chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got a ball like a golf ball as diameter at injection site/ I have got ball in my arm I have got a ball about the size of a tennis ball; Rash near elbow but not injection site; Fever; Feeling down kind of not feeling well; Fatigue, tiredness; Dizziness; Nausea; Aching for few days all over the body; Very achy; arm is sore; Aching for few days all over the body but still feeling it at the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer- sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunization. Historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization. Medical history included diabetes mellitus and obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got a ball like a golf ball as diameter at injection site/ i have got ball in my arm i have got a ball about the size of a tennis ball, rash near elbow but not injection site, fever, feeling down kind of not feeling well, fatigue, tiredness, dizziness, nausea, aching for few days all over the body, very achy, arm is sore, aching for few days all over the body but still feeling it at the injection site on an unspecified date. It was reported that, after received the 2nd dose she experienced injection site swelling about the size of a tennis ball, nausea, fatigue, fever and pain on the arm. Patient took it on Saturday and had got ball in her arm, got a ball like a golf ball as diameter at injection site and rash near elbow but not injection site. She was feeling still tired. After 4 days she had got a ball about the size of a tennis ball. It has not gone down. It was hot. Her arm was sore and she was still very achy and very fatigue. She asked if that was normal for this shot and could she have this reaction for this long. Also had fever for 1 day then it was ok also was feeling down kind of not feeling well. Added symptoms as fatigue, tiredness, dizziness, nausea, aching for few days all over the body but still felt it at the injection site. She enquired if rash, the ball on her injection site, the fatigue and not feeling well was normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia burning at injection site ,body aches, chills low grade temp 99.8 Narrative:
Pain on the left arm. Palpable submandibular nodes. Supraclavicular nodes. Muscle spasms. Everything on the left side.
Received shingles vaccine inoculation (Zostavax) on April 17, 2012. A week later (April 24th) I developed severe pain in the right ear, with shooting pain down the side of my neck. Since I am susceptible to ear pain from wind, I assumed that's what it was. The pain continued and I went to a walk in clinic April 26, was diagnosed with an ear infection, and provided antibiotics. On the evening of April 28th I noticed what looked like insect bites on the right arm. Since that day I was in a wooded area that day, I assumed these were bites. On April 30 the ear pain continued and I did see an ENT practitioner who said there was no ear infection, but possible TMJ. I showed him the welts on my arm (which had increased in number) and wondered if it was shingles; he said no. That evening and for the next two days, I developed pain in my right shoulder, elbow, and forearm. On May 2nd, I was finally able to see my family doctor who diagnoses this as shingles and prescribed anti-viral medication. The pain in my ear subsided to a few twinges, but the arm pain increased in intensity. I saw my doctor again on May 15th and he prescribed pain medication (Oxycondon) and Lidoderm Lidocaine 5% patches which I am currently using (as of May 21).  The intensity of the arm pain has not decreased and is limiting some of my daily functions and interferes with my sleeping. I assume this is the result of the shingles shot and am concerned how long these symptoms will last. However, I felt this should be reported to the CDC at this point, even though there is no resolution to the symptoms at this time.
This spontaneous report was received from a registered nurse referring to a 10 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA010085: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002523: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Vomiting and diarrhea started at 11:20pm on 3/25/21.  Vomiting subsided at 5:00am, diarrhea started at 6:00am. At present still with diarrhea.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patient were vaccinated with improperly stored doses OF PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
sore everywhere/quite achy; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills). At the time of the report, MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Acute transverse myelitis; This is a literature report. Case Description: A 76-year-old right handed previously independent male with history of hypertension, dyslipidemia and myoclonus, developed sudden onset left arm weakness and paresthesia, dizziness and imbalance 20 minutes after he received the second dose of COVID-19 vaccine (BNT162b2, Pfizer- BioNTech) in his left deltoid. By the time he presented to the acute care hospital, the weakness and paresthesia had progressed to the left lower extremity. Initial MRI brain and C-spine were unremarkable. Repeat MRI C-spine 4 days later revealed interval development of T2 hyperintensity and restricted diffusion of the spinal cord at C3-C4 suggestive of demyelinating transverse myelitis. The patient received 5 days of high-dose Solumedrol and 5 rounds of plasmapheresis during his 17-day acute hospital stay before discharge to inpatient rehab. Upon admission the patient described belt sensation around his waist, left side hemiparesis and significant trunk weakness. Sensation was intact to light touch throughout. Initial activity of daily living (ADL) and mobility evaluation revealed the patient was at a dependent level for dressing, maximal assist for bathing and toileting, moderate assist with oral hygiene, dependent with bed-to-chair transfer, and unable to walk or propel a wheelchair. Setting: Acute inpatient rehabilitation hospital. Case Diagnosis: Acute transverse myelitis.  