chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an other health care professional, author of a literature article. Background: Vaccines represent the most effective measures in public health by controlling and preventing the spread of infectious disease. They, like all other drugs, had the potential to cause allergic reactions. Components that may be allergenic include the infectious agent, specific antigen, preservatives, stabilizers, residual media and contaminants that are introduced during handling. Reaction characteristics such as time of onset, and localized vs. systemic involvement, could vary. Objective: The authors described a case of allergic reactions after administration of vaccines. Case Report: A current 11 year old male patient developed respiratory distress, seizure-like stiffening, and a fever after administration of Dtap, Hib conj vaccine (unspecified carrier) and Polio at his 2 month visit. He was hospitalized for 5 days with an extensive negative work up. Two months after this event, the patient received the Polio vaccine and developed lethargy, a full body macular papular rash and fever immediately after administration. Three weeks later, when he was approximately 5 months old, he was hospitalized for respiratory distress, and fever following the Hepatitis B vaccine (manufacturer unspecified). Patient had not been vaccinated since these episodes. Currently, standardized testing for ingredients in vaccines was not available. Skin testing with the vaccine and physician supervised challenges was offered. Additional information is not expected.
This spontaneous report was received from a pharmacist, who is also the patient's mother, referring to her daughter, a child female patient of unknown age. No information was provided regarding the patient's medical drug and allergy history, concurrent conditions or concomitant therapies. On unknown dates, the patient was vaccinated with PNEUMOVAX 23 and with PREVNAR 13 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis; every 2 years; at age 2 years, 4 years, and 6 years, for both vaccines. The reporter stated that the patient had received 3 doses of both vaccines so far. The patient, had had "no antibodies to pneumococcal disease" since an unspecified age (it was unable to clarify whether this issue had been present since birth), which was detected by a bloodwork on an unknown date. As a result, the patient had been vaccinated using the schedule mentioned above. Then, the patient had an additional bloodwork on an unknown date, which showed that he still had not developed "antibodies to pneumococcal disease". It was unknown how many doses were administered when the bloodwork was drawn and how many times the bloodwork had been done since initiation of vaccination. The outcome of the patient for no antibodies to pneumococcal disease was unknown and the causality assessment between PNEUMOVAX 23 and the event was unknown. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1710USA001713.
Pain and swelling at the injection site, approximately 36 hours' duration after onset.  Nausea and diarrhea, approximately 18 hours' duration after onset.
So, I had my first shot around the beginning of July.  I was just lethargic after the first shot but right before the 2nd shot I noticed a lump in my breast.  I had decided to tell my doctor about it and we wound up doing a 3-D Mammogram and US.  I went ahead and had my 2nd shot as I was encouraged by the CDC to do so.  I had the second shot and we did the mammogram and US and it turned out that I had an enlarged lymph node.  Also, about 12 hours after my second shot my finger tips became numb and I had trouble feeling them and I thought my circulation was being cut off from my fingers.  It was the strangest feeling.  That plus the lymph node situation...and to top it off, my period was all messed up as it didn't come for 36 days and then it came literally 10 days apart.
Rash on the chest Sores on hands, Red cuticles, Redness under fingers on both hands Rash spreads to chest, neck, face and nose Hurts to open and close hands Joint pain/ Muscle pain/ Stiffness Weakness Fatigue Pain in the back of the head Swelling Pain on feet, hurts to walk Swollen knees/ stiffness Rash spreads to back, stomach and ears and more  Treatment-Predisone 2 different times Hydroxychlororoqine Famotidine Meloxicam Loratadine
Tinnitus in my right ear.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731 ) via an unspecified route of administration in Arm Left on 20Apr2021 at 17:45 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included healthy, no chronic health issue. The patient previously took pseudoephedrine and experienced drug hypersensitivity, BNT162B2 (lot number: ER8727) on 27Mar2021 at 17:00 pm for covid-19 immunisation. Concomitant medication(s) included finasteride (FINASTERIDE), ascorbic acid, bifidobacterium animalis, biotin, calcium pantothenate, calcium phosphate dibasic, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, magnesium stearate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium selenate, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM MULTI + PROBIOTICS), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient received Finasteride 1mg, Vitamin C 500mg, Centrum Multi within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID. The patient experienced tinnitus in my right ear on 24Apr2021, 19:00 PM, four days after vaccination. It was a fluctuating multi-tone ringing that has persisted 24hrs a day since 24Apr2021 and still continued. and saw an ENT doctor as noted for a diagnosis. No treatment was given other than rest and limit noise to the right ear and be patient. If the symptoms do not resolve in 2 more weeks, the next option is Prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Treatment was not received for the event. The outcome of tinnitus in my right ear was not recovered.  No follow-up attempts are needed. No further information is expected.
