chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose; COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: 01Jun2020; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes. Did you/the patient previously receive a COVID-19 Vaccine?: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt states he is unable to lift arm. Sx since vaccine given. Referred patient to MD. This was reported today 11/13/12.
Axillary swelling; Joint pain; Tenderness of the vaccination arm; Fatigue; injection site (right deltoid) pain, swelling and redness; injection site (right deltoid) pain, swelling and redness; injection site (right deltoid) pain, swelling and redness; Muscle pain; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of AXILLARY MASS (Axillary swelling), ARTHRALGIA (Joint pain), AXILLARY PAIN (Tenderness of the vaccination arm), FATIGUE (Fatigue) and INJECTION SITE ERYTHEMA (injection site (right deltoid) pain, swelling and redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity and Sickle cell disease NOS.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced AXILLARY MASS (Axillary swelling), ARTHRALGIA (Joint pain), AXILLARY PAIN (Tenderness of the vaccination arm), FATIGUE (Fatigue), INJECTION SITE ERYTHEMA (injection site (right deltoid) pain, swelling and redness), INJECTION SITE PAIN (injection site (right deltoid) pain, swelling and redness), INJECTION SITE SWELLING (injection site (right deltoid) pain, swelling and redness), MYALGIA (Muscle pain) and PYREXIA (Fever). At the time of the report, AXILLARY MASS (Axillary swelling), ARTHRALGIA (Joint pain), AXILLARY PAIN (Tenderness of the vaccination arm), FATIGUE (Fatigue), INJECTION SITE ERYTHEMA (injection site (right deltoid) pain, swelling and redness), INJECTION SITE PAIN (injection site (right deltoid) pain, swelling and redness), INJECTION SITE SWELLING (injection site (right deltoid) pain, swelling and redness), MYALGIA (Muscle pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021. Patient demographics updated, Medical history updated, Product details updated. On 16-Jul-2021: Follow-up received on 16-JUL-2021 contains No New Information.
Vaccine expiration date 2/28/2022. Vaccine administered 3/4/2022.
Patient received first Afluria 2019-2020 in right arm and was fine.  Then he received Gardasil also in right arm and appeared to have Syncope.  Started to lean over to his left.  I went immediately to patient to assess situation.  Patient then "planked", extending legs shaking his body in a seizure movement.  Patient was disoriented at this time.  Father and I  attempted to converse with patient but he would not respond appeared "out of it".  Then he started to "faint" again and repeated the same pattern of seizure-like movement.  I then asked father to help me lie him on the ground and I placed a jacket under his head to prevent head injury.  Paramedics were called since I was still unsure if patient was having seizures or syncope.
Urticarial rash on trunk/extremities 1 day after FLUZONE (Hi - Dose), resolving on own.
Received vaccine on Mon. 5/23/11 at approximately 11:00am. By early evening, body & headaches presented. By 9:00pm, had fever, body aches, headache, red & hot injection site. Same symptoms on Tues with temp peaking at 103.6 degrees, and Wed until mid-day. Spoke w/ Dr's office - they said if temp gets higher, go to emergency room. By Wed pm, most symptoms were gone except arm pain, which went away by Friday am.
Approximately three minutes after vax, the pt experienced sweating, a feeling of throat closing, sore throat, and fever. The pt also reported it was extremely hot that day and in her car. At that time, the pt did not seek medical attention, but went to work for three hours. After three hours, she reported she felt awful. She went to the ER and was dx with tonsillitis. She was treated with Biaxin and acetaminophen. She missed three days of work.
This case reference number 2000005817-1, is a spontaneous report from a registered nurse referring to a 49 year old male. Allergies are unspecified. The patient has back problems (nos) and started taking "high dose" Motrin, vitamin C and E on 02/23/00. On 02/23/00, the patient received his first dose of Engerix-B. Two days later, on 02/25/00, the patient experienced a rash. Reporting nurse is not sure if the rash is due to Engerix-B or his concomitant medications. The most recent information, received on 02/29/00, reports the condition of the patient as unknown.
Shortly after patient received his 2nd dose of Pfizer, the patient's wife reported that he passed out in the car at the waiting area. The wife started blowing the horn and yelling for help around 12:20PM.  Paramedic on duty in waiting area reported to finding patient unconscious and then reported patient regaining consciousness and began vomiting. Patient was transported to hospital for further evaluation at 12:38pm.
I received the second dose of the GARDASIL vaccine March 26th, I was encouraged to receive the vaccine by my PCP and the nurse that administered the vaccine, though the nurse continue to urge me to get the second vaccination after I expressed to her that I didn't like how I felt after the first vaccination. She said that all of her daughters had the vaccination (all 3) and that I should get it to protect against HPV and cancer. A week later April 2nd, I noticed a large rash develop on my left upper arm, small red bumps appear on my hands and additionally another rash (slightly bruised) develop on my left leg by my knee. I've been excessively itchy, and have felt tingling all over my body and sharp shooting pains all over my body that range from my shoulders, down my arms, into my hands, down my legs into my feet. I went back to the Dr. on April 5th to inquire about the rash and the bumps and the tingling, and the nurse practitioner said I was basically healthy due to the lab work done on March 26th and that it was probably allergies and tension in the muscle in my shoulders causing the issues. She checked my reflexes which were good, but did not do any additional tests to see what the tingling and shooting pain (which I'm still experiencing as I type this) comes from.