Assessment/Results: After first 18 days of the total expected 28-day inpatient rehab hospital course, the patient gradually improved his functional status to moderate assist level for most ADLs, transfer and ambulation of 40 feet with a rolling walker. Discussion: This is the first reported case, to knowledge, of inpatient rehabilitation of a patient with acute myelitis that developed shortly after a full dose of BNT162b2 COVID-19 vaccination. Conclusion: Authors described a case of acute myelitis most likely secondary to COVID-19 vaccination with the BNT162b2 vaccine that caused severe functional impairment. The ongoing inpatient rehabilitation has helped the patient to slowly improve in strength, functions of ADL and mobility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the close temporal relationship and lack of any other possible etiology, the association between the event acute transverse myelitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a health care worker refers to about 25 patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reproter stated that on unspecified dates between improperly exposed to -10 degrees C for short (unspecified) time frames, and however the average temperature has been kept in the correct range of <-15 degrees C. It was also reported that about 25 patients received one of these vaccines (related case 1410USA004844) approximately on an unknown date in 2014 (reported as unspecified dates during this time frame of 26-SEP-2014 to 07-OCT-2014). No known adverse effects. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA004844 via same reporter link. Additional information has been requested.
Headache, body aches, stomach upset and abdominal pain, tired, generally felt unwell and was unable to do normal activities for entire day following the vaccination. Happened with both doses.
10 hours post injection, L arm began feeling sore, as expected. Normal night routine, went to bed at 12 a.m. 3: 30 a.m., I began feeling tingles  and heaviness throughout  my whole body,  extremely nauseated and needing to use the restroom. After using the restroom, I noticed I was extremely pale.  Thankfully my brother was awake, after calling for assistance,  he took my blood pressure and reported 80/40- very abnormal.  After 15-20 minutes, my BP started increasing and I started to feel better. Over all,  my BP dropping that low has never happened and I am scared to take my second dose.
Swollen armpit and chest across collar bone above breast. Redness/warm to touch.  Chills Headache Bodyache Inability to lift left arm
Experiencing headaches which are minor but recurring on a daily basis.  They are consistent.  Though minor and treatable using only Ibuprophen, aspirin or aceteminophen have no effect, they are annoying and concerned of long term because they are not going away.   Don't want to be taking Ibuprophen every day.  Did not have this problem prior to the vaccination.
Severe Orthostatic Hypotension anytime follow laying down or sitting for > 5 minutes severe requiring holding on to objects or sitting back down  with tunnelvision  that would pass after 1-2 mintues provided slowly getting back to upright positiion
Information has been received on 23-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-OCT-2016, the patient was treated by a medical group for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
The patient presented to her doctors office with nausea and vomiting. They drew labs and her liver enzymes were elevated, LDH was elevated and platelets were decreased.  She is 23 weeks pregnant at time of hospital admission on 10/16/17. Lab trends: 10/16, AST, 128, ALT, 106, LDH, 360, Platelets, 137; 10/17, AST, 457, ALT, 302, LDH, 873, Platelets, 51; 10/19, ALT, 368, Platelets, 61; 10/21, AST, 108, ALT, 194, Platelets, 125; 10/24, AST, 59, ALT, 132, Platelets, 187. By the time she was admitted Tuesday, she felt normal again but her labs were out of range. She was seen by a maternal fetal medicine specialist and consulted rheumatology. The diagnosis was HELLP syndrome vs. lupus/autoimmune flare vs. flu shot reaction. The patient was discharged 10/24 before I was able to talk with her regarding the location and type of flu shot given. She was given dexamethasone 10 mg IV Q12 hours for 48 hours then changed to oral prednisolone 30 mg oral daily.  Her labs continued to improve during the admission. She was to follow up with her home OB and rheumatologist this week with close lab follow up. At the beginning of the hospital stay, they were considering inducing labor due to possible HELLP syndrome. They did not have to do that as her labs and symptoms improved with the steroids.
Red, inflamed & itchy at injection site, lasted for a couple days, has gone down now.
My hair began to start snapping off on around 7/15/2021. As time went on there was gradual hair loss. On Sept 21st, I used a clarifying product on my hair and hundreds of hair fell out. The following day I went to my hair salon and stylist told me to see my family practitioner. I also went to immunologist on the same day and observed my hair loss, and said I needed to see a specialist after I was to see my PCP.  So went to my PCP on Sept 23rd.