I was sick for about two weeks after receiving the vaccine. I had bad headaches, hot flashes and just felt bad. I tested positive for COVID-19 on 11/3/2022. I contacted my doctor, and I was given a prescription for prednisone because I had a terrible time breathing. I recently saw my doctor because my fibromyalgia is worse after the last vaccine. I was taken CYMBALTA and my doctor increased the doses and prednisone.
Sore arm at injection sight begging about 4 hours after injection continuing till day 3, Diarrhea beginning day 3 about 4:30 Am continuing into the afternoon. Diarrhea not severe, but prevented me from leaving the house to perform scheduled activities.
around 1600 , pt reports starting to feel ill. fever, severe arm pain. was advised by pharmacist to take ibuprofen and rest arm so painful, unable to sleep last night or lift arm above head advised by this RN to apply ice and diclofenac cream and rest
Pt went to ED Did not stay - walked out. Reported hives earlier in the day & dry throat, stated she could not move her arm - RN stated in no acute distress next day pt C/O swelling, redness & pain
pt recv vax 22MAY97 & a serology test revealed a titer of <20 indicating a lack of seroconversion;
Patient fell to the floor from a sitting position after becoming dizzy 3 minutes following injections.  Did not lose consciousness.  Stated she felt nauseous.  Was nervous for injection.  Reported not eating much for breakfast.  Mom states long history of getting anxious for a variety of issues.  BP (92/62) and pulse (81) WNL.  Patient waited at clinic for 15 minutes and stated she felt fine to leave.
Seizure with fever, 10-12 hours after PCV 7 given. Lasted around 1 min. Generalized nonfocal. Medical Record received on 1/3/2005 states pharyngitis and otitis media.
At approximately 4:30am the morning after she received the second Pfizer dose, my daughter woke up with uncontrollable chills, fever and pain. She couldn't warm up. Her father picked her up from the dorm at approximately 6:30 am. She took fever lowering medicine and took a hot bath and still had chills. She then got in bed and laid under an electric blanket on high and finally fell back asleep. She woke up sweaty and feeling terrible with a sore throat, pain and fatigue. The fever and chills started back up again that afternoon. I also gave her aspirin as recommended. Various flulike symptoms dragged on for a week. She felt better for a few days the following week, then chills, low grade fever, lethargy and coughing started up again. She was affected for another week and into a third. During this time she visited our family practitioner, received the obligatory Covid test, negative. Doctor said her left ear looked red and also her throat had signs of inflammation. She was prescribed a three day dose anti-biotic, which did not help. My daughter also visited her health clinic, had her finger pricked and tested for flu, mono, anemia and Covid, all negative. They recommend more extensive bloodwork which she neglected to do and by the third week had recovered then within a week caught a cold.
After taking it got shingles twice/ Suspected vaccination failure; Got shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After taking it got shingles twice/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter reported that he or she sat at the table at the wedding as three peoples shared as they all received Shingles vaccine. The reporter stated that after received Shingles vaccine the patient experienced Shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR082619:same patient/same event
Crying for multiple hours, extreme swollen arm that?s stiff to the touch, itching, uncomfortable, pain
Red water eyes, dry cough, chills w/o fever body aches 6 hours after receiving flu shot 11/01/06. All symptoms resolved approx 9 hours later.
Passed out; Her lips were white; Slept all day and night; Fatigue; This is a spontaneous report from a contactable consumer (patient's mother)   A 15-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 11Sep2021 at 14:00 (Lot Number: 301358A), at the age of 15 years old, as 2nd single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. There were no prior vaccinations within 4 weeks of the BNT162b2 vaccination. Past drug vaccinations included the 1st BNT162b2 single dose (Lot: FA6780) administered on 22Jul2021 at about 10 am, in the left arm. The patient's mother stated that at 11am on 12Sep2021 her daughter woke up and came downstairs, then she saw stars and passed out. This lasted about a minute and then she came too, her lips were white when this happened. She was a lot better at the time of the reporting but after the passing out she slept all day and night. The reporter tried to wake her up to check on her but she kept sleeping. The patient also had fatigue on 12Sep2021 that at the time of the reporting was not all the way gone but the patient was better. The patient was treated with rest and liquids. The patient recovered from passing out and sleeping all day on 12Sep2021. The patient was recovering from fatigue. The outcome for pale lips was not specified. There was no need for a visit to Emergency Room, neither at the physician's office. According to the reporter the events were considered non-serious.   Follow-up attempts are completed. No further information is expected.
Information has been received from an RN concerning a female pt who on 10/08/1999 was vaccinated with pneumococcal vaccine 23 polyvalent and on 10/18/1999, the pt experienced redness and pain of the arm that extended to the armpit. She was seen by a physician. She was given antibiotics and recovered. No further information is available.
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal.  Thought I was on the road to recovery when the arm pain started to increase.  No rash or swelling occurred at the sight.  It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers.  On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on.  My right arm remains painful to move with nerve issues.  The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
itchy red rash on upper left arm distal to where shot was injected. rash is raised and hot to touch. 4inches by 3 inches around. oval shaped.  noticed morning of 11Nov2021.
