chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash came back; fever after second dose; tiredness came back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Typically gets a rash with the flu shot - but small and goes away in two or three days). Past adverse reactions to the above products included Rash with Flu shot. Concurrent medical conditions included Arthritis, Drug allergy (Allergic to anti-inflammatory drug used for arthritis - Clinoril), Psoriatic arthritis, Psoriasis, Blood pressure and Thyroid disorder NOS. Concomitant products included BETAMETHASONE for Psoriasis, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMINS NOS and FLUOCINONIDE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back). On 07-Mar-2021, RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient put ice on her rash.   This case was linked to MOD-2021-027848 (Patient Link).
Almost 24 hours after Tdap Injection, pt c/o pain at the injection site, redness at the injection site, swelling at the injection site and fever.
There was a large lump at the injection site for several days (small lump still palpable on 10/16/2018) with significant soreness. She refused to crawl or walk for a couple days and would stop moving and cry when she would try to crawl or walk. She showed general drowsiness, reduced appetite, and irritability in comparison to her normal demeanor. She developed a fever on 10/14/2018 which peaked at 101.4* and dissipated without medication within 24 hours. She had some irregular bowel movement on 10/14-16/2018 (some solid and some liquid poop in same diaper). She would not sleep alone or laying flat on 10/14/2018 and 10/15/2018. She was refusing portions of her bottles and food 10/13/2018-10/17/2018.
A report had been received from the Pharmacist concerning a 43 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications of the patient. The patient (who is also the reporter and is a pharmacist) administered FLUMIST (intranasal) full dose into a single nostril on 02-Nov-2014. On 03-Nov-2014 she started feeling a bit of a sore nostril and stuffy nose on one side which has not resolved at this point. Patient has been getting FLUMIST for the last few years. The outcome of the events of sore nostril on which full dose was administered and full dose in single nostril was unknown. The company physician considered the event of sore nostril in which full dose was administered and full dose in single nostril to be non serious. The reporting and company considered the events of sore nostril in which full dose was administered and full dose in single nostril with the suspect drug FLUMIST to be not related.
Patient presented to pharmacy with Covid vaccination card with monovalent Pfizer vaccine, 1st shot only. patient was given 2nd Pfizer monovalent, tri-sucrose vaccine at the site. upon processing the claim, it came with error and vaccination registry was checked and realized that pt received 24 Covid vaccines previously.
Received 2 Doses of Heplisav-B Out of Schedule; Initial Report Received on 06-Mar-2023.  A licensed practical nurse reported that a 43-year-old female patient (race and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of schedule.   Medical history and allergies were not reported at the time of vaccination. The patient was not on any concomitant medications and was not pregnant.  On 30-Dec-2022, the patient received the first dose of HEPLISAV-B vaccine (no details were reported).  On 24-Feb-2023, 57 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B vaccine (Lot # 941060, expiration date 02-Dec-2024, NDC # 43528-003-01) intramuscularly in the left deltoid. The second dose of HEPLISAV-B was given out of schedule. The provider wanted to give a third dose of HEPLISAV-B because the patient was immunocompromised and requested more information. No adverse effects were experienced by patient.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and itchy. She presented to the clinic somewhat short of breath because of her asthma, but the itching was completely new. Gave the patient an age appropriate dose of Benadryl and symptoms resided within 15-20 additional minutes of observation time.
Initial report was received on 18 October 2013 from a consumer who is also the patient. A 69 year-old female patient with a history of allergies to PCN (penicillin), tetracycline, shrimp and cat scan dye had received first dose intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number was unknown) and two hours later, experienced sore throat, food sticking to her throat, painful swallowing, a feeling of rocks in her throat and blood shot eyes. The patient went to the ER and was treated with prednisone, BENADRYL and nebulizer treatments. On 18 October 2013, the patient reported throat was just a little sore. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
A 26 year old male patient (UA) experienced a neuroparalysis after receiving RabAvert therapy for post exposure prophylaxis. The patient received RabAvert in five doses beginning 05/03/04 and completing 06/03/04. He has no past medical history or concomitant medications. The patient suffered a dogbite on his hand on 04/30/04. On 05/0304, he presented to the emergency room and RabAvert therapy and human rabies immune globulin (HRIG) were initiated. A "routine blood test" at that time and rabies titer were negative. On 05/04/04, one day after the first dose of RabAvert and HRIG, the patient developed increased salivation and muscle twitching. In June 2004 the patient was seen again in the emergency department for the same symptoms, was told he may be suffering from stress and anxiety and he was released without treatment. The symptoms increased and later in June 2004, he developed swelling, weakness and slight paralysis on the right side of his body including his leg, arm, face and lip. The partial paralysis is described as a tightness on the right side of his body, aching of the muscles on the right side and weakness of the right side of his body. He also had a right lip droop, a right eye that "hurts to close", muscle jerking, weakness on the right side of his body and face, right side arm and leg swelling, decreased control of the right side of his face and difficulty breathing. He had no difficulty ambulating. The patient saw a neurologist on 07/08/04 and was told his reflexes were elevated and he was given a working diagnosis of a 7th cranial nerve problem versus encephalitis. The neurologist has scheduled him for an MRI and wants to do a computed tomography, electroencephalogram, lumbar puncture and more blood testing. Treatment was initiated with Prednisone in tapering doses and Valtrex as of 07/08/04. OMIC
Shortly after receiving the vaccination, the patient complained of headache, dizziness, nausea. She was flushed and vomited. She was taken to the ER by flu staff at Hospital, where the flu clinic was held for employees. The patient reports that no medications were given in the ER. She was told that she had reacted to the vaccine and was advised not to receive further flu vaccines. She remained in bed at home the following day and has fully recovered without residual symptoms.
