chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acetylsalicylic acid (Aspirin) for fever, pain and fatigue.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2020223951).   On 11th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Aspirin at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Aspirin, the patient experienced fever, general body pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix in left arm and experienced fever, aches, pains, and fatigue with a low grade fever.   The patient pretreated with aspirin and had the same reactions.   The symptoms lasted 24 hours and then resolved.   The reporter consented to follow up and could follow up with the physician directly.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020AMR224651:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter
12/28/2020 Vaccination 12/30/2020 'wiped out', extreme fatigue, malaise, extreme HA, sore throat, nausea. I left work due to feeling unwell. Symptoms lasted for approximately for 3-4 days.
The patient lost consciousness about 5 minutes after receiving the vaccine. He immediately regained consciousness and EMS was called. The patient fainted again while EMS was taking vitals. He went to the ER and they found nothing wrong. He admitted to a huge fear of needles.
Lymph nodes in left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes in left arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 06-Jul-2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in left arm). At the time of the report, LYMPHADENOPATHY (Lymph nodes in left arm) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Fever, chills, muscle spasms, headache x 9 days. Lesions, cold sores on gums x 2-3 weeks. Facial neuralgia (unknown course).
unauthorized age (16 year old received Moderna vaccine); This case was received via regulatory authority (Reference number: 126869) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment product use was not provided by the reporter.
Two week after 2nd dose, leg swelling, shortness of breathe, extreme fatigue, couldn't get of bed. Depression. Extreme weakness, low energy.  Diagnosed with heart failure and leaky valve. Hospitalized in August. Symptoms also occurred after Booster shot (10/2021).Heart palpatations, shortness of breath, fatigue. Perscribed forminacide. Received flu shot and booster at the same time. Grateful to report symptoms. Doctors are unhelpful and unsupportive.
No side effects the day of the 1st vaccination.   On Sunday 2/21, I wok up with an extremely sore arm at injection site  and it felt like there was a knot the size of a golf ball underneath my skin.  On Monday, 2/22 I developed a large red circle around the injection site which grew in size along with the sore "knot" growing in size.  The red circle was not an outline.  It was a large red circle completely filled int.  The circle grew to about 3.5 - 4 inches in circumference and itched.  It peaked on 2/24.  The size of the circle and the "knot" started to reduce and by 2/28 the circle was gone and only a slight tightness at the injection site remained.  We took a photo on the "peak" day.
First 72 hours muscle pain, aches, fever, chills, headache, exhaustion, weakness, inability to do daily activities like walk, cook, grocery shop, work. First week fatigue, unable to play tennis, total body pain in every muscle affecting ability to sleep due to level of pain One and a half months later every single day systemic muscle pain continues in body: neck, face, jaw, Shoulders, upper back, lower back, tailbone pain, gluts, thighs, ankles, feet and arms and hands. Constant desire to stretch with no lasting benefit. Sciatica flare. Difficulty driving longer than a few monites, hard to sleep due to pain, no position alleviates pain. Pain in all muscles and feels deep in kidney area. All muscles affected and has not stopped since day one. Not one day of relief.
Headache, small hives around neck and chin, body aches, lasting 2 days-Wedn. and all day Thursday.Woke Friday morning, feel fine.
Patient said he felt very hot, then cold and clammy, felt weak, turned very pale in the face. He was given liquid benedryl and some water. He felt better in just a few minutes (about 10 minutes). He said he was fine later that evening and the next day.
5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-7/10 and has decreased mobility of shoulder. sporadic burning sensation in arm between elbow and wrist.
shingle outbreak; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and 2 months prior to report, she had shingles outbteak. The patient did not received 2nd dose of Shingrix till the time of report, which led to incomplete course of vaccination.
Received pneumovax injection in left thigh on 10/29/07.  Several hours later complained of pain at injection site.  Had redness at injection site. No swelling. Had pain severe enough that patient was unable to ambulate on leg for 48 hours.  Patient on medications for pain prior to this incident.  Patients primary MD consulted (and saw patient)and ordered site to be intermittently iced.  Pain and inability to ambulate resolved within 48 hours.  This information was reported to Certified Home Care Agency providing vaccine 22 days after incident occured.
Site: Pain at Injection Site-Mild, Systemic: numbness/tingling/pain from hips to feet, unable to move-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: numbness/tingling/pain from hips to feet, unable to move. Happened later in day when patient was home, was hospitalized and hospital came to decision that it was flu vaccine and asked to file VAERs report.
