chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Tiredness; Soreness at site of injection; Muscle pain, body ache; Fever; Chills; A spontaneous report was received from a consumer concerning a 29-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, vomiting, body ache/pain, tiredness/fatigue, soreness at site of injection/vaccination site pain, fatigue and muscle pain/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021 at 3:00 am, the patient developed a fever and chills. Two hours later, his side effects progressed to vomiting, body ache, tiredness, soreness at injection site, fatigue and muscle pain. His fever went from 104 degrees to 101 degrees after taking paracetamol. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events,  experienced fever, chills, vomiting, body ache, tiredness, soreness at site of injection, fatigue and muscle pain was not resolved.; Reporter'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.
SORE ARM; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815700 and 20210815185.
6 days after Smallpox vaccine was given pt returned c/o flu like symptoms.  Symptoms included fevers/chills, nausea, body aches, headache and mild rhinorrhea.  No sore throat, cough.  Pt had fever of 100.9 and HR of 120.  Other VS wnl.  Normal exam exam white pustule at vaccination site.  Small axillary node on vaccination arm.  Mild tonsillar erythema.  Normal neuro exam and resp and cards exam.
pt received Johnson and Johnson vaccine on 5/21/2021,  PT had been complaining of shortness of breath since getting the vaccine yesterday and today, pt collapsed at home, wife started CPR, EMS continued compessions and ACLS protocol when they arrived to ED he was in Vfib,  After multiple shocks, Epinephrine, bicarb, lidocaine and multiple other life saving medications were administered to no avail, pt expired on 5/21/2021 at 1729
10 Jan 14 1 P Shingles vaccination. 11 9 A Stiffness, weakness, flu symptoms. 12 9 A Red blotches on chest and back, pain, bloody discharge from mouth. 11 A Pharmacist: Take 'BENADRYL' for 3 days. 12 Jan 9 am: Enlarged red areas, brown spots, swelling, pain. 14 Jan 9 am: Blisters, stabbing and burning pain, 'sick as a dog'. 15 Jan 9 am: Worsening condition, difficulty breathing, shaking. 4 PM: Physician: "You have the shingles, 'the whole thing!' Shingles = Weeks of misery! I can see the value of taking the vaccination to prevent or reduce the possibility of getting the shingles - However, had I known that I would have the shingles the next day I would not have taken the shot.
Pt recv vax in early 1997; in 12/98 pt exp lack of response
Just in case I die because of the vaccine; I feel real bad, I feel like everything around me is moving; Light-headed; I feel like, I am gonna fall down whenever I am walking or whenever I am sitting down; I got a burning sensation in my chest, I feel like its burning; It just uncomfortable that it burns; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Aug2021 in left arm at single dose, dose unknown for COVID-19 immunisation at the age of 36-year-old. Lot number was FA7485. There was no medical history. The concomitant medications were unknown. In Aug2021, the patient reported just in case the she die because of the vaccine, she experienced she felt real bad, she felt like everything around me was moving, Light-headed, she felt like she was going to fall down whenever she was walking or whenever she was sitting down, she got a burning sensation in her chest, she felt like it was burning; it was just uncomfortable that burned. The patient was treated with ADVIL. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 10 year old female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 26Mar04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
A little more than an hour after receiving the shot My body broke out in hives all over it. My skin was red and splotchy everywhere. My skin was in credibly hot to the touch and tingly.  It remains that way for around two hours while I tried to contact a doctor or nurse. I was advised by the nurse to take an Antihistamine Which I did and Within about 40 minutes all of the symptoms were resolved. 48 hours later all of the symptoms returned and I again took an antihistamine and they resolved. 11 days after the second reaction all of the symptoms returned again. This time I did not take an antihistamine and they resolved on their own within an hour. Eight days after the third reaction all of the symptoms returned again. I did not take an antihistamine and they resolved within an hour.
patient diagnosed with MRI confirmed myocarditis following 2nd dose of Pfizer COVID vaccination
Fever 101.8 at 24hours; Fever 100.9 at 48 hours.  Fatigue. Achy. Nausea
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department.   Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
Flu-like symptoms; Malaise; Sore arm, like "hard to move"; Fever of 101F; Headache; Fatigue; Serious chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS (Patient has two heart stints). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 24-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101 (High) Body temperature high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included cardiac medications.
