chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a rash at ankle, about the size of a quarter/On the back of right thigh, a much bigger rash, small raise, red dots/Rash looks like the rash people were getting from COVID itself; observed a small red raised bumps- rash on her  ankle, legs and back thigh; CP is concerned that she might have problems in blood clotting; felt some prickling sensation on this area/Pricking sensation in ankle; This is a spontaneous report from a contactable consumer or other non hcp.   A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP7534) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient's medical history included mast cell activation syndrome from 2018: Mast cell activation syndrome, gastrointestinal bacterial overgrowth from 2019 to an unknown date Verbatim: Small intestinal bacterial overgrowth, methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing Verbatim: Genetic Mutation (MTHFR). The patient's concomitant medications included gabapentin; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ciclosporin (CEQUA); naltrexone (NALTREXONE); duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 after her first dose of vaccine about 10 hours later, the patient observed a small red raised bumps- rash on her  ankle, legs and back thigh. She also felt some prickling sensation on this area, we are cancelling it, 15Apr2021 but the patient cancelling it, developed a rash at ankle, about the size of a quarter/on the back of right thigh, a much bigger rash, small raise, red dots/rash looks like the rash people were getting from covid itself, observed a small red raised bumps- rash on her ankle, legs and back thigh, cp was concerned that the patient might have problems in blood clotting, felt some prickling sensation on this area/pricking sensation in ankle on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included carbon dioxide increased was not too high ppm. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient developed a persistent sore arm after the vaccination that has not subsided since the vaccination - patient has managed pain with TYLENOL.
Sore arm at the site of injection, full body muscle aches and weakness the morning after injection, lingering headache, and fatigue
Please select any symptoms you are experiencing:  Cough  Difficulty breathing  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose
Significantly increased Autism symptoms and reemergence of symptoms that had not been seen in over a year: pacing, arm flapping, fits of anger, poor mood, inappropriate hand gestures, decreased attention. These symptoms began the day after the vaccination and have continued and increased in severity over the past 6 days. They have yet to resolve.
Immediately  I felt like I was shot in my left arm. However, 10 hours later, I had severe full body aches from the tips of my fingers to my toes. The only place I didn't ache was my face and nose; even my head ached. I also was freezing which was worse than chills. Chills come and go but this was constact.  I slept on and off for 36 hours and then it cleared up around mid-day on Monday as if a lightswitch was turned off. After that I developed a little bit of Covid arm with slight redness & hardness AWAY from the injection site about 3 inches down and the the right. That cleared up within a couple of days and I'm fine now.
2 Month Old Received Dose of Heplisav-B; Initial Report Received on 01-Mar-2022  A medical assistant reported that a 2-month-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 01-Mar-2022, the 2-month-old patient received a dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022, and NDC # 43528-003-05) in the left upper thigh by the medical assistant (reporter). No adverse reactions have been reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient had redness and swelling at the injection site. It is still present after 6 days. I advised patient to see a doctor if it does not improve.
INTERMITTENT HEADACHES, BACK OF HEAD. DEVELOPED (TESTED POSITIVE) COVID-19 12/7/2020, TESTED NEGATIVE 12/20/2020.
Initial report received from Consumer on 01 December 2014. A 67-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in the left deltoid on 02 October 2014. On 03 October 2014, the patient had experienced muscle soreness in left arm, constant pain from the shoulder to the wrist, tired, weak and increased pain with any arm movement, pain gets worse at night. The patient had no laboratory investigations and corrective were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects reported as none. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none.
Pt vaccinated with DTP had difficulty breathing, became pale, fever, limp, blood pressure dropped. Hospitalized for hypotonic-hyporesponsive episode. Treate w/IV bolus of D5W 1/4 NS followed by IV drip. Placed on monitor; Given oxygen.
Father admitted that he lied about daughter's age in order to get child vaccinated before school starts. Patient is still 11 year old
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, lot # K026533, expiration date- 07-AUG-2017 and lot # L012838, expiration date- 10-MAR-2018. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
presents to ED this morning due to shortness of breath. He was diagnosed with COVID-19 infection earlier this week, with symptom onset originally on 9/24. He has been dealing with shortness of breath during the course of his infection, but overnight he awoke due to his symptoms, stating that he "felt like he was drowning". He also complains of a nonproductive cough and diffuse chest pain.
