chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease aggravated.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medications were provided by the reporter.  Patient had taken HUMIRA drug as solution for injection in pre-filled pen.  No treatment information was provided. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event and administration of first dose of mRNA-1273 was not specified, hence latency could not be assessed. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The event was unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event and administration of first dose of mRNA-1273 was not specified, hence latency could not be assessed. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The event was unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Case number PHEH2014US025057, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tofacitinib citrate. On MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight headache was not reported. This report was non-serious.
4 cm diameter redness, swelling, mild tenderness around injection site to anterior (L) thigh. Child walking well. No fever. BENADRYL & pain reliever administered.
Vaccine doses administered 23 days apart; Dizziness; Headache; Nausea; Body aches; Extreme fatigue; A spontaneous report was received on 08-Feb-2021 from a pharmacist concerning a 54 years aged female patient who received Moderna's COVID-19(mRNA-1273) and developed severe headache,dizziness, nausea, body aches, extreme  fatigue, and the vaccine doses administered 23 days apart.  The Patient medical history includes several autoimmune disorders.  Concomitant medications include tylenol, aleve, enbrel, and muscle relaxants.   On 06-Jan-2021, patient received her first dose  of mRNA-1273 (Batch:unknown) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of covid-19 infection.  On 29-Jan-2021, prior to the onset of events patient received her second dose of mRNA-1273(Batch;041L20) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of Covid-19 infection.  On 29-Jan-2021, patient experienced  severe headache, dizziness, nausea, body aches, extreme fatigue that resolved on 08 Feb 2021.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of the events were recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 041L20)  with reported associated AEs after the second dose of severe headache, dizziness, nausea, body aches, and extreme  fatigue. Based on the current available information and temporal association between the use of the product after the second dose and the start date of the events, a causal relationship cannot be excluded
lady screaming while being vaccinated; black and Blue arm injection site; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
50 y.o. man with musculoskeletal symptoms affecting mostly shoulder and hip girdles consistent with polymyalgia rheumatica (PMR).   He has had stiffness and pain in his shoulders that have affected his mobility.  He also has had some symptoms in his hip girdles but small joints of hands and feet have been largely spared.  He also had an almost immediate and complete response to moderate dose of prednisone but had recurrence of symptoms when discontinued.  Overall, the pattern of his symptoms and rapid response are most consistent with PMR.  On physical exam, he did not have any involvement of small joints of his hands.  He does not have any symptoms typically associated with Giant Cell Arteritis.  I discussed with him that the cause of PMR is not known but can there is higher incidence in individuals with a similar background like his.  I also discussed the treatment for PMR and have provided written instructions regarding a prednisone taper.  He is interested in received a third shot of the Moderna vaccine when available and will let me know if he has worsening of his symptoms at that time.
PATIENT STARTED COUGHING AFTER RECEIVING THE VACCINE.  BROUGHT TO MED OBS 1  BP 168/85 HR 86 RESP24 OXYGEN STS 99 ON ROOM AIR SHE STATES THAT SHE HAS BEEN HAVING HEADACHES, CHILLS PRIOR TO VACCINE, HER DOCTOR TOLD HER THAT THEY DID NOT WANT HER BP OVER 130/70 AND IT WAS 112/68. SHE STATES SHE HAS DEVELOPED SOME PAIN IN HER SHOULDER 10:07 HR 87  RESP 22  BP 155/87 LEFT ARM  OXYGEN SATS 100% ROOM AIR 10:12 HR 83  RESP 22  BP 140/83 LEFT ARM OXYGEN SAT 98 ROOM AIR 10:17 HR 73 RESP 18  BP 139/80 LEFT ARM  OXYGEN 100  PATIENT FELT BETTER SHE LEFT AT 11:15 WITH A FRIEND
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. On 21st July 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain and injection site numbness. On an unknown date, the outcome of the injection site pain and injection site numbness were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site numbness to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced arm pain and numbness which were localized, after administration of BEXSERO on unknown arm. There was no redness at the injection site. At the time of reporting, the pain and numbness were getting worse.
Pt c/o of left hand itching  at 1712. Gave Benadryl po 50 mg.  No c/o of repiratory distress, throat edema, chest pain.  VSS. 138/58 HR 86 O2sat 98%.  At 1740, pt reports no longer itching. 1813 BP 138/70 O2 sat 100 % HR 74.
Urticaria all over body. Given epinephrine & BENADRYL. TB skin done same time when vaccine given.
I do not know the exact date and time of her hair loss.  She had the shot on 8/17/15 and by 9/01/15 we started seeing her hair fall out. She has realy long straight hair. You can see hair spiked up near the scalp - meaning it's noticeable. I assumed that this is because her hormones are changing, however, I have never seen an 11 year old with hair falling out like this. Two days after the shot, she had a brief period and hasn't started her period since that time.