Janssen COVID-19 Vaccine EUA  - Severe chills.  - Fever symptoms. - Headache.  - Muscle Ache. - Tiredness.
Immediate tingling in chest, throat tightness and felt as if phlegm but had no phlegm, then ears clogged, then vocal changes sounding like frog in throat. BP went from 155/88 to 169/93.  96% RA  At 1628--Gave albuterol 2 puffs, symptoms improved. Then at 1655, pt c/o difficulty breathing, BP 161/100, EPI PEN 0.3mg given at 1658 and 911 called. BP 170/104, 78% o2sat on oxygen mask on 10L.  Chest felt tight.  EMS took pt to ER at 1715.
Vaccine given 5/28/15. On 5/29/15 pt was at school. After nap he "got stiff and was lowered to the floor" with "full body shaking". Episode lasted approx 1 min. After episode pt noted to have fever 102.9.
Acute nerve pain in right arm, right leg, and the right side of face. Started in ball of foot and radiated up to leg, then arm, then face, then eye. Sight affected. Numbness, tingling, burning pain in right arm, right shoulder, right leg. Affected strength, walking, and every day activities.  Treatment: Meloxicam before second shot. Severe allergic reaction, so treatment stopped.  Treatment: 1800 mg Ibuprofen per day. Improved symptoms, but it did not disappear.  Treatment: 1g Solumedrol for 3 days via IV. Significantly improved symptoms, but caused steroid withdrawal syndrome for a week after. Treatment: Lyrica 25mg. Stopped usage due to side effects.  Treatment: Tramacet 37.5 mg ongoing. As pain flares, I use this.
12 days after injection the left arm (injection area) is increasing in muscular pain and losing mobility.
3cm nodule right thigh started 2/3/03. Seen in office 2/5/03. No treatment.
This spontaneous report was received from medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX 0.5 ml, lot # N022856 with an expiration date 23-AUG-2019, subcutaneously for prophylaxis (anatomical location was not reported). No adverse effect was reported. Administered doses of experienced the temperature excursion form 15 degrees Fahrenheit to 46 degrees Fahrenheit (max temperature 25.4 degrees Fahrenheit) for 20 minutes and form 6 degree Fahrenheit to 14 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. Digital data logger was involved. This is one of two reports received form the same reporter.; Sender's Comments: US-009507513-1803USA009870:
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/08/2021. PATIENT FULLY VACCINATED ON 01/20/2021.
About two hours following shot, I began experiencing headache, soreness at the injection site, fatigue, and nausea (vomited once). Symptoms, without any additional vomiting, continued into the evening, where they dissipated (around 7pm), and returned early the next morning (around 3am). Once again, symptoms continued into the evening, before dissipating. I remained asymptomatic for 2 days, with nausea, headache, and fatigue returning Wednesday, August 11th (4 days following the shot). This is the first day I noticed blistering red bumps on my chest, beginning with about 3 (what I noticed without a full body inspection). Symptoms came and went (fatigue, nausea, headache) through the 11th and 12th. Friday, the 13th, I began have abdominal pains, and noticed a significant increase in the rash on my skin. It spread from my upper chest, to abdomen and some on my neck. I went to immediate care, believing I had the chickenpox (I had never had them before and do not believe I have been vaccinated). I was told I likely had them, it was still early to tell (according to Dr.). I was prescribed Valaciclovir, and instructed to take 3 times daily. Abdominal pains did not dissipate until the early hours of the morning on Sunday, the 15th, along with all other symptoms with the exception of fatigue. At this point, the rash had increased on chest and abdomen, with sporadic (minimal) bumps on my face, scalp, arms, and legs. The bumps became itchy and calamine lotion/hydrocortisone were used to soothe itch, along with claritin. It appeared that the spread of the rash came to a stop or decrease on the 17th, with scabbing beginning over the course of the next couple of days, though a few blisters still remain.