Received H1N1 FLUMIST sat with supervision 20 minutes then started walking back to class. Pt fainted in the hallway, stated he felt dizzy and lowered himself to the floor. Pt found face down on floor. Alert but lethargic and slow to respond to questions. 911 called by teacher. Discharged home from ER at 11:04
Left arm pain / Pain which radiates from the neck to down her arm; Knot at the sight of the injection of the Shingrix vaccine / bubble due to the vaccine; headache; Feeling of having the flu; Pain which radiates from the neck to down her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR230419). Concurrent medical conditions included hashimoto's disease.   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Shingrix, 10 days after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting ibuprofen, the patient experienced pain in arm, injection site induration, headache, influenza-like symptoms and neck pain. The patient was treated with ibuprofen, muscle relaxants (Muscle Relaxant) and gabapentin (Neurotin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain were unknown.   Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingric and few days later received a flu vaccine both vaccines were in the left arm and about days later she started to have left arm pain and she has a knot at the sight of the injection of the Shingrix vaccine.  The patient describes the left arm pain which radiates from the neck to down her arm.  The patient had headache and the feeling of having the flu, which resolved.  The HCP initially started her on an ibuprofen and then muscle relaxant for the arm pain, which did not help.  The customer had ultrasound done to check if there was a bubble due to the vaccine and no significant finding was noted.  The customer was asked to do physical therapy and the physcial therapy increased her left arm pain and was started on Neurotin.  The patient received the Shingrix vaccine at the pharmacy and received the flu vaccine from the HCP office. The reporter consented to follow up.  It was unknown if the reporter considered the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228597:same reporter US-GLAXOSMITHKLINE-US2020AMR230419:same reporter
Took one unrefrigerated dose of Vivotif; Spontaneous report received on 09MAR2020.  A male consumer reported that he "took one unrefrigerated dose of Vivotif" (PT: Product storage error) for immunisation. On an unknown date, the consumer took one unrefrigerated Vivotif (lot number unavailable) capsule that was unrefrigerated since it was dispensed. He was prescribed a new regimen of Vivotif but would not be able to complete that according to the recommended schedule because he will be travelling on 16MAR2020. It was reported that he had not administered any doses from the new regimen. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took one unrefrigerated dose of Vivotif (Product storage error). The consumer did not refrigerate the Vivotif since it was dispensed, and the consumer has been prescribed with a new regimen. However, the consumer did not start the new regimen as he would not be able to complete the Vivotif course before his travel date. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took one unrefrigerated dose of Vivotif (Product storage error). The consumer did not refrigerate the Vivotif since it was dispensed, and the consumer has been prescribed with a new regimen. However, the consumer did not start the new regimen as he would not be able to complete the Vivotif course before his travel date. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt reported symptoms of erythema, swelling and a rash 5 days after vaccination - lasting for 3 days in total.  Resolution was uneventful
pt began to have fever 23SEp93 99 ax-treated w/APAP-ran 99 thru 24SEP93; 630PM 24SEP93 temp rose to 102 ax approx 8PM  pt began to have sz activity; temp later 104.4 ear probe;
Injection site became more sore a week to 9 days after vaccine.  Arm was red and swollen about 6 inches down and 4 inches wide.  After 2 days of observing it, it was no better so I went to urgent care to get it checked 01/16.
Nausea and vomiting beginning approximately 12 hours post injection, lasting approximately 2 hours Severe headache beginning approximately 12 hours post injection, lasting approximately 24 hours Fever of up to 101.7 beginning unknown time post injection, intermittent, lasting approximately 72 hours "COVID Arm" beginning about 12 hours post injection and continuing through today (5 days) Itching, rash, slight swelling, slight heat. Confined to upper arm, primarily between injection site and elbow.
pt recvd vax; exp uncontrollable shaking & a rectal T of 106; seen in ofc; presented w/ fever of 105.7;exp several shaking during ofc visit; tx w/ motrin-recovered
Leg cramps in left leg and calf, Headache that lasts all day, cramps, and red splotches around injection site. Shortness of breath at times.  Legs are tired and painful at times.
pt recv vax 9AM by 12PM swelling around site w/soreness in the evening swelling increased & redness all the way up lt arm to below collar bone;also swollen lymph node lt neck;PMD recommended alternating heat/ice & advil;no diphtheria future
bones hurt; feels really sick; 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 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "bones hurt"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "feels really sick". Additional information: Caller reported having Covid before, said they had it was bad and felt really sick. Received dose yesterday, and says their bones hurt and feels really sick. Asked if needed second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Morning after: chills, nausea, aches, chest pressure, cough. That cleared after two days, but cough/pressure remained. Got worse, thought it was post-nasal drip, went to ENT, who prescribed CLARITIN and ASMANEX and FLONASE. After two weeks, worse, plus a feeling of inflammation throughout body (throat, chest, pressure on top of abdomen, bloating lower abdomen, hemorrhoids). Referred to pulmonologist, put on antibiotics (2 courses of azithromycin); still bad, put on prednisone; as soon as I went off prednisone (twice), had bad episodes where I felt a ton pressure weighing down on chest and as though airway closing up. Back on prednisone, also put on nebulizer and now weaning off prednisone while nebulizing albuterol and budesonide. Still have days where pressure and inflammation rises, but have had a couple decent days where it felt like something had cleared.
24 hours after vaccine oesophageal discomfort. Hunger spasms, improved with eating.