Immediately after getting the vaccine, I felt my heart race. I was a little lightheaded, but I thought it was normal, so I didn't notify the healthcare workers. Approximately, 20 to 30 minutes after the shot and after leaving vaccination facility, I had chest pain and shortness of breath, which stopped after about an hour. About 6 or 7 hours after the vaccine (9 or 10 pm), I started having shortness of breath, cough, mucus in my throat, slight chest pain, shivers and trembling (temperature was about 36.8 Celsius). At some point, for a few minutes, I felt lightheaded, dizzy, my speech was slow, slurry and I had brain fog. After some hours, the symptoms receded. I was able to fall asleep at about 3 am. The next day, I only felt a little shortness of breath and body aches. The second day after the vaccine, I felt almost normal except for a lingering, occasional shortness of breath.
Last night fever 104 R in only seconds; Pt was vomiting called the ER & was told to give tylenol supp; This AM fever 101R not vomiting now;
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced cellulitis (serious criteria GSK medically significant) and local reaction. On an unknown date, the outcome of the cellulitis and local reaction were unknown. It was unknown if the reporter considered the cellulitis and local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine the age group was captured as adult. The pharmacist stated that he noticed that the patients who received SHINGRIX often get localized reactions on their arms but closer to the elbow (refer case US2018GSK150513). The reporter had also noticed that one patient did get cellulitis (concerned in this case). The pharmacist did not have specific patient and vaccine information and he made a general comment on what he had been noticing. This case has been linked to the US2018GSK150513, reported by the same reporter.
pt recvd vax; 1 hr after vax pt devel hives & anaphylaxis;
Green circles that appeared on my arm; A spontaneous report was received from a female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Green circles that appeared on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01-Jan-2021, on Friday prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route at unknown anatomical location  the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events green circles that appeared on arm. (skin discoloration).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This is a spontaneous report from contactable consumer. A 29-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) intramuscularly, administered in Arm Right on 04Mar2021 12:00 as single dose and dose 2 intramuscularly, administered in Arm Left on 26Mar2021 12:00 (Batch/Lot Number: EP7533) as single dose (at the age of 29-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Aug2021, patient experienced breakthrough Infection, patient tested positive for COVID 19. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 09Aug2021 Nasal swab. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
One hour after shot I had a full upper body rash that lasted for 3 days. 5 days after shot, my left hand starting tingling and it traveled to my entire left side of body.  Over the next 9 weeks, the tingling, numbness, buzzing, joint pain and over all shocking sensation traveled all over my body.  My fingers and toes were numb, parts of my hands and legs would fall asleep and go numb.  I couldn't touch my skin because it burned.  My legs felt cold even when I was warm all over.  It feels like someone is holding the inside of my foot.  7 months later I feel my left side buzzing at night, hands still tingle. Spine aches. I get a cold sensation in my legs.  I still have two numb toes.
The patient started a Johnson and Johnson series and should have not received the Pfizer vaccines.  At the points of sale we had a name change at the register and they received the Pfizer vaccine after the Johnson and Johnson vaccine was given.
My period started right on schedule on the same afternoon the vaccine was administered. In the two days following the vaccine, I experienced muscle aches, fatigue, a slight headache, lack of appetite, chills alternating with hot flashes, and a fever that topped out at 102F. These symptoms subsided by the morning of April, 3, 2021 and I felt pretty good all day. The night of April 3, 2021, I felt an intense pulse in my left neck and palpitations in my lower left chest every six heart beats or so. This was very unusual as they started suddenly when I was relaxing on the couch watching TV and I had never experience such symptoms before. Blood pressure and heart rate checked on an at-home blood pressure monitor were slightly elevated from normal and blood oxygen levels were normal as measured on a pulse oximeter. The frequency of  the palpitations subsided in the days following; however, on April 18, 2021 I was doing some moderately intense yard work after which the palpitations returned and I could feel my heart beat throughout my neck and back. I was unusually exhausted and took a three hour nap on the floor.  Bloodwork, an ECG, an extended halter monitor, an echocardiogram, and more bloodwork were done late April and into May. The diagnosis was premature ventricular contractions with no other abnormal findings. The last week of June I was started on daily 25 mg tablets of metoprolol succinate which significantly reduced the occurrence of PVCs, but not the abnormal symptoms of chest pain and exhaustion after moderate to strenuous activity. I still have periodic episodes if PVCs which I monitor at home with a ECG monitor.
chills, body aches, injection site soreness, nausea, fatigue, low grade fever
Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms.  EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired.  She continue to wait for 30 minutes, she had 1 episode of emesis and felt better.  At the site with no issues.