Thursday morning, I was at work, and then my scalp started itching really badly. At first, I thought I had lice. I work with nurses, so I had them look and they said nothing was there, but just red marks from scratching. The itching spread down to my neck and chest. Then my whole body was itching. I didn't have a visible rash. I only had scratch marks that was red from scratching. I went to an urgent care the next morning on 11/5/2021. The doctor said I could have had an allergic reaction to my new dryer sheets. I was prescribed Vistaril 50mg 1 capsule by mouth 3xday, and then I was sent home. By Sunday it was not getting any better, so I did a virtual care visit on 11/7/2021. My palms and hands were itching so bad. The doctor diagnosed me with hives and told me to take Prednisone, Benadryl, and Pepcid. I started that on Sunday.  On Monday I was still a little itchy, but I tried not to itch. Yesterday was the best day I had so far until in the evening when I got home. I felt like I had a full-blown reaction again. My skin has never been sensitive before. When I scratch a line pops up. This morning it has gotten a little better, but it is still impacting my daily functioning.
3 days, post vax, pt started to have "tingling in both hands and feet and felt itchy all over and this lasted almost a week". Now, 1 week later, it "feels better but still have a little itching/tingling in hands/feet".
Breakthrough case of COVID  - symptoms included sneezing, runny nose, cough, and headache
Swollen bilateral lymph nodes on armpit, left side. Fever, body aches. No such adverse effects on first 2 doses.
This spontaneous report was received from a nurse and refers to a to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses (about 4-5 doses) of PNEUMOVAX 23 lot # N011867, expiry date 08-NOV-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77°F for 10 hours (h) and from 32°F to 35°F for 12 h. No previous temperature excursions were detected. Digital data logger was not involved. No adverse effects were reported.
The symptoms were cough, a mild fever, runny nose, and general aches. I did a home test and went to the urgent care, and they treated me with PAXLOVID.
Dizziness; Vision Changes; Nausea; Headache; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, visual disturbance, nausea and headache. On an unknown date, the outcome of the dizziness, visual disturbance, nausea and headache were unknown.   It was unknown if the reporter considered the dizziness, visual disturbance, nausea and headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The caller was an HCP Field Representative called in the report on behalf of the Certified Medical Assistant.   The patient received Bexsero and had complaints of dizziness, vision changes, nausea and headache. The reporter did not consent to follow up. The Field Representative had no information regarding the two reported patients as for their gender or names or medication Lot Numbers or when the medication had been given.  The Field Representative stated she would give the Medical Assistant the case number I provided if she decided to call the GSK Response Center. This case linked with US2020AMR160355, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160355:same reporter
This spontaneous report as received from an unspecified reporter refers to several patients (reported as males and females) of unknown age. On 02-DEC-2014 these patients were vaccinated with RECOMBIVAX HB (dose, route not reported, lot# reported as K012933). The reporter reported this product had been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. Additional information has been requested.
FAST HEART BEAT  (102-118 bpm in prone position - for 18 hours).
My periods are never predictable anymore. Before the vaccine I always had periods that were pretty well predictable
I've noticed swelling and tenderness in the area between my collar bone and top of  my shoulder.  Also tenderness and achiness in my arm pit, same side as the vaccine.
On 9/01/2022 patient received expired Moderna with beyond use date of 8/26/2022.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received doses of GARDASIL lot # K009482, expiration date: 16-MAR-2017 and lot # K007858, expiration date: 02-MAR-2017 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Patient says she developed a rash on her upper body which was already resolving at the time she talked to me. It was 5 days later when she talked to me (after administration). I have no idea of the actual date and time I just guessed above. She said it as a couple days after the vaccine.
A spontaneous health professional report from a regulatory authority in an article, concerns a 19 year old female. The patient's medical history included cold sweat, nausea, dizziness, and difficulty reading numbers on the day prior to death. Concomitant medications included quadrivalent human papilloma virus vaccine and meningococcal conjugate. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date. The patient died 10 days after these vaccinations from unknown causes. Despite an extensive post-mortem examination including autopsy and microscopic, neuropathological, toxicological, and chemical evaluation, the immediate cause of death could not be ascertained. Autopsy revealed no obvious cause of death. The reporter assessed the death to be serious by the criterion of death.