About 6 days following my first dose, I started to experience periods of heart racing and difficultly breathing. This lasted for several days but then went away. Again, about 6 days following my second dose, I started to experience racing heart and difficulty breathing. This has continued to occur to date. My doctor had me wear a heart monitor for 48 hrs. My resting heart rate was 91 bpm with my highest at 164 bpm ( i believe). There were no events that would trigger the tachycardia.
have had shingles 5 times/ suspected vaccination failure; have had shingles 5 times / always seem to get it on the left side of my back; allergic to the vaccine; Very painful / pain is unbearable.; This case was reported by a consumer via media 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), shingles, allergy to vaccine and pain. On an unknown date, the outcome of the vaccination failure, shingles, allergy to vaccine and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, allergy to vaccine and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was allergic to the vaccine.  The patient had shingles 5 times and always seemed to get it on the left side of the back. The shingles were very painful and the pain was unbearable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. Medical history and drug allergies were not reported. The reporter stated that a patient was administered GARDASIL outside of recommended dosing schedule, as follows: On 01-AUG-2013 first dose, 19-SEP-2013 second dose and on 14-NOV-2013 the third dose. Concentration, dose and lot number were not reported for the three doses. No adverse effects reported. The patient did not sought medical attention. Additional information has been requested.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 27-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Severe chills, muscle aches/pain throughout entire body, nausea & vomiting, inability to stand upright-legs kept giving out with me going down to floor. I had to crawl.  I received the  vaccine at approximately noon on 01/07/2021, with severe  symptoms starting at 11:30 PM. These symptoms lasted until approximately 10:00 AM  on  01/07/2021. It is now 6:30, and I still feel sick from the vaccine. I have minor chills, a mild headache, and have had no appetite all day. My entire body is extremely achey.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Lot number: F24989) at the age of 53 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 10Apr2021 as dose 2, single (Lot number: 020B21A), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: 05121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient had no Known allergies. Concomitant medication(s)/Other medication in 2 weeks included: AZELASTINE; ESCITALOPRAM; HYDROCHLOROTHIAZIDE; LOSARTAN; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; ALLEGRA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TURMERIC [CURCUMA LONGA]; LEUTINIB, Multi-vitamin and Tri-chromium. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: I tested negative (with a home antigen rapid test) on 12May2022; (03May2022) Positive, notes: After testing positive for Covid on 03May2022; (15May2022) Positive, notes: she tested at home on 15May2022 and it was positive; (23May2022) Positive, notes: As of 23May2022 I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti-viral details: product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Treatment stop date: 08May2022. Adverse event: After testing positive for Covid on 03May2022 and taking the full 5 day course of Paxlovid, she tested negative (with a home antigen rapid test) on 12May2022. At this point most of her symptoms had resolved and she not had a fever since 04May2022. On 14May2022 she developed a sore throat again and by 15May2022 it was worse, and she had a cough. She tested at home on 15May2022, and it was positive. As of 23May2022 she was still testing positive. My mild symptoms have resolved however she was having daily headaches.
Varivax vaccine on 2/15/05, chicken pox on 3/14/05.
This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored ROTATEQ. All these patients experienced incorrect product storage as all of them were administered with improperly stored ROTATEQ. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to ROTATEQ. This is one of several reports received from the same source (MARRS # 1502USA002815 and MARRS # 1502USA002816). Additional information has been requested.
Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Jan2021 01:30 at single dose for covid-19 immunization. Medical history included heart problem, she is a pump diabetic user/diabetes, mini stroke, Heart attack. The Family Medical History included heart problems and diabetes. There were no concomitant medications. Patient took the Pfizer COVID vaccine. She was reading the side effects and was wondering if she would have side effects this long after having the shot. She woke up today (26Jan2021) feeling nauseated and started diarrhea this morning. This is day 6 after the shot. No treatment. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Hot, lightheaded, dizzy, nauseated, SOB, lasted about 30 minutes. Tolerated second dose with no pre-treatment and no symptoms.