This spontaneous report as received from a pharmacist refers to a 39-year-old patient. On 10-NOV-2016 and on 10-NOV-2016, the adult patient received a doses of pediatric formulation of RECOMBIVAX HB lot # M020926, expiration date 11-AUG-2018. No adverse effects were reported.
COVID -19 Break Through Case. I received my 2nd vaccine on the 02/23/2021. My adverse event started on COVID-19 Break Through Case. I received my 2nd vaccine on the 02/23/2021. My adverse event started on 10/05/2021. I was having a severe cough and my lungs hurt really bad. I got a rapid COVID-19 test which came back negative. On the 10/11/2021, I went to the urgent care. I couldn't breathe, it hurt really bad. I tested positive for COVID-19. I had a really bad immune thorax on my left side of the body from my armpit to my waist. It looked like I was hit with a bus. I was admitted in the hospital. I had CT scan done. They found a pulmonary embolism in my body. My left lung clasped, and they inserted a chest tube, and they took 1.7 liters of blood out. They also inserted IVF in my right side to get blood clots out. I was in the hospital for 53 days and 21 days in acute rehab. I had no control over my body. I couldn't talk, walk, no balance. Basically, I couldn't do anything for myself anymore. I had no mobility. My life completely changed after I contracted COVID-19. I almost died 3 times.
Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning in lungs, blood pressure increase.  Wheeled down to emergency room. Given anti nausea medication, exrays on heart and lungs, saline IV, heart monitored
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of M-M-R II with the following lot numbers and expiration dates: M016234/31-MAR-2018, M034387/19-JUL-2018, M036543/15-AUG-2018, M039913/26-SEP-2018 and also the one reported as M042846/21-OCT-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number M042846 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. Therapy type of recombinant human albumin (rHA) has been added to the case. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1707USA005187: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
weak all the time due to the pain.; periodical numbness from the shoulder to hand in the injection arm; pain, soreness, achiness; Tired all the time due to pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm), MYALGIA (pain, soreness, achiness) and FATIGUE (Tired all the time due to pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in November 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm), MYALGIA (pain, soreness, achiness) and FATIGUE (Tired all the time due to pain). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg. At the time of the report, ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm) and FATIGUE (Tired all the time due to pain) outcome was unknown and MYALGIA (pain, soreness, achiness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Lot of unspecified medicines.   This case was linked to MOD-2021-260057 (Patient Link).
Induced a bout of vertigo which lasted 11 days, although a vertigo sufferer no prevous bout has gone more than about 3 days.  the dizziness was severe enough it prevented patient from working for at l9 days
Rash on the body noted 11/15/2005 2 days after Flu shot and Pneumovax were given. New order; Benadryl q 6 hours PRN. Hydrocortisone to rash resolved 11/18/2005.
Several hours (6 or7) after the covid booster Friday afternoon, upper abdominal pains that seemed like pancreatitis for several hours, couldn't sleep. Then the next day it was ok and then Sunday I had very sharp lower right abdominal and right flank pains that seemed like appendicitis or kidney stones symptoms. Still feel inflammation. When this happened before with my covid booster last year, I went to the ER except this time I didn't have as many palpitations or tachycardia.
Patient contacted me on 4-25-18 to inform me that his arm was red, hurting, and hot to touch. I told her to see her doctor.
Shot Fri 12th sx eve of Sun 14th neck ache on right traveled to entire neck. Very painful. Then to top of chest couldn't breathe c/o pain. Then under arm then left hip. Still there, then ankle pain still here after 10 days. Pt exhausted.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old patient of unknown gender who received vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Received 1st Moderna vaccine 3/23/21. experienced severe abdominal pain 4/7/21, had to go to ER 4/9/21. ER staff performed blood work and CT, administered antibiotic intravenously then continued with prescribed oral antibiotic. Pain had subsided by 4/14/21 (approx). Received 2nd Moderna vaccine 4/22/21. Experienced severe abdominal pain again, beginning 5/9/21. Saw my nephrologist on 5/10/21, who referred me to the infectious disease doctor. Have been receiving antibiotics intravenously through 5/26/21, changed to oral antibiotics on 5/27/21. Pain now down to 95%.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose Shingles vaccine and experienced shingles. The patient received second dose of Shingles vaccine. Follow-up would not possible as no contact details were available.