Febrile seizure approximately 8 hours after receiving immunizations. Went to emergency room & discharged home.
Patient stayed in pharmacy for 10 minutes to be monitored, then while walking back to the car felt slightly dizzy. Patient's daughter was with her to drive her home. Then patient's daughter called pharmacy in about 2 hours to notify patient complains of "halo vision" and fatigue. Pharmacist told her to stay hydrated, monitor blood pressure, call PCP office or go to ER if symptom gets worse. Patient then call 4 hours after the vaccine reporting dizziness went away but her eyes are puffed up, similar to when she eats avocado that she's allergic to. She took the allergy pill (allegra) and feels better.
sudden onset lethargy, irritability, vomiting several times (3) w/in (2) hr p/receiving vax;advised to take APAP & Pedialyte x 24 hr;much improved by following day;
joint pain; Chills; Headache; Muscle pain; had a temp (fever); This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: A1284, expiration date: 30Apr2021, NDC number was unknown), via an unspecified route of administration at the left arm (by needle left arm one time) on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history included having Covid from 20Nov2020, headaches, and plasma transfusion on 26Nov2020. There were no concomitant medications. The patient reported that she had the COVID-19 vaccine on 05Jan2021 and on the following day had a really bad SE (a lot of them) and caller couldn't understand why she reacted that way. She supposed it was because of the 90 day wait after getting the COVID-19 infection. She also mentioned that she had plasma transfusion when she had COVID-19 prior to the vaccine. She had the vaccine after having Covid. She was tested positive for COVID-19 on 20Nov2020 and was on quarantine for almost 3 weeks in the hospital. She already tested negative for COVID-19 and is already getting back to work. She is scheduled for her second dose on 26Jan2021. The patient asked " If a person had COVID-19, do they have to wait 90 days before getting the vaccine?". The patient had a temp (fever) on 05Jan2021. The patient experienced joint pain, chills, headache, and muscle pain on 06Jan2021. The patient stated that she had the Pfizer vaccine and had side effects the following day. Stated that it was really bad. She wanted to know if she still takes second dose. Is for Covid. She stated that she got shot on 05 Jan2021 and reported that a nurse told her to wait 90 days because she had the plasma transfusion when she was in the hospital with Covid. The patient is supposed to get second dose 26Jan2021. The patient stated that they came to her job and gave them the shot from (pharmacy name). The patient stated that the temp and chills went away early morning on 07Jan2021 (as reported). She stated that the muscle and joint pain, chills ended hours later (as reported). Stated that 1-1.5 weeks after she recovered from Covid that she started getting headaches again but has not had them since. Captured as provided by the patient about the headaches during Covid diagnosis but prior to receiving the vaccine. The patient stated that she was quarantined three weeks for Covid. The patient underwent lab tests and procedures which included COVID-19test: positive on 20Nov2020, and COVID-19: negative on Dec2020.  The outcome of the events fever and headache was recovered on 07Jan2021. The outcome of the events joint pain, chills, and muscle pain was recovered on 06Jan2021. The report was reported as non-serious.
Patient seen in the emergency department on 6/2 for vomiting and weakness, tested positive for COVID-19 via PCR. He was admitted from 6/2-6/6. This meets criteria for vaccine breakthrough case review.
swollen rt arm up to side of rt breast; couldn't lift arm; redness down entire arm x3 days; 4 days later mobility returned to upper arm, swelling decreased; muscle in arm stiff, rigid & arm weak; swelling occurs in rt hand w/overuse of arm;
Vaccine stored under refrigeration beyond 30 days. Moderna lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint; I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint; I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint), PRODUCT ADMINISTRATION ERROR (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint) and INTERCHANGE OF VACCINE PRODUCTS (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .1 ml. On 22-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint), PRODUCT ADMINISTRATION ERROR (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint) and INTERCHANGE OF VACCINE PRODUCTS (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint). On 22-May-2021, ACCIDENTAL UNDERDOSE (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint), PRODUCT ADMINISTRATION ERROR (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint) and INTERCHANGE OF VACCINE PRODUCTS (I gave 0.1 ml of Moderna Covid-19 vaccine to a patient and when i realized, I withdrew and administered the Pfizer Covid-19 injection to the left deltoid of pateint) had resolved.        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.   No concomitant drugs provided.  No treatment drugs provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Case VAERS from Pfizer On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
85 recruits were vaxed w/Td & Yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was prev exp;
Increased redness and warmth medial aspect of left arm, redness started on Tuesday.  Wednesday tactile fever ,chills and fatigue, are of redness 50% of upper arm