Sore arm to a point where lifting the arm was painful, large 2+ inch red very warm circle where the pneumonia vaccine was given. Pain continued for about 3 days.
The pt's hair started falling out suddenly for no apparent reason. She is losing much more than the normal about every day. Hair loss has been constant for over four weeks.
Pt recvd 3 doses of Recombivax 31MAR90, 10MAY90, & 4OCT90 & it was determined that pt was a non-responder; Reporter indicated that pt will recvd a booster dose of Engerix-B;
As soon as she gave me the shot my arm hurt so bad I could not move it. I was told it is normal and would be sore 3 days. I was not able to lift my newborn with this arm. The next day I started to have a bruise that was very small and continued to grow for 4 wks. It started out looking like finger prints and by time it was done it was the whole area from my should to my elbow. My child is now 8 wks old and it has finally went away however I still have red blotches on that arm where they gave the shot as well as on my other arm. I called all 3 of my doctors and was told it is a normal reaction yet not one of them would see me in person. They just spoke with me over the phone.
Injection rec'd 10/26/2003 administered by nurse as part of group immunization. After one week, the skin on the palms of my hands and the soles of my feet is extremely sensitive and red.  I rec'd the Swine flu vaccine 10/1976 and three wks later all the skin on my palms and soles peeled off in sheets, making these areas very sensitive--like a burning sensation.  Now this is happening again!  I have not rec'd a flu shot since 1976 because of what happened.  This year I tried again because I thought maybe things have changed.
Pt vaccinated with DTP became irritable few hrs after receiving shot, temp 10 102.4 R after Tylenol, excessive crying.
Pain was felt immediately when the flu shot was administered. It spread downward from the left shoulder to my hand, becoming painful to the touch making it impossible to sleep or perform functions like dressing  myself. It became very difficult to raise my arm or reach behind me without severe pain in the shoulder and upper arm. An MRI and X-rays were performed and physical therapy was recommended by an orthopedist. Therapy continues with some improvement. It is still difficult to perform routine functions like lifting, doing laundry, and cleaning.
Pain from lymph node under the arm where the shot was given.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in the left arm on 22Mar2021 at 18:15 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known sulfa allergy. 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 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 14:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient received unspecified antibiotic within two weeks of vaccination. On 24Mar2021 at 07:00, the patient experienced pain from lymph node under the arm where the shot was given. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. The clinical outcome of the event pain from lymph node under the arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
1000- Employee receives vaccination  1015- Pt reports dizziness to staff  1015- Pt assisted to private area for evaluation/assessment (Vitals signs, ABCs) - Denies troubles breathing or swallowing, Denies throat swelling or closure. drinking PO liquids and eats cracker  10:21- reports sensation in throat, continues to deny troubles breathing or swallowing  10:28- 25mg liquid PO diphenhydramine administered PO as 25mg/10mL PO diphenhydramine  10:31- No improvement/worsening in symptoms- emergency response team called to evaluate employee Pt is transported to Urgent Care via wheelchair per Pt request
Child had full body single spasms and fast spiking fever for 12 hrs leading up to event. About 30 hrs after shot, child had a seizure. Sitting the seizure she aspirated saliva and stopped breathing. 911 was called and within three minutes she was breathing again.
Full body rash; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8733, Expiration date: Unknown), via an unspecified route of administration in right arm on 31Mar2021 at 10:30 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. The patient's medical history included latex sensitivity. The patient's other medical history was none. The patient was not pregnant at the time of the vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. There were no concomitant medications. The patient did not receive any other medications in two weeks of the vaccination. The patient did not receive any other vaccine in four weeks of vaccination. On 03Apr2021, the patient experienced full body rash. It was reported that the patient had full body rash 3 days following first dose. The event lasted approximately 3 weeks. The patient did not receive any treatment in response to the event. The outcome of the event was recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
2 days after injection pt. arm became red, swollen and warm to touch.  Developed wrist and neck pain.  Itching as swelling came down.
Severe pain at injection site in right arm. Beginning at 5 hours post injection continuing >48 hours after injection Slight pain in left arm. Beginning at 7 hours post injection continuing >48 hours after injection Fatigue Brain Fog Lethargy
Pt came to the pharmacy and complained of having a knot at the injection site where she received this particular reaction. She said it was large when she was first vaccinated and it seems like it's going down. Upon examination, it could be very well possible that when the pharmacist was trying to administer the vaccine, they may have hit a blood vessel which could have resulted in the knot. Pt told me she didn't have any pain but the injection site was itching. I advised her to use the benadryl or hydrocortisone cream for the itch and we will revisit in a week to check for the reaction.