Redness, Swelling, at deltoid that began the next day with pain rated 2 on 1-10 scale. Pain, redness, and swelling extended from deltoid down to elbow and lasted 5 days before resolution.
Deep Venous Thrombosis; This spontaneous report was received from literature: Journal. This report concerned a 21 year old male. The objective of this study was Deep Venous Thrombosis after Ad26.COV2.S Vaccination in Adult Male.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 in Total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On initial evaluation, patient was noted to have mild erythema and edema of the left leg with circumferential diameter 40 centimeter comparative to 38 centimeter of the right leg. The patient was recommended to follow supportive care with conservative approach and discharged home. A day later, patient presented to the emergency department with worsening swelling of the left leg. On examination, left lower extremity edema was consistent with prior exam with new skin changes concerning for phlegmasia ceruleaolens. Lower extremity duplex showed absent blood flow in the left common femoral, profundal femoral, femoral, and calf veins due to occluding thrombus visualized from the iliac, femoral, popliteal to the left posterior tibial, and peroneal vein. Complete blood count including platelet count was normal. Coagulation panel included an elevated INR (international normalized ratio) at 14.3, PTT (Partial Thromboplastin Time) at 120 sec, and decreased fibrinogen at 172 mg/dl. Patient was noted to be negative for heparin-dependent platelet antibody (PF4) enzyme-linked immune sorbent assay (ELISA) IgA/M/G and serotonin release assay. Patient also received hypercoagulable workup for Factor V Leiden mutation, Prothrombin gene, serum homocysteine, anti-phospholipid antibody panel, antithrombin III activity, and protein C and S activity which were all unremarkable for underlying hypercoagulable etiology. The patient required left lower extremity venography with pharmacomechanical thrombolysis/thrombectomy with venous thrombolysis and placement of 16 millimeter by 100 millimeter left common iliac venous stent. Patient was maintained on direct thrombin inhibitor with argatroban, which was transitioned to oral apixaban upon discharge from the hospital. Venous duplex in one week is to be repeated. The patient was hospitalized on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep venous thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211039977-COVID-19 VACCINE AD26.COV2.S-Deep venous thrombosis.  This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Incorrect vaccine given.  Monovalent was given instead of the Bivalent booster as requested.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked.
Pt recvd vax 12FEB93 & showed inc levels of SGPT & SGOT but pt was asymptomatic;
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored  VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Injection site started off a little red and swollen; Injection site started off a little red and swollen; My entire upper arm is bright right and swollen with a burning itch sensation; My entire upper arm is bright right and swollen with a burning itch sensation; My entire upper arm is bright right and swollen with a burning itch sensation; This is a spontaneous report received from a contactable other healthcare professional (patient reported for herself). A 24-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route of administration on 06Mar2021 09:15 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient not had Known allergies. Patient received vaccine facility in hospital. The patient experienced Injection site started off a little red and swollen. Patient on day 4 post shot and almost my entire upper arm is bright right and swollen with a burning itch sensation on 07Mar2021. The outcome of the events was reported as not recovered.  No follow up attempts are possible, information on Lot/batch number cannot be obtained.
Pt. experienced syncope. Called 911. Pt. had low BP, low blood sugar, and abdominal pain. Paramedics were going to take her to hospital but pt declined and had a friend pick her up. Afterward she said she passed out before with shot.
Developed BAD vertigo (not normal for med) At aprox 9 PM day after shot. From 11PM- next day noon it moderated somewhat, but I still had to touch the wall without falling.  This is not normal for me. Been ok since around noon last week Sunday.  My doctor is aware of the situation. He didn't feel it was serious. We corresponded by telehealth; NOT visit.
fever; headache; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), ATORVASTATIN CALCIUM (LIPITOR) and FINASTERIDE for an unknown indication.   On 14-Apr-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) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
After 12 hours of the vaccine on 7/23 he started exp chest discomfort, heavy breathing and felt feverish. The next day on 7/24 he had aches and pain took Melatonin to sleep. As of today he is feeling better a little anxiety.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, SITE PAIN/SWELLING Narrative:
Suspect serum sickness-like syndrome after doses 2 and 3 of Moderna vaccine (given 2/4/2021 and 1/12/2022). On both occassions ~5d after had urticarial rash, fevers, chills. Send episode January 2022 had arthralgia and airway involvement.
Started bleeding profusely as if having period but an extreme version. It was 2 weeks prior to my scheduled period and my period is very regular and always arrives on time. Bleeding lasted for several days. I don't know if this will have lasting effects on my cycle or fertility going forward.
Watery diarrhea beginning several hours after administration, large volume of watery stools 2-3 times a day, continuing through today. No ill contacts. No fever, emesis or other symptoms. Exclusively breast fed.