chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had COVID-19 he had a temperature and chills and after 3 days he was gone.; Little temperature and after a day or two it went away; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA and RSV VACCINE. Past adverse reactions to the above products included No adverse effect with INFLUENZA and RSV VACCINE. Concurrent medical conditions included Hashimoto's thyroiditis.    On 07-Oct-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away). At the time of the report, COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient stated he was in clinical trials for the Moderna COVID-19 Vaccine back in 2020. The other Moderna vaccines that he took in the trials had a reaction. Now he took SPIKEVAX with influenza and RSV, but he had almost nothing. About a month ago he had a COVID-19 infection. The only difference in 3 years was he wasn't infected until a month ago. He wanted to try Paxlovid, so he went to the ER to get it which had something to do with him testing positive. His reactions from the original vaccines consisted of a little temperature and after a day or two it went away. When he had COVID-19 he had a temperature and chills and after 3 days he was gone. He said the first day if felt like he got hit by a truck. On day 2 it felt like he got run over a truck day and on day 3 it was blue skies again. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745291, US-MODERNATX, INC.-MOD-2023-745916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745291:Same reporter, Invalid case US-MODERNATX, INC.-MOD-2023-745916:Same patient, different vaccine (Spikevax 2023-2024)
Several months after booster started getting itchy blisters on arms, torso, head and neck.  Start out as red and than blister.  Extremely itchy.  Has been ongoing since early 2022 with no relief.  Patient is up all night itching.  The only relief is when she is on prednisone.  Have tried topical ointments and nothing helps.  When one breakout ends, another starts immediately..
Diarrhea onset 1 day post-vaccine.  Continued 4+ weeks with several periods of no stool for 1-5 days in between.  4 episodes of intense, nonstop screaming for several hours between 2 & 3 weeks post-vaccine.  Mild eczema-type rash on legs.  Irritibility, difficulty sleeping, fussiness & crying when trying to feed.  X-rays, bloodwork, stool cultures all normal.  Consulted pediatric gastroenterologist.  Presumed dx - milk protein allergy.  Breastfeeding mom eliminated all dairy from diet & supplement with Nutramigen when needed.  Rash continued & more dry, rashy patches appeared on trunk & face while supplementing with Nutramigen.  As of report date, stopped supplementing & is exclusively breastfeeding (with no milk products for mom) to see if rash resolves.  Diarrhea ceased 4 weeks post-vaccine but stools still not regular.  Parent notes that vaccine baby received contains milk protein.
About three weeks after receiving the vaccine and returning from a river cruise, I developed tiny welts on both legs. My skin was very itchy and irritated. I took over the counter medicine to try to help with my symptoms, but it didn't work. I had a regular six-month appointment with my dermatologist, and I had her look at them. My primary doctor thought I had scabies, but my dermatologist said no. No test was preformed to diagnosis. It's been several weeks since my last breakout, but I had one last week. I have scars on my legs from these welts.
Adverse effects after 1st dose: Nothing happened until exactly 24-hours later. Then the next day, from 3:00pm to 11:00pm: bad chills, body aches, no headaches though, tiredness, low energy, feverish. Took 2 sets of 2 tylenols. After 11pm, everything cleared.  Adverse effects after 2nd dose: BAD!!! Injection was at 2pm, reactions started by 4pm. All of the effects from the 1st dose but almost doubled in intensity and lasted 2-3 days: feverish, tiredness, unable to move body, body aches, muscle aches, headaches. Unable to work during those days!!!   Then additional effects: VERY heavy, torrential period! 1st day of period was Tuesday, May 18, one day late.   Then: Herpes outbreak on the anus (first outbreak in a long time).    WORSE EVENT YET: Around May 18, my ear was itching. I naturally have ear fungus that has been easily treated over the years. But this one did not go away.  I tried to apply the cream, clean. Nothing. By Thursday, I felt an inflammation. By Friday afternoon, I could not hear much from the left year and the right year was starting to be itchy too. Went to a Urgent Care, the RNP prescribed a drop and told me to take Ibuprofen if needed. By 10pm that night, I was in excruating pain: fever, chills, body aches, muscle aches, the ear pain gotten really bad (never experienced this level before), unable to chew, gotten really cold (needed 5 blankets). Long night. By morning, I went to the walk-in clinic of my healthcare provider - VERY sick. The ear has gotten worse and the NP explained that the body was probably unable to fight the small infection in the year because body was still under the virus effect. With my science background, I am afraid that she's right and/or that the Moderna covid vaccine has suppressed my natural immune system!!! I had a really strong immune system prior to the vaccine, records will prove it. Got sent to ER. They never took me seriously when I said that this is ALL related to the vaccine!!! Got a CT Scan, luckily the infection did not make it to the brain. They prescribed an antiobiotics and let me go. Now, ear pain moved to the right. I can't hear.