In the last week of the year I contracted Covid asymptomatically. On 2/09/22 I had a CT scan of stomach as I was experiencing abdominal pain, bloating and constipation. CT Scan revealed no Hernia, but cluster of nodules focused in anterior right lobe. Non specific but favored post infections non inflammatory focus. 17x12 MM. 3/23/22 had CT scan of lungs revealed "there is a small cluster of tree-n-bud nodularity in the right ancillary lobe. This suggests long term infection of small airways passage by bacteria.
Didn't sleep hardly any; Neck hurt; Chills in the night; Arm was sore; Fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7). At the time of the report, INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Tingling down my entire arm down through my fingers.  Not constantly but definitely often throughout the day.  Started the day I received the vaccine and is still continuing.
no adverse effect; Expired vaccine used; This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. The patient's medical history, current condition and drug reactions/allergies  were not reported. Concomitant therapies included sterile diluent.     On 22-JAN-2020 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) after its labeled expiration date (lot # R001659, expiry date: 17-JAN-2020) therapy type was recombinant therapy type (RHA) for prophylaxis (expired product administered). No additional adverse effects were reported. No product quality complaint (PQC) was reported. The outcome of expired product administered and no adverse event was unknown.
1415: approximately 10-15 minutes after vaccine; patient c/o flush & dizziness in 30 minute observation area.  Skin pink, cool, and diaphoretic. Pt reports eating lunch before vaccine. PMHx: Diabetes, Allergies: PCN-Anaphylaxis Meds: Metformin, Glipizide, Prevastatin Patient in First Aid area for assessment and observation.  A & O x 4, Speech without difficulty. Denies any other symptoms of reaction.  1419-VS: B/P: 160/100, HR 100, RR-18, O2 Sat: 96% on RA CBG-314; patient in between PCP's for medication adjustment.   1437 VS: b/p: 144/86, HR 99, RR 18, SaO2 95% on RA Cool Towels applied to neck, water given 1455: Symptoms resolved, patient cleared to leave by paramedic on duty.
Two Psoriatic type lesions (scaly, red, itchy) appeared on Right lower leg 28 hrs post-immunization. One dime-sized, other abt 20mm. Never had Psoriasis previously.  Have SLE, and symptoms of MCAS, but not diagnosed with MCAS.
Patient called to report headache beginning 1 hour after vaccination followed by lips, tongue and right side of face numb and tingling.  Advised patient to go to ER department for further evaluation.
Day of vaccine--immediately after vaccine pt c/o itching of left arm (not vaccinated arm). Pt offered IM benadryl by EMS at the vaccine drive-pt refused. Encouraged to take benadryl and pepcid at home and to f/u with ER if condition worsened. Pt reports her arms, legs, and back began to itch and she developed red splotches over the areas.  She took the Benadryl 50mg at home (did not take pepcid). She took a nap then went to the local ER after she woke up she noticed a pimple-like rash on her face. She states she was given "2" shots and one was a steroid shot. She does not know what the other injection was.  Day 2-Pt states she went fishing (temp 90+ degrees)--pt states she started sweating, became short of breath, nauseated,-felt like she did when she had covid. states rash on body had improved, still had rash on face.  By Saturday states rash on Face was worse, other rash and itching had improved. By 1 wk--rash on face has almost completely resolved.
Patient received both doses of Moderna COVID-19 vaccine in May-2021.  Was diagnosed with COVID-19 on 29-Aug-2021.  Patient has had flu like symptoms (fever, body aches, cough, runny nose, chest tightness) since 25-Aug-2021.  Got PCR test for COVID-19 on Saturday 28-Aug-2021 and received positive results on 31-Aug-2021.
Injection site is red.  About a 2 inch circular pattern. On 2/2/2021, the day after the injection suffered from upset stomach and sore joints with slight headache.
Has developed bumps on her arm from her wrist to her elbow that look like mosquito or ant bites/ Bump under her right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 30Jul2021 (Lot number: ER8736) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seizures" (ongoing), notes: Since she was 9 years old. There were no concomitant medications. The following information was reported: RASH PAPULAR (non-serious) with onset 2021, outcome "recovering", described as "Has developed bumps on her arm from her wrist to her elbow that look like mosquito or ant bites/ Bump under her right eye". Therapeutic measures were not taken as a result of rash papular.  Additional Information:   The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The caller stated his 14 year old daughter received the first dose of the vaccine on Friday 30Jul after 6pm. The patient experienced bumps from her wrist to elbow on her arm. They looked like ant or mosquito bites. The patient mentioned previous night she had a bump under her right eye. That morning she texted the caller with pictures of the bumps on her right arm, wrist and hand and on the left elbow and above the elbow. They were small bumps puffed out a little like an ant or mosquito bite. They were on both the top and bottom sides of the right arm and there were 12 bumps. It looked like they were going down then. Caller confirmed the information regarding the bumps and the location of one on the right eye and on the right and left arm. No treatment at that point as they seemed to be going down but it the got worse he could do something more. Caller asked if she should get the second dose if it was related to the Covid vaccine.   No follow-up attempts are possible. No further information is expected.