharmacy consent form about patient's age so he could receive the vaccine. First dose was administered to patient at age of 11 years old. This was discovered when Patient's other parent brought him in for dose two and Parent gave us actual birthdate.
Patient received vaccinations and immediately swelling and broke out in hives left leg was worse.  BENADRYL was given.  No signs of respiratory distress.  Dad aware of instruction any difficulty breathing go to ER.  Dad stated some rash after 2 mos immunization but did not call.
Pt recvd series of 3 Engerix-B vax  on 0,1,6 mo schedule.  Titers-neg.
11/7/2021 vaccination. 05/02/2022 went for long walk with friend. 05/03/2022 Woke up tired, exhausted. Thought it was from the walk. Started to experience cough, persisted to include post nasal drip. I thought it was a cold. I never had a fever. I thought maybe then allergies; Sudafed but it wasn't relieving or making it go away. The persistence and intensity, I made appointment with allergies. Dr. stated that it wasn't allergies but rather a 'post infection state'; no tests to see what it was. No wheezing. Put on albuterol inhaler, Flonase and antihistamine spray, a steroid 6 day course, antibiotic for a month 10 day course. I have not had my follow up yet with allergist. Almost recovered. Residual cough.
MMR given on 5/23/06. On 6/2/06 started with sore muscles, blurry vision, sore joints, upset stomach. On 6/3/06, fatigue, fever. On 6/4/06, bumps on face, spreading to ears on side mouth, neck, chest, arms, stomach, legs. Swelling of face and feet, entire body swollen. MD evaluation on 6/5/06, erythematous, macular-papular pruritic rash, inguinal lymphadenopathy and posterior lymphadenopathy, bilaterally (neck).
started experiencing covid symptoms; loss of taste; loss of taste & smell; sneezing; This is a spontaneous report from a contactable consumer (patient) from a   female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: unknown, expiration date: unknown), via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that on 23Feb2021 she had her first dose of the covid-19 vaccine and on an unspecified date in 2021, she had some adverse events and started experiencing Covid symptoms like sneezing, and loss of taste and smell. She reported that something she was experiencing were known side effects of Pfizer vaccine and she was experiencing a symptom and was trying to figure out if it was a side effect of the vaccine or if she needs to get a COVID test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Per mother: patient experienced 13 total seizures (5 major, 8 minor).  The first occurred during church and was rushed to ER for treatment.  At the time of the conversation (roughly 24 hours later), the patient was still in the hospital but in stable condition.  The patient has no history of epilepsy.
I got shingles from the vaccine/ suspected vaccination failure; I got shingles from the vaccine; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got shingles from Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SWELLING AROUND THE ANKLES; VARICOSE VEINS; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. About 2.5 weeks later, on 01-APR-2021, the patient noticed swelling around the ankles and varicose veins, for which the patient had taken acetylsalicylic acid and turmeric as recommended by his physician. Last week (APR-2021), he had a ultrasound of his lower extremities, and that came back negative. The patient also had a cardioid ultrasound as well, also coming back negative. The patient had been to vein and foot physicians. The patient mentioned that the foot physician had never seen a situation like the patient before. The patient have noticed today that his swelling and varicose veins have decreased. On 13-APR-2021,the patient got a spike protein IGG test which showed negative for antibodies. The patient was not sure if the side effects had to do the vaccine or something else. The patient would like follow-up from the safety team on what to do next regarding the negative antibody best. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling around the ankles, and varicose veins, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210440928-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine 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
This spontaneous report as received from a consumer reporting a unspecified son of a friend, a male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. On an unknown date the patient "stopped talking" after receiving a single dose of M-M-R II. At the time of the report the outcome was unknown. Upon internal review the event "stopped talking" was considered as Medically significant. Additional information is not expected.
I had the tired symptoms and fatigue next day. They got worse and i had memory issues, speech problems, stroke symptoms and severe migraines. I missed 3 weeks of work off and on in May due to all this. I ended up in the ER on May 14 for stroke symptoms and lost use of my right arm and hand for several days. I have been diagnosed with migraines with aura and told I had a severe reaction to the shot and may recover in 6 months. I am on all new meds to try to control my migraines which are now daily and more severe than ever.
Patient's daughter stated that the patient's morning blood sugar dropped to 22 on the Thursday following the vaccination. She also stated that she had the same reaction 3 days after the initial SHINGRIX vaccination, but not as significant. After giving the patient juice, her blood sugar returned to normal.
Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (Baby ASPRIN), AMLODIPINE BESYLATE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish). At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. No concomitant product was provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.