Patient indicated to receive (per Standing Order and CDC/ACIP Guidelines) and was provided PREVNAR 13 and FLUZONE HD on 9/29/17. Patient reports over the next 24-48 hours developed chills, fever, general malaise, nausea and emesis x1. Self taken to Hospital ER on 10/1/17 (per ER, was seen by Dr. att 11:15am). Patient reports she received IV Fluids and was given numerous test. Physician diagnosed that she was having a reaction to the vaccinations she received 2 days earlier.
Half an hour after receiving vaccines pt started sneezing, developed nasal congestion and hives. Mother returned to office. Child examined by MD-epinephrine 1:1000 0.15 given. Albuterol tx given. Symptoms resolved after 5 min.
Initially with fever, progressed to chills. redness to right arm at injection site down to elbow and  site hot to touch
Severe swelling of face around eyes nose and cheek area.  Tingling of tongue, pressure at lymp node areas.
Patient received a first dose Covid vaccine (013A21A) 0n 3/16/2021 and received different manufacturer (EN6202) as his second dose on 4/13/2021. No adverse events at the time of the vaccine.
Information has been received from a Registered Nurse concerning an unspecified number of patients who on an unspecified dates were vaccinated with all 3 doses of RECOMBIVAX HB (Lot # unknown). Then years later, the patients presented with low titers. She stated these patients were usually given 1 dose of RECOMBIVAX HB and then titers were conducted. The patients were usually found to have a titer indicating coverage. The outcome of the patients was not reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Case number PHEH2013US024962, is an initial spontaneous report received from a physician on 25 Nov 2013 with the follow-up received on 07 Jan 2014. This report refers to a 71-year-old polymedicated female patient. Her history conditions included chronic pain, coagulopathy, hypertension, dyslipidemia, insomnia, gastrooesophageal reflux disease, eczema, multiple allergies, osteoarthritis, chronic obstructive pulmonary disease, hypothyroidism, depression, factor V Leiden heterozygote, acute vomiting, hypoxia, dehydration, pneumonia, elevated liver enzymes, atrial fibrillation, peripheral edema, hypercholesterolemia, acute renal insufficiency, itching, headache, allergic rhinitis, osteopenia, deep vein thrombosis, fibromyalgia, cholecystectomy, hernia repair, hysterectomy, tonsillectomy and B cataracts. She was an ex-smoker. Her family history included father alive with heart disease. She was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature 0.5 ml intramuscularly into left deltoid on 18 Nov 2013 at 16:32. The reporter stated that the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for 6 hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. Vital signs which were performed on 02 Dec 2013 were normal. No more information was available. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, family history, concomitant medications, site and time of vaccine administration.
mild case of uveitis in let eye being treated with Durezol eye drops and Atropine Sulfate Ophthalmic solution
muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 (at the age of 81 years old), for COVID-19 immunisation. Medical history included highly allergic to some medications and bleeding disorder (she was on a blood thinner). Concomitant medications were not reported. On an unspecified date the patient experienced muscle spasms and spent 3 days at the hospital. She had to go again on an unspecified date in Feb2021, she got a lot of illnesses, she was also on a blood thinner and was highly allergic to some medications. Since an unspecified date she had really bad fibromyalgia. All these symptoms were usual for the patient, other than the runny nose. She needed to get a hold of her doctor, she had a follow up like right now. She wasn't supposed to go (for her appointment) until the 23Feb2021. She was scheduled for the second vaccine dose on 08Feb2021, however she was in the hospital and was wondering if it was too late. Events outcome was unknown. Information on the lot/batch number has been requested.
1 day after vaccine, experienced fatigue and a fever of 101.3 at 6PM. Temperature at 9:30 PM was 99.5. Left arm was painful to touch and swollen. Facial and neck tics began to increase. 2 days after vaccine administration,  temperature was 98.6. Arm was red, swollen and painful to touch.