This patient had severe generalized fatigue, pain, numbness at many areas of her body; chronic muscle spasms, soft tissue swelling. Diagnosed with fibromyalgia / CFS. The 60 day follow-up states fibromyalgia and chronic fatigue. Per doc 214743, chronic muscle pain, fatigue, disabled, unable to move now for 2 years patient was able to work before. The follow up received on 6/13/01 states, "the pt basically has the same complaints she had last time she was in. Unfortunately, other than for the sleep study and neurologic evaluation by Dr, none of the tests that were ordered at hospital were actually performed. The pt still has chronic fatigue as well as numerous musculoskeletal type pain, most notably in the neck and back. She still has trouble swallowing from time to time, however, she does not wish to undergo work up for this at this time. She has not had fever or headaches. She claims there is some element of depression, although she feels this is probably due to the way she feels. Impression: fibromyalgia, history of thyroid nodule, dysphagia, diffuse back pain most notably affecting the C-spine secondary to fibromyalgia/? concomitant degenerative joint disease or other etiology, allergic rhinitis, status post ablation of accessory pathway for Parkinson-White syndrome, menorrhagia/anemia/stopped iron due to gastirc upset, hypotension on the past couple of visits. Endocrinologic evaluation was recommended to rule out adrenocortical insufficiency. Plan: previously recommende tests will once again be ordered. Encocrinologic evaluation is once again recommended. Check labs. Begin Desipramine 1/2 of 25mg tablet qhs for a week and then 25mg tablet qhs thereafter. Reevaluate in a few weeks or prn." Missing vaccine informaton not available. Follow up: patient states she is permanently disabled, unable to work.  Still with symptoms of severe fatigue, and generalized body pain and numbness, mostly on left side of her body.
Covid shot 2/2, on 2/13 chest itch, on 2/14 chest arm back rash & itch. Appears to be 'like' Shingles, had shingles +- 2005, and shingles vaccine +- 2014
PT went to ED for fever 103. Blood culture drawn - positive for strep pneumo. Culture to state lab for grouping. Vax failure.
Patient admitted as inpatient on 11/28/21 due to COVID-19. Patient was tested for COVID-19 and was positive on 11/22/21 at outside facility. Severe iron deficiency anemia due to chronic blood loss.
I woke up with four nodules under my armpit and they were of different sizes; They were painful and one was almost the size of golf ball; This is a spontaneous report received from a contactable consumer (reporting on herself). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, lot number: EL9266 and Expiry date was not reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunization. Medical history included , hypothyroidism, blood cholesterol increased both from an un-known date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, and Some statin for High cholesterol both start and stop date were not reported. The historical vaccine includes first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization. Patient got her second Pfizer Covid vaccine on (Tuesday) 16Feb2021. On 17Feb2021 (Wednesday) she went to get mammogram and Wednesday night she woke up with four nodules under her armpit and they were of different sizes. They were painful and one was almost the size of golf ball and today she got another one. Could be please tell because her doctor was not been here due to storm so she couldn't call her. So my question was to you how long is that going to last and is that typical. Patient did lab work. It was just a high cholesterol. It was routine done week before but she don't remember what it was, it was just regular blood work. The outcome of the event was not recovered.
PENTACEL was ordered. When drawing up the vaccine, I used standard diluent to mix the vaccine instead of the PENTACEL solution. Therefore, patient didn't receive all components of the PENTACEL vaccine. No adverse reactions noted.
No adverse reactions reported In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
A patient received his vaccine and went over to sit in the waiting area.  A few minutes after receiving the vaccine the patient called me over to let me know he was feeling dizzy and felt like he was going to pass out.  I was able to have him lay on the floor and elevate his feet.  He was visibly sweating.  I got him an ice pack and put it on his forehead.  He never ended up losing conciousness and felt better after laying down for 5 min or so.  He eventually sat back up and stayed in the waiting area for a while longer to be monitored.  He eventually felt fine and went home.
I was pregnant when I received the first dose of the vaccination. I started to have cramping and bleeding and was determined that I went into early labor around 8/29/2021. I stayed in the hospital until I gave birth. My estimated due date was 12/7/2021 which was consistent with all pregnancy imaging/ ultrasounds/ testing.
Information has been received from a reporter concerning a 19 year old female with no medical history or drug reactions/allergies who in approximately 2007 (2-3 years ago) was vaccinated with GARDASIL (lot# not reported). There was no concomitant medication. It was reported that the vaccine did not work because in July 2010 the patient experienced contracted the HPV virus. Unspecified medical attention was sought. HPV testing and biopsies were performed. At the time of the report the patient had not recovered. No further information is available.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (exact dose, route, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp breakthrough varicella w/more than 50 lesions disseminated over entire body;pt sought unspecified medical attention;
Narrative: Per PCP note: pt reportshis bp increased after his first shot. Hed had the second vaccine (6/2021) and his bp again increased. a wk later he noted brain fog(couldnot remember thing), he noted chest pain w/ walking or exercise, some sob. this occured until maybe two mos ago.
2nd dose administered out a vail that was thawed more than 30 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered out a vail that was thawed more than 30 days.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered out a vail that was thawed more than 30 days.). On 01-Jul-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered out a vail that was thawed more than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.