Having trouble breathing when talking; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 65-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 17Mar2021 13:15 as dose 1, single (at the age of 64-years-old) for COVID-19 immunization and received unspecified Pfizer vaccine (Lot Number- Er8737) via an unspecified route of administration in left arm on 17Mar2021 as dose 2, single for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not had COVID-19, prior to vaccination. Patient underwent COVID-19 (nasal swab) test with result as negative. Patient medical history included Multiple Sclerosis. The concomitant medications were not reported. On 30Apr2021, the patient experienced trouble breathing when talking. The pulmonologist inhaler prescriptions did not alleviate any symptoms. The adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient received treatment as pulmonologist tests with unknown results and medications. The outcome of the event was not recovered.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of an unknown demographics who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB (expiry date, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that patients were injected with previously frozen 0.5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Patient developed a nose bleed approx. 15 minutes after the vaccine was given. The nose bleed lasted about 5 minutes. The pt. had no other complaints or S/S at that time. Pt. held pressure to his nose. Pt. stated that he had a history of nose bleeds. Mom attempted to be reached. Spoke with mom about 2 hours later and she verified that the pt. did have a history of nose bleeds. Instructed to monitor the pt. for the rest of the evening and call with any concerns.
Large, hardened nodule at injection site approximately 2 inches in diameter, swelling, redness, itching
joint pain bilateral arms, hands and hip; swelling of glands under left arm; Left shoulder frozen; This is a spontaneous report from a non-contactable nurse, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, post injection, the patient experienced joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen and ongoing pain was 8/10 past the 4 week. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658176/1011U). It was reported that a series of parents have been calling since the administration of the second dose of varicella virus vaccine live (Oka/Merck) to report that the children are experiencing local non-systemic reactions. The patient's parent sought medical attention via a phone call to the child's physician. Subsequently, the patient recovered at an unspecified date per the nurse "because no parents called back after initial call'. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
She's still experiencing severe muscle fatigue; muscle cramps; twitching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MUSCLE FATIGUE (non-serious), outcome "not recovered", described as "She's still experiencing severe muscle fatigue"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "muscle cramps"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "twitching".  Additional information: Reporter had the first dose of Pfizer Covid-19 vaccine 5 days ago (17Apr2021) and she was still experiencing severe muscle fatigue, muscle cramps and twitching. Reporter wanted to know if those were normal side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. states that after receiving the 1st dose of Moderna 08/31/2021, started experiencing symptoms that evening of low-grade fever, pain throughout the arm, fatigue, and nausea. Lasting estimated 72hrs. 09/08/2021 noticed red welp around the injection site with fever to touch and painful. Hard knot noticeable at the injection site. No known Primary visit.