Hypothyroid; This spontaneous case was reported by a medical assistant and describes the occurrence of HYPOTHYROIDISM (Hypothyroid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 06-Apr-2021 to an unknown date for Hypothyroidism.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (Intramuscular) 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOTHYROIDISM (Hypothyroid) (seriousness criterion medically significant). At the time of the report, HYPOTHYROIDISM (Hypothyroid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown  if the patient had acute illnesses at the time vaccination and up to one month before. Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced unexpected serious (medically significant) event of hypothyridism, which occurred 9 days after second dose of mRNA-1273. Vaccine. Patient started on LEVOTHYROXINE SODIUM 75 microgram once daily, At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-666042 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced unexpected serious (medically significant) event of hypothyridism, which occurred 9 days after second dose of mRNA-1273. Vaccine. Patient started on LEVOTHYROXINE SODIUM 75 microgram once daily, At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Hives developed over entire body at 6 hours post vaccine and lasted for 12 days. Treated with prednisone.
pt recvd vax 3PM & @ approx 8PM became limp, unresponsive & ashen lasting a few seconds; for several hrs did not respond normally so took to ER; by then was responding nl; seen by MD;
This patient is one of a cluster of 15 patients that had an injection site reaction characterized by erythema, pruritus and nodule at the injection site. Lasted 24 hrs to 1 week. No treatment given.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medication were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
flu- like symptoms; no energy at all; Nausea (thrown up once); very achy; fatigue; on and off fever; Nausea (thrown up once); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy at all), PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue) and PYREXIA (on and off fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AZITHROMYCIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN (very achy), FATIGUE (fatigue), PYREXIA (on and off fever) and NAUSEA (Nausea (thrown up once)). On an unknown date, the patient experienced ASTHENIA (no energy at all), INFLUENZA LIKE ILLNESS (flu- like symptoms) and VOMITING (Nausea (thrown up once)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue), PYREXIA (on and off fever), NAUSEA (Nausea (thrown up once)) and VOMITING (Nausea (thrown up once)) 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.
severe headache, dizziness, vomiting,  elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
Right shoulder, Right Bicep and neck became stiff 3 days (8/23/21)  post 2nd COVID vaccine.  I notified my physician a week after symptoms started (8/30/21) as I was not sure if this was just a side effect of immunity building but she does not feel it should be this severe.  My pain level is 7/10 and I am unable to move my neck, I can not lay down as this makes the pain a 10/10.  As of 8/30/21, the pain continues to be right shoulder, right bicep area, neck and is now is starting to travel down my right arm past my elbow and is radiating into  the right side of my jaw.
Syncope from sitting position after administration of HPV. Hit face on desk and (L) cheek contusion no dental or mycosal trauma.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was taken to an ER on 3/23/21 for sepsis. Notes say he later passed from cardiac issues on 3/31/21. Patient had a history of prostate cancer, Afib on anticoagulation, Atrial flutter, obesity, diabetes, HTN, coranary arteriosclerosis, and myocardial infarction.
I had some type of infection on my knee and my groin area, and it progressed to upper belly, and Sepsis. Needed emergency surgery for the doctor to put tubes in and drain it. Problem was resolved. Bacterial infection was called Cellulitis.
Patient was here for her 2nd Moderna vaccination, along with her son who was receiving his 2nd Pfizer. Pt was given Pfizer vaccination for her 2nd dose. Patient waited her 15-20 minutes post vaccination time, no signs or symptoms of reaction.
I was feeling heat in that deltoid muscle area and some achiness and itching. I didn't really pay much attention to it until about 2 weeks later the vaccine. I thought this should be going away and I took a look at it and found that there was probably the size of a baseball size area that was inflamed with a patchy rash. Somewhat resembling hives. There was definitely demarcation between the round area surrounding the site of the injection and lower down on the arm. Maybe a little bit larger than a baseball. I saw the doctor and she didn't really know what to make of it and told me there was someone else, another provider, who had a similar experience. She said that it was probably my body forming antibodies but basically, it was kind of an anomaly. I didn't realize until about July that it was actually a reaction that was widespread enough that it would be recognized as a reaction.
On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 10 I had to go to an urgent care because my left knee hurt and I was limping, on April 11 In April I went to the emergency room because I had a very strong pain in both legs, I could not walk and a severe headache, I also had a fever.   On Monday the 11th they operated on my left knee because there was a lot of inflammation, that same day the second knee became inflamed, I was hospitalized from April 11 to 17 with a lot of pain in both legs.   On April 21 I continued with a lot of pain and swelling in both legs and even in the ankles there was swelling. A rheumatologist doctor, because of the laboratory tests she conducted, did come to the conclusion that it was reactive arthritis caused by the Pfizer vaccine.   Today June 1, 2021, I still have pain in both knees and ankles, especially the right one, both knees and the right ankle are a little swollen, until May 24 I walked with a walker and I did it with too much pain.