Pt subsequently developed recurring emesis, diffuse hives, and difficulty breathing.  Patient placed on pulse oximetry and given 5 ml of Children's Benadryl po.  Pt's O2 Sats decreased to 85%.  He was then placed on O2 at 2 L by NC and he was administered 0.15 mg Epinephrine i.m.  Pt showed marked improvement with resolution of his increased WOB.  EMS was contacted to transport patient to the hospital for further evaluation.
Mom called stating the pt had knots @ the injection sites to both legs but seems to be worse on the L leg. Pt acts like the L leg is uncomfortable @ times, 0 bruising, 0 erythema, 0 drainage, 0 fevers. Also c/o L leg spasming @ times. No other complaints
The patient had a localized reaction with a 20 minute induration, larger erythema with pruritus.
Light headed Narrative: Patient became light headed after injection. we reclined her chair and put her feet up. She stayed with us for 30 minutes and returned to baseline.
swollen tongue and throat; great difficulty talking and swallowing; eating impossible at times; food must be pulverized;. These reactions have been since the second vaccination and are ongoing. They seem to get better at times but then get worse. I have no medical insurance and do not qualify. Medical does not recognize me and I am unable to complete my application.
Extreme spike in blood glucose, 197 mg/dL 04/17/21(AM fasting) 235 mg/dL 04/18/21(AM fasting) Usual AM BG is 130 to 145 mg/dL BG read April 19 (today) is 139 mg/dL. Also experienced fatigue, arm pain and COVID arm for 5 days.
vomiting; diarrhea; fatigue; weakness; chills; severe aches/pains; a "big welt" on her injection arm site; she can't keep food or water "down"; This is a spontaneous report from a contactable consumer via medical information team. This consumer reported for female (mother) patient that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Mar2021 (at the age of 73 years old) as single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the evening after receiving the dose she experienced fatigue/weakness, diarrhea, vomiting, chills and severe aches/pains. She had a big welt on her injection arm site, she can not keep food or water "down" on an unspecified date in Mar2021. She has been to the hospital 2 times. Each time she goes into the hospital, the MD gives her IV fluids and then sends her home. She wanted to know what to do to help her mother. The patient received treatment due to a diarrhea, vomiting with IV fluids and big welt on her injection arm site, she can't keep food or water down. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient called day after immunization, complaining of sore arm, fatigue, myalgia, and chills.  Patient had not yet tried anything for relief. Patient was advised to take acetaminophen (patient cannot take NSAIDs) for flu-like symptoms, can use a cold compress on injections site, and use of diphenhydramine if necessary. Advised patient to follow up with physician if symptoms do not get better/resolve/worsen.
Child developed a massive PANDAS OCD Flare and possibly cytokine storm.   He ended up in the hospital asking to die because OCD thoughts became over whelming.  Child has had PANDAS for 6 years and never had an incident like this.
About five hours after I received the vaccine I began to run a fever that averaged 102 degrees fahrenheit. At that time I also developed chills and extreme fatigue. These symptoms persisted until I fell asleep at 10:00 PM 3/13/21.  I was awakened at 1:00 AM with severe muscle spasms in my left bicep and a fever of 102.5 I started taking tylenol to begin reducing the fever. I also lost my appetite around that time. Things were pretty much the same all day 3/14/21. I went to sleep at 10:00 PM I got up every four hours to take tylenol. I woke up at 7:00 AM 3/15/21 to prepare for work my bed sheets and shirt were soaked with sweat but my fever was gone. I ate breakfast and drank a cup of coffee. When I got to work I begin having stomach problems.  When I started working I noticed that I was having a lot of trouble concentrating. I decided to leave early to go home and rest. Things have improved since then but I do have a headache that won't go away.
Patient states that she had muscle spasms on the right side of her face by her lip on 6/11/11 and then again on 6/26/11.  She said it lasted about an hour each time before subsiding without intervention.
Sedation, Arthralgia, Sweating, Chills Narrative: On 1/21/21 (day after the 2nd dose) noted sweating, chills, fatigue and arthralgias (esp in hips). Felt better the evening of 1/22/21. Had a positive COVID test following an exposure in December.
Experienced chest heaviness and shortness of breath after exercise on June 12, 20201.  Discomfort continued. On June 15, I went and was found to have elevated levels of Troponin. I was taken in an ambulance to where they said I may have suffered a heart attack however there were no blockages found after repeated EKG, Echocardiogram, and cardiac cath procedure, and MRI with contrast.
1. Squiggly lines or floaters when looking upward; onset in May 2021.  2. reports multiple joint aches; bilateral knee aches with associated "locking and giving out."  3. Trouble trouble sleeping,  4. Frequent headaches with associated nausea, dizziness, and light/noise sensitivity 5. reports NEW ONSET decreased penile erection; onset in JUN 2021. states that erection "isn't full" and also notice "no morning erections" that he normally gets. states that symptoms are still ongoing.  states that he didn't have this issue prior to deployment. denies pain with urination or abnormal penile discharge.