Little soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 23-DEC-2022. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient reported a little soreness for a couple of days and that was all.  Patient reported that much easier than putting up with an outbreak of either.
nightmares; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy NOS. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) and over-the-counter (OTC) unspecified medication for allergy, from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced extreme fatigue and nightmares. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 17Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events extreme fatigue and nightmares. The clinical outcomes of the events extreme fatigue and nightmares were not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PT WAS ADMINISTERED PEDIATRIC PFIZER. SHE FAINTED AND HIT HER HEAD ON THE FLOOR WITHIN A COUPLE OF MINUTES OF ADMINISTRATION. EMS DETERMINED PATIENT HAD LOW HEART RATE AND LOW BLOOD PRESSURE. RECOMMENDED TO TAKE TO ER
She received vaccine #2 on 02/04/2021. In the wee hours of the morning 02/05/2021, she had at least two episodes of seizure.  she was found gurgling, hypoxic, jerking of arms.
shoulder pain day of vax, itching, swelling, warm at injection site, redness. ER on 12/26 stated that vaccination may have been injected incorrectly, possibly lower than should have. ER gave Benadryl to pt.
On 6-4-2022, I started having severe headache, bilateral ear pain, sore throat, body aches, chills, head congestion, runny nose and severe fatigue. I took a Covid home test and it was negative. The next day I started having sneezing and a cough so I took another home Covid test and it was positive. On 6-6, I called the doctor and had a telehealth visit. We talked about the antivirals but we decided against those. I just took OTC ibuprofen, cold calm and increased my guaifenesin. I am better today but still have head congestion, mild sore throat, cough and runny nose with occasional sneezing. I am reporting my breakthrough case of Covid.
Sudden onset high fever 102.7 F, chills, sweats, back aches.
I had them the same place you did/Suspected Vaccination failure; I had them the same place you did; have some nerve damage; caused some pain to return; 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, nerve damage and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient had some nerve damage. The shot activated the nerves somewhat, no breaking out, but caused some pain to return. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Note    Does the patient have current symptoms of illness? Yes    Date symptoms started: 5/16/21   1.         Does the patient have a fever (subjective or confirmed)? No   2.         Does the patient have a new onset of cough? Yes   3.         Does the patient have a new onset of shortness of breath? Yes, slightly with exertion. NAD. ?  If Yes: Is the patient having difficultly breathing or in distress? No   4.         Additional symptoms: Congestion, runny nose, nausea and vomiting.  Bronchitis Suspected COVID-19 virus infection Chest pain, unspecified type  Progress Notes Encounter Date: 5/25/2021 ? ? Signed    Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions    Instructions  COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide     MAB Infusion Treatment Team:
3 hrs after shot, sore, throat, hoarse voice, tight feeling in neck, increased effort to swallow, white of eyes became redden and thick white drainage from both eyes. Increased difficulty breathing. Events occurred 11/2/2010.
Bruising at injection site and now two weeks later a rash has developed under the injection site. It is red, not raised.  It covers an area about one inch by one inch
Shortness of breath, irregular heartbeat and racing, faintness, nausea, vomiting
Patient noticed a knot in his left arm after immunization. A few days later, the knot turned into a bruise and (as of reporting), it was healing and returning to normal color.
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 male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 09-DEC-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:
Thigh and groin paresthesia, cognitive confusion,  and intense arthralgia from 1/27/21 2:00 am to 12:00 pm.
Approx 10 minutes after imm's given patient became very pale, dizzy, diaphoretic and c/o nausea. Patient transferred to bed via w/c and lies down in dark room. Ammonia inhalant used prior to patient being transferred to w/c. Pt requires a very cool compress, applied. H2O, bed monitors X 20 minutes with no further c/o. Left facility with no issues or complaints. Mother present.
Dizziness, body aches, chills, fever, loss of feeling in arm w/ injection, sweating, loss of appetite, a lot of pain and near death feelings!
Arm painful from the shoulder down to the elbow/ sharp toothache type pain; bone lesion; cyst on my left arm; barely lift my arm over my shoulder; Bone hurts; skin itches; Rash in the vaccination arm; My left arm is swollen it is very painful from the shoulder down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow), PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm) and MOBILITY DECREASED (barely lift my arm over my shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm). At the time of the report, PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow) had not resolved and PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm) outcome was unknown. Not Provided          The concomitant history was not reported. The treatment history was not provided.